Records required by TS16949 - I have identified 26, are there more?

N

nonaynever - 2008

#1
I have identified the following 26 required records under TS16949. Have I missed any?

4.2.1 Quality Management System Records

4.2.3.1 Changes to Customer Specification including effective date (new PPAP also)

4.2.4.1 Regulatory Specific Records

4.2.4.1 Customer Specific Records

5.6.1 Management Review

6.2.2 Training, education, skills, experience records

7.1 Verification, Validation, monitoring, inspection & test specific to product

7.2.2 Review of requirements, related to the product

7.3.2 Design & development inputs relating to product requirements

7.3.4 Design & development review

7.3.5 Verification of design & development outputs

7.3.6 Validation of design & development

7.3.7 Design & development changes over the product life

7.4.1 Supplier selection, evaluation & re-evaluation

7.5.2 Validation of processes for production & service provision

7.5.3 Product Identification (if traceability is required)

7.5.4 Record of customer property lost, damaged or found unsuitable for use

7.6 Calibration records & results

8.2.2 Internal Audits

8.2.3.1 Effective dates of process changes

8.2.4 Evidence of conformity with acceptance criteria (incl. person authorizing release)

8.3 Nature of nonconformities, subsequent actions, concessions

8.3.4 Expiration date of/authorized quantity of customer waivers

8.5.2 Records of Corrective Actions

8.5.2.4 Rejected/returned product test results/analysis

8.5.3 Records of Preventive actions
 
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N

nonaynever - 2008

#3
Thanks Marc

This was my first post & I did hit the search button, but nothing came up. I'll compare this list (of 27) to mine (26).
Any moderators feel free to close this thread, if needed.
 

Helmut Jilling

Auditor / Consultant
#4
I am not aware that any of my clients have a list like this. I would suggest the standards require you to have "whatever records you need to demonstrate your requirements have been met. Whether that is 20, 30 50, etc., is immaterial.
The lists all clients generally have is a Records Retention List, and that usually has a good bit more than 26, or 27.
 

Howard Atkins

Forum Administrator
Staff member
Admin
#6
I was given a list by an auditor who demanded all be referenced in the standard.
The list is in Hebrew and has 33 items (I will try to translate it).
If searching TS for records, after removing non relevant issues there are some 35 references to records.
 

Howard Atkins

Forum Administrator
Staff member
Admin
#7
I have received this list
  1. Eng. Spec/Change Implementation Date (4.2.3.1)
  2. Management Reviews (5.6.1)
  3. Education, Training, Skills and Experience (6.2.2 e)
  4. Evidence that realization process and product meet requirements (7.1d)
  5. Requirements Review results (7.2.2)
  6. Manufacturing Feasibility (7.2.2.2)
  7. Design Inputs (7.3.2)
  8. Design Review results (7.3.4)
  9. Design Verification results (7.3.5)
  10. Design Validation Results (7.3.6)
  11. Design Change Reviews (7.3.7)
  12. Supplier Evaluations(7.4.1)
  13. Control Plans (7.5.1.1)
  14. Validation of (Special) Processes (7.5.2 d)
  15. Product Identification (where traceability is required) (7.5.3)
  16. Lost and/or Damaged Customer Property (7.5.4)
  17. Basis for Calibration (where not traceable to standards) (7.6 a)
  18. Calibration results (7.6 )
  19. Validity of Previous Measurements when Equipment found out of Calibration (7.6)
  20. Audit results (8.2.2)
  21. Process change Dates (8.2.3.1)
  22. Evidence of Product Conformity, Acceptance Criteria and Release Authority (8.2.4)
  23. Nature of Nonconformities, Subsequent Actions – including Concession (8.3)
  24. Customer. Waiver Expiration Date (8.3.4)
  25. Results of Corrective Actions (8.5.2 e)
  26. Rejected Part Analysis (8.5.2.4)
  27. Results of Preventive Actions (8.5.3 d)
as part of a TS READINESS REVIEW CHECKLIST from a CB
 
#8
Hi Howard:
I'll run a quick check - after breakfast (USA time) but I think the first one should be the 'review of engineering specs' - since the requirement is to ensure the review happens within 2 working weeks.......The org. would have to record when received and when reviewed to demonstrate this.
Likewise, #3 should read "Competency, awareness and training", since the actions taken to address any issues of competency have to be addressed.

I'm thinking this might be a specific CB interpretation of the records they require, but may not be the same as the TS requirements.......
Sorry to be an anorak about this:lmao:
:2cents:

Andy
 

Howard Atkins

Forum Administrator
Staff member
Admin
#9
Hi Howard:
I'll run a quick check - after breakfast (USA time) but I think the first one should be the 'review of engineering specs' - since the requirement is to ensure the review happens within 2 working weeks.......The org. would have to record when received and when reviewed to demonstrate this.
Likewise, #3 should read "Competency, awareness and training", since the actions taken to address any issues of competency have to be addressed.

I'm thinking this might be a specific CB interpretation of the records they require, but may not be the same as the TS requirements.......
Sorry to be an anorak about this:lmao:
:2cents:

Andy
You should eat your breakfast first
4.2.3.1
....The organization shall maintain a record of the date on which each change is implemented in production.
6.2.2
e) maintain appropriate records of education, training, skills and experience (see 4.2.4).

Sorry to be a wellington boot:cool:
 
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