Writing appropriate ISO 13485 Audit Report Findings

[QAengineer13]

Hello all,

During the audit session it was identified that the manager was not familiar with the procedures although he has been trained before, in my report what would be a better positive way of writing the finding against the manager .

" The auditee was not familiar with the XXXX procedures , recommendation for refresher training " ...will this be appropriate.

any recommendation/suggestion?

Thank you.

 

[AndyN]

Hello all,

During the audit session it was identified that the manager was not familiar with the procedures although he has been trained before, in my report what would be a better positive way of writing the finding against the manager .

" The auditee was not familiar with the XXXX procedures , recommendation for refresher training " ...will this be appropriate.

any recommendation/suggestion?

Thank you.

Before you do this, may I suggest that you go back and ask this person WHAT they do? Also, ask for evidence of the RESULTS of what they do and see if it's working well. Then compare what they do to what's written down. Did you ask them why they aren't following the procedure? Did you ask them if they helped to create the procedure and if it's even close to being a good description of what they do?

You have not done, IMHO, a complete or effective internal audit. You have, BTW, jumped to a huge conclusion, based purely on an assumption that refresher training is the answer - NOT YOUR JOB!

Sorry to be blunt, but your management will take this the wrong way unless you go back and do what is really required of you as an auditor...to provide them with a service.

 

[QAengineer13]

Before you do this, may I suggest that you go back and ask this person WHAT they do? Also, ask for evidence of the RESULTS of what they do and see if it's working well. Then compare what they do to what's written down. Did you ask them why they aren't following the procedure? Did you ask them if they helped to create the procedure and if it's even close to being a good description of what they do?

You have not done, IMHO, a complete or effective internal audit. You have, BTW, jumped to a huge conclusion, based purely on an assumption that refresher training is the answer - NOT YOUR JOB!

Sorry to be blunt, but your management will take this the wrong way unless you go back and do what is really required of you as an auditor...to provide them with a service.

Thanks Andy for your input.

I did not provide the whole scenario in the forum, see below

The R& D manager who is in charge for a design change project, was not able to present how the project was initiated and what procedure from QMS was referred to and used and the different components of of 820.30 which are applicable for the Design change and the evidence of QMS supporting design control internal procedure, there is a gap.

He mentioned the project was handed over to him few months back, so I asked the next question was there a proper handover and whether it was documented and no records existed, and hence my recommendation which I was intending to write was

"" The auditee was not familiar with the XXXX procedures , recommendation for refresher training " .

I believe that if you are a team leader and managing personnel for project and the leader himself is not aware about the QMS procedures its a huge gap which needs to be addressed ASAP. Do you agree?

 

[Golfman25]

Thanks Andy for your input.

I did not provide the whole scenario in the forum, see below

The R& D manager who is in charge for a design change project, was not able to present how the project was initiated and what procedure from QMS was referred to and used and the different components of of 820.30 which are applicable for the Design change and the evidence of QMS supporting design control internal procedure, there is a gap.

He mentioned the project was handed over to him few months back, so I asked the next question was there a proper handover and whether it was documented and no records existed, and hence my recommendation which I was intending to write was

"" The auditee was not familiar with the XXXX procedures , recommendation for refresher training " .

I believe that if you are a team leader and managing personnel for project and the leader himself is not aware about the QMS procedures its a huge gap which needs to be addressed ASAP. Do you agree?

I would disagree. You don't need the guy quoting chapter and verse of a particular procedure. Just let him explain what he does and if he delegates a task, have the delegate explain. If the project was handed to him and the transfer was not properly documented, is he even responsible for the documentation? Or is that on the person who transferred it? Sometimes you have to lead them to the answer -- i.e.; do you have this form? Then compare what the people explained with the procedure/requirement and go from there.

 

[AndyN]

He mentioned the project was handed over to him few months back, so I asked the next question was there a proper handover and whether it was documented and no records existed, and hence my recommendation which I was intending to write was

"" The auditee was not familiar with the XXXX procedures , recommendation for refresher training " .

I believe that if you are a team leader and managing personnel for project and the leader himself is not aware about the QMS procedures its a huge gap which needs to be addressed ASAP. Do you agree?

