Need examples of Preventive and Corrective Actions (Need to correct audit findings)

[6thsense]

Need examples of Preventive and Corrective Actions (Need to correct audit finding

Ok. i was thinking along those same lines as Andy. The 30 should be for you to give the auditor the CAPA. this should involve you making a presentation (here we use a table/matrix) that covers the non-conformance, clause of the standard, non-conformance number, non-confromance description, the proposed CAPA, the person responsble for acting out the CAPA and when u expect the NC to be closed. i also think u will need to have the requests for the CAPA in place on file......if this shld be satisfactory to the auditor.

you can work on the other 9yards gradually if its so chaotic.

im green correct me if its all wrong. im here to learn

 

[Lorenzo36]

Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Yes, it's 30 days Andy. Let me give you some more details. Prior to me being hired (3/10/08) the company had a Re-certification Audit (not surveillance) on 2/25/08. During THAT audit the company had 3 Major and 2 Minor findings, which of course was not good. So, the company hired a consultant and HE suggested 20 days to correct the findings. The follow-up audit was 3/20/08. Well the 3 major and 2 minor C/A's were accepted by the auditor. However, during the follow-up he discovered more Nonconformances, this time 1 major and 6 minors. Obiviously, the auditor was not impressed, so due to the previous findings from 2/25/08 and findings from 3/20/08 he demanded (more-or-less) Corrective Actions immmediatley (30 days). It is my understanding that the company is extremely on thin ice. IF and that's a big "IF" I complete and implement Corrective Actions within the 30 days I think we'll be ok. If "NOT" I don't know what's going to happen. For me, it's not that I don't understand the Standard (ISO/AS), it's a question of wether or not I can address the findings with the time allowed. I guess, what I really been looking for here on this Forum are quick answers (for me), just to get through this audit (without findings). Then, later I can fix the whole Quality Management System. Anyhow, I have my work-cut-out, I'll be extremely busy here at work (12 hrs/day) and at home. Here are the findings from the follow-up audit:
1. Minor: Configuration Management not audited for a year - (this is why I need to create an audit checklist)
2. Minor: NonConforming Product not segregated and identified
3. Minor: Internal Audit Procedure was out dated
4. Minor: Control of Document Procedure out dated
5. Major: Corrective Action Procedure does not comply with the requirements of the standard
6. Minor: No evidence of Preventive Actions-(this is why I need examples of preventive action)
7. Minor: No procedure for Control of External Documents (this one I really need help)

 

[CarolX]

Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Lorenzo36

Let me try to help a bit with number 6.

I am sure you are already performing activities that are PA in nature. For example -

Incoming inspection
Vendor surveliance
Calibration
Machine maintance

These are just a few that can be considered "preventive".

In our system (which is not AS) - we just list these activies in our PA section of our QMS and list the reference procedures for these activities.

Hope this helps a bit.

 

[vinqua]

Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

You could make a CAPA form which would combine Preventive and Corrective Action.

You have to first fill the appropriate section below:

ASSOCIATED AUDIT, PROCESS(ES), & COMPLAINT(S) TO REFERENCE 0
Indicate whether its a Corrective or Preventive action.
Corrective Action Preventive Action

You have to fill out the source of problem.
NON-CONFORMING CONDITION / SOURCE OF PROBLEM /SUGGESTION FOR IMPROVEMENT
(usually orginator fills this out and sends it to QA dept for evaluation. Originator signs and dates this)

Originator(s): Date of Issue:

IDENTIFIED CAUSE / INVESTIGATION
The responsible manager(s) shall investigate nonconformities or potential problems and identify the cause by asking the question ‘why’ several times

Responsible Manager(s):

CORRECTIVE ACTION PLAN
The responsible manager(s) shall determine action(s) required to correct the problem or make improvements and identify any resulting changes in methods and procedures

Responsible Manager(s):

PREVENTIVE ACTION PLAN
The responsible manager(s) shall determine action(s) required to prevent occurrence or recurrence of the problem and make improvements and identify any resulting changes in methods and procedures

Responsible Manager(s):

VERIFICATION OF EFFECTIVE CORRECTIVE & PREVENTIVE ACTION
The assigned person verifies effective corrective action by sampling evidence that the problem has not recurred.


(a person has to verfy if the corrective action can be closed)
Person Verifying Corrective and Preventive Action: Date of Verification:
Can this CAR be closed? YES NO

Quality Assurance Manager and Management Representative verify that the Corrective and Preventive Action has been adequately completed and does not have an adverse affect on the medical device, quality system, or compliance.
Quality Assurance Manager: Date:
Management Representative: Date:

 

[CliffK]

Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Yes, it's 30 days Andy. <big snip>... during the follow-up he discovered more Nonconformances, this time 1 major and 6 minors. Obiviously, the auditor was not impressed, so due to the previous findings from 2/25/08 and findings from 3/20/08 he demanded (more-or-less) Corrective Actions immmediatley (30 days).

