Process and Product Audit Checklist - Product Realization, Effectiveness of Process

D

Dawn

The new TS standard requires process and product audits. I have not had much experience with these; only system audits.
Does anyone know where I can find a sample of a process audit checklist for auditing product realization and effectiveness of process performance?

Can anyone tell me where I can find a checklist for a product audit to verify conformance to all specified requirements, such as product dimensions, packaging, labeling.
Thanks, ahead!
 
D

Dawn

Kevin,
We have control plans when auto specified. When not customer specified, we have process sheets which are pretty much the same thing.
 

Kevin Mader

One of THE Original Covers!
Leader
Admin
Dawn,

Sorry for the late response.

You may be able to structure a checklist for the operations/processes from your auto control plans generic enough that may be applied to other non-auto areas.

In a system audit, your looking for objective evidence that the system meets the quality program and any governing standard. The same is true of process and product audits. You may have operations that are performed in accordance with specific standards (ASTM for example) or products must meet a CE requirement. You are still obligated in meeting and self imposed or created work standards or practices. Creating working papers for the audit is the same.

In the absense of any particular standard requirements, you may want to determine what customer driven requirements you might have. And audit for effectiveness. The audit tool is there to check how the plan is functioning and if it delivers as expected.

I hope this helps.

Regards,

Kevin
 

Ettore

Quite Involved in Discussions
Re: Process and Product Audit Checklist - Product realization, Effectiveness of proce

Good morning

I'm going to review the manufacturing site (for a new line) quality management system with APQP team.
We are going to use the product /process quality checklist provided in appendix A-4 of APQP second editions like suggestet at page 26 point 3.2.

Can we define it a process Audit?

Can we use the product /process quality checklist provided in appendix A-4 also for process audit like required by ISO TS?

(We usually have just a programm of System Audit. For System Audit usually we have a check list based on our internal quality system procedures)

Bye
 

Ettore

Quite Involved in Discussions
Re: Process and Product Audit Checklist - Product Realization, Effectiveness of Proce

Good Morning
Nobody interested to give suggestions?
The answers may also be useful to others.
Or not?
Claes A little effort, you can suggest the best.
Bye
 
Last edited:
D

Doug

Re: Process and Product Audit Checklist - Product Realization, Effectiveness of Proce

For ISO/TS 16949, I used Control Plans/FMEA for the Process Audit and Customer Requirements for the Product Audit. Did your output meet their expectations (contact or PO).
 

qusys

Trusted Information Resource
Re: Process and Product Audit Checklist - Product Realization, Effectiveness of Proce

Good Morning
Nobody interested to give suggestions?
The answers may also be useful to others.
Or not?
Claes A little effort, you can suggest the best.
Bye

I already knew them and they are good tool to plan a process or product audit, but they should not be seen a check box to sign but as a guideline , a trail to manage a process/product audit. This advice is also reported in APQP blu book at page of Apprendix A in Purpose of the check lists. They could be a good starting point, but take also into account what TS requires for product audit that shall be done at appropriate stages of the production and of shipping to verify the conformity to requirements ( dimension, functionality , packaging , labelling) with established frequence and process audit on each mfg process shall be done to assess the related effectiveness.
 

Raffy

Quite Involved in Discussions
Re: Process and Product Audit Checklist - Product Realization, Effectiveness of Proce

Hi, :bigwave:
For Process Audit Checklist, I am using the Turtle Diagram, while for Product Audit Checklist (Refer to attachment), basically I also got this form from the forum, somebody share it, I modify some of the column for our needs.
Hope this helps.
Best regards,
Raffy :cool:
 

