Quality Manager wants Internal Auditor to softgrade the findings - What shall I do?

[lamorenita_QA]

Hi I need advice from covers- This may not be related to this msg. but, did not know where to look. I am lead auditor for an ISO 13485,9001 certified company.There was a recent change for the QA mgr. who did not want the job, and is now telling me I need to soften my findings during audits, I was instructed to use opportunity for improvement on major non conformance findings. I responded by saying, i was hired to be honest, and my internal audit procedure requires me to document nonconformances if they are found, I also stated that as QA Mgr. you have the authority to accept all nonconformances noted, but being a responsible auditor I could not fudge an audit. I requested that if this was required of me now, to please document in writing this instruction. The QA mgr. did not like this, and said they wanted me to prioritize the company business plan. I have talked to my VP about this, but no changes happened. This person was previously demoted, and stayed because husband is close with the owners of the company, (this is a famly run business) please advise and help me!

 

[AndyN]

Re: Auditing against a procedure you had input to

The grading of internal audits is controversial and may lead to some emotional responses. Before we can tell you anything, it would be useful to know the types of audit findings you believe are "major" - give us some examples. In my experience, unless the wording of the audit nc indicates a major issue, you won't be taken seriously. There needs to be balance in reporting. Really, you shouldn't be grading findings like this, IMHO, but if the system was set up that way it may not be yours to change.

Share some typical (names removed) nc statements here and their grading and we can review them...

 

[lamorenita_QA]

Re: Auditing against a procedure you had input to

Hi just completed an internal audit-

• work order operation out of sequence installing housing at beginning of product assy,
• date code expiration mssing on labels, no traceability(shelf life nonconformance),
• increase of part defects 9% from Q1=Q2 (no corrective action addressed)
• missing product work order
• solder process not performed to mfg work instruction (special process not documented)

These are some of the samples that I was instructed to record as observations or opportunities for improvement- as far as our internal audit process, Our CB gave it the only positive finding from our re-certification audit in june. We received 1 major, and 9 minor findings, I have been the 3rd lead auditor in 4 yrs, i am undecided on how to deal with this. please advise

 

[amit_rd]

Re: Auditing against a procedure you had input to

Hi just completed an internal audit-

• work order operation out of sequence installing housing at beginning of product assy,
• date code expiration mssing on labels, no traceability(shelf life nonconformance),
• increase of part defects 9% from Q1=Q2 (no corrective action addressed)
• missing product work order
• solder process not performed to mfg work instruction (special process not documented)

These are some of the samples that I was instructed to record as observations or opportunities for improvement- as far as our internal audit process, Our CB gave it the only positive finding from our re-certification audit in june. We received 1 major, and 9 minor findings, I have been the 3rd lead auditor in 4 yrs, i am undecided on how to deal with this. please advise

You are stuck in a tricky situation. I completely understand that its easy to say than do, but I will take the risk to advice you following:

1. Is it possible for you to redefine your audit procedure which describes responsibilities so that you are only responsible for identifying observations and then the management rates it to major/minor/OFI.

This way your integrity will remain intact and those accountable for rating NCs will also get the taste of truth.

2. Is this manager taking actions for the OFIs ( I mean major converted to OFI), If not, your procedure may address that actions are mandatory irrespective of the rating and this as well will help you solve the problem to certain extent.

I hope it works for you, best of luck.

 

[lamorenita_QA]

Re: Quality Manager wants Internal Auditor to softgrade the findings - What shall I d

Thank you for our advice, during this discussion I did mention to my QA mgr. to revise our internal auditing procedure by removing the auditors discretion in assigning the class of finding, giving this responsibility to the Qa mgr only, she did not like this suggeston, she wanted me to start using only observation or OFI's on audit reports. I think we are at a standstill, because she wanted me to do this without any record of her decision. Should I cave in? please advise.
Thank you in advance for any advice.

 

[Big Jim]

Re: Quality Manager wants Internal Auditor to softgrade the findings - What shall I d

Thank you for our advice, during this discussion I did mention to my QA mgr. to revise our internal auditing procedure by removing the auditors discretion in assigning the class of finding, giving this responsibility to the Qa mgr only, she did not like this suggeston, she wanted me to start using only observation or OFI's on audit reports. I think we are at a standstill, because she wanted me to do this without any record of her decision. Should I cave in? please advise.
Thank you in advance for any advice.

Your integrity is not appreciated. You have bent over as far as any reasonable person would require. Dust off your resume. In your letter of resignation tell them that your integrity is more valuable than they seem to think it is.

Good luck!

 

[AndyN]

Re: Quality Manager wants Internal Auditor to softgrade the findings - What shall I d

Only the process owner for the procedure should authorize such a change - so if that's you, you may have little option. If it's the QA manager, then she'll have to authorize it and it's off your back!

 

[Sidney Vianna]

Re: Quality Manager wants Internal Auditor to softgrade the findings - What shall I d

Should I cave in? please advise.
Thank you in advance for any advice.

You mentioned ISO 13485 certification. Is the organization under FDA's jurisdiction? If so, be very careful.

Softgrading findings under ISO 13485 would be unethical, as you mentioned. Softgrading findings under the FDA QSR 820 could be a criminal act and legal consequences very severe.

Why don't you send an email to the QA Mgr. explaining why you don't feel comfortable softgrading the findings? When things start to be written and records could be subpoenaed, people tend to back off from inducing others to do unethical acts.

 

[ssz102]

Re: Auditing against a procedure you had input to

Hi just completed an internal audit-

• work order operation out of sequence installing housing at beginning of product assy,
• date code expiration mssing on labels, no traceability(shelf life nonconformance),
• increase of part defects 9% from Q1=Q2 (no corrective action addressed)
• missing product work order
• solder process not performed to mfg work instruction (special process not documented)

These are some of the samples that I was instructed to record as observations or opportunities for improvement- as far as our internal audit process, Our CB gave it the only positive finding from our re-certification audit in june. We received 1 major, and 9 minor findings, I have been the 3rd lead auditor in 4 yrs, i am undecided on how to deal with this. please advise

hi,your product is wire-harness too?
these findings are belong to executive force is not enough from your descriptions, i think the requirements are statemented in your documents

however, your QA mgr and related leader thought it too trouble, so they didn't think it necessary do
if you try to anaysis the results or impact cause by these problem show them, then let them decide whether do or not, is that appropriation?

 

[Weiner Dog]

Re: Quality Manager wants Internal Auditor to softgrade the findings - What shall I d

Good day-

What you are struggling with, I have also personally struggled. This is why I'm now a contractor and consultant, instead of working at an actual medical device company. In a nutshell, I see top management (who hired the QA manager) hold internal concerns (basically ego, greed, ignorance, etc.) over the need to balance regulatory and quality compliance. They will get away with it in the short term, but they will eventually get caught and penalized. With the democrats back in office, FDA is back in the compliance mode.

Do not do anything illegal. Do not softgrade your findings. If the QA manager wants to softgrade them, let him/ her do it and do not sign the revised report.

Maybe, it's time to move on? You can not change these people. I tried when working for 2 orthopedic companies. For one of them, my boss shortly quit after me and our boss had a new career making license plates...

George