Product Audit - Explanation and samples of the report - TS 16949

Elsmar Forum Sponsor

Howard Atkins

Forum Administrator
Staff member
Admin
#22
VW is the manufacture of vehicles.

VDA is the German Automotive manufacturers organisation

VDA 6.1 is for Quality system audit
VDA 6.2 is for Quality system audit services
VDA 6.3 is for process audit
VDA 6.4 is for Quality systems audit production equipment
VDA 6.5 is for product audit
VDA 6.6 is for produict audit services

I hope this helps
 

Douglas E. Purdy

Quite Involved in Discussions
#24
Our decisions for product audits came from the AIAG definition as follows:

"The intent of the product audit is verification that the control plan controls in different stages of production, including the shipping dock. The process audit verifies that the process is followed, whereas the product audit verifies that the control plan is followed.

Many years ago, this used to be the job of the inspector who would randomly sample products and verify that the operator was indeed doing the necessary inspection.

The product audit asks the question: How does the organization know if the product checks as required by the control plan are carried out? This is the intent of the product audit. Organizations must sample products and manufacturing processes, including the dock, to ensure that the product dimensions, functionality, packaging and labeling are occurring as planned."
As I have made it known in other threads, I am a Newbie in TS. Where is this AIAG definition? It sounds more like a guidance statement. I believe I am leaning more with Howard's views and perspective on the matter of TS 8.2.2.3., but I am still trying to establish a plan for Supplier QMS Development Audits, Layered Process Audits, Internal QMS Audits, Manufacturing Process Audits, and Product Audits.

Any suggestions or recommendations from anyone would be appreciated. Of course I continue to read various threads from the cove to help in my understanding.

Thanks,
Doug
 

Jim Wynne

Staff member
Admin
#26
Our decisions for product audits came from the AIAG definition as follows:

"The intent of the product audit is verification that the control plan controls in different stages of production, including the shipping dock. The process audit verifies that the process is followed, whereas the product audit verifies that the control plan is followed.

Many years ago, this used to be the job of the inspector who would randomly sample products and verify that the operator was indeed doing the necessary inspection.

The product audit asks the question: How does the organization know if the product checks as required by the control plan are carried out? This is the intent of the product audit. Organizations must sample products and manufacturing processes, including the dock, to ensure that the product dimensions, functionality, packaging and labeling are occurring as planned."
The definitions don't make any sense--they're typical AIAG bafflegab. For example, how does having an inspector look at product "...verify that the operator was...doing the necessary inspection"? Wouldn't the inspector have to see the operator inspection being done in order for the verification to be sensible?

It's possible (and even laudable) to have a control plan that includes no "product checks." So how would you do a "product" audit in accordance with the quoted definition?

Then there's this: "How does the organization know that the product checks as required by the control plan are carried out?" A better question would be "If you assume that the requirements of the control plan are not being carried out (which must be the assumption if product audits are considered necessary), what are you doing to solve that problem?" Hint: auditing won't help.

This is not to say that auditing isn't helpful, but if the reason for auditing is that you don't trust people, nothing good can come of it. Give people whom you trust good processes and the means to execute them, and you can go fishing instead of doing all that auditing, or trying to characterize different types of audits by nonsensical definitions.

If an audit doesn't help people to do a better job, it doesn't make any difference what you call it.
 
A

Athies

#27
Hello ALL,
Just noted in the TS Semiconductor Supplement(for semiconductor parts suppliers).Clause 8.2.4S
"Note Due to semiconductor packaging techniques, it is not required that part testing be performed on parts packaged for shipping unless specifically required by the customer.
Does this also apply to Product audit

Thanks Guys
Athies
 

Manix

Get Involved!!!
Trusted Information Resource
#28
I am having a bit of a dilema with internal audits and how we do them.

The form we currently complete for PRODUCT AUDIT, seems to address both process and product auditing! I can give you the examples of the questionaire we complete for a product audit:

There is no inspection of thew product here as I can see!

Works Order

1) Production sample issue:
Spec/Drawing Issue (if relevant)

2) Check BOM is as master

REFERENCE W.O

3) Have traceability numbers (EM/GI) been logged for the stock items? Give x1 example:

4) Has >Picked By= column been signed?
Has >Checked By column been signed?