I don't agree with your summary that refresher training is correct. You are anticipating why someone wouldn't (apparently) be able to quote chapter and verse is due to training. There are countless reasons for that, including that some folks just don't audit well! It might even be your approach to the audit! This person may not take you seriously, because you didn't sit down with them before the audit, plan it with them and then, when you arrive to do the audit, they aren't going to support you and may come across as "casual" about the whole thing! Believe me, been there, done that...

 

[QAengineer13]

I really appreciate your inputs, if you join a company new and perform an internal audit in your second week, the least you will expect from the auditee who has been with the company for 10 years or long to atleast mention where the procedure are controlled and take a print out and walk through the procedure even if they don't remember the number or the process flow.

@ Golfman25 : I did not expect him or anyone for that matter to quote a chapter or a verse of a particular procedure the least I was expecting him is to explain for which he struggled or not even bother to get the internal procedure for reference. I agree he is not responsible for the documentation pertaining to transfer.

This is preliminary.I will help them and work with them to make them better for audit in the future.

I reckon it was premature of me to say refresher training! (Point taken)

 

[Jen Kirley]

I really appreciate your inputs, if you join a company new and perform an internal audit in your second week, the least you will expect from the auditee who has been with the company for 10 years or long to atleast mention where the procedure are controlled and take a print out and walk through the procedure even if they don't remember the number or the process flow.

I would expect the manager knows what needs to be done, perhaps not to lead me through the process using the procedure as a tool unless that manager owns the procedure(s). Does he?

It comes down to responsibility and authority. The auditee is audited to the extent and depth that his or her responsibilities and authorities apply. I will expect a supervisor who does housekeeping inspections to access the current form in the system, but it's about the system's ease of accessibility as much as that person's training.

 

[ctregoning]

This is what is difficult about internal auditing. I have had the same findings and it is difficult. The person may be able to do their job but if an outside auditor comes in and finds that this person cannot explain how they do their job according to the written procedure, there very well could be a nonconformity. Your job is to find things BEFORE the outside auditors do. But I suggest you maybe make this an "observation" since perhaps the person was having a bad day.

That said, maybe you could say, "the audit found an employee who seemed to be somewhat unclear on XYZ procedure."

We all tend to just do our jobs and may have difficulty saying how we do our jobs as per the procedure. But that could be deadly during an outside audit.
I never recommend a solution to the finding(s); that is not the job of the auditor. Our job is to report the findings. Findings are a good thing! Better you find them that the outside auditor! Your company and probably this manager would be THANKFUL you found them and not the FDA inspector.
Just my humble opinion.

 

[John Broomfield]

QAEngineer,

Many QA professionals expect managers to be familiar with their precious procedures and, like you, they want to cite any lack of understanding as a nonconformity.

First, those responsible for the process must understand the process and its requirements for effective planning, operation, control and monitoring. The documented parts of the procedure for doing this should belong to them (not you) and it should reflect the reality of the work (aka process). Many documented procedures are works of fiction.

Second, any failure of training is a process problem, not a personal problem; although training includes selecting the right people!

But, as auditor, I would focus not on theoretical knowledge but on the practical aspects of them monitoring their processes. How do they know it is effective? What do they expect to see to correct a nonconformity? Have they initiated corrective action to remove the reasons for frequent correction? Clause 8.2.3 is much more useful to everyone concerned.

Any nonconformity statement should state three things

• The applicable requirement;
• The evidence of not meeting the requirement; and
• The nature of the nonconformity.

Your claimed nonconformity does not come close to being complete, clear and correct.

John

 

[QAengineer13]

This is what is difficult about internal auditing. I have had the same findings and it is difficult. The person may be able to do their job but if an outside auditor comes in and finds that this person cannot explain how they do their job according to the written procedure, there very well could be a nonconformity. Your job is to find things BEFORE the outside auditors do. But I suggest you maybe make this an "observation" since perhaps the person was having a bad day.

That said, maybe you could say, "the audit found an employee who seemed to be somewhat unclear on XYZ procedure."

We all tend to just do our jobs and may have difficulty saying how we do our jobs as per the procedure. But that could be deadly during an outside audit.
I never recommend a solution to the finding(s); that is not the job of the auditor. Our job is to report the findings. Findings are a good thing! Better you find them that the outside auditor! Your company and probably this manager would be THANKFUL you found them and not the FDA inspector.
Just my humble opinion.

Thank you, I am glad you were able to relate to my situation! I agree with you, my job is to help the team with findings and continuously improve our process and system.