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Home>Major Activities>Seminars and Workshops in 2018>Quality Assurance and ISTA Accreditation for Beginners



Date
June 19-21, 2018
Venue
International Congress Center (Epochal Tsukuba), Tsukuba, Japan
Co-organizer
Workshop Organizer: ISTA (International Seed Testing Association
Local Organizer: NARO (National Agricultural and Food Research Organization), Japan
Background / Highlights of Activity

The International Seed Testing Association or ISTA is the main organizer of this workshop. Its local organizer is the National Agricultural and Food Research Organization (NARO) and FFTC is the sponsor of the workshop. According to the procedure of the  ISTA Laboratory Accreditation Programme, in order for a seed laboratory to be an ISTA accredited laboratory, it is required to first become a member of ISTA. The laboratory will be subjected to an audit to determine the capacity and capability thereof, and a certain level of competency has to be achieved. In addition, it is necessary to draft an original quality assurance manual for each laboratory. These documents include a “Quality Manual”, “Standard Operational Procedures (SOPs)”, and “Working Instruction” respectively.

It is necessary to prepare this documentation for each seed testing laboratory according to each situation in detail, and SOPs include training of samplers and analysts, education of analysts, document management, equipment validation, corrective measures, management review etc. According to these documents, quality control and laboratory operation can be conducted, and highly reliable test results can be reported. However, this documentation requires a lot of labors and demands on where to build from and where and how to construct it were received from several laboratories in Japan and the South East Asian region. For this reason, we held this workshop in order to set up a quality assurance system and to help in the documentation work such as producing complicated manuals.

Objectives of the Workshop

  • Disseminate information on the quality assurance and management skills provided by the ISTA Accreditation Standard at the international level in order to enable ISTA Certificate (ISTA’s seed quality certificate) to be issued by seed testing laboratories in each country as required by the international trade of agricultural seeds.
  • Visit the NARO Seeding Management Center (ISTA Accredited seed testing laboratory) which acquired ISTA accreditation in order to learn how the seed testing laboratory which introduced the quality assurance and management technology is operated.

 

Summary of presentations

In the overview of the International Seed Testing Association (ISTA), Dr. Masatoshi Sato introduced the ISTA organization's short history which started in 1924. Their vision is to promote and obtain uniformity in seed testing for the national and international seed testing laboratories in the world. ISTA has four objectives, according to ISTA Articles, the objectives of the Association are (1) develop, adopt and publish STANDARD PROCEDURES for sampling and testing seeds and promote uniform application of these procedures, and (2) to promote research in all area of seed science and technology. Their global members are distributed all over the world. Among those members, there are 98 members in Europe, 67 members in the Asia Pacific Region, 10 members in Australia, 20 members in Africa, 13 members in South America, and 20 members in USA/Canada. They are working on 4 major pillars: (1) International Standardization of Reporting Results; (2) International Standardization of Methodologies; (3) International Standardization of Laboratory Performance; and (4) International Exchange of Scientific Results. Thus the main role of ISTA is to make the International Standardization and Certifications of the seed testing experiment and report rules.

After slightly understand ISTA’s goal, Dr. Florina Palada started to introduce to quality assurance, which is the most important reason why ISTA need to set up so many rigorous rules. They are not just focused on the product itself but also on the quality of the producer or seller service. Dr. Palada introduced the Quality Management System, which including quality planning, quality control, quality assurance, and quality improvement. In addition to convincing their customer that their laboratory is the most reliable, members needs to go through their entire process and prove they have control. Therefore, quality must be planned, organized and resources must be made available. For seed testing, quality means having reliable results, but not always mean that the seeds are of a high quality.

Dr. Palada then further explained the general management concept. Using an organized documented structured set of procedures for means to dealing with any problem that arises, or better have means of avoiding problems. To manage the planning, the manager must give a specific Job Descriptions for staff to ensure there is no ambiguity about who is responsible for what. Besides the written tables/registers and check-list, there always should have Record Keeping for the important parts, such as the sample history trace. Efficient Management is highly related to forward planning. Dr. Palada also emphasized the most important asset for an organization is PEOPLE. Managers should always pay attention to Motivation, Trust, Interpersonal Relations, Personal Sensitivity, Ability to Work in Teams, and Discipline. Management in all businesses is the act of getting people together to accomplish desired goals and objectives using available resource economically, efficiently and effectively. It comprises planning, organizing, staffing, leading or directing, training and controlling an organization of the purpose of accomplishing a goal.

