SQF Edition 10 Change Management: From New Requirement to Best Practice

Tammie Van Buren: Welcome everyone to our webinar on this lovely Wednesday. SQF edition 10 change management. You know one of the things we say is that change management's always been in the code. It's just kind of been hidden. So we're going to draw it out as a separate element. New for edition 10.

So I'm joined today by Prasant and I'm gonna go over one slide, tell you about our antirust and then I'm going to hand it off to him and let him introduce himself. So as always SQFI, we follow the FMI antirust statement. We're not here to violate antirust law by talking about things we shouldn't like dividing up of territories or price fixing or boycotting. Any of those topics we're just going to stay away from. As always, if you would like a copy of that, please reach out to SQFI. We are happy to provide you a copy.

But today we're going to talk about change management, food safety. Those are topics we can talk about without violating the antirust law and so with that if the conversation heads that way I will speak up you feel free to speak up and we will u move on but Prasant tell us a little bit about yourself

Prasant Prusty: Well Tammie thank you very much for this opportunity and thanks SQFI for giving us the platform to present a change management ment experience to the SQF audience. About myself I'm the founder and CEO of Smart Food Safe but before that I call myself I used to be an SQF practitioner and SQF auditor and so the food safety has gone in my blood and because of that I'll be sharing my practical experience regarding the change management and the new requirements anyway so let's talk about the change management. So in today's what I going to cover our agenda for today will be talking about the change management in edition 10 which is coming shortly. What are the clause requirements from SQFI and how do you build a change management process? Since this is a new requirements, I'm pretty sure we will get a lot of question. Hey, I am SQF edition 9, I want to go to edition 10.

How do I build a change management process? And then we'll share some practical examples about how do you build a change management record and when you go through an audit definitely you will have to demonstrate your readiness to the change management requirements. We'll talk about that and finally we will go about the going digital right now everybody's talking about AI smart technologies is there a way our change management can be digital or better efficiency we will talk about that and then we will have some time for the Q&A around 10 to 15 minutes at the end we will take some questions from the audience okay so with that note let's talk about edition 10. We all know about edition 10 is coming very soon and today we still have edition 9 but the three major elements are coming up in the edition 10 the food safety culture change management and environmental monitoring. But today we are going to learn about what is change management, how can I adapt to a new change management requirement. But more importantly, how can we use this new requirement to best practices in our SQF certification progresses.

Okay. So now let's talk about what is change management. As you know that SQF has a beautiful guidance document available on their website. If you want to learn more about that, I would recommend please go and download the change management guidance from SQFI website that has a lot of information and that can answer most of the question you may have from this demo. Okay. So now change management the three important pillars of change management process and I would call that people process and everything we do must be justified by a risk.

So without a risk there is no justification. So now let's talk about people. You know people own the process. Your food safety program or SQA program your food safety culture it's owned by the people so that mean they are they plays a critical role in your change management process your process that's where the change happens so you need to understand where in the process the change is happening and then what's the risk every time you try to do something you always ask what's the risk of this change so in that now let's talk code. Okay. What does the SQF Code says?

The new requirement in Edition 10 SQF clause 2.3.5. And I'm going to read a line by line so that we understand the requirement. The site SAL document and implement a procedure to evaluate any changes including temporary, emergency, unplanned or those made as a result of corrective action process that could impact food safety or the food safety system. So these are the SQF Code requirements and it applies to what your product formulation or manufacturing processes. It could apply to your materials could be ingredient label imports equipments. It could it could apply to your specification or it could apply to your food safety plan.

So anything and everything could be applicable to a change management process. And escape also requires you that changes shall be confirmed or validated, documented, communicated as necessary in a time frame that ensure your food safety is maintained. So that is what the SQF requirement. Now let's break down the requirements into let's take about some practical examples why change management age is required in the food safety. So you have been coming from the you are coming from the industries and you know let's take a practical example. Now the business wants to save energy by reducing the cooking time that could be a practical example but we also know that costsaving measure could have a practical implication on your lethality of the heat treatment.

Whatever you are trying to do, if you're trying to save energy and that could also create a force of risk or you are trying to change a packaging material supplier without going through a change management process. If your new packaging supplier does not have the same level of chemical composition, that might introduce additional chemical migration contamination. Or if you have a food safety food safety management system and which is interconnected from the receiving to shipping. If anything changes in that whole process from receiving to shipping that can cause a food safety incident because something has been changed. So the requirement here why food safety why change management matters because ultimately it has got implication to your food safety integrity your audit readiness. Of course any food safety incident may also come with a regulatory implications and more importantly the consumer trust.

Okay. So why foods? Why change management is so important for food industry? We all know that when you have got a multi-site operation and a one changes made in one site which is not properly communicated or implemented on other sites that can have your implication even though you did not initiate the change but it was done by some other site which you are part of your regulatory requirements. If you have got any other require requirements from the regulatory changes technical complexity you know sometimes we have a corrective action but because it's not practically possible within the window we may have to do some patchwork and that could that could require a initiative change requirement and most importantly the food safety culture the food safety culture and I always say this to everybody that the people own the food safety culture. That means the people own the food safety program.

