The Fda’s 21 Cfr Part 11 Regulation Welcomes an Online, Electronic Quality System

June 22nd, 2009
Marci Lynn Crane asked:


If you’ve dealt with a paper based quality system or even with a hybrid quality system, an online, centralized, electronically regulated quality system probably sounds like something akin to Nirvana, which probably isn’t far from the truth…at least as far as quality systems go!

The FDA Agrees

The FDA too finds electronic quality systems (especially during audits) to be far more effective and efficient. Electronic submissions for pharmaceuticals and clinics are also far more effective—for everyone. The FDA however is still “on the job” and has worked to develop appurtenant regulations for electronic quality systems.

21 CFR Part 11

Simply put, regulation 21 CFR Part 11 (1997) allows companies to utilize electronic archiving systems and accepts electronic signatures as valid. This FDA decision was a landmark one since it essentially takes manual quality systems and “okays” their virtual counterparts which as most professionals are aware are far more effective.

Which online quality system will suit your company best?

Even though you know (and the FDA knows) that electronic quality systems are more effective than paper-based or hybrid systems, it can still be a difficult enterprise trying to find the best quality system for your company. However, Regulation 21 CFR Part 11 can act as a guide for your quality system shopping spree.

21 CFR Part 11 Requirements

Take a look at the following 21 CFR Part 11 requirements and determine whether or not your potential quality systems are performing up to standard.

Part 11 Section 11.101

In Part 11 Section 11.10 it is apparent that the control of documentation is essential for the quality system that you decide to invest in. The section emphasizes “ensur[ed] authenticity, integrity, and when appropriate confidentiality of electronic records.” In other words, look for a quality system that will manage documents but not just your quality documents; look for a system that will manage any company document including any documents associated with regulatory compliance.

Part 11 Section 11.102

In Part 11 Section 11.10, the “minimiz[ation] [or the] possibility of repudiation by signer,” is required. In other words, look for a quality system that makes sure your process isn’t going to end up in production just to end up going backwards in a chain of failed quality. Look for a quality system that can set up customized routes of approval and make sure that the quality system also provides solid protection against unauthorized user break-ins (look for SQL protection for instance).

Part 11 Section 11.10a3

In Part 11 Section 11.10a it becomes apparent that validation is important to the FDA and rightly so. Make sure to look for a quality system that provides validation services. If a company provides validation services for their own software solutions, chances are they know valuable OQ, IQ, etc. procedures backwards and forwards.

Part 11 Section 11.10 i4

Part 11 Section 11.10i requires that training has taken place for all persons who utilize the quality system. The FDA needs to know if regulated company employees are capable of doing what they say they can do. Look for a quality system that provides training management and training control. Perhaps you thought such “an animal” didn’t exist. Think again! Many quality and compliance tasks, responsibilities and procedures can now be integrated into unified and streamlined processes. Look for a quality system that can grow and that already has plenty of options for your company’s needs.

When all is said and done, finding a quality system seems essential when you factor in today’s regulatory and “demand-for-quality” expectations. Search for the quality system that fits the characteristics mentioned above and you’ll have found a quality system worth considering.

1-4 mastercontrol.com/regulations/part11.html



5 Reasons Medical Device Companies Should Automate Their Quality Systems

June 19th, 2009
Marci Lynn Crane asked:


Medical device companies manage their respective quality systems not with the goal of “staying busy” but with the ideal of producing high-quality, innovative products that don’t jettison a trail of product recalls and process deviations along the way. Every medical device designer, manufacturer or quality control representative would likely agree that medical device companies should standardize a process that gives birth to high quality products and simultaneously attacks every deviation, nonconformance or customer complaint with the speed and vigor of Spartan warriors.

Simple enough?

It would seem so but even with all the combined brain talent of designers, manufacturers and quality control personnel this ideal bionic process still seems like nothing more than a medical device nirvana. In fact, current quality system management habits within most medical device companies emulate Isaac Newton’s first law by remaining “in a state of uniform motion…unless an external force is applied…”1

The External Force for Medical Device Quality Systems

The external force that should be applied to most medical device quality systems is the force that is inevitably required by almost every industry. That force is technology. The right technology can help medical device companies create the streamlined and automated quality system processes that WON’T vary under any circumstances unless confirmed and logical data points to evidence-based deviations, nonconformances, customer complaints, etc.

That’s one reason for medical device companies to start automating their quality systems with the right quality system management technology. Listed below are 4 more:

#2: The FDA is Moving along the Automation Pathway

Let’s face it. The FDA rules the U.S. regulatory roost and every medical device company that wants to produce or sell products in the U.S. has to conform to its quality system regulations. Conforming with FDA regulations becomes easier when FDA requirements are duly anticipated by medical device companies. For example, a recent FDA News bulletin states that, “FDA-mandated electronic Medical Device Reporting (eMDR) could happen in a soon as 18 months,” which means that medical device submissions will soon have to be submitted electronically and medical device submissions are far easier to submit electronically when they are consistently managed electronically with an automated quality system solution.

#3: Decrease Quality System Breakdowns

George Bernard Shaw once said that “The problem with communication … is the illusion that it has been accomplished.”3 The illusion that information is being communicated or that employee morale is “fine” is often the sign of communication breakdown. Communication breakdowns are catalyzed by tedious paper-based routing procedures, capsulated quality processes that disconnect product lifecycles, customer complaints that never reach the investigations department, approvals that are too numerous to complete quickly, possible deviations that can’t be backed with proof, etc., etc.

Once medical device companies automate document control, information routing, approvals, quality data connections (customer complaints to CAPA investigations, etc.) and provide tracking and reporting features that help readily identify deviations and nonconformances, REAL communication suddenly engenders results—not illusions.

#4: Uniting Quality Systems Across Geographic Barriers

When a medical device company begins to expand or continues to do so, automated software that is web-based becomes the pot of gold at the end of the rainbow. Web-based solutions for instance allow companies to expand on a national or global level and still stay abreast of salient information. Medical device companies (depending on their current situations) are also likely to benefit from a software provider that allows medical device companies to select from various networking options (shared licences, EFP replication, etc.).

#5: Help Make Quality an Aspect of Every Department

For many medical device companies, quality system management is in the hands of the quality control team. Although this establishment of responsibility has worked in the past, quality system management now must move faster and more efficiently to meet increased demands for quality products. The truth is that much of a quality system can be managed bit by bit and employee by employee when training is automated and a quality management system (plus associated information) is available quickly for the right employees in the right departments.

Medical device companies also need to search for a training software solution that can be automatically triggered by essential document changes and that can control GLP, GCP and GMP training tasks (plus other training tasks) across a company wide spectrum.

Curt Porritt, VP of Marketing at MasterControl says the following in his article entitled Adopting Technology in the Life Science Industry: Why Is It Taking So Long? states and paraphrases the following:

“…according to Life Science Insights, an IDC company, over 60% of survey respondents cited GMP/GCP/GLP processes as the main driver for increased IT spending. In this same survey, 62% of respondents said they intended to spend more on electronic data integration tools. When asked why they intended to spend more, their main reasons (in the order cited) were: increased collaboration, regulatory compliance requirements, reduced time for one or more processes, and reduced costs for one or more processes.”5

Conclusion

Mary Collins, director of regulatory and industry relations for

Image Solutions Inc. says the following in regards to the implementation of electronic software solutions:

“No matter how you get started [implementing electronic solutions], you [must] get started now. Over the next 10 years, you will see the different regions of the world come closer together and harmonize more on electronic requirements, and, to some extent, their regulatory requirements.” 4

For medical device companies, the advice remains the same. Staying connected with quality system technology will help med device companies keep pace with changing quality system standards.

________________________________________

References

1 csep10.phys.utk.edu/astr161/lect/history/newton3laws.html (Retrieved Jan. 24, 2008)

2 FDA News email (Received Jan. 24, 2008)

3 wisdomquotes.com/cat_communication.html (Retrieved Jan. 24, 2008)

4 mastercontrol.com/newsletter/feature/adopting_technology_1007.html (Retrieved Jan. 24, 2008)

5 http://209.85.173.104/search?q=cache:4Vn3H0TV2O0J:www.parexel.com/pdfs/e-solutions%2520in%2520clinical%2520trials%2520-%2520R%26D%2520Directions%25207.07.pdf+E-Solutions+in+Clinical+Trials:+Digital+Dilemma+Michael+D.+Christel+pharmalive.com&hl=en&ct=clnk&cd=1&gl=us (Retrieved Jan. 24, 2008)



The Influence of Package on Quality Guarantee Period

June 8th, 2009
Tracy Bao asked:


Abstract: this article briefs on the relationship between barrier property of package materials and product quality guarantee period as well as the package cost; introduces principle of quality guarantee, testing items (transmission testing, sealing testing and aging testing) and the importance of comprehensive testing.

