Production signing off on their own work

B

Bekka

#1
Hello,
I have a question that I can not find the answer to here on Cove or anywhere else. We are a medical device manufacturing company with a class 2 device. We adhere to CMDR, ISO 13485:2003 FDA 820. I am the internal auditor and was auditing when I seen a form with production performing a functional check an the final QC then signing the final QC acceptance( the same person) then QA having final release. From previous auditor I was told that production can not sign off on their own work. I spoke to my QA Directory and QA Manger and we started digging into the standards to see if we could find a clause in the standards that said anything of this. The Directory thought it was against the Cgmp's but again I could not find any objective evidence of this. Can production perform a functional check then sign off on it and accept it with QA having the final release?
Thank you for any help :)
 
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M

MIREGMGR

#2
There is no requirement in 21CFR 820 that Production and Quality even be divided. All that a final acceptance system (under 21CFR 820.80) has to do is ensure that all production of finished devices meets (pre-defined) acceptance criteria, plus a few details.

The general guideline that Production and Quality be divided originates in the universal good-management recognition that people and systems don't perform at their best when they have conflicting motivations.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
If I'm not mistaken it's part of the TQM (Total Quality Management) methodology that the highest level of quality management is when everybody act as their own QA.

In other words: "who will guard the guards?..." Instead of adding more and more layers and cross-checks, it's much more efficient to invest in a cultural change towards own-scrutiny. I am aware though that this ideal is very hard to put into practice!...
 

Wes Bucey

Quite Involved in Discussions
#4
Hello,
I have a question that I can not find the answer to here on Cove or anywhere else. We are a medical device manufacturing company with a class 2 device. We adhere to CMDR, ISO 13485:2003 FDA 820. I am the internal auditor and was auditing when I seen a form with production performing a functional check an the final QC then signing the final QC acceptance( the same person) then QA having final release. From previous auditor I was told that production can not sign off on their own work. I spoke to my QA Directory and QA Manger and we started digging into the standards to see if we could find a clause in the standards that said anything of this. The Directory thought it was against the Cgmp's but again I could not find any objective evidence of this. Can production perform a functional check then sign off on it and accept it with QA having the final release?
Thank you for any help :)
The previous auditor was a victim of "mission creep" - adding non-existent requirements and claiming them to be "required." Whenever you have such a question, resort to the tried and true mantra of a Cove member:
"SHOW ME THE SHALL!"

meaning "produce the citation of chapter and verse that shows this is a requirement." In fact, although this is NOT an ISO or FDA requirement, it "might" be an organization's own requirement. Even then, it should be written somewhere, NOT someone's interpretation.
 
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B

Bekka

#5
Thank you Wes... I have been battling the previous auditor and thier interpertation of the standards for quite awhile now and I have adopted the show me attitude as well. But this one kinda got me, the Directory and Manager as they thought it was written as well...This makes things alot easier...yahoooo!:thanx::thanx::thanx::thanks:
 

Wes Bucey

Quite Involved in Discussions
#6
Thank you Wes... I have been battling the previous auditor and thier interpertation of the standards for quite awhile now and I have adopted the show me attitude as well. But this one kinda got me, the Directory and Manager as they thought it was written as well...This makes things alot easier...yahoooo!:thanx::thanx::thanx::thanks:
That said, you may be interested in a relatively recent post of mine which refers to two much earlier posts which include the topic of eliminating separate inspectors and empowering operators (when adequately trained to be competent) to perform on-the-spot inspections, eliminating lag time between production and inspection and therefore also eliminating the possibility of making more non-conforming product during the lag time.
I not only preached this; I practiced it! See
http://elsmar.com/Forums/showpost.ph...9&postcount=18
and
http://elsmar.com/Forums/showpost.ph...6&postcount=20

especially in post 18, where I write, emphasis added Quote:
We had no quality inspectors (we did have quality trainers and guys who acted as "court of last resort" when a question would arise.) Operators did own first article inspections, based on control plan/inspection plan agreed with customer as part of contract review. Another operator would perform a redundant first article inspection with different inspection instruments. Marked sample with BOTH inspection reports was sent to customer for confirmation before production began.

In-process inspection, SPC, etc. was performed by operator in real time. If nonconformance was discovered, production would halt - all operators would collaborate on finding and curing cause, only calling in outside help if solution eluded them. Inspection records, charts, etc. went right to computer where they were available in real time to in-house folk and customers.

Operators had autonomy to bring in experts from our suppliers of material, capital equipment, and expendable tooling to stay up to date on industry innovation. Sometimes, we shut the whole shop down and chartered a bus to take us to the International Machine Tool Show to spend the day.

If an operator wanted to see a customer's operation and how his product was used, we made it happen. Similarly for a supplier's operation.

As almost any consultant will agree, the crux of streamlining an organization's operation lies in the mental attitude of the top leaders. Despite what some soothsayers may say or write, it is extremely rare for the tail to wag the dog, meaning staff members do not initiate projects with any hope of success unless the top management makes a real commitment to support the initiative (this means tangible ACTION, not "lip service.")

In other posts, I have discussed the evolution of automated inspection and data entry, beginning with hard wiring inspection instruments directly into computer networks and using bar code scanners throughout the production to track the status of an order, progressing up to WIFI and RFID. Each change to the process requires FMEA (Failure Mode & Effects Analysis), economic analysis and ROI. Certainly, using mistake proofing tools like inspection jigs and specialized instruments is a good step in the right direction for increasing the efficiency and effectiveness of the ENTIRE production cycle, from handling quotations and procuring raw materials up through and including packaging, shipping, and collecting payment.
 
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