Comparison between ISO/IEC 17025 accredited laboratory and GLP recognized laboratory

I would like to introduce the similarities and differences between GLP and ISO 17025 requirements as follows.

Scope:
GLP is developed for conducting non-clinical laboratory studies that support applications for research or marketing permits for products regulated by the FDA.

ISO 17025 applied to all laboratories where testing and/or calibration are performed and/or formed part of inspection and product certification. In principle, ISO 9001 is adopted in ISO 17025.

Similarities between both requirements:
i) Requirements on organization and personnel
ii) Requirements on equipment, sampling and validation
iii) Requirements on reporting / record and control of records

A schematic diagram showing the overlapping and specific requirements between an ISO/IEC 17025 accredited testing laboratory and an OECD GLP facility.

(Source: Engelhard T. et al., 2003)

The differences are shown in the following table.


ISO/IEC 17025 accredited laboratory has approximately 70% of the managerial and technical issues of the GLP directives covered, while 30% can be provided as an extension of the existing laboratory quality management system.

The simple checklists for preparing HOKLAS (Hong Kong Laboratory Accreditation Scheme) ISO 17025 accreditation and GMP audit are shown as follows:

Checklist for HOKLAS assessment:
1. Documents authenticating that the applicant laboratory is a legal entity or part of a legal entity
2. Quality manual & Operation procedure manual
3. Latest audit schedule
4. Summary of the findings of the latest quality and management system review
5. Test/calibration procedure manual(s)
6. Measurement uncertainty estimation
7. CV’s and copies of qualification documents for new nominees for signatory/operator approval
8. Laboratory floor plan
9. Laboratory organization charts, with key positions clearly identified
10. Sample test/calibration records
11. Sample test/calibration reports
12. Relevant proficiency test reports
13. Scope of accreditation to be assessed
14. Other documents (please specify)

Checklist for GMP audit (included GLP):
1. Business Registration Certificate
2. Floor plan
3. Organization chart, personnel qualification and signature record
4. Information sheet of key personnel (Authorized Person, QC manager and Production manager)
5. No. of full time and part time staff for manufacturing, QC and packaging
6. Full product list (with breakdowns of dosage forms & formulations)
i. Type of sterile pharmaceutical dosage (such as eye drops, single-dose injections, etc.)
ii. Other type of pharmaceutical dosage (such as tablets, capsules, powders, etc.)
7. List of major production equipment and QC equipment
8. Validation schedule of manufacturing processes and test methods
9. Stability study schedule
10. Others


Reference:
21CFR58: GLP for Non-clinical Laboratory Studies
ISO/IEC 17025: General requirement for the competence of testing and calibration laboratory
Engelhard T., Feller E. & Nizri Z. (2003) “A comparison of the complimentary and different issues in ISO/IEC 17025 and OECD GLD” Accred Qual Assur, Vol. 8, pp208-212.

The Institute of Industrial Engineers (Hong Kong) visiting Technology Support Centre (TSC) in Science Park

A technical visit to TSC in Science Park was organized by The Institute of Industrial Engineers (IIE) on 15th January 2010. IIE (HK) has developed from its origin as an offshore chapter of the American Institute of Industrial Engineers to an affiliated member of the worldwide Institute of Industrial Engineers representing Industrial Engineering professionals in Hong Kong. The visitors included HKU students, and HKUST students and a professor.

I gave a talk regarding the implementation of Quality and Safety Management System in TSC. After that, our different laboratories were introduced to them in a tour, including Probe and Test Development Centre, Reliability Laboratory, Wireless Communications Test Laboratory, IC Failure Analysis Laboratory, Solid State Light Laboratory and Material Analysis Laboratory, as well as, Biotechnology Support Laboratory.

After the visit, we took a group photo under the golden egg.



Finally, I obtained a souvenir from Mr. Harry Li (President of IIE, HK).

For more information of IIE and TSC:
http://www.iiehk.org/introduction/
http://lab.hkstp.org/default2.asp

Visit to China Factories of TCL Corporation and Eastech Asia Technology Limited

I visited TCL Corporation and Eastech Asia Technology Limited on 8 Jan 2010, which was organized by HKSQ. The event was summarized below.