Keywords: quality guarantee period, remnant gas, barrier property and sealability

 

The most important function of package is to protect products. During the process of storage and transportation, products are often destroyed and influenced by various disadvantageous conditions and factors. However, this can be avoided and reduced by adopting suitable package.

The protective function of package realized by people in the initial period is its resistance to all or part of the impact and damage of external forces. Later it was discovered that package is able to prolong quality guarantee period of some products (for example, food, pharmaceuticals and chemicals). The research shows that quality deterioration is mainly caused by the content of certain kinds of gas within inner package. That is why controlling gas content of inner package can efficiently prolong the quality guarantee period of products, usually realized by using barrier property materials. For that reason, materials with barrier property have witnessed the rapidest development in recent years. Moreover, barrier property of materials becomes one of the most important testing items. 

1. Quality Guarantee Principle of Barrier Property Package

The specific content of inner gases within package can directly influence the quality of products; among which, oxygen gas and moisture have the most significant influence.

As is well known, oxygen gas exerts the biggest influence on food quality. Generally speaking, bacteria reproduction will cause food deterioration, and the content of oxygen gas in storage environment is one of the main factors of bacteria growth and reproduction.

In fact, it is not that the lower the content of oxygen gas is, the bigger extent that bacteria can be suppressed in growth and reproduction. This is because in environment of lower oxygen concentration, the growth and reproduction of some anaerobic bacteria will be accelerated. Therefore, only when oxygen content of inner package is controlled within a proper range can the quality guarantee period be effectively prolonged. Although fruits and vegetables are preserved with different principle, if barrier property is too good to the extent that proper breathing is hindered in the cause of storage and transportation, preservation period cannot be favorably prolonged. 

The content of moisture of packing environment can also influence product quality, especially to pharmaceutical and precise electronic components. Moisture is the medium of chemical reaction. On the one hand, the extremely big humidity can cause chemical to absorb moisture and subsequently result in deliquescence, dilution, decomposition, mildew, and distortion of drugs. On the other hand, the too small humidity will accelerate the efflorescence of medicines. Medicine is a kind of special product, the quality of which must be secured within quality guarantee period. Therefore, materials with excellent barrier property must be used in their package.

The preservation of different products also varies in their requirements. For example, the content of carbon dioxide should be controlled in the packing of carbonic acid drink. Therefore, there are certain requirements for carbon dioxide transmission through such packing materials. When optimal preservation condition of product is determined according to their specific characteristics, corresponding packing method and packing materials can be selected to prolong quality guaranteed period of products to the maximum extent. In some cases where quality guarantee period is decided by market requirement, barrier property of material can be reversely calculated to design reasonable packaging structure so as to save packaging costs.

2. Barrier Property and Sealability

Generally speaking, the tests of barrier property and sealability are essential in evaluating barrier property of package materials and package structures.

Barrier property is said in connection with package material, with film and sheet as the main test objects. The thicker the material is, the better its barrier property. However, the increase of thickness will inevitably cause corresponding increase of package cost, follow-up transportation cost and preservation cost. Therefore, modified technology is usually employed to improve material barrier property while controlling package cost within an economical range. Multi-layer of film is one commonly used modified technology, which can be used to design material structure according to the required barrier property.

When design material structure, barrier property is only one of the factors to be considered. Other performances, like the diaphaneity, the heat sealability and so on should also be taken into consideration. At present, barrier property of materials can be tested using special barrier property testers, such as the differential-pressure method transmission testers for common gases of oxygen, nitrogen and carbon dioxide, etc, moisture transmission testers for moisture, the equal-pressure method gas transmission instruments for oxygen and carbon dioxide as well as the organic gas transmission instruments for organic gases with special odor.       

Test object of sealability test is the wrappage, such as container and plastic bags. Sealability test is an effective measure to test the effects of sealing place. It can also be used to test defects of seal effect of other places as well as the phenomenon of leakage or damage.

Both barrier property test and sealability test take gases as their test object. However, they vary significantly in their test range, with the former used for gas leakage in large quantity and the latter used to test gas transmission of micro content. Barrier property testing is carried out on the premise of flawless materials (to finished package, it means excellent integral sealability). Otherwise, there will be no significance.

3. Overall Test of Package Barrier Property and Processing of Remnant Gases

Gas environment of inner package mainly depends on two aspects: overall barrier property of package and the content of remnant gas after completion of package.

Overall barrier property of package is not equal to that of material. Barrier property of package which is made of high barrier property material is unnecessarily good. Sealing place of packaging bags and connecting place of bottle body and bottle cap are the weak points of overall barrier property of package, and are places easy to appear leakage. At present, the understanding of barrier property is rather one-sided. Material test is highly valued while importance of overall barrier property is not fully realized, which is related with the slow development of transmission instruments and its test methods. The TOY serial oxygen transmission instruments introduced by Labthink can perform oxygen transmission testing of film and package in required positions with excellent test results. Labthink has also realized the overall transmission testing of carbon dioxide.

Except vacuum package, there are certain remnant gases existing in inner package, which (especially oxygen) will impose influences on some sensitive products. That is why the processing of remnant gases becomes extremely important. Modified gas package and vacuum package are widely used in packages with high deoxygenation requirements. Moreover, adding deoxygenation elements in the packaging material can greatly increase oxygen barrier property of materials as well as absorb the remnant oxygen of inner package. Gas content (at present, only oxygen and carbon dioxide can be tested) of package top space can be tested with headspace analyzer. However, the test precision is not high and it is only used as an assistant test.

4. Other Test Items

Special attention should be paid to the aging of high polymer materials. Material aging is caused by aging element existing within polymer structure or polymer ingredient, such as unsaturated double bond, branched chain, carbonyl and terminal hydroxyl. Polymer aging, which needs to be tested by aging test, will result in the changing of physicochemical property. It is not desirable to determine the quality guarantee period of products with transmission data of material obtained in normal condition without aging test.

Labthink Instruments Co., Ltd.

No. 144 Wuyingshan Road, Jinan 250031, China

Tracy Bao  info@labthink.cn

Tel: 0086 531 85061153  fax:0086 531 85812140

 

 



After Testing with QTP or LoadRunner, Manage your tests with HP- Quality Center

June 6th, 2009
yogindernath asked:


Introduction to Quality Center:

Quality Center is a versatile tool brought out by HP, for managing the complete application testing process. When we say the management of the application testing process; it includes the process of customizing the test project, defining the releases, specifying requirements, planning of tests, execution of tests, tracking of defects, issuing of alerts on changes, and finally analyzing the results.

It should not be misunderstood as a tool for testing the functionality of the applications. Not being a testing tool as such, it does not use any scripting language. Or in other words, we can’t write or execute any script in Quality Center.

Quality center can be used to write functions in such way that enables us to open the Test script in a performance-testing tool like QuickTest Professional and when desired, we can save it in Quality center.

Key Features of Quality Center:

Following features render Quality Center as a most versatile test management tool.

1) Maintains a Common Repository

2) Offers Automatic Traceability Matrix

3) Excellent Bug Tracking facility

4) Offers Automatic Reports and Graphs generator

How to use the Quality Center:

Broadly we can bifurcate our process of using Quality Center into following four Modules or phases.

1) Requirements Module

2) Test Planning Module 

3) Test Execution Module

4) Defects Management Module 

1) Requirements Module:

It comprises of clear identification & validation of all functional and performance requirements expected to be tested in our application. These requirements, once described with ample clarity provide the test team a solid foundation on which the entire testing process is based. The process involves listing out the entire Primary or Main Requirements (Say MR1, MR2, Mr3 etc.) along-with sub-requirements or Child Requirements (Say CR1, CR2, CR3 etc.).

For the entire Requirement identified above, a Test is planned. For Manual Testing, the term “Test” refers to creation of a Test Case, while for an Automated Testing, the term “Test” refers to creation of a Test Script.

Requirements Module of Quality Center offers facility of defining two types of Requirements Like:

1) Defining New Requirement

2) Defining New Child Requirement

The Requirement module displays the information through following fields:

1) Author: Displays the user name of the person who created the requirement. By default, this is the login user name.

2) Comments: Displays the comments about the requirement.

