What documents/forms to give to Third Party Internal Auditors

N

noboost4you

#1
We are subcontracting our first Internal Audit. What documents/forms should we be able to provide to the Internal Auditor that they would need to conduct a thorough audit?

Here is what I plan to give them. Please add any additional documentation:
1. Quality Manual
2. Audit Nonconformity Report (auditor can list single nonconformities, their corrective actions, and their follow-up actions)
3. Internal Audit Summary Report (contains: audit date, department/processes audited, auditor, audit team members, list all minors/majors, strengths, post audit review, and items to address for next audit)

Should there be more? And, should we give these documents/forms to the Auditor before he asks for them or only after he asks for them?

Thanks
 
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T

Ted Schmitt

#2
We are subcontracting our first Internal Audit. What documents/forms should we be able to provide to the Internal Auditor that they would need to conduct a thorough audit?

Here is what I plan to give them. Please add any additional documentation:
1. Quality Manual
2. Audit Nonconformity Report (auditor can list single nonconformities, their corrective actions, and their follow-up actions)
3. Internal Audit Summary Report (contains: audit date, department/processes audited, auditor, audit team members, list all minors/majors, strengths, post audit review, and items to address for next audit)

Should there be more? And, should we give these documents/forms to the Auditor before he asks for them or only after he asks for them?


Thanks
Documents #2 and #3 I presume are your internal forms? If yes, no problem for the external auditor to use them... suggestion, ask to see so you can do a little Benchmarking... :notme:

Has your contracted auditor asked for anything? Does he have any experience with your company? processes? If I where him, besides the QM, I´d ask for the procedures, process mappings, last two internal audit reports (+plus any CAPA´s generated) and the last CB report (if you are at liberty to send it out)... just for starters...
 
N

noboost4you

#3
I don't believe there has been any direct contact with the auditor scheduled for our company. All communication has gone through our consulting agency. As far as I'm concerned, no documentation has yet to be requested.

So to answer your questions, the auditor does not have experience with any part of our company.

Currently we have one interaction of processes chart. It follows this flow:
Cust. Requirements->Order Inquiry/Quote->Receive PO->Order Entry->etc.

Do all processes need written procedures? Or can the verbal training and competency of personnel be sufficient?
 
T

Ted Schmitt

#7
I don't believe there has been any direct contact with the auditor scheduled for our company. All communication has gone through our consulting agency. As far as I'm concerned, no documentation has yet to be requested.

So to answer your questions, the auditor does not have experience with any part of our company.

Currently we have one interaction of processes chart. It follows this flow:
Cust. Requirements->Order Inquiry/Quote->Receive PO->Order Entry->etc.

Do all processes need written procedures? Or can the verbal training and competency of personnel be sufficient?
When is the audit schedule for? Ask the consulting agency for the auditor´s contact info and go over necessary info with him...

What you mentioned above is the interaction of processes... have you mapped out each macro process?

Not all processes need written procedures... but I am an advocate for documentation... see 4.2.1 c) documented procedures required by this standard (6 mandatory) and d) documents needed by the organization to ensure the effective planning, operation and control of it´s processes... now how you wish to document the processes, it´s entirely up to you and your organization (procedures, work instructions, flow charts, picture charts or even the process map itself etc...)

How do you have this verbal training documented? 6.2.2 c) evaluate the effectivness of actions taken (effectivness of this verbal training - how do you demonstrate it?) In regards to the competence, it´s up to you to determine the necessary competence required for the job...

Hope this helps a little more...
 
N

noboost4you

#8
When is the audit schedule for? Ask the consulting agency for the auditor´s contact info and go over necessary info with him...

What you mentioned above is the interaction of processes... have you mapped out each macro process?

Not all processes need written procedures... but I am an advocate for documentation... see 4.2.1 c) documented procedures required by this standard (6 mandatory) and d) documents needed by the organization to ensure the effective planning, operation and control of it´s processes... now how you wish to document the processes, it´s entirely up to you and your organization (procedures, work instructions, flow charts, picture charts or even the process map itself etc...)

How do you have this verbal training documented? 6.2.2 c) evaluate the effectivness of actions taken (effectivness of this verbal training - how do you demonstrate it?) In regards to the competence, it´s up to you to determine the necessary competence required for the job...

Hope this helps a little more...
Yes, we have an interaction of processes chart. What I wrote above was the beginning of the chart. But that is the one and only chart. For example, I don't break Order Entry down any further in another chart. Order Entry is strictly Order Entry as displayed on the processes chart. Could it be broken down? Of course, but is it necessary? That answer could go either way.

I put together the 6 required procedures and included them in the Quality Manual. Other processes, such as Production, have over 100 work instructions that are meant to be For Reference Only. We train our personnel to the point where they don't need to reference any work instruction on a daily basis. The WIs are only there incase someone has a mind lapse.

There is verbal and hands-on training for 6 weeks for new hires. After 6 weeks, they take a test. Upon passing the test, they receive a training certificate. The test results and the certificate are our documented training and competency records.

Our consultant said not to offer any documentation prior to arrival. Only divulge information if requested. I was just asking to get the opinions of others who have been through this before.
 
T

Ted Schmitt

#9
Yes, we have an interaction of processes chart. What I wrote above was the beginning of the chart. But that is the one and only chart. For example, I don't break Order Entry down any further in another chart. Order Entry is strictly Order Entry as displayed on the processes chart. Could it be broken down? Of course, but is it necessary? That answer could go either way.

I put together the 6 required procedures and included them in the Quality Manual. Other processes, such as Production, have over 100 work instructions that are meant to be For Reference Only. We train our personnel to the point where they don't need to reference any work instruction on a daily basis. The WIs are only there incase someone has a mind lapse.

There is verbal and hands-on training for 6 weeks for new hires. After 6 weeks, they take a test. Upon passing the test, they receive a training certificate. The test results and the certificate are our documented training and competency records.

Our consultant said not to offer any documentation prior to arrival. Only divulge information if requested. I was just asking to get the opinions of others who have been through this before.
Sounds like you are OK and on your way... in regards to offering info before hand, I guess that can go either way also... the more info and experience the contracted auditor has with your company, the more value added audit you will receive.... one more question, who will audit the internal auditing process?
 
N

noboost4you

#10
Meaning who will audit the auditor? From what I understand, there is only one guy coming in to do it. Nobody here has Internal Auditor training, yet.
 
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