What are some of the findings found during your desk audit and how was it conducted?
- Thread starter gpainter
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Claes Gefvenberg
Admin
The manual: We threw it out and wrote a new one. 10 pages proved to be quite sufficient...
The rest of the system: We have been quietly adding the stuff we needed to add since ISO9001:2000 was released and we did not miss the opportunity to also tweak the QMS when we went for the ISO 14001 badge last year. When we really got to grips with the upgrade, most of the required stuff turned out to be there already.
One interesting fact: We found that we were able to clean out a whole lot of (unused and quite unnecessary) stuff from our system.... Thus, the size of the QMS actually decreased...
/Claes
The rest of the system: We have been quietly adding the stuff we needed to add since ISO9001:2000 was released and we did not miss the opportunity to also tweak the QMS when we went for the ISO 14001 badge last year. When we really got to grips with the upgrade, most of the required stuff turned out to be there already.
One interesting fact: We found that we were able to clean out a whole lot of (unused and quite unnecessary) stuff from our system.... Thus, the size of the QMS actually decreased...
/Claes
S
Sam
Marc said:
For TS2 the desk audit is simple; consisting of reviewing the QM for the scope, the seven required procedures,or reference to them and process definitions.
There were no findings.
R
Rachel
gpainter,
Our document review basically involved me sitting down with the auditor for a day and walking him through our procedures. We have a quality manual (which I believe is about 20-30 pages - not all text, though), the six required procedures, and ten "process SOPs" which outline the main core processes at our facility. Other than that, we have the lower-level SOPs that are more department/process-specific, and then work instructions. He looked mainly at the manual, the six required, and the ten process. No findings.
Keep in mind that the intent of the documentation review ("desk audit") is to ensure that your documentation meets the requirements of the standard. Basically, as long as you have a quality manual that details the three points in 4.2.2, and the six procedures that are required - and as long as any other procedures that you have do not violate anything stipulated in the standard, you're aces.
Cheers,
-R.
Our document review basically involved me sitting down with the auditor for a day and walking him through our procedures. We have a quality manual (which I believe is about 20-30 pages - not all text, though), the six required procedures, and ten "process SOPs" which outline the main core processes at our facility. Other than that, we have the lower-level SOPs that are more department/process-specific, and then work instructions. He looked mainly at the manual, the six required, and the ten process. No findings.
Keep in mind that the intent of the documentation review ("desk audit") is to ensure that your documentation meets the requirements of the standard. Basically, as long as you have a quality manual that details the three points in 4.2.2, and the six procedures that are required - and as long as any other procedures that you have do not violate anything stipulated in the standard, you're aces.
Cheers,
-R.
J
Jonell
I simply had to email my quality manual (all 5 pages of it) to the CB for his review and approval prior to his coming.Marc said:
Jonell
P
pga_gold
Our Desk Audit
In our desk audit, we spent one day reviewing the QM and a second day reviewing our COPs. There were several editorial changes that needed done on the QM. Goofy stuff really...it was "recommended" that we change all "Quality System" wording to "quality management system" wording. Waste of time!
As for the COPs...we spent a great deal of time reviewing the inputs and outputs and process measurement and monitoring. We were a little off base when we initially established process monitoring. The measurements for our manufacturing process were more geared toward product rather than process effectiveness.
I just realized that the information I gave dealt with our pre-assessment audit and not the actual desk audit. I'll post it anyway, maybe it's useful for someone.
In our desk audit, we spent one day reviewing the QM and a second day reviewing our COPs. There were several editorial changes that needed done on the QM. Goofy stuff really...it was "recommended" that we change all "Quality System" wording to "quality management system" wording. Waste of time!
As for the COPs...we spent a great deal of time reviewing the inputs and outputs and process measurement and monitoring. We were a little off base when we initially established process monitoring. The measurements for our manufacturing process were more geared toward product rather than process effectiveness.
I just realized that the information I gave dealt with our pre-assessment audit and not the actual desk audit. I'll post it anyway, maybe it's useful for someone.
Round up the usual suspects
I'm training a handful of new auditors. They went into it with vigor.....most of what we found was document control issues. The usual things....people changed their procedures and never ran the revision by doc control, or received their new rev but were still working to the old.
I'm training a handful of new auditors. They went into it with vigor.....most of what we found was document control issues. The usual things....people changed their procedures and never ran the revision by doc control, or received their new rev but were still working to the old.
Jonell said:
We did about the same as above. Mailed the Quality Manual 15 days ahead of the audit.I remember the auditor did confirm the presence of mandatory documents like Quality Policy, Quality Manual, those 6 documented procedures. Auditor had few questions about the " exclusions".
Later these were verified during the site visit audit (field work).
We took the approach of writing the Quality Manual in the same flow of Product Realization linking the supporting process at the appropriate places.
I remember there was a poll in this forum around the same (July-Oct 2002) time frame in the very same topic about Quality Manual- Process approach. I saw only very few took this approach.
I guess this approach is not so common. Auditor took some time to re-orient from the ISO sections clauses sequence and get adjusted to this flow. Eventually, he liked this approach of writing Quality Manual.
Oops, I almost forgot. We had a finding to revise the Quality policy to include an "explicit commitment to continual improvement".
Govind.
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