Outdated Document Control Procedure & Upcoming Audit

S

starfish

#1
Hello everyone.

I hope your ok with me coming onto the forum to ask for help please.

We have a document control procedure that does not actually reflect what we do in the business. The Quality Manager has prepared it, their has been a reviewer and an approver, and all have signed it off, but it is out of date relating to the organisation and processes.

We have got a draft procedure, that the Quality Manager has reviewed and does not agree to some of the changes, this is now with the director for review.

The document control responsibility for the company is actually under review as I write, as unfortunately there is politics involved and the actual responsibility is not very clear, as the company wants the document control responsibility away from the quality manager.

We have our recertification audit very, very soon, and I am concerned as to what to say in defense of signing off on an old procedure, and would it be worthwhile explaining about the document control process been under review?

Please any guidance?

Thanks:thanks:
 
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Stijloor

Staff member
Super Moderator
#2
Re: Document Control Procedure & Audit -urgent request

Politics? Oops!! Very detrimental to managing a Quality System.
This calls for Top Management intervention, that's what Management Review is for.

Explaining this to an external auditor? I am sure that any auditor worth her/his money would like to see an up-to-date status review and objective evidence.

Good luck!

Stijloor.
 
Last edited:
D

Duke Okes

#3
Re: Document Control Procedure & Audit -urgent request

Have the personnel involved with writing, reviewing & approving the procedure actually go out and audit it!
 
S

starfish

#4
Re: Document Control Procedure & Audit -urgent request

Thank you, can you please just explain " status review and objective evidence". I have completed a gap analysis of our QMS and revised the very old procedure, but unfortunately the Quality Manager, did not agree with the changes, this led to the document been put on hold, and the historical procedure now been signed off (which does not conform), and we have our recert audit on Wednesday.

Do you think it would be worthwhile in the audit meeting with the Auditor to go through the gap analysis and show him the task plan that we have put in place, or let him audit us on an old procedure. Its a mess.
 

Stijloor

Staff member
Super Moderator
#5
Re: Document Control Procedure & Audit -urgent request

Thank you, can you please just explain " status review and objective evidence". I have completed a gap analysis of our QMS and revised the very old procedure, but unfortunately the Quality Manager, did not agree with the changes, this led to the document been put on hold, and the historical procedure now been signed off (which does not conform), and we have our recert audit on Wednesday.

Do you think it would be worthwhile in the audit meeting with the Auditor to go through the gap analysis and show him the task plan that we have put in place, or let him audit us on an old procedure. Its a mess.
If I was the auditor, I wanted to know what the status is of correcting the procedure. I want to see evidence of how this is communicated to the folks that have review and approval authority. I want to see evidence of reasons of the delay. That will allow me to determine "Management Commitment."

Stijloor.
 
S

starfish

#6
Re: Document Control Procedure & Audit -urgent request

Thanks very much. I can not understand why the Quality Manager has signed off and said he had prepared the procedure, and got the review and approver to sign off on something that is not how the document control process exisits in the company. The people that have signed off, (reviewer and approver) are the responsible people that are not happy with the significant changes that the Quality Manager has made to the newly drafted procedure, so it is a can of worms.
 
S

starfish

#7
Re: Document Control Procedure & Audit -urgent request

thanks for the replys, much appreciated, has anyone else got any further guidance?
 
Q

Quality-Geek

#8
Re: Document Control Procedure & Audit -urgent request

An option (of last resort) could be to let the auditor find it.

I had to work with a Production Manager many years ago who did not want to follow the document control procedure. He also didn't like to follow the work instructions - production associates were often told to disregard the work instructions and make the parts faster. ("Faster" usually resulted in more customer returns, but he never saw that.) Ultimately I allowed this to be found during a surviellance audit. :notme: We got a major finding on it and had to shell out a lot of time and money to fix the document control problems. The end result was a stronger system and an unhappy production manager. He had to learn to deal with the system instead of going around it.

Is the quality manager responsible for the QMS? Who is? Can the people who are responsible for the document control responsibilities have specific information about those responsibilities put in their job descriptions?
 
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