Does a new product need a "Management of Change" form?
Hi guys!
Small question.
So me & my team are reviewing and updating our "Management of change" forms.
They brought up that product development shall have a form on there.
My question: Now a "new product" is literally a new product, meaning we are not "changing" anything... so it wont fall under this. What would fall is perhaps change in product formulation/ingredients and other items that we are changing. New product is something different, and should be handled different. Is that correct?
IT's really a flowchart approach anytime you make a change to the product. Starting with a "significant change" sort of thing where the parameters of the product are changing (e.g. new formulation wihout a 1 for 1 ingredient replacement).
Nightmare scenarios happen all the time where someone changes to an "equivalent" supplier ingredient, but the new supplier has egg or something in it, causing an allergen issue. Or alternatively R&D/marketing decided they wanted fresh diced tomatoes vs. canned, a HUGE FS risk change.
The issue tends to be that youre R&D groups or manufacturing groups may not have the knowledge necessary to tell when it's a minor vs a major change, hence the need for formal change management. What I've done to minimize the work involved is to have a form routed for every change, that way QA has eyes on it, but make it simple for QA to finalize the form with a quick "oh yeah this is no big deal, one canned tomato to another with the same spec, easy".
My form looks something like this:
Change initiator section:
-Date, implementation date
-Type of change (new equipment/construction, new ingredient, new process)
-Description of change
-Reason/justification for change
Sent to QA, QA Section:
-Does this change require a food safety plan update/review?
-Does this change require a food quality plan update/review?
-Does this change require a process validation?
-Doe sthis change affect a prerequisite program, procedure, or activity?
-Is any new construction/equipment compliant with our maintenance/equipment standards?
Attach supporting documentation to anyhthing that needed to be reviewed.
Route for approval, QA representative, maintenance or production representative.
With this method you're two signatures away from approving small changes, and QA can hold up if it ends up being substantial.
We do roughly the same thing as FF&F describes above. Even if it's for new packaging for the exact same product. The form gets filled out, so that appropriate people are aware of the change.
Marshall
We do roughly the same thing as FF&F describes above. Even if it's for new packaging for the exact same product. The form gets filled out, so that appropriate people are aware of the change.
Marshall
I understand that, my question is about "new products" as in an entire new product, not a "change" to an existing product.
The process we use is the same. The new item is identified as such and any new ingredients, equipment or processing methods are included on the form for review.
Marshall
SQF, I presume?
We kept NEW product development separate from management of change. Yes - there are going to be a lot of similarities between the two, but we had a lot more information geared towards external approvals, trials, analytical testing, shelf life testing, formulations, etc. in a product development document.
SQF, I presume?
Yes
We kept NEW product development separate from management of change. Yes - there are going to be a lot of similarities between the two, but we had a lot more information geared towards external approvals, trials, analytical testing, shelf life testing, formulations, etc. in a product development document.
Yes that was what I was looking for. As new product development should undergo slightly more processes as you mentioned : needing more information gathered.. and I assume it is a longer processes than just a "change".
Yes that was what I was looking for. As new product development should undergo slightly more processes as you mentioned : needing more information gathered.. and I assume it is a longer processes than just a "change".
It really depends. Some new products aren't very complex, but still need to go through a different process than a management of change. Management of change processes can be simple or challenging as well, but they aren't the same.
I wouldn't want to use a product development document for implementing a new holding hopper for existing products. However, a new product development process might include a management of change if existing equipment has to be revamped, or new equipment brought in.
I wouldn't want to use a product development document for implementing a new holding hopper for existing products. However, a new product development process might include a management of change if existing equipment has to be revamped, or new equipment brought in.
Yup in that case you are then going to use the change document, because you are changing a process related to an "existing" product. But as an entirely new product being made, you would use product development form.