Product and Process Audit Procedure Example for ISO/TS 16949:2002

I

IGORTS

#1
I´m needing a guide for audits of Proc. and Product.
Has someone any idea about where I could find a general checklist of proc. audit an product audit.

thank you:cool:
 
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Manoj Mathur

Quite Involved in Discussions
#4
PROCESS AUDIT CHECKLIST

As Required for ISO/TS 16949:2002

QUALITY MANAGEMENT SYSTEMS
(Based on VDA 6 Part – 3)

Prepared by :

Manoj Mathur

1. Product Development

Requirements What to look for Assessor Notes / Objective Evidence
A. Product Development Planning
1. Are the customer requirements available?
2. Is Product Development Plan available and the targets are defined & maintained?
3. Are the resources for realization of Product Development planned?
4. Have the product requirements been determined and considered?
5. Have the feasibility been determined based on the available requirements?
6. Are the necessary personnel and technical conditions for the project process planned / available?
B. Realizing Product Development
1. Is Design FMEA raised and are the improvement measures established?
2. Is Design FMEA updated in the project process and the established measures realized?
3. Is a Quality Plan prepared?
4. Are the required release / qualification records available at the respective times?
5. Are the required resources available?
C. Process Development Planning
1. Are “Product Requirements” available?
2. Is a process development plan available and are targets determined & maintained?
3. Are the “Resources” for realization of Serial Production Planned?
4. Have the process requirements been determined and considered?
5. Are necessary personnel and technical preconditions for the project process planned / available?
6. Is Process FMEA raised and are improvement measure establi-shed?
D. Realizing Process Development
1. Is Process FMEA updated when amendments are made in Project Process and are the established measures implemented?
2. Is Quality Plan prepared?
3. Are the required releases / qualification records available at the respective times?
4. Is a Pre-production carried out under serial conditions for the serial release?
5. Are the Production & Inspection Documents complete and are available with concerned people?
6. Are the required “Resources” available?

ELEMENT 5 : SUPPLIER / INPUT MATERIALS

Requirements What to look for Assessor Notes / Objective Evidence
5.1 Are only approved quality capable suppliers used?
5.2 Is the agreed quality of the purchased products guaranteed?
5.3 Is quality performance evaluated and corrective actions introduced when there are deviations from the requirements?
5.4 Are target agreements for continual improvements of products and processes made & implemented with the suppliers?
5.5 Are the required release for the delivered serial products available and the required improvement measures implemented?
5.6 Are the procedures agreed with customer, regarding Customer Supplied Products, maintained?
5.7 Are the stocks levels of input materials matched to production needs?
5.8 Are Input Materials / internal residues delivered and stored according to their purpose?
5.9 Are the personnel qualified for the respective tasks?

ELEMENT 6 : PRODUCTION

Requirements What to look for Assessor Notes / Objective Evidence
A. Personnel / Qualification
1. Are the employees given responsibility & authority for monitoring the product / process quality?
2. Are the employees given responsibility & authority for production equipment & environment?
3. Are the employees suitable to perform the required tasks and their qualification maintained?
4. Is there a personnel plan with a replacement ruling?
5. Are “Instruments” to increase “Employee Motivation” effectively implemented?
B. Production Materials / Equipment
1. Are Product Specific quality requirements fulfilled with the production equipment / tools?
2. Can the quality requirements be monitored effectively during serial production with implemented inspection, measuring and test equipment?
3. Are the work and inspection stations appropriate to the needs?
4. Are the relevant details in the production and inspection documents complete and maintained?
5. Are necessary auxiliary means available for adjustments?
6. Is an approval for production starts issued and are adjustment details as well as deviations recorded?
7. Are the required corrective actions carried out on schedule and checked for effectiveness?
C. Transport / Parts Handling / Storage / Packing
1. Are quantities / production lot sizes matched to requirements and are these purposefully forwarded to next work stations?
2. Are products / components appropriately stored and the transport means / packing equipment tuned to the special properties of the product / components?
3. Are rejects, reworks and adjustment parts as well as internal residues strictly separated and identified?
4. Is the materials / parts flow is secured against mix ups / exchanges by mistake and traceability guaranteed?
5. Are tools, equipment and inspection, measuring and test equipment stored correctly?
D. Fault Analysis / Corrective Action / Continual Improvement
1. Are quality and process data recorded complete and ready to be evaluated?
2. Are quality and process data statistically analyzed and are improvement programs derived from this?
3. Are the causes of product and process non-conformances analyzed and the corrective actions checked for their effectiveness?
4. Are processes and products regularly audited?
5. Are product and process subject to continual improvements?
6. Are target parameters available for product and process and is their compliance monitored?

ELEMENT 7 : CUSTOMER SERVICE, CUSTOMER SATISFACTION

Requirements What to look for Assessor Notes / Objective Evidence
1. Are customer requirements fulfilled at delivery?
2. Is customer service guaranteed (if contractually agreed)?
3. Are complaints quickly reacted to and the supply of parts secured?
4. Are fault analysis carried out when there are deviations from the quality requirements and are improvement measures implemented?
5. Are personnel qualified for each task?
 
K

kapil_gupta14

#7
product audit & process audit

As per TS requirements Manufactring process audit to cover all manufacturing process, but whether same freq as in system audit will be applicable,mean process audit to be carried out throughout the shifts-whether in day/night.
Product audit criteria -follow controlplan
 
#10
i want checklists include all Audit scecklists in excel sheets :rolleyes:
Welcome to the Cove!:bigwave:

You have posted in the ISO/TS 16949 forum - are you looking for checklists for automotive processes? Or are you seeking other types of checklist- there are many. Some can be found if you click on the green box - at the top of this page marked 'Post Attachments List".

You should also read Helmut's warning. If you want to do internal process audits, some other checklist is not going to be an effective substitute for creating your own. Look at the examples, find one you like, but build your own set of questions etc. based on your own process(es)
 
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