2 replies to this topic

[Verdy]

Hello all! Was hoping to get some guidance or opinions on this new clause.

 

According to this handy dandy cheat sheet from SQF about the clause, it gives the example of "a marketing team requests a new flavor of yogurt for a seasonal promotion" as a planned change for this clause.

I am having a hard time understanding WHY this would be considered a 'planned change'. Wouldn't this fall under product development? 

 

I work at a small ice cream factory and we get folks asking for custom flavors often. Each time we make something, we go through our check lists for new products/ingredients, etc etc.  While I'm not on the product development side, I understand the process and the paperwork that does into it. 

I understand the examples of 'having to source from a new supplier' and 'need to make a temporary repair', those are make perfect sense!
 

If anyone could give me some guidance on this, I would greatly appreciate it!  Help me to understand this, I beg!

[GMO]

Product development is a planned change. It's an example of one. 

 

So as part of that your food safety or HACCP plan needs to be reviewed if the plan is considered to have potential to change the food safety risk and, where in doubt, I'd review it anyway. One of the sub clauses in that section which I assume you meant 2.3.5 is "changes in formulations" so that does include new products and product tweaks. 

 

So I'd write a procedure to explain which changes are in scope and what you do for that change. So I'd include your existing checklists and how they assess it is or isn't a potential for food safety risk and capture all of that in the procedure. So for example, if you're changing one fruit flavouring for another but nothing else, it probably is very low risk so doesn't need a HACCP review but you'd capture that in your NPD documentation.

 

I'd then also include other occasions where planned change might happen as per the clause, i.e. new manufacturing processes, (e.g. changing your mixer), new materials or ingredients if it's not already covered by your NPD forms or reference it if it is, new specs and suppliers, etc etc etc.

 

I think all they're getting at with this clause is "are you considering the food safety risk ahead of the change" and NPD forms part of that but not all of it. To be honest I could think of far more examples that I think that clause should contain but doesn't that should be considered before change. For example, changes in manning, changes in customer etc. 

[Tony-C]

Hi Verdy,

 

Section 2.3.5 is a new element in Edition 10 combining all references to change in Edition 9. A lot of changes tend to fall under product development, the change does need to be approved and as long as your procedures reflect that there is no problem.

 

The SQF Code requirements are:

This procedure, at a minimum, shall include changes in:

i. Product formulations and manufacturing processes for products included in the scope of certification;

ii. Materials, ingredients, labels, other inputs, or equipment;

iii. Specifications for raw materials and packaging, chemicals, processing aids, contract services, and finished products; and

iv. The food safety plan including critical control limits.

Changes shall be confirmed or validated, documented and communicated, as necessary, in a time frame that ensures food safety is maintained.

 

SQFI have do in fact provide a nice Change Management Guidance Document here.

 

The content of the guidance includes: What does it mean?

A robust change management process forces the organization to ask critical questions before proceeding:

• Will this change introduce new hazards? Does it affect prerequisite programs, critical limits or other preventive controls in our food safety plan?

• Could it cause compliance issues with the FDA or other regulations?

For example, adjusting a cooking time to save energy might reduce the lethality of a heat treatment, risking survival of pathogens like Salmonella. Or, changing packaging film might introduce chemicals that migrate into food if the substances used to manufacture it are not approved by regulations. Change management safeguards the process by requiring validation studies, supplier checks, updated procedures, and clear communication to staff so everyone knows how to handle the change safely.

 

There is also a detailed section on Procedure Content which is worth looking at and includes:

A change management procedure may include, among others, the following steps:

1. Initiation of Change

2. Impact Assessment

3. Risk Assessment

4. Approval

5. Implementation

6. Validation and Verification

7. Documentation and Communication

8. Review and Closure

 

I normally use a Process Change Approval Form for changes. I posted an example on the forums quite a while ago here: How to Document Changes in System/Process. I use a simplified version for minor changes.

 

Kind regards,

 

Tony