Design and Development: 7.1.4 - Change Control - What is a good change control system

[TownDawg]

The only records of the scheduling/progress of an engineering change that the project control group keeps are the "Design Change" matrix and the individual PAL schedules for on each "NAD".

 

[TownDawg]

The above FINDING (albeit a PAR) was issued by the internal audit team recently. The finding was in response to the question: "Do you have a process to to control and react to changes that impact product realization? Describe the process for verification and validation of the effects of any change, including those caused by the supplier are reviewed. "

How would you respond?

 

[TownDawg]

Other questions asked include the following:

1) Who is a part of those meetings? Is there a standard agenda, and certain forms used to show evidence of the meeting and discussion?

2) How does the organization track action items and deadlines arising from the engineering change process?

3) How does the organization identify the change, and communicate to the customer? Is there similar notifications done when manufacturing processes are changed? Show examples.

 

[TownDawg]

The auditee is more than willing to deploy a system that better meets the requirements. The auditor is not sure what they want to see -- other than the current system does not seem to meet what is required.

"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, 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."

Thoughts?

 

[TownDawg]

hMm... no response. Everyone must be having a typical Monday.

Basically, I was just hoping to hear from some of you, regarding your current ECR/ECN system to see what improvements could be suggested.

 

[D.Scott]

I'm not sure I understand what you are looking for. To answer the questions posed, we would have to know what your system was and how you address each of those in your company. The third post outlines the requirement as stated, but still doesn't ask a question. It appears you are looking for improvements but improvements to what? Are you questioning the auditors finding?

Maybe I am missing your point?

Dave

 

[TownDawg]

Most likely. You know how it is on Monday. You THINK you have described a problem well -- only to find that no one knows what you are asking.

I'm asking for some examples of good engineering change systems. The process, the records. etc.

This way i can compare what we have to what is considered best practice.

 

[rjhill]

Re: Design and Development: 7.1.4 - Change Control - What is a good change control sy

I think I understand. Formal change control is not a software application, but usually defined throug several company procedures. I work in medical devices, a regulated industry and this is a fundamental part of product development and any changes made after you are in production.

I’m trying to say there is no simple answer. You might look on slide shar for change control in medical devices.

Hope this helps.