3) Creation Date: Means the date on which the requirement was created. By default, the creation date is set to the current database server date.

4) Creation Time: Means the time at which the requirement was created. By default, the creation time is set to the current database server time.

5) Description: A description of the requirement.

6) Direct Cover Status: The current status of the requirement. Various types of requirement status can be like Not Covered, Failed, Not Completed, Passed, No Run, N/A, Not direct cover etc. By default, the status is Not Covered.

7) Modified: Indicates the date the requirement was last changed.

8) Name: The requirement name.

9) Old Type: The type of obsolete requirement.

10) Priority: The priority of the requirement, ranging from low priority (level 1) to urgent priority (level 5).

11) Product: The component of the application on which the requirement is based.

2) Test Plan Module:

It comprises of the prime activity i.e. creation of clear and concise Test Plans in line with the requirements formulated in the Requirements Phase. A nicely prepared test plan enables us to assess the quality of our application at any point in the testing process. Before proceeding ahead, with the help of Traceability Matrix, it is ensured that all the requirements have been duly addressed in the Test Plans.

Addressing all the requirements, various Test Plans are created either manually or automatically.

The process involves following key steps:

a) Creation of a folder

b) Creation of an empty test.

c) Launching of the available functional testing tool like HP – Quickest Professional etc.

d) Creation of the Test Scripts. 

e) Saving the Test Script in the empty script file already created.

f) Repetition of above steps till creation of test plans covering all the test requirements gets completed.   

  

For maintaining an automatic traceability, it is essential that the tests in the test plan meet our original requirements. Hence links are added to keep track of the relationship between our requirements and the tests.

A test can cover more than one requirement, and a requirement can be covered by more than one test, hence linking can be done accordingly. We can link requirements and tests to the defects. This can help you ensure compliance with our testing needs throughout the testing. If a requirement changes, we can immediately identify which tests and defects are affected, and who is responsible for it.

3) Test Lab Module:

As the application undergoes changes, the manual and automated tests are run in our project with a view to identify the areas of defects and make judgement on the product quality.

The flow of this module is as under

a) Creation of Test Sets: A test set is a group of tests in a Quality Center project designed for achieving some particular testing objectives. The process begins with the identification of all the end-to-end scenarios, followed by creation of individual test Sets for every such end-to-end scenario.

After creating the test sets, tests set folders are created and assigned to development and QA cycles based on the project timeline.

b) Scheduling Test Runs: Quality Center enables us to control the execution of tests in a test set. We can set conditions, and schedule the date and time for executing our tests.

We can define the sequence in which to execute the tests. For example, we can define to run “test2” only when  “test1” has finished, and run “test3” only if “test1” has passed.

c) Running of the Tests: After defining the test sets, we are ready to execute the tests. We can select all the tests in a test set, or some specific tests. Our selection can include both automated and manual tests. We can run either a single test or all the tests in the test set. 

# Running Tests Manually: When we run a test manually, we execute the test steps defined by us during test planning stage. We declare a step either pass or fail according to the fact whether the actual results of the application matched the expected output or not.

# Running Tests Automatically: While running an automated test, the selected testing tool opens automatically, runs the test, and exports the test results to Quality Center. When we run a manual test, an e-mail is automatically sent to the specific tester, prompting to run the manual test.

d) Analyzing Test Results: After a test run, the test results are analyzed to identify the failed steps and to determine whether a defect has been detected in our application, or if the expected results of our test need to be updated. In case a defect gets detected, we can create a new defect and link it to the test run, or link an already-existing defect with the test run.

After the test execution gets finished the results can be analyzed through the Functional Testing Tool itself (like QuickTest Professional). The identified defects can be directly posted through the QuickTest Professional itself, alternatively the Defects Module of HP Quality Center can be used.

4) Defects Module:

This module is like a Bug Tracking Tool and helps us in reporting the design flaws in our application. This provides all the facilities to manage the defects like adding of defects, changing the status of defects and analyzing the defects etc.

a) Adding Defects: When a defect is found in the application, it is submitted to the Quality Center project. The project stores the defect information and it can be accessed by the authorized users only say like the members of the development, quality assurance, and support teams. This new defect can be associated with the cycle and release in which it was detected. The new defect can be associated with the test we ran, for future reference

b) Reviewing New Defects: During this stage we decide as to which defects needs to be fixed. The project manager usually performs this task. Here we change the status of a new defect to “Open”, and assign it to the concerned member of the development team for fixing.

c) Repairing Open Defects: This involves identifying the cause of the defects, modifying and rebuilding the application. Application developers perform such activities. When a defect is repaired, we assign it the status “Fixed”.

d) Testing a New Application Build: Involves running of the tests on the new or 2nd build of the application. If the defect does not come up again, we assign it the status “Closed”. However If the defect is detected again, we assign it the status “Reopen”, and it is returned to the previous stage. The quality assurance manager or project manager usually performs this task. Doing testing on 2nd build on wards is called Re-Testing or Regression testing.

Repeated testing from the Test Lab Module to Defects Module is carried out till all the defects get fixed.

e) Analyzing Defect Data: View data from defect reports to see how many defects were resolved, and how many still remain open.

Interconnectivity of Quality Center & QuickTest Professional (QTP):

Applications can be tested using following two ways:

 

1) Through QuickTest Professional: By defining path for Quality Center while being in QuickTest Professional.

2) Through Quality Center: By launching QuickTest Professional while being in Quality Center.



Total Quality Management In Libraries

May 31st, 2009
Senthilvelan M asked:


Total Quality Management in Libraries

M.Senthilvelan

 

WHAT IS   QUALITY?

The word Quality has many different meanings ranging from conventional to those that are strategic in nature.  Conventional meaning of quality usually describe a quality as one which looks good, works well, which is reliable etc.,  Strategic meaning of quality is concerned with “meeting customer requirements”.  When a manufacturer is able to meet the exact   requirements of the customer consistently then that is called as Quality.  Quality then need not always mean good, reliable, long lasting etc.  If the manufacturer provides what the customer demands (good or bad) then that is Quality.

Some classical definitions of quality are as follows:

Quality if physical or non physical characteristics that constitutes that basic nature of a thing or is one of its distinguishing features. Quality should be aimed at the needs of the consumer, present and future.

By Deming Webster’s Dictionary

TQM is “a system of continuous improvement employing participative management and centered on the needs of customers” (Jurow & Barnard, 1993). Key components of TQM are employee involvement and training, problem solving teams, statistical methods, long-term goals and thinking, and recognition that the system, not people, produces inefficiencies. Libraries can benefit from TQM in three ways: breaking down interdepartmental barriers; redefining the beneficiaries of library services as internal customers (staff) and external customers (patrons); and reaching a state of continuous improvement (Jurow & Barnard, 1993).

A library should be focusing on providing the best services possible, and be willing to change to serve its customers. To determine if changes need to be made, a librarian might ask:  What do the customers come in for? How can I look at the efficiency of my library? How do we serve the current users that exist today? First learn about the customer, then solve the problems. An American, W.Edwards Deming, developed the concept of Total Quality Management (TQM) after World War II for improving the production quality of goods and services. The concept of TQM is applicable to academics. Many educators believe that the Deming’s concept of TQM provides guiding principles for needed educational reform. In his article, “The Quality Revolution in Education,” John Jay Bonstingl outlines the TQM principles he believes are most salient to education reform. He calls them the “Four Pillars of Total Quality Management.”

Principle 1: Synergistic Relationships:-

According to this principle, an organization must focus, first and foremost, on its suppliers and customers. In a TQM organization, everyone is both a customer and supplier; this confusing concept emphasizes “the systematic nature of the work in which all are involved”. In other words, teamwork and collaboration are essential. Traditionally, education has been prone to individual and departmental isolation. The very application of the first pillar of TQM to education emphasizes the synergistic relationship between the “suppliers” and “customers”.

 The product of the successful work together is the development of the student’s capabilities, interests, and character. In one sense, the user is the customer for the library, as the recipient of educational services provided for the student’s growth and improvement. Viewed in this way, the library is the  suppliers of effective learning tools, environments, and systems to the users, who is the customer for library. The library staff  must educate the users regarding how to access the resources in the library for the users s by teaching them.

