Auditing ISO9001/AS9100 7.3 Design and Development Quality System Effectiveness

[Mary - QA Manager]

I have been tasked to create checklists for one element of ISO9001/AS9100 Section 7.3 Design and Development.
I found an old checklist and it looks like the person cut and pasted each section of the documented process into the checklist. Is this acceptable?

 

[Mark Meer]

Re: Quality Systems Effectiveness

What is the purpose of these checklists?
(a) To demonstrate/gauge your system's effectiveness? (as implied by the thread title)
or
(b) simply to demonstrate compliance to your procedures and 9001 requirements?

If (b), then what you've described might work fine.
If (a), however, you'd probably be better defining/gathering some actual metrics and comparing them to your objectives...

 

[Mary - QA Manager]

Re: Quality Systems Effectiveness

Hi Mark, thanks for your reply. As I read the Internal Auditing procedure it states I am directed to look for "opportunities" for improvements. Not all elements of the company's contain the words shall, must or will. If these words are not in the element can I still audit them and place them on the check sheet?

 

[dsanabria]

I have been tasked to create checklists for one element of ISO9001/AS9100 Section 7.3 Design and Development.
I found an old checklist and it looks like the person cut and pasted each section of the documented process into the checklist. Is this acceptably?

Check this checklist that auditor use.

You could also use the checklist (OER) in AS9101D

Hope this helps.

 

[Mary - QA Manager]

Thanks dsanabria...I have seen the AS9101D checklist and was wondering if I should insert the section of the process that address that element?

 

[Mary - QA Manager]

Where can I find some info on PEAR? My boss did mention we would be using this for the internal audit.....

 

[dsanabria]

Where can I find some info on PEAR? My boss did mention we would be using this for the internal audit.....

You could use the PEARS in the AS9101D or AS9101E

Send me a PM so that you could evaluate which ones are more applicable or useful to your needs.

 

[AndyN]

I have been tasked to create checklists for one element of ISO9001/AS9100 Section 7.3 Design and Development.
I found an old checklist and it looks like the person cut and pasted each section of the documented process into the checklist. Is this acceptably?

You really should be auditing the "process" of design and development, not the element. The process SHOULD have been created and, in doing so, some evaluation to show where each requirement of ISO 9001/AS9100 7.3 has been addressed. Your checklist should then be developed from the process, including the specifics of inputs, outputs, responsibilities, authorities, objectives and measurements your own management have laid down. This will make your task SO much easier.

 

[Mary - QA Manager]

Can you elaborate just a bit here...than cutting and pasting the procedure is fine to use as a checklist?

 

[Sidney Vianna]

Where can I find some info on PEAR? My boss did mention we would be using this for the internal audit.....

The IAQG related forms can be found @ http://www.sae.org/iaqg/forms/index.htm