5) Has production workers been recorded?

6) Have QC signed off W.O (if applicable)

7) Any customer special requirements stated? if so state:

8) Has 7 been actioned correctly?

9) Have all dates been recorded?

Packaging/Labelling

1)Is the packaging as stated on W.O / Product Sample

2) Does label state:
a) Part Numebr
b) Customer part number
c) Carton Qty
d) W.O / DDI Number State:
e) Company Name and Address
f) Inspection stamp in place
g) Operators stamp on top
h) Others


General
Action:

a) 1) Are operators trained for the job they are doing?
2) Is training matrix up to date?
b) 1)What Test/Checks are used?
2) Is product correct to specification / drawing?
3) Are quality objectives met?
4) Are machine parameters set to specification?
5) Are gauges listed on control plan available?
6) Is manufacturing equipment in good condition?
7) Is all test equipment in calibration?
c) Is process correct to Control Plan (where applicable)
d) Is process correct to Work Instructions (where applicable)
e) Are requirements for process capability/performance met (where applicable)
f) Are their any areas where improvement to product could be achieved?
g) Are appropriate records being generated on correct issue of documentation?
h) Cleanliness of work area?
i) Are stores / despatch records correct (where relevant)?

I understand it does check the product for conformance, but is there a need for all the process checks as part of the product audit?

No for me this mainly deals with process checks and a few product requriements. I cannot get my head around this being a Product Audit, as I aggree with Howard, that a Product Audit should specifically check the product for conformance to requirements. This just seems to check the requirements for process have been met with a little bit of product conformance thrown in there for good measure!

Am I right? DO you guys see this as a Product Audit?

I am trying to formulate some streamlined Database approach type systems and this has become my starting point. Your comments would be appreciated.
 
Last edited:

Howard Atkins

Forum Administrator
Staff member
Admin
#29
I am attaching a very generic product audit check-list which can be modified for all uses.

The auditing of processes in my view is one of the most disputed areas of the standard.
The requirement of the standard generally is to audit in a process manner.
8.2.2.2 requires that you audit all manufacturing processes to see if they are effective.
In previous standards when sections 9 and 10 were audited you did not have to go to all manufacturing departments.

Now you do, the emphasis is on each
 

Attachments

Manix

Get Involved!!!
Trusted Information Resource
#30
I am attaching a very generic product audit check-list which can be modified for all uses.

The auditing of processes in my view is one of the most disputed areas of the standard.
The requirement of the standard generally is to audit in a process manner.
8.2.2.2 requires that you audit all manufacturing processes to see if they are effective.
In previous standards when sections 9 and 10 were audited you did not have to go to all manufacturing departments.

Now you do, the emphasis is on each
Yes I understand the process approach. My point is that we have a process audit as well as the "Product Audit" covered above.

Let me explain briefly why I have had this issue:

We carry out some light assembly on our lines, which is what the above audit will cover. We don't however manufacture or assemble all of our product portfolio. Yet we should audit our products at regular intervals as per TS. Some parts we don't even see here, as they are shipped from our manufacturing partner straight to the customer.

I was looking to build a regular product audit system specifically for the products we don't currently see hit our site. In doing this I thought I would see how it could be incorporated into our current product audit procedure. It would be difficult to implement such a system as so much would simply not apply to a product not manufactured on site. Obviously these kind of audits are carried out by our manufacturing partner, and taking on board Jim's comments, I guess us carrying out the audits could be seen as waste! I.e. we don't trust the manufacturing source to ensure product quality continuously!
 