Principle 2: Continuous Improvement and Self Evaluation

The second pillar of TQM applied to education is the total dedication to continuous improvement, personally and collectively. Within a Total Quality library setting, administrators work collaboratively with their users. The foundations for this system were fear, intimidation, and an adversarial approach to problem-solving. Today it is in our best interest to encourage everyone’s potential by dedicating ourselves to the continual improvement of our own abilities and those of the people with whom we work and live. Total Quality is, essentially, a win-win approach which works to everyone’s ultimate advantage. According to Deming, no human being should ever evaluate another human being. Therefore, TQM emphasizes self-evaluation as part of a continuous improvement process.

Principle 3: A System of Ongoing Process

The third pillar of TQM as applied in academics is the recognition of the organization as a system and the work done within the organization is an ongoing process.  Quality speaks to working on the system, which will identify and eliminate the flawed processes.  Since systems have made up of processes, the improvements made in the quality of those processes largely determine the quality of the resulting product.

Principle 4: Leadership

The fourth TQM principle applied to education is that the success of TQM is the responsibility of top management. The librarians must establish the context in which users can have benefit by providing best services through the continuous efforts and improvement in the services.  According to the practical evidences, the TQM principles help the library in following clauses:

 1) Redefine the role, purpose and responsibilities of libraryschools.

 2) Improve library as a best user center for a best “way of life.”

 3) Plan comprehensive leadership training for users at all levels.

 4) Create staff development programmes.

 5) Use research and practice-based information to guide both policy and practice.

In order to achieve the above as opportunities to the academic scenario, in addition to patience, participatory management among well-trained and educated partners is crucial to the success of TQM in libraries, everyone involved must understand and believe in principles. Some personnel who are committed to the principles can facilitate success with TQM. Their vision and skills in leadership, management, interpersonal communication, problem solving and creative cooperation are important qualities for successful implementation of TQM.

14 STEPS TO TOTAL QUALITY MANAGEMENT

Based on his work with Japanese managers and others, Deming (1986; Walton, 1986) outlined 14 steps that managers in any type of organization can take to implement a total quality management program.

1) Create constancy of purpose for improvement of product and service. Constancy of purpose requires innovation, investment in research and education, continuous improvement of product and service, maintenance of equipment, furniture and fixtures, and new aids to production. 2. Adopt the new philosophy. Management must undergo a transformation and begin to believe in quality products and services.

      3.  Cease dependence on mass inspection. Inspect products and services

          which only enough to be able to identify ways to improve the process.

    4.   End the practice of awarding business on price tag alone. The lowest priced goods

         are not always the highest qualities; choose a supplier based on its record of   

          improvement and then make a long-term commitment to it.

   5.   Improve constantly and forever the system of product and service. Improvement is

         not a one-time effort; management is responsible for leading the organization into

         the practice of continual improvement in quality and productivity.

6.     Institute training and retraining. Workers need to know how to do their jobs

         correctly even if they need to learn new skills.

7.     Institute leadership. Leadership is the job of management. Managers have the

        responsibility to discover the barriers that prevent staff from taking pride in what

        they   do. The staff will know what those barriers are.

8.  Drive out fear. People often fear reprisal if they “make waves” at work. Managers

     need to create an environment where workers can express concerns with confidence.

9.  Break down barriers between staff areas. Managers should promote teamwork

     by helping staff in different areas/departments work together. Fostering  

     Interrelationships among departments encourages higher quality decision-making.

10. Eliminate slogans, exhortations, and targets for the workforce. Using slogans

     alone, without an investigation into the processes of the workplace, can be offensive

     to workers because they imply that a better job could be done. Managers need to

     learn real ways of motivating people in their organizations.

11. Eliminate numerical quotas. Quotas impede quality more than any other

      Working condition, they leave no room for improvement. Workers need the

      flexibility to give customers the level of service they need.

12. Remove barriers to pride of workmanship. Give workers respect and

     feedback about how they are doing their jobs.

13. Institute a vigorous program of education and retraining. With continuous

      improvement, job descriptions will change. As a result, employees need to be

    educated and retrained so they will be successful at new job responsibilities.

14. Take action to accomplish the transformation. Management must work as a

       team to carry out the previous 13 steps.

 

 

 

HOW LIBRARIES HAVE IMPROVED SERVICES WITH TQM

Many libraries have implemented TQM successfully. Harvard College Library created a task force which rewrote the library’s vision statement, and considered changes that would have to be made in order to develop a new organization culture–one that “highlights the changing nature of staff roles and responsibilities in an era of pervasive change” (Clack, 1993). With the help of consultants, Harvard learned about TQM, and found that its principles of service excellence, teamwork, ongoing training and skill building, process/systems focus, continuous improvement, and cooperation across boundaries could help them make the changes they needed.

The Oregon State University Libraries also decided to test TQM. Two small teams, the Shelving Team from the stack maintenance unit, and the Documents Team from the government publications unit worked with outside facilitators. Each team surveyed users and staff and found that some issues, perceived as critical by staff, were not perceived as critical by customers and therefore needed rethinking in terms of TQM. The Shelving Team, which wanted to address the problem of long lasting shelving backlogs, found that the shelvers, who worked alone on the floors, felt isolated and unmotivated to make progress. Using this information, the team devised a plan for shelvers to work in small groups and have an assigned floor. The result was an increased “espirit de corps,” tidier shelves, and less backlog (Butcher, 1993).

Sirkin (1993) suggests some ways a library might use the principles of TQM to enhance library services.

Create service brochures and information kits

Conduct a user survey about library services

Change hours of operation

 Provide a more convenient material return

 Simplify checkout of materials

 Use flexibility in staff assignments

 Ask vendors to give product demonstrations

 Give new staff a thorough orientation

 Create interdepartmental library advisory groups

  Improve the physical layout of the library

  Track complaints

  Develop an active outreach program

  Publicize new or changed services

  Develop user and staff training materials

  Target services to specific groups

   Offer electronic document delivery

POTENTIAL CHALLENGES IN LIBRARIES

While TQM clearly has positive aspects, implementing it can have potential challenges as well. Jurow and Barnard (1993) identify four barriers to the adoption of TQM in libraries:

1)  Vocabulary: objections to terms such as “total,” “quality,” and “management”

2) Commitment: TQM takes several years to implement and requires a long-term

     Commitment by library managers

3) Process: Our culture tends to be impatient and we try to solve problems quickly,    

     to TQM’s careful process analysis; and (4) professionalization: professional staff can  

     be resistant to turning over their practices and services to what they perceive as

    the  uninformed whims of the customer”.

Riggs (1992) summarizes the notable principles of TQM:

(1) Manage by fact: make library decisions after careful analysis of data gathered

     With tools such as check sheets, histograms, and Pareto charts;

(2) Eliminate rework: library work is often labor intensive-simplify it and make

     sure, it is done properly the first time;

(3) Respect people and ideas: staff is the library’s most valuable resources, and

     they should be encouraged to point out problems without fear of management;

(4) Empower people: trust library staff to act responsibly and give them the

     appropriate authority to make decisions that can improve the quality of work they do.

 

 

 

CONCLUSION

Libraries are apt places to implement TQM.  Libraries are service organizations dedicated to their users (customers). By formulating a strategic plan, and following it with a commitment to continuous quality improvement, library managers can transform and improve their organizations.

REFERENCES & SUGGESTED READINGS

Butcher, K. S. (1993). Total quality management: The Oregon State University Library’s experience. “Journal of Library Administration,” 18(1/2), 45-56. (EJ 469 102)

Deming, W. E. (1986). “Out of the crisis.” Cambridge, MA: Massachusetts Institute of Technology, Center for Advanced Engineering Study.

Jurow, S. & Barnard, S. B. (1993). Introduction: TQM fundamentals and overview of contents. “Journal of Library Administration,” 18(1/2), 1-13. (EJ 469 099)

Mackey, T. & Mackey, K. (1992). Think quality! The Deming approach does work in libraries. “Library Journal,” 117(9), 57-61. (EJ 446 234)

  

 

 



Assessment of the Impact of Industrial Effluents on the Quality of Irrigation Water and Changes on Soil Characteristics (a Case of Kombolcha Town)

May 30th, 2009
Eskinder asked:


INTRODUCTION

With the ever increasing demand on irrigation water supply, farmlands are frequently faced with utilization of poor quality irrigation water. In many parts of Ethiopia, waste water, which are disposed to wells, ponds, streams and treatment plants, are used as a source of irrigation water as well as for drinking (Alemtsehaye, 2002). But, the continued application of poor quality irrigation water can reduce the yield of farmlands. Water quality for agricultural purpose is determined on the basis of the effect of water on the quality and the yield of the crops, as well as, the effect on the characteristic changes in the soil (FAO, 1985). The most commonly encountered soil problems used as a basis to evaluate water quality are those related to the salinity, water infiltration rate, toxicity and a group of other miscellaneous problems (Richardson, 1954; Wilcox, 1966).

