Records of New Processes for AS9100 - AS 9100 certification audit

[tkevmoore]

Our transition from ISO 9001 to AS 9100 (revision B) meant that we had to create and document several new processes (Raw Material Validation, Production Tool Validation, etc.). Even though we have known the certification schedule for several months, things being what they are, the processes weren't documented until recently.

I was very concerned that I wouldn't have records of these new processes for our upcoming certification audit. However I have been told that you just need to have the process documented for the certification audit and evidence for the following surveillance audit. Sound correct?

 

[BadgerMan]

Re: New processes for certification audit

Sound correct?

Not in my experience. That would be correct for a stage one assessment (doc review) but not stage two which has always involved providing evidence of effective implementation of the subject procedures.

 

[rclanzillotto]

Re: New processes for certification audit

Are these new procedures in effect and being implemented. I'd expect records from the effective date. If there is no production since the effective date of the procedure, then explain that to the auditor. Best regards

 

[Sidney Vianna]

Re: New processes for certification audit

However I have been told that you just need to have the process documented for the certification audit and evidence for the following surveillance audit. Sound correct?

Absolutely NOT. Audit conclusions must be based on OBJECTIVE EVIDENCE. A typical management system audit must verify that a system is implemented and it is effective.

Having a piece of paper describing a process is a start, but NEVER sufficient evidence to demonstrate to a knowledgeable auditor that a process is implemented.

Good auditors would expect you to demonstrate implementation, not only documentation.

 

[howste]

I was very concerned that I wouldn't have records of these new processes for our upcoming certification audit. However I have been told that you just need to have the process documented for the certification audit and evidence for the following surveillance audit. Sound correct?

I agree with Sidney. Whoever told you that was misinformed. That's a great way to end up with major nonconformities.

 

[Big Jim]

Getting back on point. You may not need a documented procedure for the items you list. It might be in your best interest to do so, but their are only a few topics listed in the standard that must have documented procedures.

If those items are not among the list, and you can function effectively without it being documented, you don't need to document it.

Here is a list of procedures that must be documented as I have identified them (I don't know if I have identified them all so use this list at your own risk).

Required Procedures

ISO 9001:2000 & AS9100 Revision B

1. Control of Documents (4.2.3)
2. Control of Records (4.2.4)
3. Internal Audit (8.2.2)
4. Control of Nonconforming Product (8.3)
5. Corrective Action (8.5.2)
6. Preventive Action (8.5.3)

AS9100 Revision B

7. Documented Procedures Clearly Referenced (4.2.2)
8. Control of Supplier Records (4.2.4)
9. Control of Production Equipment (7.5.1.3)
10. Responsibility for review & authority for disposition of nonconforming product (8.3)

 

[Joy]

Hi,
it is good that you came to forum before finalising the certification audit date.
In addition to appropriate comments of my friends, I would like to remind you following.
If you refer AS9100 Rev.B,1.scope,1.1 General,you would find following "This International Standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and "

So you need to demonestrate to your auditor that you have met your customer requirements consistently.How do you do that without proper records?

My suggestion would be: run your processes as per your documents for six months (at least),ensure all required records are available for this period and then invite the CB to do your audit.It would be enjoyable for both.

If you have received the idea/assertion from a CB that only documents are required for the audit,it would be better for you to find an alternative CB which demands to see records and verify processes for adequacy and appropriateness as per documents.