3 replies to this topic

[ft.tgif]

6.3 Planning of changes

 

When the organization determines the need for changes to the FSMS, including personnel changes, the

changes shall be carried out and communicated in a planned manner.

 

The organization shall consider:

a) the purpose of the changes and their potential consequences;

b) the continued integrity of the FSMS;

c) the availability of resources to effectively implement the changes;

d) the allocation or re-allocation of responsibilities and authorities.

 

I need some help understanding b) the continued integrity of the FSMS. We have an operational change control form set up for this clause, and we want to use it as we are switching from soy lecithin to sunflower lecithin in our product. Would this change (soy lecithin to sunflower lecithin) affect the continued integrity of our FSMS? We have updated our hazard analysis worksheet for raw materials as we've added sunflower lecithin, however there is literally no change to the process. 

 

Can I get some examples from you guys where an operational change affects the continued integrity of the FSMS? I just want to verify what I understand from this clause 6.3 b) is correct. From my understanding, if it requires changes to the process flow, allergen management or the CCP/OPRP, then I would say the continued integrity of the FSMS is affected by this change. Am I right? Please correct me if I got this all wrong. 

[Lyon.Lin]

Hi, ft.tgif

Sharing my organizational opinion, FSMS can be generalized into 4 activities including: 

1. Risk management

2. Strategy management

3. Resourcing management

4. Food safety management

 

Any change will have a chance to impact all of these management activities.

 

Based on your situation (soy lecithin to sunflower lecithin), the example as following:

1. Risk management for the changing need to be done including:

    a. Determination of internal/external issues

    b. Identification of interested parties and their needs and expectations

    c. Risk assessment that might impact the FSMS strategy

 

2. The changing activity needs to be consistent with the food safety policy and objectives. Put this change into the internal audit focus, and reporting for the changing activities in the management review meeting.

 

3. Supplier assessment needs to be done if it is a new ingredient for the company. Any resources needed for the sunflower lecithin, including equipment/tool/device, storage conditions, training etc.

 

4. Food safety management:

    a. Establishing sunflower lecithin specification

    b. Retaining lab inspection report based on the local regulation

    c. Coding the sunflower lecithin for the traceability

    d. Completing the supplier information detail for emergency contact and supplier control

    e. Revised the HACCP plan relevant to the sunflower

    f. Any specific instrument need for the sunflower lecithin, I think this is not an important point for this change, maybe.

    g. Validation and verification need to be done for the PRP and HACCP relevant to the change

 

All of the above need to be considered but not limited to it, and then you might have enough confidence to declare the changes are not impact the integrity of the FSMS of the company.

[ft.tgif]

 

Hi, ft.tgif

Sharing my organizational opinion, FSMS can be generalized into 4 activities including: 

1. Risk management

2. Strategy management

3. Resourcing management

4. Food safety management

 

Any change will have a chance to impact all of these management activities.

 

Based on your situation (soy lecithin to sunflower lecithin), the example as following:

1. Risk management for the changing need to be done including:

    a. Determination of internal/external issues

    b. Identification of interested parties and their needs and expectations

    c. Risk assessment that might impact the FSMS strategy

 

2. The changing activity needs to be consistent with the food safety policy and objectives. Put this change into the internal audit focus, and reporting for the changing activities in the management review meeting.

 

3. Supplier assessment needs to be done if it is a new ingredient for the company. Any resources needed for the sunflower lecithin, including equipment/tool/device, storage conditions, training etc.

 

4. Food safety management:

    a. Establishing sunflower lecithin specification

    b. Retaining lab inspection report based on the local regulation

    c. Coding the sunflower lecithin for the traceability

    d. Completing the supplier information detail for emergency contact and supplier control

    e. Revised the HACCP plan relevant to the sunflower

    f. Any specific instrument need for the sunflower lecithin, I think this is not an important point for this change, maybe.

    g. Validation and verification need to be done for the PRP and HACCP relevant to the change

 

All of the above need to be considered but not limited to it, and then you might have enough confidence to declare the changes are not impact the integrity of the FSMS of the company.

 

 

Thanks for the detailed answer. However, I still don't really understand, what does it actually mean when the integrity of the FSMS is impacted? If I have already considered all the above items, and for example I need to establish the material specification for sunflower lecithin, does this mean that the continued integrity of my FSMS is impacted?

Edited by ft.tgif, 27 August 2021 - 04:16 PM.

[Lyon.Lin]

Hi ft.tgif,

 

OK, I try another way.

 

The definition of the management system "the set of interrelated or interacting elements of an organization", and system elements include the structure, roles, and responsibilities, planning, and operation. And when can find out the integrity of the management system included the above.

 

For your situation changing the soy lecithin into sunflower lecithin, everything you have done to the soy lecithin, all need to do again. And this will contain a lot of things.

 

So you need to establish the specification to ensure the FSMS integrity will not be impacted.

 

And if you do not establish it, clause 8.5.1.2 will be impacted. And the FSMS will lose a puzzle piece, "sunflower lecithin specification".

 

And for the word "continued" means the characteristics of the FSMS change are continuously risky. Not just change one and all done, the change needs to be monitored to ensure this change really does not impact the FSMS.

 

Hope this is helpful for you~