Engineering/Document Change Notice Procedure required?

J

jonedm

#1
I'm helping a small manufacturing firm achieve 9001:2008 registration. They do no design work, only manufacturing. They're small and trying to document a minimal set of formal procedures. They passed their Stage 1 audit, Stage 2 coming in mid-March. Is a formal procedure (and form) required for changing documents? Or can change requests be verbal with a summary of the change recorded in the signoff section of the document? The current Doc Control procedure, which the auditor reviewed and said looks fine, does not mention the need to use a form, only that changed documents must go through the same approval process as the original document before being implemented. Thanks in advance for your thoughts.
 
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Big Jim

Super Moderator
#2
Follow the guidance of your auditor. It is not a procedure that is required to be documented. The six required ones are for control od documents, control of records, internal auditing, control of nonconforming product, corrective actions, and preventive actions.

No other procedures have to be documented as long as you have an effective method to handle it.
 

Ajit Basrur

Staff member
Admin
#3
I'm helping a small manufacturing firm achieve 9001:2008 registration. They do no design work, only manufacturing. They're small and trying to document a minimal set of formal procedures. They passed their Stage 1 audit, Stage 2 coming in mid-March. Is a formal procedure (and form) required for changing documents? Or can change requests be verbal with a summary of the change recorded in the signoff section of the document? The current Doc Control procedure, which the auditor reviewed and said looks fine, does not mention the need to use a form, only that changed documents must go through the same approval process as the original document before being implemented. Thanks in advance for your thoughts.
Welcome to the Cove :bigwave:

Google gave these SEARCH results :)
 
D

DrM2u

#4
I'm helping a small manufacturing firm achieve 9001:2008 registration. They do no design work, only manufacturing. They're small and trying to document a minimal set of formal procedures. They passed their Stage 1 audit, Stage 2 coming in mid-March. Is a formal procedure (and form) required for changing documents? Or can change requests be verbal with a summary of the change recorded in the signoff section of the document? The current Doc Control procedure, which the auditor reviewed and said looks fine, does not mention the need to use a form, only that changed documents must go through the same approval process as the original document before being implemented. Thanks in advance for your thoughts.
Like Jim said, there are only (6) procedures that are required to be documented per ISO 9001:2008 ... and a document can address more than one procedure (see Note 1 under 4.2.1)! Usually a procedure identifies/defines WHAT you do. So your doc control procedure is fine if it specifies that "changed documents must go through the same approval process as the original document before being implemented". This was also confirmed by the auditor, most importantly.

Now the question becomes HOW you do it (control document changes). It is up to you if you want to document an instruction and/or a form on HOW to control document changes. I have previously attached a procedure and a form that you can review for reference. The procedure is called 'Change Control' and the form is called 'Change Request'. You can find them by searching the Post Attachment List. There you will find other examples of related procedures and forms to review & evaluate. Pick something that makes sense and you can build on to meet your roganization's needs. Have fun!
 

jkuil

Quite Involved in Discussions
#5
As you state that they do only manufacturing and no design I asume that they are a contract manufacturer? Therefore you may not be the owner of the product or manufacturing process specification, the contacting client is. In the contract between your firm and their clients they need to include procedures how change requests must be handled. Their clients may not be happy when the product does not meet their requirements, or due to a change in manaufacturing procedures they have a higher risk of non-conforming products. Therfore, there clients may have requirements for recording and submitting change requests.
 
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