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Need examples of Preventive and Corrective Actions (Need to correct audit findings)
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Need examples of Preventive and Corrective Actions (Need to correct audit findings)
Need examples of Preventive and Corrective Actions (Need to correct audit findings)
Need examples of Preventive and Corrective Actions (Need to correct audit findings)
Need examples of Preventive and Corrective Actions (Need to correct audit findings)
Need examples of Preventive and Corrective Actions (Need to correct audit findings)
Need examples of Preventive and Corrective Actions (Need to correct audit findings)
Need examples of Preventive and Corrective Actions (Need to correct audit findings)
Need examples of Preventive and Corrective Actions (Need to correct audit findings)
Need examples of Preventive and Corrective Actions (Need to correct audit findings)
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Some Related Topic Tags
corrective action (ca), preventive action (pa)
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  Post Number #9  
Old 26th March 2008, 09:46 PM
Wes Bucey's Avatar
Wes Bucey

 
 
Total Posts: 11,082
Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Quote:
In Reply to Parent Post by Lorenzo36 View Post

Bucey, yes I guess you could call me "green" and would agree. Why do I agree? Because in my 16 yrs of Quality I've never have had to correct so, so, so many problems. It's not just problems on the "surface", they go beyond that. So for me, this by-far is my biggest challenge yet! AND I have to correct all this in such a short time (30 days), so as you can see I'm under alot of pressure. I guess I was spoiled at my previous jobs, all I did was maintain the department, everything was always up-to-date and organize. Yes, certain areas of the standard (AS9100) are new to me (configuration management), which is why I'm on this website asking for help. You, Andy and certain individuals have been very helpful. Considering the circumstances, in the end I believe in myself, I'll get this "thing" turned-around for this company. Thanks.
Don't panic. 30 days is plenty of time to show you are "on track" to correcting the NC list presented by the auditor. With a good documentation that you ARE working on fixing the system, most registrars will give you an extension as long as it appears you are making progress and have actually fixed one or two of the more glaring deficiencies.

Tell us about the bosses/owners of your company. Are they on track to help you, regardless of whether they are "quality savvy" or do they give you the impression they are dumping everything in your lap?

If they are dumping everything in your lap, you have to make it clear you need authority, cooperation, and budget to fix things or it will be impossible for anyone (even pros like many of the folks here in the Cove) to salvage your AS9100 certificate of registration from a reputable registrar.

Don't hesitate to tell them you have hooked up with a great source of help here in the Cove. We can guide you and your bosses back to "the way" [Tao.]

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  Post Number #10  
Old 26th March 2008, 10:34 PM
AndyN's Avatar
AndyN

 
 
Total Posts: 8,470
Let Me Help You Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

It occurs to me that the 30 days is normally for submission of the plan, not the whole 9 yards of actions. Of course they can take longer than the 30 days to implement, so that should give you some relief.
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  Post Number #11  
Old 27th March 2008, 06:17 AM
6thsense

 
 
Total Posts: 138
Quid Pro Quo 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
Thanks to 6thsense for your informative Post and/or Attachment!
  Post Number #12  
Old 28th March 2008, 01:11 PM
Lorenzo36

 
 
Total Posts: 22
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)

Last edited by Lorenzo36; 28th March 2008 at 01:23 PM.
Thanks to Lorenzo36 for your informative Post and/or Attachment!
  Post Number #13  
Old 28th March 2008, 02:18 PM
CarolX's Avatar
CarolX

 
 
Total Posts: 2,168
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.
  Post Number #14  
Old 28th March 2008, 03:06 PM
vinqua

 
 
Total Posts: 32
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:
  Post Number #15  
Old 28th March 2008, 04:56 PM
CliffK

 
 
Total Posts: 447
Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Quote:
In Reply to Parent Post by Lorenzo36 View Post

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.
Quote:
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.
Quote:
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.
Quote:
3. Minor: Internal Audit Procedure was out dated
4. Minor: Control of Document Procedure out dated
What does outdated mean?
Quote:
5. Major: Corrective Action Procedure does not comply with the requirements of the standard
Need the wording of the NC to help with this.
Quote:
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.
Quote:
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.
Thanks to CliffK for your informative Post and/or Attachment!
  Post Number #16  
Old 10th July 2008, 03:26 AM
meo786

 
 
Total Posts: 56
Re: Need examples of Preventive and Corrective Actions (Need to correct audit finding

Dear,

chcek it may be useful for u
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: doc MR-04 Procedure for Corrective & Preventive action.doc (51.0 KB, 925 views)
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