Internal Re-audit after Major Finding during ISO 9001 Re-Certification Audit

L

Lorenzo36

#1
Background:
On July 2 and 3, our company was audited for re-certification (ISO9001); there were 2 major findings and 4 minors (our certification expires at the end of July 2012).
1st Major - related to our Design Plan requirements.
2nd Major - related to shipping non-conforming product.

Here's our dilema:
Corrective Actions have been implemented, and now I plan on internal re-auditing. However, a co-worker of mine and I have a disagreement regarding the requirments to re-audit after a Major Finding.

Now, to my knowledge, after corrective actions have been implemented we should conduct an internal re-audit of the areas where the Major Findings were discovered.

My co-worker disagrees. His opinion is, there's no need to re-audit, he believes we should just follow our internal audit schedule. As per our schedule, the first audit is not due until September.

Any thoughts / comments?
 
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qusys

Trusted Information Resource
#2
Background:
On July 2 and 3, our company was audited for re-certification (ISO9001); there were 2 major findings and 4 minors (our certification expires at the end of July 2012).
1st Major - related to our Design Plan requirements.
2nd Major - related to shipping non-conforming product.

Here's our dilema:
Corrective Actions have been implemented, and now I plan on internal re-auditing. However, a co-worker of mine and I have a disagreement regarding the requirments to re-audit after a Major Finding.

Now, to my knowledge, after corrective actions have been implemented we should conduct an internal re-audit of the areas where the Major Findings were discovered.

My co-worker disagrees. His opinion is, there's no need to re-audit, he believes we should just follow our internal audit schedule. As per our schedule, the first audit is not due until September.

Any thoughts / comments?
The clause 8.2 of ISO 9001 states that an audit programme shall be planned taking into account the status and the importance of the process and areas to be audited as wel as the result of the previous audits.Based upon this , a re audit shall be necessary. What does your internal procedures foresee for internal audit?
Probably, you should also review that after thes major ncn.
This is my understanding and thought. Consider that share this also with mgmt because there was a major non conformity.
Hope this helps:bigwave:
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
If the major nonconformance(s) came from a registration audit I would expect they would re-audit that process (it could mean another visit) in order to maintain the certification.

For internal audit program I would absolutely confirm the corrective actions are in place in order to close the NC; but September is not long from now and the process changes should have some time to prove to be effective so I would feel okay in waiting until September to re-audit internally.
 
S

snappy

#4
You are required to determine the effectiveness of the action taken before closing the corrective action. This is the follow up that is required of 8.5.2.f).

You are not required to perform an internal audit of the entire process, just verification of the effectiveness of your action to address the finding(s).

You might consider auditing the process more frequently, in keeping with the "status and importance" requirement. However, there is no requirement to increase auditing frequency due to receiving a major nonconformity.
 

Ninja

Looking for Reality
Trusted Information Resource
#5
Just a thought...only sorta related to your question...

When was the last time those two areas were the subject of an internal audit? Did the internal audit find any problems?

In addition to asking "When should we re-audit?"...have you asked why the previous internal audit didn't avoid two majors in a registration audit? I think that might be an important question to answer for yourselves.
Is the internal audit process effective? If it isn't, then it really doesn't matter when it is done.

Just thinking out loud...
 

qusys

Trusted Information Resource
#6
Just a thought...only sorta related to your question...

When was the last time those two areas were the subject of an internal audit? Did the internal audit find any problems?

In addition to asking "When should we re-audit?"...have you asked why the previous internal audit didn't avoid two majors in a registration audit? I think that might be an important question to answer for yourselves.
Is the internal audit process effective? If it isn't, then it really doesn't matter when it is done.

Just thinking out loud...
I would like to add to your thoughts loud that probably also management review was not properly a flawless activity...
what about?:bigwave:
 
S

ssz102

#7
i don't think need to re-audit, however, the validation and verification taken actions should be implementing!
 
#8
Lorenzo, of course you need to audit the actions taken! Anyone who'd say otherwise clearly isn't competent in audit program management! In fact, you may have to go and audit it a couple or more times! Based on experience, you will need to ensure the corrective action has indeed 'stuck'.

I have similar comments to Ninja's and Sanppy's. Why on earth did this happen? If we take that the ncs were valid - it would be useful to know what they were, you have to take a long hard look at the effectiveness of your audit program management.

My guess is that you aren't considering status and importance when you schedule them and are planning a whole 12 month calendar in advance to cover the system once a year - or similar. Tell us and we can put the two issues together for you...
 
C

ChrissieO

#9
Background:
On July 2 and 3, our company was audited for re-certification (ISO9001); there were 2 major findings and 4 minors (our certification expires at the end of July 2012).
1st Major - related to our Design Plan requirements.
2nd Major - related to shipping non-conforming product.

Here's our dilema:
Corrective Actions have been implemented, and now I plan on internal re-auditing. However, a co-worker of mine and I have a disagreement regarding the requirments to re-audit after a Major Finding.

Now, to my knowledge, after corrective actions have been implemented we should conduct an internal re-audit of the areas where the Major Findings were discovered.

My co-worker disagrees. His opinion is, there's no need to re-audit, he believes we should just follow our internal audit schedule. As per our schedule, the first audit is not due until September.

Any thoughts / comments?
An audit schedule is not a document written in stone and is a live working document and you need to get this through to your co-worker.

  1. How can you plan at the begining of the year what you are going to need to audit during the rest of the year?
  2. Are you sure you wont have any previously unidentified process failures?
  3. Are you sure you are not going to introduce any new processes?
  4. Are you sure that the managment team are not going to want to look at individual processes for whatever reason throughout the year?
  5. Are you sure you wont have any major nonconformaties from external or internal audits that will need to be re addressed?
  6. Are you sure you are not going to have any customer complaints that may warrant the audit/review of a process?
  7. Are you sure that there are not going to be any outcomes from MR that may require you to audit a process?

..................and the list goes on

Yes there are areas that are a must but the majority of your audits should be driven by the business needs at any one time.

If I was in your situation, I would re-audit the major findings to ensure the effectiveness of your corrective action.

We are a reasonable size bsuiness group which is part of a multi national. Our own scope covers 4 locations and approximately 300 heads. The activities within our scope range from Warehousing and lgoistics to Customer Setvice, Inventory planning etc.

At the begining of the year we schedule key audits, probably only about ½ dozen, then work with the management team to develop the schedule on going. i.e. not doing audits just for the sake of it but auditing where a need has been identified.

This adds far more value to your auditing process and helps get the buy in of the management team, this certianly helps when NCs are raised and you are trying to get corrective action in place, because they have requested the audit they take responsibility of any NCs.

Chrissie
 
Last edited by a moderator:

somashekar

Staff member
Super Moderator
#10
Now, to my knowledge, after corrective actions have been implemented we should conduct an internal re-audit of the areas where the Major Findings were discovered.
First, its a major.
Now the CA is implemented.
I have no idea if the CA has been accepted and your audit project closed, however note that audit is a planned activity and is a sample based exercise.
If you are doing anything too immediately after CA implementation, you are doing your re-varification and effectiveness monitoring, which is much more important and essential.
Based on the status and importance, you plan audit program (This typically is a case) going ahead so that you have sufficient records, evidences, and other observations to your audit judgement.
Audit is not a part of the CA process. It forms a part of the tool that monitors and measures planned activities and its effectiveness.
 
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