Audit Differences - Process, Product, Internal? (4 questions) - TS 16949

C

ctblalock

#1
What is the difference between a process audit that conforms to/complies with 8.2.2.2 AND an audit of a manufacturing process that is performed during an internal audit of the QMS?

I believe that they are the same in scope and focus. If so, and if I audit ALL manufacturing processes during my semi-annual system audits, am I addressing/satisfying 8.2.2.2?

Another related but separate question regarding 8222 & 8223, in any given manufacturing process we verify component or sub-assembly (operation output) conformity of select/critical processes five times per day by checking a sample piece against it's specification/requirement. "Select/critical" processes are determined based on customer requirements, RPN values, control plan designations, etc. First, is this an audit or an inspection? Second, does it satisfy 8.2.2.2, 8.2.2.3, both or neither?
:argue:

Thanks for your input.
ctb
 
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Howard Atkins

Forum Administrator
Staff member
Admin
#2
We have discussed some of these issues before
ctblalock said:
What is the difference between a process audit that conforms to/complies with 8.2.2.2 AND an audit of a manufacturing process that is performed during an internal audit of the QMS?

I believe that they are the same in scope and focus. If so, and if I audit ALL manufacturing processes during my semi-annual system audits, am I addressing/satisfying 8.2.2.2?
See these threads for some previous discussion including my views :
TS 16949 Interpretations: 8.2.2.4 Internal Audit Plans
Standard for TS 16949 process audits?
Integrate System Audit, Manufacture Process Audit and Product Audit

ctblalock said:
Another related but separate question regarding 8222 & 8223, in any given manufacturing process we verify component or sub-assembly (operation output) conformity of select/critical processes five times per day by checking a sample piece against it's specification/requirement. "Select/critical" processes are determined based on customer requirements, RPN values, control plan designations, etc. First, is this an audit or an inspection? Second, does it satisfy 8.2.2.2, 8.2.2.3, both or neither?
:argue:

Thanks for your input.
ctb
I would say this is an inspection as it is an integral part of your quality plan and is in fact a for of final inspection.

There is maybe a linguistic issue here that I think that the US use of the word audit is closer to the meaning of inspection than I would use.
The definition of audit in ISO 9000:2000 (has it changed?) is
3.9.1
audit
systematic, independent and documented process (3.4.1) for obtaining audit evidence (3.9.4) and evaluating it objectively to determine the extent to which audit criteria (3.9.3) are fulfilled
my emphasis
and thus the using of audit as part of the flow of the production means that it is not independent.
I have always felt that the "dock audit" of QS9000 was not really an audit rather than a form of final inspection.
anyone:frust:
 
V

vanputten

#3
I don't know how you define "manufacturing" but I will asssume it means Product Realization. You have more processes than just product realization. Process audits are auidits of any of your processes, not just manufacturing or product realization.

"Process Audit" is a larger scope since it includes all processes, not just manufacturing processes.

Based on the definitions of audit and inspection in ISO 9000, an audit and an inspection could be the same thing depending on how they are structured. However, the defintion for inspection seems to imply it is a one time thing where as an audit is a process of repeated evaluations of evidence to criteria.

Regards, Dirk
 

Bigfoot

Involved - Posts
#4
Howard Atkins said:
We have discussed some of these issues before


See these threads for some previous discussion including my views :
TS 16949 Interpretations: 8.2.2.4 Internal Audit Plans
Standard for TS 16949 process audits?
Integrate System Audit, Manufacture Process Audit and Product Audit


I would say this is an inspection as it is an integral part of your quality plan and is in fact a for of final inspection. This could also be viewed as a Product Audit. TS 16949 "8.2.2.3 Product audit
The organization shall audit products at appropriate stages of production and delivery to verify conformity to all specified requirements, such as product dimensions, functionality, packaging and labelling, at a defined frequency." As long as they are fulfilling the requirement stated here.


There is maybe a linguistic issue here that I think that the US use of the word audit is closer to the meaning of inspection than I would use.
The definition of audit in ISO 9000:2000 (has it changed?) is

and thus the using of audit as part of the flow of the production means that it is not independent.
I have always felt that the "dock audit" of QS9000 was not really an audit rather than a form of final inspection.
anyone:frust:
I agree with you in part about the "dock audit" being a form of final inspection. If the "dock audit" was performed using a sampling of the dimensions - characteristics then it would be more of a final inspection than being a Product Audit. :agree:

IMHO the method described for the check of the sub-assembly fits into a Product Audit better than a "dock audit" would. :2cents:
 
C

ctblalock

#5
vanputten said:
I don't know how you define "manufacturing" but I will asssume it means Product Realization. You have more processes than just product realization. Process audits are auidits of any of your processes, not just manufacturing or product realization.

"Process Audit" is a larger scope since it includes all processes, not just manufacturing processes.

Based on the definitions of audit and inspection in ISO 9000, an audit and an inspection could be the same thing depending on how they are structured. However, the defintion for inspection seems to imply it is a one time thing where as an audit is a process of repeated evaluations of evidence to criteria.

