Document Approval for Adequacy Prior to Use

S

Slonarch

#1
Dear All,

I am a long time lurker who has found this forum extremely informative on a variety of occasions. Thank you very much for the wealth of information!

I am a QA manager in the middle of updating our QMS to make it ISO9001-compliant.

This time I could not find anything by searching the forum, even though I am sure the question has already been discussed plenty of times. The ISO 9001 states in 4.2.3 a) that documents should be approved for adequacy prior to use. Let's assume that the document is developed by the person who is capable of evaluating it's adequacy, such as myself an engineer developing a technical document. Can it be approved by the same person? If not, what if a company has only one engineer who is reporting directly to the president - will it have to hire a second one just for the sake of compliance with this language?

If the self-approval is possible, I am thinking of assigning document-issuing authority to certain functions in the company, for example all drawings must be issued by the engineers. Anybody can draft and prepare them, but an engineer has to post the final version to our document library. In that case document release will constitute either self-approval if the document was developed by the issuer, or approval if the document was developed by someone who does not have issuing authority. Will this pose a problem during the ISO certification?

Thanks in advance for the feedback!
 
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Pancho

wikineer
Super Moderator
#2
The standard does not require composition and approval of a document to be done by different persons. As you suggest, if done by the same person, the author-reviewer must be competent to do both. However you do it, your doc control procedure should describe it.
 
D

Dennis M

#3
The iso9001 is a gimmick to fatten the cash cow. I have been manufacturing for thirty five years, both in aerospace ( turbine blade manufacturing & design) and automobile manufacturing (engines). I would like to known if anyone of the powers to be can tell me if a CBN insert can be CDV or PVD coated, with a .0005 coating (Tialn). If so, what CBN would be best recommend for a temp range in excess of 1500 F that would also incorporate the question of a brazing temp. This of course would be a question void from the iso text.

My point. We are still in a learning curve that make development restricted to someone with far less ability in understanding the answer than asking the question.

New to the block Dennis M
 
#4
The iso9001 is a gimmick to fatten the cash cow. I have been manufacturing for thirty five years, both in aerospace ( turbine blade manufacturing & design) and automobile manufacturing (engines). I would like to known if anyone of the powers to be can tell me if a CBN insert can be CDV or PVD coated, with a .0005 coating (Tialn). If so, what CBN would be best recommend for a temp range in excess of 1500 F that would also incorporate the question of a brazing temp. This of course would be a question void from the iso text.

My point. We are still in a learning curve that make development restricted to someone with far less ability in understanding the answer than asking the question.

New to the block Dennis M
Welcome to 'the block' Dennis. Your initial post is somewhat controversial and I'm not sure how many people who visit would have much idea of your point. However, feel free to become more fully acquainted with the tone and content of posts here and hopefully, your 35 years will come in helpful.

BTW - many of us are involved in ISO 9000 - or similar - and probably won't agree in your 'cash cow' statement...and it doesn't have anything to do with your question...
 

somashekar

Staff member
Super Moderator
#7
Dear All,

I am a long time lurker who has found this forum extremely informative on a variety of occasions. Thank you very much for the wealth of information!

I am a QA manager in the middle of updating our QMS to make it ISO9001-compliant.

This time I could not find anything by searching the forum, even though I am sure the question has already been discussed plenty of times. The ISO 9001 states in 4.2.3 a) that documents should be approved for adequacy prior to use. Let's assume that the document is developed by the person who is capable of evaluating it's adequacy, such as myself an engineer developing a technical document. Can it be approved by the same person? If not, what if a company has only one engineer who is reporting directly to the president - will it have to hire a second one just for the sake of compliance with this language?

If the self-approval is possible, I am thinking of assigning document-issuing authority to certain functions in the company, for example all drawings must be issued by the engineers. Anybody can draft and prepare them, but an engineer has to post the final version to our document library. In that case document release will constitute either self-approval if the document was developed by the issuer, or approval if the document was developed by someone who does not have issuing authority. Will this pose a problem during the ISO certification?

Thanks in advance for the feedback!
At times like this I always think and act on this one line ...
" Clarity and sincerity of the purpose "
If you have one Engineer only who can approve and he is competent for this based on his knowledge and experience, then so be it. You must stand up and say during the audit that it is only this one person who has all the information and authority to approve related documents prior to use, and the engineer as well must be capable to demonstrate this and respond to questions about his authority given.
 

Randy

Super Moderator
#8
The iso9001 is a gimmick to fatten the cash cow. I have been manufacturing for thirty five years, both in aerospace ( turbine blade manufacturing & design) and automobile manufacturing (engines). I would like to known if anyone of the powers to be can tell me if a CBN insert can be CDV or PVD coated, with a .0005 coating (Tialn). If so, what CBN would be best recommend for a temp range in excess of 1500 F that would also incorporate the question of a brazing temp. This of course would be a question void from the iso text.

My point. We are still in a learning curve that make development restricted to someone with far less ability in understanding the answer than asking the question.

New to the block Dennis M

What on earth are you talking about and what does it have to do with the subject of this Thread which is about "Document approval"?:confused:
 
S

Slonarch

#9
2Pancho, CarolX, somashekar:
Thank you for your feedback! Will proceed with the plan.

2Dennis_M:
I understand your point. In fact, I would say that at least in small to midsize manufacturing companies, a situation where the person who develops the technical paperwork is most qualified to approve it is typical, and since in the vast majority of cases of the systems I have seen approvals are granted by a person different than the author, it is a good example of how the considerations behind ISO 9001 are usually misunderstood and the QMS is not implemented properly.

2Moderators:
Thanks for moving my post here, I missed this subforum!

PS
While thinking about our procedure, I realized that when the approval is a proof of managerial support, such as in case of QMS procedures, approvals would typically be granted by an upper manager who does not write them. But that's a different story.
 
M

Mark E.S. Bernard

#10
Dear Colleague,

This is a very similar query to the query yesterday concerning self-auditing. It’s also very similar to an issue that comes up over-and-over again in the financial sector concerning the segregations of duties.

In my opinion, you have to do what you have to do to stay in business, as long as it’s within the boundaries of the law. If you don't have the staff to create the segregation of duties then you need to document the issues and have top management sign-off on the exception.

In some cases that exception will be acceptable and in others it may not. I've included some basic "compensating" controls below that we use in the financial sector. The inclusion of these will add strength to your written exception.

In small organizations, it is more likely there may be insufficient personnel to allow the various activities to be performed by the recommended number of independent personnel. As separation of duties becomes less possible more emphasis must be placed on:

•Review of Supporting Documentation;
•Limiting access to facilities/assets;
•Transaction Authorization;
•Departmental Reconciliation; and
•Independent verification by internal/external auditors.

General Safeguards include:

•Organizational Chart created;
•Ethics and policies have been documented and adopted;
•Documented Procedures;
•Employees who handle cash, checks, etc. are bonded;
•Consecutive vacation days off - at a minimum 5 days;
•Budgets are used and variances investigated;
•Special entries require management approval;
•Reports issued to departments for monthly reconciliation;
•User access tracking;
•Tracking data inserts, modifications, and deletes;
•Limiting access to necessary system areas;
•Keeping user id’s and passwords secure; and
•Periodically testing security roles.


Sincerely,
Mark.
 
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