We are now in product gamma phase, there has a number of changed on parts drawing, which made by headquarter product design team, is it neccessary for our company raising a "Change Application Review Sheet" each time n get the approval from related department? actually we do not have rights to reject these change...thanks for your feedback.....

We are now in product gamma phase, there has a number of changed on parts drawing, which made by headquarter product design team, is it neccessary for our company raising a "Change Application Review Sheet" each time n get the approval from related department? actually we do not have rights to reject these change...thanks for your feedback.....

Hi R29728

I'm not quite sure what's entailed in your "Change Application Review Sheet", but, if it's intended to inform other interested/involved parties of the impending change, then, the short answer is "Yes, you must raise a Change Application Review Sheet".

Whether or not you have a right to reject these changes is irrelevant. You have to have a defined process in place to control Product and Process Changes. I know you already have a copy of the standard, but for the purposes of this discussion, I have attached some of the relevant clauses of the ISO/TS Specification below (blue text), which highlights, that your Product/Process Change Control document must facilitate the following:

1) Give intererested/involved parties an opportunity to evaluate the impact of the change, and to start planning for the consequences of that change.
2) Ensure that verification and validation activities are conducted - If the Product Engineers identify a Product design change, the Process Engineers definitely have to assess the impact on the manufacturing process, and make changes as appropriate.
3) Ensure that the customer is aware of and has approved, or waived their right to approve changes.
4) And so on....It's fairly clearly laid out in the requirements.
5) P.S. - Don't forget to integrate your "Customer-specific requirements" relating to Product/Process Change Control...and I'm sure they must have some!.


Here's just a few things that might be impacted by changes:

- Process Flow Diagrams
- Floor Plan Layout
- Process FMEA (s)
- Work Instructions
- On-line Inspection Instructions
- Equipment/ tooling Installation
- Station Training Video (s)
- Equipment Set-up sheets/PM sheets.

See the attached Product/Process Change Notification Form to see an example of how many more areas and activities might be impacted by a Product Design Change.

Hope this helps.
Patricia Ravanello


7.1.4 Change Control
- The organization shall have a process to control and react to changes that impact product realization.
- The effects of any change, including those changes caused by any supplier, shall be assessed, and verification and validation activities shall be defined, to ensure compliance with customer requirements
- Changes shall be validated before implementation
- For proprietary designs, impact on form, fit and function (including performance, and/or durability) shall be reviewed with the customer so that all effects can be properly evaluated
- When required by the customer, additional verification/identification requirements such as those required for new product introduction, shall be met
NOTE 1: any product realization change affecting customer requirements requires notification to, and agreement from the customer
NOTE 2: The above requirement applies to product and manufacturing process changes

7.3.7 Control of design and development changes
- Design and development changes shall be identified and records maintained
- The change shall be reviewed, verified and validated, as appropriate, and approved before implementation
- The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered
- Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).

Please do not forget any new measurement systems and training that may be required to be addressed.

Thanks for all of your supports, I got the answer....Thanks a lot...