Not having an internal audit during the year

[PVMRS]

I agree with pkost. handle the issue with non-conformance / deviation system. At the same time, collect all the information about the on-line deviations, QA review observations on different processes / documents, failure investigations, conformance reports of your last year audit observations etc., during the year and their corrective actions on each of the observations which will help you to justify to auditor that your QMS is in state of control.

This will enable you to explain auditor better to avoid a major observation during audit.

as a preventive action, make a compulsory agenda point in management review meetings such that it will not miss and management focus will be there on audit observations.

 

[AndyN]

This will enable you to explain auditor better to avoid a major observation during audit.

If I were a betting person, I wouldn't put money on it. If the CB auditor sees no audits were done during the year, then that's how it's going to be recorded. As such, it will read like a major (which it is). There's zero way to paint it any other way. In fact, it's of benefit to the organization to give management the wake up they likely need...

 

[Eredhel]

Some of the quality changes I've wanted to implement here I have had to make the conscious decision to let customers and/or auditors drive them. When you have a chance to let someone else be the bad guy to your company, let them do it.

 

[mtespiritu]

What Randy said. You will be having a difficult certification audit if you can not provide evidence of doing at least some internal audits. Most expectations is this is done at least annually, but as Randy states, what does your procedure say - as you might be in nonconform with your own procedure.

I have posted a similar question to this one and I would like to clarify my understanding again especially on the "frequency/periodic" requirement for the internal audit programme. We have an internal audit procedure and mentions the frequency of internal audits. However, the common documented evidence asked by our external auditors is a calendar where the planned audits are plotted. Even if I plot a quarterly schedule, when these are delayed even for a few days, I believe that these becomes unnecessary nonconformities. Am I correct? After all another requirement is records as evidence for the audit programme implementation and these could easily be proved by internal audit reports.

 

[Jim Wynne]

I have posted a similar question to this one and I would like to clarify my understanding again especially on the "frequency/periodic" requirement for the internal audit programme. We have an internal audit procedure and mentions the frequency of internal audits. However, the common documented evidence asked by our external auditors is a calendar where the planned audits are plotted. Even if I plot a quarterly schedule, when these are delayed even for a few days, I believe that these becomes unnecessary nonconformities. Am I correct? After all another requirement is records as evidence for the audit programme implementation and these could easily be proved by internal audit reports.

Your question was answered by @John Broomfield in the other thread, no?

 

[Johnnymo62]

I think the frequency/periodic issue should be handled in a procedure listing these. Like John B listed.

You may specify your own criteria, for example:
1. Audit every process at least once a year
2. Audit the critical processes every quarter
3. Audit the new processes within their first month of operation
4. Adjust the frequency according audit results

An internal audit schedule can be a separate item. It can be a "live" editable schedule. I have used a spreadsheet that spreads them out through the year. I have given myself the flexibility to move them around and not have closing time requirements.

This has passed numerous audits.

 

[John C. Abnet]

I have posted a similar question to this one and I would like to clarify my understanding again especially on the "frequency/periodic" requirement for the internal audit programme. We have an internal audit procedure and mentions the frequency of internal audits. However, the common documented evidence asked by our external auditors is a calendar where the planned audits are plotted. Even if I plot a quarterly schedule, when these are delayed even for a few days, I believe that these becomes unnecessary nonconformities. Am I correct? After all another requirement is records as evidence for the audit programme implementation and these could easily be proved by internal audit reports.

Yes. You are correct. Ask the registrar to show where the standard requires a "calendar" (it does not).

Actually, IF a "calendar" schedule approach is used, it STILL must show that consideration has been given to the defined inputs and risks, which can alter the frequency based on those inputs and risks.

Hope this helps.
Be well.