Kombolcha is one of the few towns in Ethiopia with a relative greater number of large-scale manufacturing plants including Textile Factory, ELFORA-Meat Processing Factory, Tannery, BGI-Brewery Factory, Steel Product Industry and Flour Factory. On top of this, the town is selected to be an industrial town by Amhara National Regional State of Ethiopia, which indicates the industrial development and its associated pollution risk will increase in the future. The existing industries have been discharging their wastes into the surrounding environment, in particular to the near by river. According to the local woreda agriculture office, more than 25,000 farmers are diverting the effluent contaminated rivers water to irrigate about 2695 ha of farmlands in order to grow different crops including cereals, vegetables and fruits (Kalu Woreda Agricultural Office, 2006). In addition, the latest report from the local agricultural administration office explains that despite the fact that many farmers and enterprises have used the local rivers for irrigation since long time ago; no study has been conducted yet on the chemistry of the polluted river water for its irrigation suitability (Kalu Woreda Agricultural office, 2007). In Kombolcha, perhaps the most important factor in predicting and managing farmland soil is the quality of irrigation water being used.

The main intention of the study is to provide concrete information on the magnitude of the industrial liquid wastes and help farmers and policy makers to take the necessary corrective measures on time. The impact of industrial liquid wastes on the irrigation water quality  was assessed  by examining  the concentrations of Na+, Ca2+, Mg2+, BO3-3, CO3=, HCO3-, Cl- and values of pH and SAR in the polluted irrigation rivers water through laboratory analysis. Soil samples were also taken to assess the quality of the irrigation water effect on the irrigated farm soils properties.

 

MATERIAL AND METHODS

Location of Study Area

The study area is found in the town of Kombolcha which is located on the north central part of Ethiopia placed immediately south east of Dessie in the Amahara region at 11o06’ north latitude and 39o45’ east longitude. River Borkena crosses the town emerging from the east and running to the west direction. In its way all through the town, it receives effluents indirectly through its tributaries rivers named Worka and Leyole. Most of the factories are found closely together in the middle of the town near by the tributary rivers of Borkena.

Methods Samples of irrigation water and farmland soils were collected in three phases with in the irrigation period of the study area. Acceptable standard methods and instrumentations were followed during sample collection procedures. Sampling site selection: Based on the outlining of the irrigation sites and waste disposal points, three areas were selected to take water and soil samples viz a farmland at the above the effluent points (control) which was irrigated by effluent free (freshwater of River Borkena) water and two farmlands below the effluent points which were irrigated by effluent contaminated rivers water (River Leyole and River Worka). The mean values of the parameters in the control fresh irrigation water source and the effluent contaminated water of the other water sources were compared with the widely accepted standards set by FAO. The soil samples of the respective irrigated farmlands were also considered to assess the extent of the impacts of the effluent contaminated irrigation water on the characteristics the soils. The chemical parameters that have been measured in the diverted irrigation water were also determined from the soil samples of the selected irrigated farmlands. Both surface and subsurface soil samples were taken once from the fresh water irrigated farmland (control or background) at the upper and three times from the effluent mixed irrigated farmlands at the lower of the effluent points through out the irrigation period of the study area. TDS, ESP and SAR were computed following the formulas stated in FAO soil bulletin 42. Chlorides, nitrogen-nitrate, sulfate, chromium and some samples of phosphate were found to be below the detection limit in the first phase samples analyses.

Water samples: 9 water samples were taken from January 2007 to June 2007. The sampling frequency was in three phases throughout the irrigation season. In first phase, additional parameters were analyzed other than the mentioned ones in the internationally accepted irrigation water quality guidelines by FAO (1976c; 1985) in order to have a better understanding on the water quality characteristics. The chemical variables analyzed in the second and third phase were made to stick only to those recommended in the FAO standard guidelines.

Samples were taken from two sites. One is from a main diversion channel (from the fresh water of River Borkena) above the effluent points.  These samples served as background and were non effluent contaminated; the others were from the main channels at lower of the effluent points which were diverted from industrial effluent recipient rivers named Leyole and Worka. The samples were collected at the same location in all phases of samples collection from the irrigation surface water sources of the selected farmlands. All samples were collected by grab method. While taking the samples, the time of the effluent discharge from the factories was watched out and made the sample collection so in order to take advantage of the effluent presence in the collected irrigation water samples. One liter of water sample was collected per location in a plastic bottle thoroughly cleaned by distilled water. The plastic bottle was rinsed with the water to be sampled just before sample collection and was labeled and recorded on the Water Information Sheet. The samples were then stored in refrigerator at less than 40C temperature till it was delivered to the laboratory for analyses. All samples were transported in ice box and delivered with in two days.

Soil samples: Before sample collection, site characterization and soil profile descriptions were done by close observation and examination of dug pits on the study areas. First, the surface characteristics were recorded. Then, the soil description was made according to the Guidelines of FAO (1990).

Nine composite surface soils samples and 21 subsurface soils samples were taken from the farmlands irrigated by the above three sources of irrigation water in the irrigation period of the study area.  The control soil samples were taken from a farmland placed upper of the effluent points which were irrigated by fresh water (effluent free). The other two areas are found below the effluent point and were irrigated by the effluent contaminated river water of Leyole and Worka rivers.

Composite surface soils: samples were taken from the center of shovel slice in a 30cm by 30cm core. This was repeated randomly at 20 different spots with in the demarcated farmlands. The collected samples were put in a plastic bucket and thoroughly mixed and at the end, 500gm of soil is removed as the composite sample representing the whole field. The samples were made to air dry for a few days and transported for laboratory analyses in plastic bags. While sampling, areas of back furrows or dead furrows, old fences rows, areas used for manuring or hay storage and livestock feeding, small gullies, slight depressions, terraces, waterways or unusual areas were all avoided.

Subsurface soil samples: A pit, in all of the three demarcated sampling areas, was dug to take subsurface soil samples; a depth of 90 cm pits was dug at the selected farmlands. A sample of 500gm soil was removed in each 30cm sections downward. The morphological and other characteristic of the soil was examined in the dug pits which were large enough to allow observations. Sampling from the boundaries of the horizons was avoided. The rule of soil description was made to follow the guidelines of FAO (1996) for soil description. The samples were air dried and transported along with the surface soil samples with in a few days in plastic bags. All soil, surface and subsurface, samples in the plastic bags were labeled and recorded by codes on the Soil Information Sheet.

Physico-chemical determination of soil and water samples: pH values were read on ORION model SA720 pH meter with a standard solution calibrated at pH values of 4.7 and 9.2. Electrical Conductivity was read on EC meter InoLab (WTW series) which was calibrated using 0.01NKCl standard solution. The cations Na+, K+, Mg+2, and Ca+2 were determined by atomic absorption spectrometer (Varian SP-20).  CO3= and HCO3 - were measured by titration using phenolphthalein and methyl orange indicators respectively. Chloride was titrated by Argentometry methods. The instrument used for phosphate, nitrate and sulfate measurement was UV visible spectrophotometer. All analyses  followed the standard procedures as outlined by USSL staff (1954).TDS and SAR were calculated by formulas as it is suggested in FAO Soil Bulletin 42 (1985).

Data analysis and interpretation techniques: To make irrigation suitability evaluation and quality difference comparison, the values of the chemical variables of lower farmlands irrigation water and soil samples were taken after computing the average of the three phase samples collected in one irrigation period (start, middle and last irrigation times). At the upper farmland (background), a single variables measurement of soil was taken at the starting period of the irrigation season. These values were used for testing of significant irrigation water quality changes due to industrials effluent discharge in to the irrigating rivers. The most widely applicable irrigation water quality guideline, which is set by FAO, was selected for suitability evaluation. The assumptions made by the selected guideline were then evaluated against the local conditions and it was generally found that most of the assumptions of the chosen guideline for evaluation of irrigation water quality of the rivers are the same to the actual conditions of the study area. There are no as such wide deviations between the assumptions of the guideline and the related local conditions study area. Finally, the values were compared to their respective standards recommended by the internationally accepted guideline in order to evaluate their degree of restriction on use for irrigation.

