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Corrective Action for Noncompliance with Internal Audit Procedure

S

slowrow

#1
Our company did not comply with its Internal Audit Procedure, we missed 20 of the 27 elements. Suggestions on how to issue a CAPA would be much appreciated. I am new to the organization and to my position.
Thank You
 
#2
Our company did not comply with its Internal Audit Procedure, we missed 20 of the 27 elements. Suggestions on how to issue a CAPA would be much appreciated. I am new to the organization and to my position.
Thank You
It would be helpful you you post the entire nonconformance exactly as written.
 

John Broomfield

Staff member
Super Moderator
#4
Our company did not comply with its Internal Audit Procedure, we missed 20 of the 27 elements. Suggestions on how to issue a CAPA would be much appreciated. I am new to the organization and to my position.
Thank You
slowrow,

What do you mean by element? Is this a predermined checklist with 27 controls to check? Or is it that only 7 of the 27 processes were audited?

The term element does not appear in clause 8.2.2.

You have two pieces of information missing:

  1. Please describe the nature of the nonconformity as the opposite of a requirement specified in clause 8.2.2 or in your documented internal auditing procedure.
  2. Please describe the evidence that this requirement was not fulfilled.

We can then help with the nonconformity statement for your corrective action.

BTW, it may be too late for PA or preventive action.

John
 
S

slowrow

#5
Perhaps "element" isn't the best term to use. There is a predetermined checklist with 27 controls to audit, i.e., 4. QMS: 4.1 General Requirements; 4.2 Documentation Requirements; etc.

The NC: failure to follow established procedure for quality audits to assure the QS is in compliance with the established QSRs and to determine the effectiveness of the QS, as required by IOS 13485:2003, as well as QSR 21 CFR 820.22, CMDR SOR98/282, and MDD 93/42/EEC. The "Company" procedure states that all processes, procedures, and work instructions of the QS are audited at least once annually. The approved 2013 Internal Audit schedule indicates several "elements" were not audited.

Ah, that was a mouth full!! Thank You :thanx:
 

John Broomfield

Staff member
Super Moderator
#6
Perhaps "element" isn't the best term to use. There is a predetermined checklist with 27 controls to audit, i.e., 4. QMS: 4.1 General Requirements; 4.2 Documentation Requirements; etc.

The NC: failure to follow established procedure for quality audits to assure the QS is in compliance with the established QSRs and to determine the effectiveness of the QS, as required by IOS 13485:2003, as well as QSR 21 CFR 820.22, CMDR SOR98/282, and MDD 93/42/EEC. The "Company" procedure states that all processes, procedures, and work instructions of the QS are audited at least once annually. The approved 2013 Internal Audit schedule indicates several "elements" were not audited.

Ah, that was a mouth full!! Thank You :thanx:
slowrow,

Where does it say that all controls in the checklist must be audited?

After all, most checklists are an aid to the auditor who has to meet the audit objective within a limited timeframe.

Did the auditor fulfill the audit objective by taking a smaller sample?

If not you may have evidence of ineffective and incomplete auditing or you may have evidence of insufficient resources to fulfill the auditing procedure.

Be careful to ensure you cite the evidence and the correspondingly correct clause 8.2.2 or 6.1a because you want effective corrective action that stops recurrence of this type of nonconformity.

So, complete your CAR's nonconformity statement by stating the:

  • Requirement that was not fulfilled
  • The evidence of not meeting the requirement
  • And the nature of the nonconformity (the problem to be solved)

Let us know what you end up with.

John
 
P

PaulJSmith

#7
Jan has offered a document which is a very good guide to developing a correct non-con statement. It can be found with a search of the Post Attachments List for "Developing Problem Statements." I highly recommend it.

Or, try this link.
 

kgott

Quite Involved in Discussions
#8
Our company did not comply with its Internal Audit Procedure, we missed 20 of the 27 elements. Suggestions on how to issue a CAPA would be much appreciated. I am new to the organization and to my position.
Thank You
The actions you need to take are corrective. You need to investigate why they wern't done, the contributing factors to why they wern't done and what needs to be done to rectify and permanently prevent a re-occurance of the issues.

You then need to agree on who is going to take what actions and agree with them on a reasonable time for them to implement those actions.

Then you need to write something like:

xyz action's is/are to be implemented by xyz date. The manager of abc is responsible for implementation, determining wether or not the action taken is effective and for closing out the matter by doing xyz.

If your in a smallish organisaton you can do this using a spreadsheet. There are a number of them if you click on the "Post Attachments List" in the narrow green box near the the top of the page you are reading.

Hope this helps
 
#9
Perhaps "element" isn't the best term to use. There is a predetermined checklist with 27 controls to audit, i.e., 4. QMS: 4.1 General Requirements; 4.2 Documentation Requirements; etc.

The NC: failure to follow established procedure for quality audits to assure the QS is in compliance with the established QSRs and to determine the effectiveness of the QS, as required by IOS 13485:2003, as well as QSR 21 CFR 820.22, CMDR SOR98/282, and MDD 93/42/EEC. The "Company" procedure states that all processes, procedures, and work instructions of the QS are audited at least once annually. The approved 2013 Internal Audit schedule indicates several "elements" were not audited.

Ah, that was a mouth full!! Thank You :thanx:
You may have written more into your internal audit procedure than you needed to. The danger there is that once it is part of your procedure, you need to do it. You may benefit from reviewing and revising your procedure and removing things that are not needed that you missed.
 
M

melissa87

#10
Hi,
I am in a similar kind of situtaion.


I have the following question regarding classII medical device.

My company is a startup and did not know anything about QMS. The engineers designed and developed the device in the period 2005 to 2011 and with a help of FDA consultant wrote 510K and submit it to FDA. FDA approved the device in 2012.

They also got 5 prototypes built too. FDA came to investigate us earlier this year but we did not sell any and never went to production stage so FDA said that since you are in verification and validation stage so there is nothing to investigate. We will come later.

Now my boss wants to go to production stage but design control does exsist. The 510k that engineers wrote do include

1. verification and validation documents
2. Test Results
3. Design Input
4. Design outputs
etc.

But there was no Design Control SOP or any other SOP exsisted at that time. I recently joined this company earlier this year. Now my boss wants to go to prodcution stage asap.

I have all the documentation regarding production stage like DMR, FMEA , Drawings, CAPA SOP, Document control SOP, etc.

But the Design Control needs to be done and formally put in place and evolved. My question is

1. If I do Design Control now, how would FDA will view it at the time of the next Audit becuase it never exsisted when it should exsisted and I might not be done with it soon and my boss wants to go to production. I might get all done during production.
2. Can I initiate Design Control work using a CAPA( Corrective Action)?

Please comment!

Melissa
 
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