In the next section, Dr. Palada taught the participants how to build a Quality Documentation. The beginners needed to understand the quality document pyramid and ISTA accreditation standard requirements in this presentation. The basic ideas for a quality documentation are "Record according to the needs" and "Do what you write, Write what you do." Quality Document Pyramid is a hierarchical structure as the base consists of detailed work documents and forms to record the data, the middle is to describe the activities in more detail, procedures might be valid for several units, and the top is to describe the quality system in accordance with the stated quality policy and objectives and the accreditation standard. The most important two ISTA requirements above all are that all rules, handbooks, manuals, instructions and reference data relevant to the work of the laboratory must be current, up to date, and readily available to staff, and the documents must be written as detailed as necessary to allow staff to perform their tasks.

In introducing document control of quality documentation, Ms. Rita Zecchinelli had shown the document control principles and the meaning of document control. Basically, ISTA members are required to keep all original observation records, and written in detail as possible so that after reading the record, the new staff must be able to do or continue the work. There are six principles while making document control: (1) the laboratory work is described in documented procedures; (2) every document has a unique identification, page number, total page number, version number, date of validity; (3) documents are reviewed and approved prior to use; (4) documents must be periodically reviewed and revised if needed; (5) changes made from one version to the other must be marked; and (6) documents are located where they are needed. One copy of old versions of each document should be kept for at least 6 years. The Document Control of ISTA Accreditation Standard is in 10.2.2 to 10.2.5 (see the attachment 1). After the introducing, all participants used the concepts they learn from the above to do a small practice and working in group discussion.

Next Ms. Rita Zecchinelli introduced the calibration and testing materials for management of equipment. The calibration in the seed testing laboratory included the seed blowers, sample equipment, balances, grinding mills, thermometers and temperature probes, pH meters, electro-conductivity meters, and so on. The ISTA Rules give the specification for materials used in the seed testing laboratories which could have an effect on the outcome of the test: (1) Germination Substrates; (2) Chemical Solutions; (3) Water. Focus on the materials and equipment that will affect the testing result and always keep records of every important detail, and save those records base on the materials or equipment using periods.

Mr. Eddie Goldschagg demonstrated the means of quality assurance equipment divider check. It needs to be sure that: (1) representative working samples are obtained; (2) the divider divides the sample into two halves; (3) there is no selection of material during the dividing process; and (4) that inert matter and the other seeds are divided into two halves. Also, the SOPs needs to be established if the dividing process will be influenced by the operator.

Ms. Zecchinelli then mentioned the quality assurance consumables growing media substrate specification checks. ISTA Requirements and Rules for germination media including the composition (such as paper, sand, and organic growing media), water retention, pH, conductivity, and cleanliness and freedom from toxicity, which all have detail definitions in the “International Rules for Seed Testing”.

However, the ISTA Rules does not give procedures for measurement of the different attributes. By using the "ISTA Handbook on Seedling Evaluation", the members can find the Standard Operating Procedures (SOPs) guidelines showing how the following attributes of growing media can be measured: water retention, pH, conductivity, and cleanliness and innocuity. Ms. Zecchinelli said all results that every laboratory produced can only be compared to its own records, there is no fixed standard to ISTA.

In the internal quality control section, Dr. Palada gave the participants the idea of requirements of accreditation standard, which is mentioned in "ISTA Accreditation Standard for Seed Testing and Seed Sampling", 10.3 quality control procedures. Except for those details standard in the ISTA Accreditation Standard, Dr. Palada said the implementation is also very important. The staff that works in ISTA member's laboratory should always be informed about the programme. The monitoring outcome should not show the analysts names. Member's customer should always get the 'SAME' result regardless. Most importantly, It's not about persons, it's about the system.

In the section of non-conforming work, corrective action, and preventive action, Dr. Palada defined that non-conformity here means non-fulfillment of a requirement, which requires the expectation that is stated, generally implied or obligatory. Before or after the non-conformity situation happened, you can have three different kinds of reacting: (1) correction, which means action to eliminate a detected non-conformity, it needs only a short time to complete it; (2) corrective action, which is action to eliminate the cause of a detected non-conformity or other undesirable situation, it should be correct and avoid it to happen again, so it needs more time than correction; (3) preventive action, it means action to eliminate the cause of a potential non-conformity or other undesirable situation, to stop it before the problem happens.

