IATF16949(ISO9001) {8.5.6} Control of changes - Explained

IATF16949(ISO9001) {8.5.6} Control of changes

See ISO 9001:2015 requirements.

The organization shall review and control changes for production or service provision, to the extent necessary to

ensure continuing conformity with requirements.

The organization shall retain documented information describing the results of the review of changes, the

person( s) authorizing the change, and any necessary actions arising from the review.

8.5.6.1 Control of changes —

supplemental

The organization shall have a documented process to control and react to changes that impact product realization. The effects of any change, including those changes caused by the organization, the customer, or any supplier, shall be assessed.

The organization shall:

a) define verification and validation activities to ensure compliance with customer requirements;

b) validate changes before implementation;

c) document the evidence of related risk analysis;

d) retain records of verification and validation.Changes, including those made at suppliers, should require a production trial run for verification of changes

(such as changes to part design, manufacturing location ,or manufacturing process)to validate the impact of

any changes on the manufacturing process. When required by the customer, the organization shall:

e) notify the customer of any planned product realization changes after the most recent productapproval;

f) obtain documented approval, prior to implementation of the change;

g) complete additional verification or identification requirements, such as production trial run and new product validation.

Explanation - The organisation should follow Change Control Management Process as below 

CHANGE CONTROL MANAGEMENT

1.  As and when there are changes in product or process due to following situations or circumstances the change management procedure is followed and the changes will be communicated to customer and external interested parties with no undue delay.

2.  Change control management is applicable in case of following situations.


  The changes made in tooling or as a note on the design record and not covered by an engineering change.
  Production from new or modified tools (except perishable tools) including additional or replacement tooling.
  Production following rearrangement of existing tooling.
  Production from tooling and equipment transferred to a different plant location or from an additional plant location.
  Change of supplier for part non-equivalent material or services.
  Product and process changes related to components of production, productions manufactured internally or manufactured by external provider that impact fit, form, function or performance.
  Change in test, inspection method, new techniques (no effect on acceptance criteria)
  Regulatory Action
  Product Recall or when there is an event that could create adverse publicity
  Change of Suppliers
  Change of Manufacturing Process at Supplier End

3.  After receipt of engineering change Request from Customer, Supplier and internal then update the details in Product / Process Change Tracking Sheet.

4.  Review the changes feasibility as per feasibility review sheet. 


5.  Notification shall be given to customer through mail / Engineering change Request Cum Approval Note.

6.  Prepare the Engineering Change Timing Plan for execution of engineering changes

7.  After producing the samples carry out the Before and After study of samples according to Engineering Change Request.

8.  Submit the samples to the costumer with Before & After Study Report and PPAP if required.

9.  Submit Material Break Point Advice to Customer and receive approval of the same

10.  Receipt the approval or PSW from the costumer.

11.  Update the Engineering change summary in the Product / Process Change Tracking sheet.

12.  Make the changes in affected documents and formats wherever necessary.

13.  Dispose the stock which is as per specification before engineering changes.

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