Attachments

  • PRODUCT AUDIT CHECKLIST.xls
    27 KB · Views: 3,106
Thread starter Similar threads Forum Replies Date
P May I combine the Process Audit and Product Audit into Delphi's LSR? Customer and Company Specific Requirements 3
J Product and Process Audit according to ISO/TS 16949:2009 Process Audits and Layered Process Audits 9
A How to calculate the Effectiveness of the Process and Product Audit System Internal Auditing 10
D Dock Audit (Product Audits and Process Audits) database wanted Quality Assurance and Compliance Software Tools and Solutions 20
Ajit Basrur Process and Product Audit format needed Process Audits and Layered Process Audits 1
Icy Mountain Product Audit Process Requirements - Clause 8.2.2.3 IATF 16949 - Automotive Quality Systems Standard 35
M Different types of audit definitions - System, Adequacy, Product, Process, Compliance Internal Auditing 5
R Quality System vs. Process vs. Product Audit - TS16949 IATF 16949 - Automotive Quality Systems Standard 49
V How to Fit a Product Audit for a Batch Process? TS16949 General Auditing Discussions 2
C Audit Differences - Process, Product, Internal? (4 questions) - TS 16949 General Auditing Discussions 7
H How to Integrate System Audit, Manufacture Process Audit and Product Audit Process Audits and Layered Process Audits 5
Y Process audit & product audit -- The same as VDA3 & 5? Process Audits and Layered Process Audits 6
A Definition Process Audit vs. Product Audit - What are the differences? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 12
Y QMS Audit, Process Audit, Product Audit - Can these be audited together? Process Audits and Layered Process Audits 7
C Audit Checklists: Quality Management System - Manufacturing Process - Product IATF 16949 - Automotive Quality Systems Standard 6
I Product and Process Audit Procedure Example for ISO/TS 16949:2002 Process Audits and Layered Process Audits 9
T New process capability analysis required when changing a product on the same line? IATF 16949 - Automotive Quality Systems Standard 6
A Cosmetic product registration process EU Medical Device Regulations 0
C Product compliance process REACH and RoHS Conversations 10
M Process Flow of ECN Product User and Service Guides Process Maps, Process Mapping and Turtle Diagrams 1
S Combo Product Assembly Process OQ Qualification and Validation (including 21 CFR Part 11) 0
M How to show the effect of the failure mode on the manufacturing process as a customer of product design process? FMEA and Control Plans 3
M Process & Product Characteristic in Control Plan FMEA and Control Plans 17
L Product and process Deviation procedure Manufacturing and Related Processes 1
H Verification Process for the existing MDS Product IEC 62304 - Medical Device Software Life Cycle Processes 5
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
V Process, component or full product re-qualification: leaded to unleaded solder Qualification and Validation (including 21 CFR Part 11) 8
P Images of Product for Automated Process - How long to keep? US Food and Drug Administration (FDA) 2
W Core Process Metrics AS9100D for Product Planning? Quotes and sales? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
I Corrective Action Tracking for Product and Process in the same system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Release of the first batch of a cleared product before process validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Sidney Vianna AS9100 News PPAP in the Aerospace Sector - What is it? AS9145 - Requirements for Advanced Product Quality Planning and Production Part Approval Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
V IATF 16949 Manufacturing Process & Product Audits IATF 16949 - Automotive Quality Systems Standard 1
I Process compressed air and contact with the product (ISO 8573-1:2010) Qualification and Validation (including 21 CFR Part 11) 0
M IATF 16949 - Cl. 8.3.3 - Product design inputs, manufacturing process design inputs IATF 16949 - Automotive Quality Systems Standard 4
C IATF 16949 - Product Safety Escalation Process Timeliness IATF 16949 - Automotive Quality Systems Standard 8
V For a Drug-Device Combination Product, 'Design Control' Process is triggered at? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
I FDA Exempts Product Codes from 510(k) Process (Class II Medical Devices) US Food and Drug Administration (FDA) 0
G Process for Product Safety - Ideas for Documenting Process for 4.4.1.2 IATF 16949 - Automotive Quality Systems Standard 3
V Product Development - When to start calculating Process Capability Capability, Accuracy and Stability - Processes, Machines, etc. 3
M Compliance with IATF 16949 Clause 8.3.4.4 Product Approval Process IATF 16949 - Automotive Quality Systems Standard 2
L Return of Product Process - Procedure or Flowchart Misc. Quality Assurance and Business Systems Related Topics 14
R Testing a Product Recall Process IEC 27001 - Information Security Management Systems (ISMS) 8
K Auditing New Product Introduction Process General Auditing Discussions 21
L Medical Device New Product Design & Development- How long does this process take you? Other Medical Device and Orthopedic Related Topics 1
B ISO 9001: Question on Process Performance and Product Conformity ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G ISO 14001 & Product Design Process Environmental Aspect Review Requirements ISO 14001:2015 Specific Discussions 7
J Should I have Process or Product Focus in PFMEA? FMEA and Control Plans 3

Similar threads

Top Bottom