Since water samples were taken from three different rivers located above and below the effluent points, the test statistics for the significant quality difference in water samples was run by The Independent-Samples T Test. The absence of irrigation practices at the upstream parts of the wastes draining rivers (River Leyole and Worka) forbids the easiest and rather straight forward quality changes between upstream and downstream water samples due to the intrusion of effluents. Besides, as all the three rivers originate from the same neighboring catchments areas with more or less the same geological and biophysical characteristics, the quality of the rivers water is assumed to be the same unless otherwise another external element, like the industrial effluents, is introduced in the rivers.  To overcome the mentioned limitation, water and soils samples were taken from another neighboring site with non effluent contaminated river water (River Borkena) and irrigated farm soils.

SPSS VERSION-13 software has been employed to run the test. The T Test procedure produces two test of difference between water samples parameters in the two distinct rivers under investigation. One test assumes the variances of each parameter in the two rivers samples are equal. The Levene Test Statistics tests this assumption. Based on this test, for a significance probability (Sig.) of greater than 0.1, equal variances in the rivers is assumed. Other wise it is ignored and the second test which assumes unequal variance is taken. The frequency of sample variables measurements were three, and the hypothesis was tested at significant level (alpha) 0.05.

RESULTS AND DISCUSSIONS

Quality and suitability of the rivers’ irrigation water: The water samples that have been analyzed to measure the levels of electrical conductivity, sodium, chloride, calcium, magnesium, carbonate, bicarbonate, pH and boron. In addition, sulfate, phosphate, nitrogen-nitrate, fluoride and chromium were added to ***** their levels in the first phase of sample collection. The measured values of the parameters were recorded three times over the six months. Some of the parameters, like nitrate, chromium and sulfate, were found to be below the detection limit of the laboratory instruments. Other important parameters like TDS and ESP were computed by the formulas stated in FAO Soil Bulletin 42 (1985). The adjusted SAR (adj RNa) was recalculated using the newer equation adapted from Suarez (1981).

The T test for the pair of upper control water and Leyole irrigation water shows that the mean of Na+, Cl-, HCO3-, B+3 concentrations and the value of EC are greater at the latter (See Table 1). On the contrary, the concentration of Ca+2, CO3= and the value of pH were lesser at the latter. Mg2+ was found to be the same in both rivers’ irrigation water. Statistically, it was seen that there is a significant difference (at P£ 0.05) in mean pH value and Na+ concentrations between the two sampling locations. Other water parameters (EC, Cl-, HCO3-, SAR), though they indicated appreciable difference in concentrations, they were found to be significantly not different in concentration when compared in the two irrigation water rivers. The T test for the pair of control fresh water and Worka river irrigation water also reveals that there is a significant (at P£ 0.05) quality difference between them in Na+, Mg+2 concentrations and SAR (Table 9). The other mean parameters (Cl-, CO3=, HCO3-, B+3, and pH) were found not significantly different in the two rivers. Chemical parameters, like electrical conductivity, sodium, chloride, bicarbonates, boron, pH, and SAR were found to be at higher concentration in the effluent mixed irrigation water of River Worka in relative to the background effluent free water. The comparison between the two effluents contaminated rivers by the T Test shows all chemical variables but chloride ions are not different significantly (at P£ 0.05).

Effect of industrial effluent on selected soil properties of irrigated farmlands: as the suitability of water for irrigation is evaluated based on the criteria indicative of its potential to create hazardous soil conditions to crop growth, the effect of  the applied irrigation water was referred specifically in terms of  salinity, water infiltration, specific ion toxicity and related miscellaneous problems. I. Salinity: The mean electrical conductivity of the control irrigation water was 0.4807 dS/m and is put as none restricting for irrigation. The electrical conductivity of Leyole and Worka rivers irrigation water increased to1.624 dS/m and 1.260 dS/m respectively. Based on the standards of FAO (1985), these figures plunge nearer to a potentially slight degree of restriction to use for irrigation. The salinity of all irrigated farm soil at the upper areas was found to be less than even 0.05 dS/m (Table 11); this is justified by the low salinity of the applied irrigation water and the practice of surface irrigation methods which help to leach down salts in the rooting depth. However, there was an increase in salinity at the lower area farm soil with 0.0413dS/m and 0.038dS/m for each effluent contaminated irrigated farmlands as compared to 0.017dS/m of upper fresh water irrigated farmlands. This may indicates that the irrigation water of Leyole and Worka rivers is elevating the salinity of the lower areas farmlands soils.

II. Water infiltration: since EC values of all rivers are was not found enough cause permeability problem, the salinity of all irrigation sources is not a factor to cause infiltration problems. The concentration of sodium as compared to calcium and magnesium, which is measured in terms of sodium adsorption ratio (SAR), was found to be less or none restricting in the control irrigation water; however, in the effluent contaminated water of Leyole and Worka rivers, which was detected be 7.71 and 8.18 respectively, it was found high and is potentially restricting. The effect of high SAR water irrigation is noticeable in the soil samples of the irrigated farmlands causing excessive exchangeable sodium percentage (29.24%) in the lower farmlands soils relative to the upper area farm field which has only a maximum ESP of 8.83%.

III. Specific ion (sodium and chloride) toxicity: The ions of primary concern were chloride, sodium and boron ion toxicity because these ions are usually related to water toxicity and industrial wastes in arid and semi-arid areas (FAO Soil Bulletin, 1985). But the toxicity effects need to be explained by taking into account indicator crops, which is not the intention of this particular study. However, the assessment of these ions in the water and soils of the irrigated farms could show the general trends with the associated risks of toxicity.

 

The mean concentration of chloride was quite low in all irrigation water sources and the restriction on use for irrigation is none. The soil samples possessed the smallest (below detection limits) content of chlorides too. At the lower of the effluent points, a little higher reading was obtained in both surface soil samples of Leyole river irrigated farmlands and sub surface soil sample of Worka river irrigated farm fields.

The mean sodium ion concentration of the upper control water of the Borkena river was determined to be less (30.33 ppm / 1.32me/l) and none restriction on use. But the levels in effluent mixed water of Leyole (186.67 ppm / 8.11me/l) and Worka (195 ppm / 8.48me/l) rivers were higher and can pose moderate restriction on use for irrigation. Accordingly, the soil samples of the downstream farms displayed 160% to 400% increment of sodium ions as compared to the upper farmlands soil samples. The increased level of sodium at the lower of the effluent point’s irrigation water and farmland soils can be attributed to the presence of caustic soda, for the purpose of washing, in the effluents of Kombolcha Textiles, ELFORA Meat Processing and BGI brewery factories. Besides this, the existence of high bicarbonates in the effluent mixed of the two rivers cause Ca+2 and Mg+2 to form insoluble minerals leaving Na+ as the dominant in solution.

At the upper fresh irrigation water of the Borkena river, the mean boron concentration was 0.3 ppm and is none restricting to irrigation. At the lower areas, it was highest (1.15 ppm) in Leyole river which is slight to moderate restriction on use. In the irrigation water of Worka river, it was 0.97 ppm and is near to slightly restricting on use for irrigation (Ayers and Westcot, FAO 1985).  All soil samples at the lower areas were below the detection limits, but on areas lower of the effluent points, some samples were indicating that boron is introduced in the surface and subsurface soil of the fields. This could be because of the presence of boric acid in the effluents from the tannery factory.

IV. Miscellaneous: These include measurements of bicarbonate, carbonates, calcium, magnesium and pH of the water. The mean concentration of bicarbonates in Leyole river irrigation water (734 ppm/12.03me/l) was exceptionally high and is beyond the accepted level. But the concentration in control water of the Borkena and Worka rivers irrigation water was 290.67 ppm (4.76me/l) and 367 ppm (6.01me/l) respectively (Table) and is in the normal range of concentration for use in irrigation. The bicarbonates ion conditions in the water of the  irrigation rivers led to have the same related distribution of bicarbonate content in the soil of the irrigated farm fields with highest accumulation in Leyole river irrigated farmlands (4873.67ppm/ 79.9me/l)  and lowest in farmlands irrigated by the fresh water of the control river  (Table). The increased levels of this ion in the soil can be attributed to the long term application of the effluents. The level of carbonates, calcium and magnesium in the irrigation water samples of the three sources were all in the normal range and do not show a notable difference between upper and lower of the effluent point’s soil and water samples.

 

Mean pH of the upper control water of the Borkena river and Leyole river water were found to be 8.37 and 7.14 respectively, which is both considered to be in the normal range for irrigation. The average pH in the irrigation water of Worka was 8.8 and is beyond the safe limits. The higher value of pH in Worka river is perhaps attributed to the presence of carbonates ions in the water. The soil samples of the upper areas farm fields indicated that pH value increases with the soil depth. The presence of high bicarbonates in the Leyole river water can justifies higher pH values in the soil solution. The sediment loads from industrial solid wastes of the tannery, textiles and steel product factories was seen to fill canals and ditches that are diverted from river Leyole  causing costly dredging and maintenance problems.

