Engineers In The test Laboratory - Does this affect the Laboratory Scope?

Marc

Hunkered Down for the Duration
Staff member
Admin
#1
Date: Tue, 6 Apr 1999 15:33:36 -0400
From: "Peter S. Unger"
To: 'Greg Gogates'

Subject: RE: Thinking caps required!

Cindy Lawson raises an interesting issue which some in-company labs face (i.e., the use of facilities by personnel outside of the control of lab management).

The scope of a lab's desired accreditation plays an important part in answering this question. How an accreditor would assess this type of lab situation would depend on whether the R&D engineers were performing tests for which accreditation is desired. If the tests done by the R&D engineers (they are just borrowing the lab's equipment and facilities) are outside the scope of the lab's desired accreditation, then the accreditation body would only concern themselves with how the lab maintains effective control and integrity of those facilities and equipment used for accredited tests that might also be affected by the R&D intervention. Accreditation bodies would also want to be assured that R&D engineers are not issuing reports and misrepresenting them as coming from an accredited laboratory.

On the other hand, if the R&D engineers were taking part in carrying out accredited tests, they would have to demonstrate relevant Guide 25 compliance and competence to carry out those tests, just as if they were full-time lab staff. In addition, the lab's organization structure and quality system controls would be examined to see how these "subcontractors" (the R&D engineers) were trained and supervised to ensure reliable performance.

Peter Unger
A2LA President
5301 Buckeystown Pike
Frederick, MD 21704-8373
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
Marc German Engineers Fail the Paternity Test World News 4
G DFMEA buy-in strategies for Design Engineers APQP and PPAP 22
D Recommended Training for Design Engineers in IATF 16949 Cl.8.3 - Design & Development Design and Development of Products and Processes 0
C Standard for Calibration of Engineers Square General Measurement Device and Calibration Topics 2
W Engineers signing off the back of the Route Pack Card AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M True Position and MMC (Dilemma Between Engineers) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S Can you help me on manpower planning for Supplier Quality Engineers ? Misc. Quality Assurance and Business Systems Related Topics 4
J Skills and Training for Engineers: How are your Engineers selected AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
N Engineers and Managers (joke) Funny Stuff - Jokes and Humour 4
Stijloor German automakers' expansion plans hit by shortage of engineers World News 2
A Help Engineers understand the differences between Bill of Materials and Routers Document Control Systems, Procedures, Forms and Templates 9
Ajit Basrur How Engineers view things differently :) Funny Stuff - Jokes and Humour 10
M The Engineers' Christmas Funny Stuff - Jokes and Humour 2
A Society of Manufacturing Engineers - CMfgE Professional Certifications and Degrees 3
John Broomfield What do engineers do in their retirement? Coffee Break and Water Cooler Discussions 3
R How do SQEs (Supplier Quality Engineers) report in your company? Supplier Quality Assurance and other Supplier Issues 11
Q Re-Organization - A group of 15 QEs (Quality Engineers) Quality Manager and Management Related Issues 11
R Documentation Review Matrix to track all documents written by my QA engineers Document Control Systems, Procedures, Forms and Templates 4
S Licensed Quality Engineer - Which states actually license "Quality Engineers"? Quality Manager and Management Related Issues 22
Q How to Introduce a Quality Management System to Engineers? Quality Manager and Management Related Issues 16
J Control of Product Drawings - Engineers don't follow the same protocol ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
C Temporary employment agencies for temporary quality engineers and/or quality managers Career and Occupation Discussions 3
P AS9101 Supplier Audit Form - Teach and help new engineers at my company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
V What are the roles and responsibilities of quality system engineers? General Auditing Discussions 1
ScottK Are there any IIE (Institute of Industrial Engineers) members on board? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
S Design and Development Estimation and Offer - Sales vs. Engineers Design and Development of Products and Processes 2
K Soc. of Manuf. Engineers (SME)/Assoc. for Manuf. Excellence (AME) Lean Certification Professional Certifications and Degrees 4
T TV Mounting Question for Mechanical Engineers Coffee Break and Water Cooler Discussions 20
D Lean 6 Sigma book recommendations for young, inexperienced manufacturing Engineers Book, Video, Blog and Web Site Reviews and Recommendations 4
Marc Engineers Working Harder for Their Paycheck - 2006 Design News Salary Survey Career and Occupation Discussions 0
A Woman as Described by Engineers Funny Stuff - Jokes and Humour 1
P Evaluation of personnel suppliers (Contract / Temporary - Engineers) Supplier Quality Assurance and other Supplier Issues 8
A Gage R&R concept - Nearly 50% of the QC engineers rejected the part Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
S AS9100 Training Recommendations for Engineers - Seeking Reccommendations Training - Internal, External, Online and Distance Learning 3
A ISO 9001 2000 vs. Engineers - When does the Engineers responsibility end? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D SPC books for engineers who are just getting into SPC Book, Video, Blog and Web Site Reviews and Recommendations 11
D SPC training games - Basic training for manufacturing shop-floor guys and engineers Statistical Analysis Tools, Techniques and SPC 13
E MSA for Push and Pull test Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
Z IEC 60601-2-25; Frequency response test Medical Device and FDA Regulations and Standards News 0
J Confusing on Harmonic Emissions/Voltage Fluctuations/Flicker test for CISPR 11 Class A Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Routine production tests - dielectric voltage withstand test IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Test Method Validation Qualification and Validation (including 21 CFR Part 11) 4
Crimpshrine13 Laboratory Scope - Calibration vs. Test Methods - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 3
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
E Mentor for Test Method Validation (TMV) Design and Development of Products and Processes 2
L ASQ's Biomedical Auditor Course Test ASQ - American Society for Quality 1
W Regarding Requirement for Hi pot & Leakage Current test Station Set-up IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
R Regulatory Affairs Certification (RAC) prep - Practice test versus actual exam Professional Certifications and Degrees 0
R SAT (System Accuracy Test) temperature according to AMS2750E AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1

Similar threads

Top Bottom