TS 16949 - Clause 8.2.2 - Internal Audit

[FlavioLima]

Hi Folks !!!!

I need your support again. I'm not specifically related to QMS implementation, but received this task and it gets me nuts.
This time We've been reviewing an existent procedure for internal audit (QMS, manufacturing process and produt) and following are my questions:

a. Is the subject of audit for manufacturing process and produt (1)the existence of process control evidenced by datasheets, checklists, and product checklists, etc or (2)the outcome data colected by application of these documents?

b. Is there any opposition if I split my procedure of internal audit in two (one part just regarding QMS audit and other regarding manufacturing process and product audit)?

c. Is possible to delegate responsability of schedule and prepare audits to any other departament than Quality?

Best regards.

Flávio Lima

 

[Bigfoot]

Hi Folks !!!!

I need your support again. I'm not specifically related to QMS implementation, but received this task and it gets me nuts.
This time We've been reviewing an existent procedure for internal audit (QMS, manufacturing process and produt) and following are my questions:

a. Is the subject of audit for manufacturing process and produt (1)the (Manufacturing Process audit is to verify effectiveness of the mfg. process to it's planned arrangements and it can be done via the process controls evidence;(ie: datasheets, checklists, etc)existence of process control evidenced by datasheets, checklists, and product checklists, etc or (2)the outcome data colected by application of these documents? the outcome of data collected by these documents could be a Product Audit only (= Conformance to specification) and not assess effectiveness of the Process. an example could be results from a rework or secondary operation that is not identified in the process control documents

b. Is there any opposition if I split my procedure of internal audit in two (one part just regarding QMS audit and other regarding manufacturing process and product audit)? It is your system / audit function if it fits your organization better for you to perform them in that way then do what is right for your business.

c. Is possible to delegate responsability of schedule and prepare audits to any other departament than Quality? I think that would depend on who is assigned responsibility of Management Rep & Internal audits. Again it is your system and if you can do this and maintain an effective Internal Audit programme then do what is right for your business.

Best regards.

Flávio Lima

Flavio,

I added my comments in Red to your questions. Hope these help in answering your questions. Remember it is your business - you run it - how you meet the requirements is up to you as long as you meet them.

 

[Caster]

Sounds good to me

Hi Folks !!!!

I need your support again. I'm not specifically related to QMS implementation, but received this task and it gets me nuts.
This time We've been reviewing an existent procedure for internal audit (QMS, manufacturing process and produt) and following are my questions:

a. Is the subject of audit for manufacturing process and produt (1)the existence of process control evidenced by datasheets, checklists, and product checklists, etc or (2)the outcome data colected by application of these documents?

b. Is there any opposition if I split my procedure of internal audit in two (one part just regarding QMS audit and other regarding manufacturing process and product audit)?

c. Is possible to delegate responsability of schedule and prepare audits to any other departament than Quality?

Best regards.

a) My thought is that you do a product audit <also known as a dock audit> to check that the parts are in spec. Just verify some final and in procees checks on a sample of finished goods.

A process audit checks that people are following their documented system, doing checks as required, reacting to problems and so on. If you are in autotmotive, it can be a check that the control plan is being followed.

b) Good idea indeed. I do a "desk audit" to ensure that the procedures as written meet the requirements. No one is involved in this audit, it is a boring clerical exercise only. After that, we just audit the owner to see that proceudres are being followed as written.

c) I think this is an excellent idea. The more people invloved the better. Also useful to open peoples eyes to the big picture to see what other people do. Also fun to have the customer audit the supplier process. This helps people find the problems at the process interfaces.

I think you are on the correct path with these ideas!