I want discuss auditing of D&D in ISO 9001:2000

First discussion is I want to audit in very small company having single product line,and responsible from design to installation During the certification audit oragnization well implemented D&D step as mentioned in 7.3 of ISO 9001:2000, Now Question is during 1st followup after one year oragnization not done any minor design related change in their product, design is completely same as registration audit, now i want to do design audit during follow audit, now what i have to see. :applause:

I want discuss auditing of D&D in ISO 9001:2000

First discussion is I want to audit in very small company having single product line, and responsible from design to installation During the certification audit oragnization well implemented D&D step as mentioned in 7.3 of ISO 9001:2000, Now Question is during 1st followup after one year organization not done any minor design related change in their product, design is completely same as registration audit, now I want to do design audit during follow audit, now what I have to see. :applause:

The new standard is ISO 9001:2008. No new requirements....;)

When you do the D&D audit again, you'd expect to see the same process and that the D&D folks still understand the process as designed. That's it.

Stijloor.

I want discuss auditing of D&D in ISO 9001:2000

First discussion is I want to audit in very small company having single product line,and responsible from design to installation During the certification audit oragnization well implemented D&D step as mentioned in 7.3 of ISO 9001:2000, Now Question is during 1st followup after one year oragnization not done any minor design related change in their product, design is completely same as registration audit, now i want to do design audit during follow audit, now what i have to see. :applause:

Hi Vijay,

If thats the case, its time to sit back and relax :tg:

Btw, you can have a look at all your records relating to 7.3 viz.

7.3.2 Design and development inputs relating to product requirements
7.3.4 Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any necessary actions

Additionally ensure that no changes have been effected to the previous design :)

I want discuss auditing of D&D in ISO 9001:2000

First discussion is I want to audit in very small company having single product line,and responsible from design to installation During the certification audit oragnization well implemented D&D step as mentioned in 7.3 of ISO 9001:2000, Now Question is during 1st followup after one year oragnization not done any minor design related change in their product, design is completely same as registration audit, now i want to do design audit during follow audit, now what i have to see. :applause:

So, why do your want to audit it? If nothing's changed, and I mean nothing - no product changes, no personnel changes, nothing, then why are you doing it? You will be wasting their time and yours.

Of course, if you are auditing them to see if anything's changed, that's different!

If they are responsible for installation, I'd be interested in that activity. It's 'close' to the customer! Unless they haven't done any installations!

BTW - why are you doing this audit?

Either from an internal or external audit perspective, processes scheduled to be audited should take into account the status of the activity.

If the process was deemed conforming during the last audit and no additional design & development work has taken place since then, there is no value re-auditing it.

Either from an internal or external audit perspective, processes scheduled to be audited should take into account the status of the activity.

If the process was deemed conforming during the last audit and no additional design & development work has taken place since then, there is no value re-auditing it.
What Sidney has mentioned is certainly one of the sources based on which auditor can confirm whether any change has actually taken place with respect to design. If one has time, you can also look up:
1. Masterlist of docs to find out whether any amenment has been issued during the review period.
2. Customer feedback to find out whether any design-related comment has been received and auditee has taken appropriate action.
3. Nonconformity reports to find out whether any design-related NCs have been recorded.
There can be a few more like these.

What Sidney has mentioned is certainly one of the sources based on which auditor can confirm whether any change has actually taken place with respect to design. If one has time, you can also look up:
1. Masterlist of docs to find out whether any amenment has been issued during the review period.
2. Customer feedback to find out whether any design-related comment has been received and auditee has taken appropriate action.
3. Nonconformity reports to find out whether any design-related NCs have been recorded.
There can be a few more like these.

This would be good input for a management review (well the second two would), but since the OP says there's been no D & D activity, there's basically no point - what you describe needs to be taken into account in a corrective action, but we'd still have to wait for implementation of something.........

This would be good input for a management review (well the second two would), but since the OP says there's been no D & D activity, there's basically no point - what you describe needs to be taken into account in a corrective action, but we'd still have to wait for implementation of something.........
I guess we are discussing what an auditor should do if the auditee in D&D says 'No change, buddy, since last audit' (and not about 'mgmt. review'). Do we expect auditor to say 'ThanQ' and go back or you expect auditor to verify what auditee has said. In my mail, I suggested that apart from what Sidney suggested(IR reports), a few more docs could be added,scrutiny of which may provide the evidence to confirm whether any change has occurred in design or not!

I want discuss auditing of D&D in ISO 9001:2000

First discussion is I want to audit in very small company having single product line,and responsible from design to installation During the certification audit oragnization well implemented D&D step as mentioned in 7.3 of ISO 9001:2000, Now Question is during 1st followup after one year oragnization not done any minor design related change in their product, design is completely same as registration audit, now i want to do design audit during follow audit, now what i have to see. :applause:

Hi vijaysonawane,
welcome to the cove. :bigwave:
With regard to Clause 7.3 D&D, there could be no change, however, as per Clause 4.2.3 b) to review and update as necessary and re-approve documents. This means though there were no changes in 7.3, there should be an evidence that the documents pertaining to Clause 7.3 has been reviewed.
Hope this helps.
Best regards,
raffy:cool:

Hi Vijay,

If thats the case, its time to sit back and relax :tg:

Btw, you can have a look at all your records relating to 7.3 viz.

7.3.2 Design and development inputs relating to product requirements
7.3.4 Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any necessary actions

Additionally ensure that no changes have been effected to the previous design :)

Thanks sir ,

But the followup audit perticularly in repeat (recertification )audit we have to cover all the process then we have to right same sample model as objective evidence,

One thing i got from all you that i should not do audit, here i want to do the audit as mendatory requirement as mentioned above , i have to cover all the process including design in the repeat audit with objective evidence and sample taken for design audit.:argue:

Maybe we could ask you to answer the questions we asked you?

Without knowing more as to why you are doing this audit we can't help. There's no point in auditing someting which hasn't changed (forget document reviewing) and hasn't been implemented since the last time. Sidney told you straight!

Give us the background to why this audit is being done.....

Yes sir,

complete Agree !!

:agree1:

Hi vijaysonawane,
welcome to the cove. :bigwave:
With regard to Clause 7.3 D&D, there could be no change, however, as per Clause 4.2.3 b) to review and update as necessary and re-approve documents. This means though there were no changes in 7.3, there should be an evidence that the documents pertaining to Clause 7.3 has been reviewed.
Hope this helps.
Best regards,
raffy:cool:

Yes sir,

complete Agree !!

:agree1:

You will be wasting your time, since this has nothing to do with the D & D process. Why would any document have been reviewed, if nothing changed? Also, looking at documents, is NOT an audit of the implementation of the D & D process............