Hi all,

I am currently reviewing our company "Design/Change Control" process. Currently, changes to a product or process go through one form - all the orginator of the form needs to do is describe the proposed change and write a validation protocol and QA seem to do the rest!

After some intial consultations with individuals that use the system, I have found that they don't really like the form & they don't understand it.

Has anyone got any examples of design changes for products once they have been transferred into production? I would very much appreciate it!

Thanks

Hi all,

I am currently reviewing our company "Design/Change Control" process. Currently, changes to a product or process go through one form - all the orginator of the form needs to do is describe the proposed change and write a validation protocol and QA seem to do the rest!

After some intial consultations with individuals that use the system, I have found that they don't really like the form & they don't understand it.

Has anyone got any examples of design changes for products once they have been transferred into production? I would very much appreciate it!

Thanks


I removed the form - it is not structured for the medical field and migh tbe confusing to some.

Hi all,

I am currently reviewing our company "Design/Change Control" process. Currently, changes to a product or process go through one form - all the orginator of the form needs to do is describe the proposed change and write a validation protocol and QA seem to do the rest!

After some intial consultations with individuals that use the system, I have found that they don't really like the form & they don't understand it.

Has anyone got any examples of design changes for products once they have been transferred into production? I would very much appreciate it!

Thanks

If you would like to share your form, we covers could comment and give you suggestions for improvement :)

Btw, your phrase "QA seem to do the rest" sounds harsh - Quality is everybody's responsibility and everyone should share. All activities relating to Change Proposal should be handled by a team comprising mainly of Engg, Operations and Quality.

Here is our ECR Form. QA has nothing to do with it - Only Engineering can review & approve. Anyone can submit it though.
:bigwave:

Thanks for sharing the form. You probably would like to include Quality approval in the approval process.

Thanks for sharing the form. You probably would like to include Quality approval in the approval process.

Like I said, Quality has no authority on Engineering changes. Only Engineering can approve a change.
Edit: Form removed. Sorry, my form is for the ISO 9001 system, not medical. My mistake.

I am going to try and attach our sample.

We have quality, materials and engineering sign off, that they are aware of the upcoming change, then once all paperwork, ppap, P.O.'s etc...etc.. are completed they must sign off again.

We had to do this, because materials was complaining, "I was never told the material was changing (just an example)".
Of course all this is discussed during APQP, however, the signature holds each department accountable for their requirements.

Like I said, Quality has no authority on Engineering changes. Only Engineering can approve a change.

I understand you referred Quality has no authority on engg changes in your organization but I recommend you include

The review and approval of an ECO should not be a technical review of the change (that's an engineering function) but should be an implementation review. Proper planning of change implementation is where most companies fall down. Attached is the ECO form and CCB process is use.

Our Engineering does all of that. That's why QA is not included and is not applicable in our case. There is extensive research prior to a change.

Then I am confused to what you are looking for. You said what you have doesn't appear to be working. But if your engineering does everything, why do you need a new form? Does your engineering change all the necessary paperwork (operator instructions, specs, PPAP, etc)?
Does engineering order the material, if the change is a material change?

I agree, changes START in engineering and probably get final approval there, however, the implementation process into production is usually when things get messed up, someone, somewhere drops the ball, or doesn't get informed of the change.

Sorry crusader,,, yes confused you with orginial poster:truce:. But it is a Monday afterall:notme:!

The review and approval of an ECO should not be a technical review of the change (that's an engineering function) but should be an implementation review. Proper planning of change implementation is where most companies fall down. Attached is the ECO form and CCB process

It depends on what is considered the purpose of the ECO form, not the process. Engineering changes usually follow this path:

There is a perceived need for a change, perhaps to add functionality, improve existing functions, or to correct design errors.
The rationale for the change is documented or otherwise made known.
The idea is reviewed, and a decision is made as to whether or not the change should be implemented.
If a decision is made to implement the change, its implications are considered, including any necessary tooling and other process changes, disposition of existing stock, updating of process and user documentation, the timing of implementation, etc.
Formal documentation, including information regarding all of the first four steps, is drafted. Note that the documentation should begin with step 1, and is updated as the ensuing steps occur.At this point, there needs to be some formal notification of the change to the affected parties. That's what we generally think of as an ECO, or ECN. In some companies, there are three documents: The initial request for a change (ECR), the official approval of implementation (ECO) and notice to affected parties (ECN). What matters in all of this is that (A) the impetus and rationale for the change is documented; (B) the implications of the change are understood and documented and properly implemented and (C) affected parties are duly notified of what's going on. There should be a clear trail from the initial idea to the actual implementation of the change, but how it's documented is a matter of choice and preference.

I don't agree with you when you say Quality has no authority to approve a change.
In fact every department envolved in the change process has got authority to reject or except the change.

I don't agree with you when you say Quality has no authority to approve a change.
In fact every department envolved in the change process has got authority to reject or except the change.

Maybe in your org but not mine.

Edit: I removed the form as it only applies to ISO 9001 and not the medical field. I only posted it as an example of a design change form in general. My mistake. Sorry.

Maybe in your org but not mine.

Crusader,

If you are dealing in medical devices and dealing with FDA, the quality approval is a requirement.

As per 21 CFR Part 211.100, " These written procedures including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit. "

Though 21 CFR Part 211 deals with drugs, it is advisable to have quality approval for devices too.

Hello all,
I've been looking all morning and finally found the thread I think I need. I just performed an audit on our process control process. I have attached a copy of that CAR and the objective evidence. I am having a problem not being biased over this root cause and corrective action.
At the bottom of the 5WHYS sheet is the statement from our procedure. Would you all please read this and give me your honest opinions; is this an acceptable root cause in your opinions?8043