CONCLUSION AND RECOMMENDATION

Through this study, it is clear that the industrial waste has substantially changed the irrigation water quality diverted from the two rivers and consequently, some chemical elements also increased in the soil of the irrigated farmlands. EC of Leyole and Worka rivers was differentiated to be a slightly restricting. As onion is a major vegetable grown in local area, based on Ayers (1977) prediction; if the irrigation water is used continuously, the prevailing EC values might causes a potential 10% yield decline. Leaching is needed to avoid the associated long term risks.

According to Mass (1987), some of the crops grown in the local farms irrigated by Leyole River (like onion, carrot, potato and cucumber) would also be sensitive to the prevailing concentration of BO-3. Notably, the Na+ and SAR content of Leyole and Worka rivers were higher and would pose permeability problems (surpassed the safe limits). Since the root system of most crops develop best in the upper 30 cm of the soil (FAO Soil Bulletin 55, 1985), the existing higher SAR levels of irrigation water in the soils render problems of drainage, tillage and surface crusting and these could affect crop yield. The existence of Vertisol also pronounces the effect of low infiltration because of the swelling and shrinkage of soil containing clays minerals and the subsequent collapse of soil pores (Levy and Miller, 1997). If sprinkler irrigation method is applied in the future, the concentration of Na+ could also cause foliar injury on the growing local vegetable like tomato, pepper, potato and maize (Mass, 1990). 

The higher HCO3- concentration in Leyole river irrigated soil solution can harm the mineral nutrition of plants, since excesses HCO3- affects the uptake and metabolism of nutrients. Higher soil pH (9.08 – 9.36) values was found in Leyole river irrigated farmland soils. Such values of pH in farm soils may have a profound effect on availability of plant nutrients, as micronutrients, for instance; iron, manganese, zinc, copper, and cobalt are less available at a pH > 8.5 (Ayers and Westcott, FAO 1985).

All chemical parameters analyzed in the surface composite soil samples were found to be higher in farmlands irrigated by effluent mixed irrigation water of the two rivers. This indicates that the trend of the chemicals, which are important for suitable irrigation, is alarmingly increasing. The problems seems exacerbate in the town farmlands soil type, as Ayers and Westcott (1985) state low quality irrigation water is hazardous on clayey soil (particularly in Worka irrigated farmlands), while the same water could be used satisfactorily on sandy and/or permeable soils.

Since quality of water is an important priority for both environmental and economic reasons, it is vital that the fate of wastewater effluent in the surrounding rivers is to be well understood.

Soil permeability problems (excessive Na+ and SAR) can be improved by blending the fresh water of the Borkena River with the effluent contaminated water, in particular to Leyole River. Blending proportion and implementation could be guided by the local agricultural administration. Other practices that can be done at individual farm level may include cultivation and deep tillage, increasing duration of irrigation, changing the direction of irrigation to reduce slope, collecting and recirculation of run off water, using organic residue, using soil or water amendments (gypsum, elemental sulfur etc.) and changing irrigation water supply.

Analysis of effluents only by the parameters selected under this research study is not adequate. Heavy metals, Organic and synthetic pollutants are suspected to be discharged with the liquid wastes and are rarely analyzed  and thus it demand further investigation to assess their effects on the activity of soil microorganisms, crop productivity and crop quality.

Assessment on the trend of the farmlands yield should be conducted in order to have better perspective of the effluents impact on soils. It also creates awareness (to factories officials and farmers) of the problems, thereby urging to seek for corrective measures. Recent reports from the health center (2006) of the town indicated that the nearby community is frequently exposed to upper respiratory tract infection, asthma, malaria and skin diseases. Studies need to be conducted on the water quality and emission value of particulate matter in to the air in order to ***** their clear impact on health. Since Kombolcha is chosen as a city of industrialization by the Amhara National Regional State of Ethiopia, all concerned bodies must focus on appropriate industrial waste management strategy and integrated with the industrial development.

 REFERENCES

 

Alemtsehaye Birru. 2002. Assessment of the fertility and pollution status of irrigated vegetable farms around Addis Ababa city. Final report. Addis Ababa Agricultural Office, Addis Ababa, Ethiopia.

Kalu ‘Woreda’ (province) Agricultural Activities Annual Report. June, 2006.

R.S. Ayers.  1977. Quality of Water for Irrigation. Journal of the Irrigation and Drainage Division. ASCE. Vol. 103. No. IR2. P. 140.

Ayers, R. S. and D. W. Westcott, FAO 1985. Water Quality for Agriculture. Irrigation and Drainage Paper No. 29, Rev.1.Food and Agriculture Organization of the United Nations. Rome, Italy.

Biswas, A, 1998. Environmental Planning Management and Development. PP.208 – 402.

FAO. 1985. Soil Bulletin 55, Guidelines: land Evaluation for Irrigated Agriculture. Roma, Italy: Food and Agriculture Organization of The United Nation

FAO.1985. Soil Bulletin 42, Soil Survey Investigation for Irrigation. Rome, Italy. Food and Agriculture Organization of The United Nation

FAO. 1998. Conservation and Development of Dry Land Resources.  (CD-ROM). Land and Water Digital Media Series No. 2. Rome: FAO

Levy GJ, Miller WP (1997) Aggregate stability of some southern US soils. Soil Sci Soc Am J 61:1176–1182.

Mass (1987) Salt Tolerance of Plants. CRC Handbook of Plant Science in Agriculture. B.R. Cristie (ed.). CRC Press Inc.

Mass (1990) Crop Salt Tolerance. Agricultural Salinity Assessment and Management Manual. K.K. Tanji (ed.). ASCE, New York. pp 262-304.

National Urban Planning Institute. 2001. Report On: Development Plan of Kombolcha Town.

Richards, L. A. (ed.) (1954). Diagnosis and Improvement of saline and alkaline Soils. United States Department of Agriculture. Agriculture Handbook No. 60. Washington, D.C., USA.

U.S. Salinity Laboratory Staff, 1954. Diagnosis and improvement of saline and alkali soils.

Westcot, D. W. and R. S. Ayers. 1985. Irrigation Water Quality Criteria, In G. S. Pettygrove and T. Asano (eds.) Irrigation with Reclaimed Municipal wastewater: A Guidance Manual.

 

 



Quality Assurance - Why It’s Important

May 21st, 2009
dreweli1980c@yeah.net asked:


Modern day companies greatly value quality assurance because it helps them keep a check on the quality of their products and services. A good quality product or service leads to satisfied and loyal customers and that is the main goal of every entrepreneur. A business that compromises on quality in the long run loses out on loyal customers.

Different Methods

To ensure that customers are happy with the quality of their products and services, companies employ a variety of scientific measures for quality assurance. Since most businesses are often short-staffed, quality assurance is usually handed over to market research companies. These companies use several different methods to see where the company stands on quality issues.

Mystery shopping is one of the most popular methods of quality assurance. Here, a trained personnel visits the business outlet, pretending to be a genuine shopper and has a look at the quality of the product and services. While employees will not know who the shopper is, the shopper will be making distinct notes on the quality. They may even use recording devices for further research later.

Another common quality assurance method is using a customer survey. Customers are interviewed with a set list of questions regarding the quality of the company’s products or services. Their responses help the company understand customer expectations better and provide areas for improvement.

Once the quality assurance process is carried out, the results are evaluated and the company then goes about thinking of ways to improve. If customers are particularly enjoying some aspect of their service or product, the company must ensure that quality aspect is maintained. Improvements may involve a variety of factors such as improving the product or even improving the services provided by an employee at a store.

There are several quality assurance market research companies out there that can do a really good job of carrying out the process on your behalf. They not only help to evaluate the quality of your business, but also offer other services such as analyzing the competition, training programs, remote monitoring etc.

But the problem often arises when either, the companies don’t know how the quality assurance process should be carried out; or when they don’t know what sort of market research company they should employ to help them. For this purpose, www.totalqualityassuranceservices.com is a great choice.

The website has a number of highly informative articles related to quality assurance. Businesses can learn more about quality assurance and how it can help them. The site also discusses a range of industries and how quality assurance should be carried out in each.