Somewhere in the previous QA manager's files (now your files) there should be a document outlining the CB's policies for correcting NC's, (usually depending on major/minor category) and for pulling the registration. I raise this point only because it sounds like the auditor is dispensing a bit of frontier justice. Find out what the real requirements are, do your best to meet them and insist that the auditor meet them as well.

Here are the findings from the follow-up audit:
1. Minor: Configuration Management not audited for a year - (this is why I need to create an audit checklist)

I think you mean audit plan or audit program? Most people use the word checklist to mean the things you would ask during the audit. Anyway, the audit plan is just a schedule that identifies the processes/departments you will audit and the dates.

Oh, and get the audit done and get any resulting NCs closed.

2. Minor: NonConforming Product not segregated and identified

Is segregating nonconforming product really a requirement of AS9001? It isn't part of ISO 9001 (it used to be, and some auditors still have it in their mental checklist, which is how it gets into NCs). But you must identify it.

3. Minor: Internal Audit Procedure was out dated
4. Minor: Control of Document Procedure out dated

What does outdated mean?

5. Major: Corrective Action Procedure does not comply with the requirements of the standard

Need the wording of the NC to help with this.

6. Minor: No evidence of Preventive Actions-(this is why I need examples of preventive action)

Preventive/predictive maintenance. SPC and other forms of trend analysis. Contingency planning. Analyzing CA for applicability to other products/processes/functional areas. All as applicable.

7. Minor: No procedure for Control of External Documents (this one I really need help)

This one can be a real mess. Be aware that there is disagreement on the Cove about just what documents you need to include in the procedure. It certainly needs to cover AS9001 and any other standards that govern your product. Some would add machine manuals and similar documents to the list, but not everyone here agrees with that necessity. If you choose that path, you may find yourself making an inventory of every equipment manual in house, which would be a fertile field for future NCs.

 

[meo786]

Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Dear,

chcek it may be useful for u

 

[mg2010]

Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Is segregating nonconforming product really a requirement of AS9001? It isn't part of ISO 9001 (it used to be, and some auditors still have it in their mental checklist, which is how it gets into NCs). But you must identify it..

The requirement is to "identify and control" the non-conforming product. My experience (in an AS9100 aerospace environment) is that auditors are only happy if you control the product by segregating it.

This is a bit naughty, as the reworded requirement should allow you to manage NCP without creating quarantine cages, etc. but in reality, the auditors won't allow it. I tried this by means of a clear visible tagging system, but it was eventually picked up by the AS9100 auditor as a non-conformance.

 

[Qualqueen]

Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

1. Minor: Configuration Management not audited for a year - (this is why I need to create an audit checklist)
2. Minor: NonConforming Product not segregated and identified
3. Minor: Internal Audit Procedure was out dated
4. Minor: Control of Document Procedure out dated
5. Major: Corrective Action Procedure does not comply with the requirements of the standard
6. Minor: No evidence of Preventive Actions-(this is why I need examples of preventive action)
7. Minor: No procedure for Control of External Documents (this one I really need help)

Lorenzo,
Maybe this will help. I've posted this before and it's where I post all PARs.

#6 - We use an Action Item Log to list all our PAR's. It's also where any actions needed to be done from a Management Review Meeting are posted and just everyday reminders. Check it out. Your effectiveness is documented right on the log and you just keep a running file. Works great for us and our auditor loved it. In your procedure indicate Preventive actions are documented on the Action Item Log and make it a form in your system.

As for #7 - check out this Master log. It's a record for all WI, Docs - internal and external - pg.3 ,Procedures etc. in your system. Hope this helps and good luck

 

[ajkenney]

Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Lorenzo,
Maybe this will help. I've posted this before and it's where I post all PARs.

#6 - We use an Action Item Log to list all our PAR's. It's also where any actions needed to be done from a Management Review Meeting are posted and just everyday reminders. Check it out. Your effectiveness is documented right on the log and you just keep a running file. Works great for us and our auditor loved it. In your procedure indicate Preventive actions are documented on the Action Item Log and make it a form in your system.

As for #7 - check out this Master log. It's a record for all WI, Docs - internal and external - pg.3 ,Procedures etc. in your system. Hope this helps and good luck

Hi Qualqueen, Your sample 'Action Item Log' and Master Docs Log are great! Good job! Thanks for sharing too! A few little mods and they'll work fine for us as well! Cheers!

 

[Raffy]

Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Hi
This is with regard to the new requirements of ISO9001 2015 for Preventive Action, is the Corrective Action Impact as required by TS16949 can be used as replacement for Preventive Action? Please advice.
Thanks in advance.
Best regards,
Raffy