Regards, Dirk

Dirk,

Thanks for your response. Yes, I do mean "product realization" when I say "manufacturing" and yes, we have other processes (SOP's, MOP's, other COP's, etc). However, my original question is focused principally on 8.2.2.2 and whether or not internal audits of the QMS (which include audits of manufacturing processes) satisfy 8.2.2.2 or if additional manufacturing process audits must be performed?

Thanks,
ctb
 

bpritts

Involved - Posts
#6
ctblalock said:
Dirk,

Thanks for your response. Yes, I do mean "product realization" when I say "manufacturing" and yes, we have other processes (SOP's, MOP's, other COP's, etc). However, my original question is focused principally on 8.2.2.2 and whether or not internal audits of the QMS (which include audits of manufacturing processes) satisfy 8.2.2.2 or if additional manufacturing process audits must be performed?

Thanks,
ctb

ctb --

Strictly speaking, I suppose that you could argue that a single audit could cover both the full qms audit (meeting both 8.2.2.1 and 8.2.2.2). My thought would be that this misses an opportunity to do more frequent and focused audits on the "manufacturing processes". I recommend that my clients do one QMS audit (meeting 8.2.2.1) annually. We would usually sample a few manufacturing processes for this audit.

Then, we do individual manufacturing process audits using an abbreviated
checklist. We do lots of these - at least several per month-- to make sure that we cover every part number. (No, the standard doesn't say
to cover every part number; but that's our goal). We also do audits for
lots of reasons - when a new job is launched, when a complaint is received,
or just for the h*** of it.

The benefits of this are:

-- a broad look at 30,000 feet, with compliance to TS -- occasionally

-- a microscope taken on the manufacturing floor, where products -- and
money -- are actually made-- frequently.

-- participation as an internal auditor changes the work performance of the
auditor when they are doing their regular job! But it's too expensive,
and not terribly productive, to teach a lot of internal auditors all the details
of TS. But it's easy to teach them to do the micro process audit. (4 hrs
training vs. weeks).


By the way - on an earlier, separate issue - how can you tell an inspection
from an audit? By what you do in response to a nonconformity.

If an inspection -- segregate the material and do a disposition - scrap,
sort, rework. End of story.

If an audit - Determine root cause and take systemic corrective action.


Regards.

Brad
 
B

buffalo

#7
Hi,
I have the same problem with Ctblalock: "whether or not internal audits of the QMS (which include audits of manufacturing processes) satisfy 8.2.2.2 or if additional manufacturing process audits must be performed?".

In this thread, bpritts said that "Strictly speaking, I suppose that you could argue that a single audit could cover both the full qms audit (meeting both 8.2.2.1 and 8.2.2.2). My thought would be that this misses an opportunity to do more frequent and focused audits on the "manufacturing processes". I recommend that my clients do one QMS audit (meeting 8.2.2.1) annually. We would usually sample a few manufacturing processes for this audit." So why the TS does not simply state "the organization shall audit manufacturing process more frequently than others"


In other thread Howard Atkins emphasised in the mainrequirement each manufacturing process as QMS audit can skip some manufacturing process. So why in clasue 8.2.2.4 the TS requires "internal audits shall cover all quality management related processes".

My doubt becam bigger as Charles Corn was bumbfounded about the 2nd party audit as: "the auditor stated that our internal audit program couldn't utilize the TS specification for our process audits and rather that process audits had to be conducted 'versus the process using the process itself as a basis for the audit".

Any body can help clarify this problem.

Thank a lot
 

Helmut Jilling

Auditor / Consultant
#8
ctblalock said:
What is the difference between a process audit that conforms to/complies with 8.2.2.2 AND an audit of a manufacturing process that is performed during an internal audit of the QMS?

I believe that they are the same in scope and focus. If so, and if I audit ALL manufacturing processes during my semi-annual system audits, am I addressing/satisfying 8.2.2.2?

If they were intended to be the same in scope, there would have been no point in making it a separate layer of auditing.

I believe it is more appropriate to interpret it this way:

The system level audit is of the processes defined in your system (cl 4.1), the inputs, outputs, how they are performing to their criteria and objectives/targets. How are we doing as a company?

Manufacturing Processes must be audited as well. This includes every mfg. process that you do - molding, welding, painting, assembly, etc. Many people audit it using a control plan, but it should also include how each of these processes serves the next process in the sequence of steps. Doing this will tend to be a much more detailed audit than the system level.

Product audits can be done in various ways, but here the focus is on each part number and product quality, and not so much on the processes.

Each level of these audits looks at activities from different angles. Not at all the same scope.

ctblalock said:
Another related but separate question regarding 8222 & 8223, in any given manufacturing process we verify component or sub-assembly (operation output) conformity of select/critical processes five times per day by checking a sample piece against it's specification/requirement. "Select/critical" processes are determined based on customer requirements, RPN values, control plan designations, etc. First, is this an audit or an inspection? Second, does it satisfy 8.2.2.2, 8.2.2.3, both or neither?
I think this would only satisfy the intent of 8.2.2.3, Product Audits.
 
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