Suggestions on conducting Internal Audit of a new site

[prady2581]

Hi All,
We have a upcoming stage 2 audit for additional branch site for Certification of ISO 9001. This site is tied to all process central branch and supporting activities. I am conducting a internal audit for this site. Would like to ask follows queries.

1. Is all elements of QMS should be audited ? (eg Management responsibility / continual improvement these are already Audited from Mgmt Team)
2. What all other imp points which will be checked by CB in Stage 2.

 

[dsanabria]

So that we are on the same page - there are sites, one of the is the main one where all of the QMS is done and the other site does some of the work.

Q. In your QM - what activities have you excluded and clearly specified that those are done at the primary site only. Base upon your clarification of scope for that site - everything else will be audited.

 

[prady2581]

Thanks Dsanabria. This new site is not the main QMS and "Do" activities are performed.

This site acts as supporting activities to main sites (already certified for ISO 9001) mostly for assigned tasks " Do " Phase.

All process, tools, documents are centrally available and followed, hence there it is only stage 2 audit. From stage 2 perspective what I need to take care of in terms of any documentation requirements (if any).
a) Internal Audit
b) do I need to include this location in our QMS, if yes need suggestion on how to include it appropriately the reason being this site is only acts as Supporting activities to main sites.

 

[somashekar]

You need to include for sure...
By a statement of scope and activities done at the new site within your quality manual.
By proper process and interactions mapping in the quality manual.
By proper authority and responsibility determination and communication
By considering in your internal audit scope
By inclusion in your management review process
By proper communication of quality policy and objectives
.
..
...

 

[dsanabria]

Thanks Dsanabria. This new site is not the main QMS and "Do" activities are performed.

This site acts as supporting activities to main sites (already certified for ISO 9001) mostly for assigned tasks " Do " Phase.

All process, tools, documents are centrally available and followed, hence there it is only stage 2 audit. From stage 2 perspective what I need to take care of in terms of any documentation requirements (if any).
a) Internal Audit
b) do I need to include this location in our QMS, if yes need suggestion on how to include it appropriately the reason being this site is only acts as Supporting activities to main sites.

During the Stage 1 audit - did anyone explained the process to you? This is somewhat concerning, so send an e-mail to the auditor and ask for an agenda or for what would the auditor be looking at. Talk to the registrar and find out how this other site would be handled.

Think of it as a facility that the auditor has not seen so he would want to look at all documentation that you have right now which includes pertinent internal audit, documentation peraining about theproduction or warehouse proceessse, any contract reviews / purchasing operation, nonconformances and certifications

 

[rajeshprajapati]

Hi, I just faced 1st stage AS9100 audit. External Auditor has asked me whether I have carried out internal audit on your consultant(outsourced activity) who is helping you to get AS certification?

I am confused what should be the acceptance criteria for approving such agencies who is already an expert in this field. I just want to check whether they are qualified enough to support us or not?

Please help.....

Rajesh Prajapati

 

[dsanabria]

Hi, I just faced 1st stage AS9100 audit. External Auditor has asked me whether I have carried out internal audit on your consultant(outsourced activity) who is helping you to get AS certification?

I am confused what should be the acceptance criteria for approving such agencies who is already an expert in this field. I just want to check whether they are qualified enough to support us or not?

Please help.....

Rajesh Prajapati

You have an auditor that has a poor understanding on outsource - here is the definition from AS9100 4.1

"These processes shall be managed by the organization in accordance with the requirements of this International Standard.

Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system."

Presently, there are no specific criteria that tells you that if you use an outside consultant that you must audit them. However, you should always make sure that they are competent.

Bottom line, if it is not in clause 7, you are not required to audit or review (Don't get me wrong - not a bad practice but if the auditor writes you up - let us know which clause he used and appeal the NCR.

or

Time to find a competent auditor.

 

[rajeshprajapati]

Thank you dsanabria. Can you please elaborate little further on what could be the possible checkpoints to check the competence level of a consultant?

Rajesh

 

[dsanabria]

Thank you dsanabria. Can you please elaborate little further on what could be the possible checkpoints to check the competence level of a consultant?

Rajesh

Start with education / courses taken and years consulting.

Then ask for referral and verify with other clients as to their input in hiring this consultant.

Finally, have upper management interview him or another individual that you think is competent.

Remember, this is the beginning of your journey and you want somebody to guide you appropriately. Usually, season veterans will also educate you in the process.

Let me know if this helps.

 

[prady2581]

Hi Dsanabria,

From ISO 9001 Certification Audit requirement (Stage 2) is there any requirement that update in the Quality Manual should be present before the Audit.
We have internal Audit schedule for this site.
A internal reference is logged and identified changes required on the Quality Manual for this particular site.

This is because is it appropriate to update the Quality Manual (adding this new site ) as this site is yet to get certified