Many Hats - Responsibilities Conflict of Interest

Jerry Eldred

Forum Moderator
Super Moderator
#1
I looked in my "draft" version of ISO 17025, and in 4.1.4 j., NOTE 3 it said that "..in laboratories with a small number of personnel, individuals may have more than one function and it may be impractical to appoint deputies for every function."

I am not a 17025 expert. But it doesn't appear to be an issue. There are probably many companies out there with one man labs (I have run a few of them over the years). And even in mid-size labs, there aren't always enough people around to have a separate person fill each job title.

I think one of the key issues is that there shouldn't be conflicts of interest. You may need to be sure and have an auditor from another area (if you have dedicated QA auditors in a QA dept or equivalent) audit the lab periodically. That would be the external person to assure conformance.

In 4.13.1, it says, "...audits shall be carried out by trained and qualified personnel who are, wherever resources permit, independent of the activity being audited."

The part about "...wherever resources permit..." is the allowance for smaller operations, who don't have resources for separate personnel to be able to audit themselves. The hard line philosophy seems to me to have come from the MIL-STD days when DCAS was really hard lined about believing all contractors were out to steal from the government (some of them were).

But I think times have changed in that it is expected that people have integrity, and we should reasonably guardband when it makes sense. But not in all cases does it actually make sense.

So my layman's take on this is that it is acceptable to wear multiple hats within the lab. The un-acceptable course would be that the lab can't be run by production departments, marketing, finance, or other departments who would have a potential conflict of interest (i.e.: production needs to get product out the door, finance has to keep costs as low as possible, etc.).

Hope this is of some help.

------------------
 
Elsmar Forum Sponsor
D

D.Scott

#2
I don't see a problem unless there is something specific you haven't mentioned. 17025 requires that someone with suitable knowledge and experience be in charge. They must possess the required professional skills to do the job. There is no restriction on what this person can be called (quality manager, head person, work leader etc.) The only requirement is that this person serve as the technical head. If the QM is the work leader and head calibration person, and also cleans up at night, I see no problem.

Maybe some of the others have had some real life audit experience with this and can shed some other light.

Hope this helps.

Dave
 
J

JerryStem

#3
I am the Quality Manager here, and also the Calibration Standards Dept. Mgr. (There is also a Service Dept. Mgr.) We do service/calibrations of coating/plating thickness measurement equipment here, the machines (Service) and the calibration standards for them (Standards).

We are Guide 25, working on 17025. Our auditor had no problems with us (there are ~8 employees,including owner and wife/accountant).

I am going thru 17025 right now and do not remember seeing anything different in this area. (Other areas, on the other hand...)

Jerry
 
R

Ryan Wilde

#4
There are a few "one person cal labs" that are accredited to Guide 25/17025 right now that I know of offhand. Being the person that does everything is not a conflict of interest, although it is a huge task to take onto your shoulders.

As far as the QA Manager reporting to the lab supervisor, that depends. If the QA manager is the person that ensures the quality of calibration results (through spot checks, etc.), then yes, generally that person fills a function under the lab supervisor. If you are speaking of the person that writes and ensures the quality SYSTEM, then the general answer would be no, he/she would generally report directly to upper management. In most cases, QA is a department unto itself. In the case of a rather sizeable aircraft company in the Pacific Northwest, it is the most feared entity in the company, and it reports way up the corporate food chain.

Ryan
 
Q

qaadrian

#5
Many Hats

Supervision has just authorized one person to be a quality manager, a work leader over the calibration lab and also the head calibration person (calibrates all types of equipment). Wouldn't this be a case of conflict of interest? What does ISO 17025 say about this? Supervision says that a shortage of manpower forced him to make this decision.

Also, should the QA Manager report to the supervisor over the calibration laboratory? Does 17025 provide any guidance? Thanks.
 