Businesses always want ways for them to do better than their competition but without adequate knowledge, often fail to realize that they’re not considering some basic practices. All the marketing in the world can’t help a product or a service if the quality is poor. By getting all the right information about quality assurance, a business can ensure they are doing things right. If they are doing something wrong, this is the opportunity to fix it. A good quality assurance team can enhance the success of a business.



Top 10 Situations When Quality Outweighs Quantity

May 18th, 2009
Bella Harris asked:


The well known paragraph sited in Mill’s Utilitarianism is often believed to be misunderstood. While many people understand this to be read that Mills means that irrespective of the amount of a lower quality pleasure the higher quality should always take precedent.

While many people dispute the literal understanding of Mill’s intention, the phrase is still used to represent the fact that many times and in many situations having a material object or pleasure of high quality is far more effective both financially and psychologically than having an abundance of poor quality ones.

Below are ten different situations where for one reason or another, but basically for financial investment it is better to purchase high quality products or services rather than investing in a lower quality in vast quantities.

1. Internet email marketing: It is a myth that the more people you have on an emailing list the higher the return. You could potentially have thousands of people on a list but unless they are productive consumers they are worthless. It is far better to have one thousand good consumers who show serious interest in your products or services.

2. Food: high quality food which is appetising and fresh far outweighs a vast quantity of un-nutritious and poorly prepared food.

3. Shoes: recession dressing may be one of the latest ways to beat the credit crunch, but all style gurus and health experts are recommending that a couple of good quality shoes are far better than a copious amount of poor quality ones.

4. Clothes: Like above the influx of cheap clothes shops does enable people to buy more, however good quality clothes are a far sounder investment in the long run.

5. Wine: Wine connoisseurs will argue that one bottle of fine wine far outweighs many bottles of cheap plonk! There will be those of course who disagree, however it is highly unlikely that they class themselves as true wine connoisseurs!

6. Professional tools: Anyone who uses tools for his or her trade will agree that it is far better to but high quality tools which can be relied on than numerous inferior ones which may let them down.

7. Leaflets: professionally devised and printed leaflet will have more of an impact on potential and actual clients than vast quantities of home-made or poorly produced leaflets.

8. Friends: It is far better to have a few really good friends whom can be trusted and loved than a large circle of friends who are fickle.

9. Jewellery: rather like shoes and clothes have high quality jewellery is a much better investment than numerous pieces of poor quality ones. Back in the 70s Gerald Ratner lost his retail jewellery empire in the UK overnight by a flippant remark he made about the poor quality of the jewellery being sold in his stores. A very expensive error on his part!

10. Business cards: First impressions really do count and therefore having quality business cards to give to clients will be far more cost effective and productive than a quality of poorly made ones which look unprofessional and amateurish.



Your Next Quality System: the Determination of Failure or Success in Regulated Environments

May 15th, 2009
Marci Lynn Crane asked:


In today’s world of regulatory compliance and arduous product competition, a well-planned quality system is highly recommended. For life science and high-tech companies an efficient quality system is even more essential. In fact, a quality system for these industries is a ‘fight-or-fly’ ‘do-or-die’ affair. In other words, a quality system for life science and high-tech professionals can be one of the largest factors in determining positive end results, financial success and the customer satisfaction that companies concerned with high-standard quality production and regulated by the FDA, ISO, EMEA, and/or SOX desire.

So what’s the problem?

If life science and high-tech professionals know that a streamlined quality system is of the utmost importance, why do many companies lag in quality while failing to meet compliance standards?

The answer is that many life science and high-tech companies are holding on for dear life to quality systems that don’t work. Whether the quality system is paper-based, a hybrid or a Web-based system it still won’t function without specific goals, a flexible control plan and technology that provides both speed and support. To learn more about quality control goals and realistic “tempering” strategies that can be implemented via technology options read the following 5 steps to quality control success:

Step #1: Know Your Company’s Goals for a Better Quality System

The phrase “quality control” implies two types of goals that must be met and properly balanced within a regulated environment. The word “quality” for instance can imply the type of goals that will lead to product success and the genuine satisfaction of customers. The word “control” implies the tempering agents that won’t allow quality goals to “cross the line” of various realistic factors. These agents may include financial limitations, document management, compliance standards, the ability of employees to perform, dynamics between company departments, etc. Both quality goals and control tempering agents are important. Quality goals usually occur in the minds of managerial professionals and the tempering agents occur via technological solutions and via company employees.

Record your quality centered goals first and then let the tempering process occur in steps #2-5.

Step #2: Adapting Goals to Financial Factors for a Better Quality System

Once you have recorded your goals it’s time to temper them to reality, and what are more realistic than finances?

Obviously you want to have the highest amount of quality control that you can afford so look for a quality system that will (at the very least) provide Web-based document control (see step #3) and some sort of audit control. Also, look for a system that can grow over time (i.e. expand into additional quality processes with NonConformance, CAPA or Change Control solutions).

Step #3: Assessing Document Management for a Better Quality System

Since documentation control is required for almost every quality control or compliance procedure, it makes sense to make document management a priority for every quality process.

Whether a quality process is based on audits, CAPAs or change control procedures, look for a document control application that can streamline your quality processes and meet all regulatory compliance standards.

Step #4: Assessing Compliance Management for a Better Quality Control System

Meeting compliance regulations is on every life science company’s to-do list. Compliance regulations can greatly temper your original quality goals. For this reason, it is essential to invest in quality system technology that will change as regulations change, and provide the necessary updates for your quality system solution. Validation support is also a plus. Some companies offer validation scripts so that you can complete validation in-house.

Step #5: Assessing the Ability of Employees to Perform for a Better Quality System

The ability of your employees to understand quality and compliance standards and to act on those standards is of vital importance. How can you estimate your employees’ ability in order to best understand how your initial quality goals might be affected by their behavior? Consider investing in a software training solution that integrates with your document control solution. The solution should include the automated tracking of training related documents, should be Web-based, should include the automated assignment of tasks and tests as well as connections (if finances permit) to change control or audit results. The solution should also include automated test grading and escalation capabilities in case some employees aren’t quite rising to the occasion.

Conclusion for a Quality System Article

No matter what your quality goals are, it does matter how you choose to temper those goals with the right technology and the right people. Stop and consider the many ways in which your quality system could be better.



Six Sigma Cost of Quality

May 4th, 2009
Tony Jacowski asked:


Six Sigma provides a solution to the problem of connecting quality and costs.

Categories of Costs

You can broadly categorize the cost of quality as the cost of poor quality (COPQ) and the Cost of good Quality. The cost of poor quality covers internal as well as external costs that are a result of the defects in the products. The cost of good quality covers those costs incurred on the deterrence of non-conformance as well as for the assessment of these products for conformance.

The cost of poor quality would include internal and external failure costs. When the defects are found before delivery of the product to the customer, these costs are called internal failure costs. Costs for rework, re-designing, shortages and downtimes come under this category.

When the costs are incurred after delivery to customers and lead to customer dissatisfaction, they are external failure costs. For example, costs such as customer complaints, repairs, warranty issues or even sales reductions are external failure costs.

Costs of good quality are used for prevention and appraisal. Costs incurred for quality planning, error proofing, quality education, training and so on would fall under the category of prevention costs.

Costs for testing, audits and standardizing measuring and testing equipment are appraisal costs.

Quality Processes

Most quality initiatives fail to correlate quality level with companies’ bottom lines - but Six Sigma has a solution to that. Six Sigma provides the way by building the quality as part of the processes. It aims at doing things correctly in the beginning. The philosophy is that of a determined effort to achieve zero defects, which is possible if the process is a smooth one.

If processes are improved, the appraisal and prevention costs will be reduced. They can never be taken to zero - but the reduction will have a positive effect on performance.

Poor quality leads to higher costs as well as customer dissatisfaction. The sales that are lost means loss of revenue, which may become critical if not handled carefully and on time. Thorough measurement of quality can help prevent such situations. The biggest amount of loss is from non-conformance detected by customers.

Along with the cost of repair or replacement, companies lose out on goodwill and reputation, which worsens when the customer informs other customers about the same. Further costs may have to be incurred if there is any litigation. Additionally, if the detection of errors in done in the early stages when they happen, the causes can be determined easily. A time lag in detection leads to further delay in removal, unless the exact reason is located.

Timely collection of quality cost data supports performance improvement. To be effective, the cost of quality has to be combined with other quality information systems to ensure that root causes are handled properly.

When you achieve a sigma level of six, you will find that the cost of quality is less 1% or less, which means improved performance; while when sigma level is 2 or 3 the cost of quality as a percentage is just as bad as 40%.