Final Product Audits - What happened to QS-9000 Clause 4.10.4.2?

N

Norman V

#1
What happned to QS 4.10.4.2 (Final Product Audits)?

Ok, I've been comparing QS9000 with TS16949, and it looks like at least one thing got lost in the shuffle.

What happened to QS element 4.10.4.2, Final Product Audit? It's not listed on Rad Smith's "road map" (see http://www.qualitydigest.com/pdfs/ISOTS16949.pdf).

Am I wrong, or did this requirement fade away quietly?

Does anyone know where I can find a "reverse" QS9000 to TS16949 comparison, that lists things out by the QS element number instead of the 16949 reference?

Thanks,

Norman V.
 
Elsmar Forum Sponsor
A

Al Dyer

#2
Check TS-16949, 4.17.2.4 Product Audit.

It does not say the words Dock Audut but infers that product audit includes 'delivery".
 
N

Norman V

#3
Al,

In TS16949:2002, this is now element #8.2.2.3. I am aware of this.

However, to me, this requirement now makes tons more sense, since "all specified requirements" can be audited at the "appropriate stages" instead of tearing down a unit that is already assembled and packaged. Thsi is especially problematic if your final product is a finished assembly instead of a sub-component.

This seems to confirm my suspicion that the TS16949 standard improves upon the QS9000 "dock audit" concept of checking the product after it is all the way through the process.

Thanks for the reply,

Norman V.
 
A

Al Dyer

#4
Norman,

Thanks for the input! I don't have a "legal" copy of the new version, just the draft version and I didn't want to totally jump the gun.

In my opinion, "dock audits" should be based on some measurement whether internal or customer generated. None of us can dock audit all product.
---------------------------------------------------

I wonder if a robust final inspection/audit will suffice as opposed to going to the final packaged product and tearing it apart to check the product.

By doing that aren't we opening up a can of worms? Could I.D., Bar Code, Destination, Count, Traceability possibly be compramised?

Just thinking out loud to nobody in particular.
----------------------------------------------------:bigwave:
 
R

Randy Stewart

#5
I reported this "dock audit" as rework (repackaging, etc.) and applied the company initiatives of 30% reduction in rework to the "appropriate frequency".
:biglaugh:
 
D

dewie

#6
IMHO, the final product audit is to verify that the final product including packaging, meets customer requirement. That is to verify whether all inspections and tests are done as per customer's requirement....like an assessment of system or paper audit.
This verify includes how the product is packed and how the packaging is....comparing to customer's approved standard of packaging.
But i have no idea of the delivery to TS 16949 standard...:frust:

i'm not sure if i get wrong...:confused:
 

Manoj Mathur

Quite Involved in Discussions
#7
Once again I want to revive this thread. I need more Information on this Product Audit (Dock Audit). In my Product (Aluminum Alloy Wheel Rims), Does this audit means the check for Heat Treatment Goodness, Check for Elongation Property, Check for Alloy Composition and some other Long Term Checks????

If it is true How can I Delay my Consignment to Dispatch for the want of Product Audit (Dock Audit),

If this intent is only upto Packaging, Lebelling and certain other short term auditing requirements Pl. share it.

Thanks,
 
D

D.Scott

#8
Manoj - I recently went through this with our auditor. IMHO you are required to confirm packaging, labeling, paperwork, product characteristics (not tests), apperance items, and as you say - other short term. I also feel you should confirm that all tests and inspection were done and that they passed (or a waiver is on file to release the parts prior to test results).
Additional testing would be out of the question. The requirement is that the inspected product be on the dock ready to ship. If additional testing were required you would have to move the product to a hold area awaiting results. The product would no longer meet the requirements of a dock audit and you would have to start over. If the test were destructive, it would change the ship count and all the prepared documentation. If the intent was to do all testing EXCEPT destructive testing, it would say so.
We argued a lot, but I didn't get written up on it.

Dave
 
Q

qsmso

#9
Process and product audit method

Dear Cove's friends,
I am thinking about how to make my IQA procedure for TS2. Here is my idea:
1. System audit using check list, schedule by department basis.
2. Process audit and Product audit for Manufacturing, using control plan with check list to ask deeper for product spec or process spec applied.
3. Dock aucit, at the finished goods warehouse.

What is your recommendation about this approach?
One more question, normally I assign my QC technician to perform dock audit. However, when we move dock audit into IQA, DO I HAVE to qualify my QC technician to be an TS internal auditor too? (If we consider about Ford's requirement also)

Dear Manoj,
Could you kindly please share your TS procedure regarding IQA to me?