Thread starter Similar threads Forum Replies Date
J Defined responsibilities in a small company where people wear many hats ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Crusader How many hats do you wear at work and how do you cope? Coffee Break and Water Cooler Discussions 37
I How many gauges in a Go/No Go Gauge? General Measurement Device and Calibration Topics 7
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
Watchcat How Many Notified Bodies are "Enough" Already? EU Medical Device Regulations 18
S How many mandays required for the below mentioned standards IEC 27001 - Information Security Management Systems (ISMS) 3
N MDR review process by notified body - How many steps exist in the review process EU Medical Device Regulations 0
F How many signatures do we need on calibration certificates? ISO 17025 related Discussions 8
M Informational From RAPS – Operating System Vulnerabilities in Many Medical Devices, Germany’s BfArM and Device Firms Warn Medical Device and FDA Regulations and Standards News 0
R Validation of Medical Device Hardware containing Software - How many to Validate ISO 13485:2016 - Medical Device Quality Management Systems 1
K How Many Samples to send for Chemistry Testing Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
N MDSAP Participants 2019 - How many companies are participating YTD? ISO 13485:2016 - Medical Device Quality Management Systems 20
S How many of you are using Robotic process automation for calibration lab management? ISO 17025 related Discussions 0
G Measuring customer parts on a CMM - How many decimals to report to the customer? ISO 17025 related Discussions 28
J Supplier choice limitation - Many of them dont have PSCR, VDA or even ISO 9001 VDA Standards - Germany's Automotive Standards 0
O Clean room performance qualification (pq) - How many times can I do each test? Manufacturing and Related Processes 8
G How many samples you require to test during PQ for validation of a equipment? ISO 13485:2016 - Medical Device Quality Management Systems 1
D IATF 16949: Do we have too many processes? Are they all the same? Registrars and Notified Bodies 7
D QMS Performance Based on how many NCRs were generated month to month Nonconformance and Corrective Action 8
S How many QMS processes and procedures? ISO 13485:2016 - Medical Device Quality Management Systems 2
L How many of you are Certified to IATF 16949 IATF 16949 - Automotive Quality Systems Standard 12
G How many Uncertainty Measurements for Micrometers and Calipers? Measurement Uncertainty (MU) 3
R How many Corrective Action Request can be Issued by DCMA for a single issue? Nonconformance and Corrective Action 2
A Training Program Help - Old docs, new docs, so many docs... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M How many Pieces to Test - Sterility Testing USP EU Medical Device Regulations 2
P Are we an outlier for so many variations of Change Management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M SPC with many data points from one dimension Statistical Analysis Tools, Techniques and SPC 16
S How many times do you have the term 'Requirements' in your Quality Manual? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
L How many working hours to required to implement ISO 14001 ? ISO 14001:2015 Specific Discussions 6
B ISO/TS16949 Internal Auditing - How many auditors? Internal Auditing 4
R Training Production Employees When We Have SOOO Many SOPs Training - Internal, External, Online and Distance Learning 9
P Scope Extension Audit - How many days? Do I audit all AS9100 requirements? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J How can I manage Occurence Rates in FMEA efficiently when I have many processes? FMEA and Control Plans 9
V How many times the quality agreement has been invoked? ISO 13485:2016 - Medical Device Quality Management Systems 3
C How to document many document control systems with one Document Control Procedure? Document Control Systems, Procedures, Forms and Templates 6
A How many laboratories are accredited to ISO 17025 in the USA? ISO 17025 related Discussions 5
R Is it possible to randomly select samples from 1 column to many column Using Minitab Software 2
L How many ISO Standards are there and time allowed for Closing NCs? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S How many mandays are required for QMS audit? Internal Auditing 5
Ajit Basrur FDA - "We Moved Forward on Many Fronts This Year" - Margaret A. Hamburg, M.D. US Food and Drug Administration (FDA) 1
F AS9100 - How many times can the same auditor audit your system AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
J APQP Project Management in Excel - Many projects APQP and PPAP 8
S How many production runs will it take for SPC monitoring to stop? Statistical Analysis Tools, Techniques and SPC 10
M How many documents total do you currently have? Document Control Systems, Procedures, Forms and Templates 6
N How to Fix this Problem that is caused by so many different issues... Quality Tools, Improvement and Analysis 20
Ajit Basrur GHTF Releases many documents on Nov 5, 2012 ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 8
T How many complaints, defects and non-conformances are typical? Customer Complaints 5
A How many processes for an FDA Quality System (QSR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
B How many days after an interview should I follow up on the status of the interview? Career and Occupation Discussions 10
somashekar How many trials at least ... Brain Teasers and Puzzles 1

Similar threads

Top Bottom