Ms. Zecchinelli introduced the internal audits to the participants. ISTA accreditation standard had mentioned about three audit parts: system part, technical part, and equipment part. For system part, it should be done by someone who has received training in audit and quality assurance. The technical part should be done by someone who has received training in audit and has some laboratory experience and should be done every year. The equipment part should be done by someone who has received training in audit and has laboratory experience. It could also be combined into the technical part. It's good to have a team of auditors because a bunch of people could avoid the point of view been too subjective. The Audit focus should not to a person, but to the sample which has the problem. Also, improve the audit system, not for the ISTA auditors, it should be accepted by the staff working in the laboratory. Ms. Zecchinelli taught the participants how to prepare a checklist for internal audits according to the Accreditation Standard, and made the participants practice by creating a checklist for auditing on their own.

In next section, Ms. Zecchinelli provided the laboratory with an overview of the storage of samples. The ISTA Requirements in this part is in the ISTA Accreditation Standard 6.2.2, ISTA Rules 2.5.1.7, and 2.5.3. Ms. Zecchinelli mentioned there are two factors which affect the storage most after the initial quality of the seed: seed moisture content and temperature. Seed can be stored for years at low moisture content and low temperature conditions. Other factors affecting the longevity are biological factors (external factors), such as insects, mites, bacteria, fungi, and rodents. ISTA’s recommended that it is necessary for making a quality control check on seed storage. It will be better to prepare 2 quality control check samples, just in case there is one that is in low quality. After a year in store, the quality control samples should be removed and disposed.

In next section, Ms. Zecchinelli said after the seed is been tested, the test results might give different results every time. The variation is due to 6 main sources of variation: sampling, quality of the seed lot, size of the sample examined, differences in assessment of seed analysis, test conditions, and lapse of time between tests. The amount of variation to be expected is embodied in Tolerance Tables, which allow us to know the results consistent situation and if the particular result consistent with a specified standard. If the tolerance is exceeded it means that there is a significant difference between results. In ISTA publication, there is a comprehensive series of Tolerance Table which is available for their member to use.

Dr. Palada explained their goal of management review is not just a simple review done for the Management or just to fulfill the requirements of the ISTA Accreditation standard, and it is not a solo show of the quality manager. The management review is actually a good tool to show what the laboratory accomplished and how it performed. After the management review was done, the information should be shared with the laboratory staff.

Last but not least, the ISTA Rules for seed sampling section was presented by Mr. Goldschagg. He provided some actual practices, processes and pictures and tools introductions to show the participants how to manipulate it in the right way. The most important things that samplers should take note of is the Heterogeneity in a seed lot, once the seed lot have difference in the content, it might lead to not obtaining a representative sample and un-reliable results. The Heterogeneity might be the seed’s size, humidity, quantity, and quality. Mr. Goldschagg said it is needed to have quality assurance in seed sampling to ensure high quality seed testing.

In the third day of the workshop, Ms. Zecchinelli explained the way of how to check the balance. The balance which uses for seed testing has two quality assurance controls: internal check and external calibration. Usually, the internal check should be done once a week. The maximum weight is not the maximum of the balance, but the maximum of seed weight that the laboratory will test. The laboratory should define their tolerances base on the standard of their country. The calibration weights should be done every 5 years and used only for calibration purposes, and the working weight should be checked once a year. Handle the weights using only forceps or gloves. On the other hand, the external calibration should be done once a year to establish a connection between the balance and a known standard. After the explanation, participants practiced with the balance that NARO provide.

Finally, Mr. I-Cheng Chen made an introduction for the field trip tour, by presenting as an example of an ISTA Accredited Laboratory. He introduced the seed testing laboratory of Taiwan Seed Improvement and Propagation Station (TSIPS) in Taiwan. The TSIPS was established in 1913, it has three functions: the analysis of seed and seedling, the supply of quality seed and seedlings, and the Industry technical service and counseling. Seed testing laboratory (STL) was established in 1959, became a member of ISTA in 1962, and joined TSIPS in 2012. Its main task is testing domestic seed and international seed, by following the ISTA Certificate and ISO/IEC 17025:2017, they successfully set up the standard process in their laboratory. At the end of his speech, Mr. Chen presented an example of STL seed testing task and technology, to give the participant a full picture of their seed testing process.