Best regards to all,
QSMSO
 
#10
qsmso asks,
I" am thinking about how to make my IQA procedure for TS2. Here is my idea:
1. System audit using check list, schedule by department basis.
2. Process audit and Product audit for Manufacturing, using control plan with check list to ask deeper for product spec or process spec applied.
3. Dock aucit, at the finished goods warehouse."

1- That would be acceptable. Even though TS2 is "process oriented" we still have to evaluate the "shalls" of the Specification.

2- This too would be acceptable. Just depends on whether or not your auditors are trained and capable of doing both.

3- There is not a requirement in TS2 to do a separate "dock" audit. This should be a part of the product audit.

And,
"One more question, normally I assign my QC technician to perform dock audit. However, when we move dock audit into IQA, DO I HAVE to qualify my QC technician to be an TS internal auditor too? (If we consider about Ford's requirement also)"

Yes, all people doing audits must meet customer specific requirements.
 
Thread starter Similar threads Forum Replies Date
M Dock Audits - 4.10.4.2 Final Product Audit QS-9000 - American Automotive Manufacturers Standard 4
M CE / FCC Compliance for components + final product CE Marking (Conformité Européene) / CB Scheme 2
M Movement of Final Product from One Warehouse to Another Manufacturing and Related Processes 2
D Diagnostic Reagent Stability Studies - Final Product Packaging EU Medical Device Regulations 8
S Outsourcing manufacturing of final product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Stands and rack for final product is corroded Food Safety - ISO 22000, HACCP (21 CFR 120) 3
T Final inspection and testing of product from validated processes Misc. Quality Assurance and Business Systems Related Topics 1
K Final Inspection for Software Product - Functional Test? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
M Product Release - Final acceptance activities and acceptance records ISO 13485:2016 - Medical Device Quality Management Systems 8
R Final Product Prints - Are Final Product Prints required by ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M The Impact of Appraisal Costs in the Final Product Cost Software Quality Assurance 1
S First Article Inspection in an AS9100 service industry (Final product non tangable) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 13
S NonConforming product NCR during Manufacturing vs. NCR only at final inspection AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 21
A Biocompatibiltiy testing of materials (ISO 10993-1) vs. Testing of final product? ISO 13485:2016 - Medical Device Quality Management Systems 5
M Final Product Audit Specification - Assembly Operation example or form Document Control Systems, Procedures, Forms and Templates 1
M Problem creating a specification for "Final product audit" Customer and Company Specific Requirements 4
E Clause 7.3 - Verification and validation of the sub assemblies and the final product? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Final Release Responsibilities - Separate responsibility for the release of a product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S QS-9000 Clause 4.10.4.2 - Final Product Audit vs. Dock Audit QS-9000 - American Automotive Manufacturers Standard 6
C Final Product Audit (QS-9000 Paragraph 4.10.4.2) QS-9000 - American Automotive Manufacturers Standard 14
I Mother bobbin final inspection criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
D Using non-conforming components even though the final assembly is conforming? Manufacturing and Related Processes 5
M Informational EU – MDCG 2019-12 Designating authority’s final assessment form: Key Information Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final and update guidances – Software Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Special Premarket Notification [510(k)] Pathway Medical Device and FDA Regulations and Standards News 0
M Informational Final guidance – GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carc Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Acceptance Review for De Novo Classification Requests Medical Device and FDA Regulations and Standards News 1
M Informational US FDA Final Guidance – Humanitarian Device Exemption (HDE) Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classificati Medical Device and FDA Regulations and Standards News 0
V Removing final inspector for medical device manufacturing Lean in Manufacturing and Service Industries 4
M Informational US FDA Final guidance – Postmarketing Safety Reporting for Combination Products Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final guidance – Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health – Final Rule Medical Device and FDA Regulations and Standards News 0
M Informational US FDA final guidance – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Medical Device and FDA Regulations and Standards News 0
M Informational US FDA final guidance – Utilizing Animal Studies to Evaluate Organ Preservation Devices Medical Device and FDA Regulations and Standards News 0
M Informational US FDA final guidance Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Unique Device Identification: Convenience Kits Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions Medical Device and FDA Regulations and Standards News 0
T Final process capability results - What I am supposed to present? Cp and CpK? APQP and PPAP 11
M Informational IMDRF final document – Assembly and Technical Guide for IMDRF Table of Contents Submissions Medical Device and FDA Regulations and Standards News 4
M Informational USFDA Final Guidance – Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Final Rule – Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices Medical Device and FDA Regulations and Standards News 0
A Doubt on multiple inspection carrying out for same balloon number during Stage Inspection and Final Inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
M FDA News USFDA Final Guidance – Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Final Guidance – Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 2
M Informational USFDA Final Guidance – Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Final Guidance – The Least Burdensome Provisions: Concept and Principles Medical Device and FDA Regulations and Standards News 0
Similar threads


















































Top Bottom