Thread starter Similar threads Forum Replies Date
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
F Product audit sampling plans IATF 16949 - Automotive Quality Systems Standard 3
G Addressing Non-Conformances from an Internal Audit that are not product related ISO 13485:2016 - Medical Device Quality Management Systems 11
D What are the important things to keep track of in product audit checklist? Software Quality Assurance 3
B Is it necessary to conduct product audit of entire product which is manufactured in the company as per IATF IATF 16949 - Automotive Quality Systems Standard 4
Q IATF 16949 - Product audit - Must each product be audited? IATF 16949 - Automotive Quality Systems Standard 6
U Dock Audits - Isn't waiting to do an audit when the product is "supposed" to ship a little late? Manufacturing and Related Processes 12
W Product Audit - It must be a separate and distinct activity (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 4
S IATF 16949 - Manufacturing and Product Audit Approach IATF 16949 - Automotive Quality Systems Standard 19
B TS16949 Section 8.2.2.3 Product Audit - Requirements for various Customers IATF 16949 - Automotive Quality Systems Standard 10
K Please share a Product Audit Checklist for a Wafer Fab Document Control Systems, Procedures, Forms and Templates 3
Q Internal Audit of Product Quality Complaint System (21 CFR Part 820) Customer Complaints 9
C TS16949: Product Audit vs. "Regular Checks" Internal Auditing 1
P May I combine the Process Audit and Product Audit into Delphi's LSR? Customer and Company Specific Requirements 3
J Questionable Audit Finding about Revision Levels of Product Manual CD's ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C Requirement for NB audit with Discontinued Product EU Medical Device Regulations 3
J Product and Process Audit according to ISO/TS 16949:2009 Process Audits and Layered Process Audits 9
S Supplier Audit Questionnaire for aerospace product suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
C Anvisa Manufacturer Audit - Product produced at two different Sites Other Medical Device Regulations World-Wide 3
W Definition Product Audit - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
O Product Audit for Rubber Parts for Automotive Industry IATF 16949 - Automotive Quality Systems Standard 3
Q How to Audit the Client Quality System - Product Failure caused by no Maintenance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L EN 45011 (European Standard for Product Certification) Audit Checklist needed Other ISO and International Standards and European Regulations 3
A Non-Conforming Product vs. Supplier Audit Finding Supplier Quality Assurance and other Supplier Issues 8
Q Product Audit Check List according to VDA VDA Standards - Germany's Automotive Standards 1
A Seeking: documentation for intrinsically safe product audit General Auditing Discussions 6
A How to calculate the Effectiveness of the Process and Product Audit System Internal Auditing 10
michellemmm Software Product Development Quality Assurance (PDQA) Audit Checklists Software Quality Assurance 12
Q Product Characterization Audit - What is "Characterization" IATF 16949 - Automotive Quality Systems Standard 7
R Product Audit Checklist according to ISO/TS 16949 IATF 16949 - Automotive Quality Systems Standard 24
D Dock Audit (Product Audits and Process Audits) database wanted Quality Assurance and Compliance Software Tools and Solutions 20
Q What should be Audited in a Product Audit IATF 16949 - Automotive Quality Systems Standard 14
harrysons Product Audit Checklist - Please give some advice or share your opinions Software Quality Assurance 10
A Product Audit - Traceability of Sand used Internal Auditing 8
B What is in a Product Audit? TS 16949 Clause 8.2.2.3 Process Audits and Layered Process Audits 21
K Help in meeting the requirements in 8.2.2.3 Product Audit of TS 16949 IATF 16949 - Automotive Quality Systems Standard 5
I Definition Product Audit vs. Dock Audit vs. Layout Audit - Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 29
V Is Product Audit Mandatory as per ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 19
somashekar Product audit for using the safety mark (ETL) on label Other Medical Device and Orthopedic Related Topics 2
Ajit Basrur Process and Product Audit format needed Process Audits and Layered Process Audits 1
R Product Audit Summary Form needed IATF 16949 - Automotive Quality Systems Standard 5
B What is the full name of QKZ in product audit? IATF 16949 - Automotive Quality Systems Standard 8
H Product Audit - TS 16949 Clause 8.2.2.3 IATF 16949 - Automotive Quality Systems Standard 18
K Mock Audit Log Form Template for Product Recall/Return at Food Plant Document Control Systems, Procedures, Forms and Templates 8
P Product Audit looking at Conformity, not Effectiveness General Auditing Discussions 6
C Audit NonConformance - Evidence of Post Market Vigilance and Product Recall. ISO 13485:2016 - Medical Device Quality Management Systems 6
J AS9100 Clause 7.4.3 Verification of Purchased Product (audit Finding) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 30
Q Dock Audit - Reasons to do dimensional checks during product dock audit Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
Icy Mountain Product Audit Process Requirements - Clause 8.2.2.3 IATF 16949 - Automotive Quality Systems Standard 35
H Specification Description - Product audit on the production floor IATF 16949 - Automotive Quality Systems Standard 4

Similar threads

Top Bottom