We firstly arrived at TCL Corporation which was established in 1981. TCL is a global leader in consumer electronics, mobile communications and home appliances (e.g. DVD player, recorder and Blu-ray recorders).

Our Vice-chairman (Humphrey Lee) introduced Hong Kong Society for Quality to TCL during the visit.


Then a representative of TCL showed the background of the company and its quality management system. TCL is the abbreviation of “The Creative Life” (In Chinese terms: 創意感動生活). TCL has 20 manufacturing and processing plants located in various countries including China (7x), Poland, Mexico, Thailand and Vietnam.

They encouraged the usage of 3 Wins Business Model (including TCL, Customer and Supplier). 4 pillars quality framework were also discussed. They are:
DQ – Development Quality
SQ – Supplier Quality
IQ – Industrial Quality
FQ – Field Quality

Another representative of TCL gave us a brief of TPM (Total Production Management).

There are 8 key improvement items that TCL achieved in 2009 as follows:
i) Reduction of WIP
ii) Improvement of efficiency
iii) Suggestion of improvement
iv) OPL (One Point Learning) – Knowledge and Experience Accumulation
v) Quality failure analysis
vi) Lesson of improvement
vii) Faster talent training system
viii) Concurrent development

Faster talent training system was showed as follows.

Factor visit path

We need to wear a pair of antistatic slippers (ESD protection) before entering the plant.

After the tour, I, on behalf of HKSQ, presented the souvenir to TCL representative to express our appreciation on the visit arrangement.

Lastly, we took a group photo in front of TCL Corporation.

(P.S. Two sentences in conference room were found quit interesting and recorded as follows:
講自己, 不講他人! 講主觀, 不講客觀! 講內因, 不講外因!
所有的麻煩都是我們自己造成的, 也是我們自己可以掌控的. )

After lunch, we went to the Eastech Asia Technology Limited, which was founded in 1971. It specializes in manufacturing audio, video, acoustics and information/internet electronics products for consumer and commercial applications (e.g. Home-Theatre-in-a-Box (HTiB), Blu-ray receiver, DVD Music Centre, Sound Bar, Speaker Systems, etc.).

As usual, Humphrey briefed the objectives and mission of HKSQ to Eastech at the beginning.

And then a representative of Eastech introduced their quality management system to us.

He said that Lean concept was employed to enable the driving force of continuous improvement in the following areas:
i) Productivity improvement
ii) Quality improvement
iii) Cost and inventory reduction
iv) End-to-end cycle time reduction
v) Work force engagement

The 12 paradigms of “simple PHILIPS Leadership” (also called Lean Leadership Paradigms) were mentioned as following.
i) Long-term focus on purpose
ii) Market-in (flow & pull)
iii) Overall optimization (reduce waste)
iv) Standards enable continuous improvement
v) Make the problem visible
vi) Stop and fix the problem
vii) People as assets
viii) A leader is a teacher
ix) Go see for yourself on the gemba
x) Why? Why? Why? Why? Why?
xi) Plan slowly, act quickly
xii) Everybody solves problems

During the tour, Eastech staff explained the implementation of the quality system to us.

One special thing we observed was the burn-in testing. Since so many products were subject to the test, the capacity of traditional temperature chamber was found not enough. They modified a room to become a burn-in chamber (with setting at 40C) for mass testing.

After that, we moved to Eastech model line (O-ring) for small volume production. By applying Lean principle, staff stood during work to improve the efficiency. Staff were allowed to have a 10 min rest per 2 hr. Dr. Chin and I took a photo of model line.

Finally, I presented the souvenir to Eastech representative for their kindly arrangement.

We took a group photo in front of Eastech Asia Technology Limited.

(P.S. We also found two sentences in conference room which were meaningful and recorded as follows:
公司願景: 以熱忱的承諾, 改善人們於視聽娛樂的生活模式.
勤奮 節儉 創新 納賢 )

The photo showed our return and CP Chow (HKSQ past chairman) was our visit coordinator.

For more information of the visited companies:
www.tcl.com
www.eastech.com