 

Highlights of discussion

The following issues were raised during the question and answer portion of the speaker presentations:

  • Management Plan usually is done by two different kind of manager: the technical manager and the quality manager. Small companies sometimes need to put two positions in one person. In this case, they can request other person or people, whose send by other reliable companies or department of member of ISTA, to help to do the management plan.
  • Because the testing in the seed testing laboratory cannot be stopped, the quality document should appoint deputies in a suitable way in the absence of staff, and make the new staff easily to understand and continue the work.
  • The ISTA rules are more inflexible than iso9001.
  • Those documents and records should always been easy to understand, but not necessary to be beautiful. It should make the laboratory’s staff understand the goal of the laboratory.
  • The documents should be translated for all the language that the staffs use, because some staffs are not native English speaker. The laboratory documents were written in native language, only certain  chapters of the QM and SOP need to be translated to English for the auditors from ISTA during the accreditation (once per 3 years).
  • If one laboratory have no expect compare standard, then the elaborate of the laboratory is the monitor average of the laboratory staffs result.
  • A laboratory have to define the limit of their ‘miner’, usually it is not easy to define by others, they might find there is always happening with same problem within the laboratory.
  • It will be best if the staff know about audit is coming before 10 days.
  • If the laboratory gets the customer complaint of the quality, they should check the condition and retest the storage sample.
  • ISTA Handbook is not the rule, it is only a guideline that members can reference.

 

Educational trip

The ISTA speakers and the workshop participants, together with the staff of NARO and FFTC visited the Center for Seeds and Seedlings (NCSS) of NARO. NCSS was established within Ministry of Agriculture, Forestry and Fisheries (MAFF) in 1986. It has 13 foundation seed farms and 3 seed testing laboratories. In 2001, NCSS was separated from MAFF and reorganized into an Incorporated Administrative Agency. After that, in 2016, NCSS combined with National Agricultural and Food Research Organization (NARO) to be NARO’s member. There are four main duties of NCSS: Seed inspection, Activities of PVP G-Man, DUS Growing Testing for PVP, and Production of Foundation Seeds. Besides Tsukuba Headquarters, NCSS still have 11 stations, which included 1,814ha of total area, 835ha cultivated land, and 258 staff in Japan. The two types of inspections that NCSS implements are: (1) to control quality of commercial seeds distributed in Japan under the Seeds Act system; and (2) to certify quality of requested seeds from seed dealers for facilitation of seed trade issuing certificate.

Major findings, recommendations and conclusion

  1. ISTA is an organization which provides the guidebook and standards for the seed testing laboratories, to help those laboratories become more uniform.
  2. In the condition of standard uniform in every laboratory, it will make the seed testing result more reliable, and it will ensure the accurate determination of the quality of seeds in international trade, which is very important base factor to all the farmers and agricultural economy.
  3. Some standards are fixed by ISTA, but some of the standards are needed to be made by the laboratory itself, due to every country having different governmental laws and regulations. Laboratories (member or non- member) can provide a method Validation Test (MVT) plan to ISTA relevant Technical Committee (TCOM) for establishing a new testing method. TSIPS is now processing a MVT of papaya seed with several ISTA accredited laboratories from EU, New Zealand, Africa and South East Asia.
  4. ISTA speakers emphasize that the most important elements in the management of seedling testing is people, or so called staff. To manage the testing, one should always focus on the system or problem that one are dealing with, not the person involved there in. Try to communicate more to understand the reason why the staff is making mistakes. As an ISTA accredited laboratory, we are asked to monitor the performance trend of individual analyzer to make sure the testing results are reliable.
  5. This workshop is only for the beginner, for those who are interested in getting more information, may participate more in series of training in the future. TSIPS is looking forward to have closer cooperation with FFTC to host this kind of international workshop in Taiwan. This experience is very useful for us on applying for ISTA activities in the future.
  6. Because the seed international transportation is already a big issue now for the world, it is necessary for seed testing laboratory to set up their quality assurance through certificate like ISTA provide, FFTC and Mr. Chen from TSIPS suggested that we should cooperate more closely with ISTA in the future, to get the new standard in time, and to share our new knowledge with the world.

Highlights
Quality Assurance and ISTA Accreditation for Beginners