If your people do not own the food safety program, then their behavior, their mindset could initiate food safety risk. Now, how are the change classified? And I'm pretty sure most of would you agree most of your changes are unplanned or temporary or emergency in food industry you would find is always on plan temporary emergency changes and those are the key drivers of your food sector risk. So our objective and what SQ expectation is that all those unplanned temporary or emergency changes must be rooted through a planned change management process and this is what we are going to talk about in this today's presentations. So the way you remember the seven principles of your HACCP plan, we build some six elements of your change management process which we call that these are the foundation of any change management process. Number one policy and the scope.

If you do not have a written down policy or procedure how the change management should occur then you would you would not be able to you would not be able to demonstrate your compliance. So everything starts with documentation. You need to demonstrate how are you going to manage the change. Number two, who is going to manage the change? What is what is the role of an SQF practitioner or your plant manager or the change owner or the production. So who owns the change and who are part of the change management process risks assessment is very important.

I know that HACCP principles talks about risks assessment. Similarly for every change management risks assessment is a very important criteria. So risk assessment if you ask me how do I objectively determine the risk. So most of the time you say hey the risk is low but if I ask you how did you determine what was your basis behind the risk assessment did you use any kind of decision tree or likelihood severity metrics. So that is an important part of your change management to justifi to identify the risk, justify the risk and add change control based on the risk. Then how do you document your change management process?

You may have to have some kind of checklist, some kind of record keeping so that the change is captured. How do you communicate a change has happened? And as I was giving an example that multi-site changes one site made some changes to the supplier or to the process and the other side if they are not properly communicated then you would not be able to handle that change in your site. So the training and the communication and the last part you got to review your changes are they are they effective are they completed as requested that is also important component of your change management process. Now let's break down to step by step how can we create a change management process. Now step number one you have to initiate a change.

So the change should be the change initiation should be available to everybody in the organization in the company to initiate. So the way anybody can initiate an health and safety incident they should be also initiate a change request. The change request could be could be structured in a way that the why you are requesting the change. What are the implication of the change? We'll talk about that in a moment. So your change request should include not just a subjective line.

Okay, I'm going to include a change in my ingredients, packaging material, process, equipment, supplier where the change is going to be initiated. So what's the change why and who's requesting it? So once you have your change request defined properly the next step will be impact assessment. And this is the classic example the multi-site example I was telling you. So if you do an impact assessment that my changes can impact within the site or outside the site then I'll be able to take appropriate change actions during my change control planning. So the impact assessment is a very crucial step in terms of my change management.

So whatever change we try to incorporate is always an impact to the product or the process or the people or the food safety. So depending upon how what's the change so impact assessment could be defined by product impact or equipment impact or your different impacts. Now risk assessment. So how do you make sure that the risk of this change is objectively calculated? So we can use the same like the HACCP likelihood and severity matrix where you can have a 2x2 or we can also have a three-dimensional likelihood severity and the detectability three-dimensional change risk assessment or we have seen some organization they have a change decision tree like the HACCP decision tree Q1 Q2 Q3 you could also build a change decision tree at the end of the decision tree you will end up in identifying if the risk is minimal, major or critical. So once the risk assessment has been defined then some business may require called feasibility study.

Is my change feasible? Now let's say somebody is saying I would like to build a wall between the between the between the two different production lines to separate my allergen cross-contamination. But building a wall might not be a feasible solution. So then it has to be also taken into consideration is the change feasible. Is there any kind of implication on my financial implication on my process implication on my on my production downtime? So they also have to be what you call taken into consideration as part of your risk assessment.

So once the change is assessed from a risk assessment impact assessment now let's build our action planning our action planning is nothing but to perform this change these are the steps must be completed for example I want to it's I'm introducing a new allergen to the process line I may have to update my procedure for allergen monitoring. I may have to update my sanitation procedure to include the new allergen. I may have to validate my allergen control to make sure the new allergen has been controlled in the in the in the new way. So that has to be defined in terms of action plans and action plans can be assigned to internal or external user. Sometimes some changes may be implicated and because of your external participants and we always sometimes we forget okay we think change is internal but external participants may also be part of our change action plan so that if they're coming on site our contractors service providers they should be also part of my change action plan. So once the action plan has been defined now we could go to the approval stage.

In the approval stage this is the gatekeeping stage where we can decide that the action plan the risks assessment the impact assessment are justified before you move forward to the next steps. So here it could be a your change owner it could be a Q manager will be going to review the changes and they approve before you go to the next step. Now implementation. So this is where we see the biggest challenge because change management does not belong to the quality function or the food safety function only. Change management belong to entire organization. So ensuring the changes or change action plans are assigned, communicated, documented and followed up if not completed is a very important step in our change management process.

And you may have your multi-ep department involvement. Your department maintenance, production, quality, procurement or finance. They have to be assigned these change action plans and they have to complete the change action plans on time so that before we move to our next step, our remedies or the change are completed. Your document control is very important part of your change action plan. Mostly your any changes you bring in may include your procedural changes, your monitoring record changes, your HACCP plan changes, your kappa changes, your supplier approval changes. So everything you do part of your SQF system may get implicated because of the change.

So that document those respected documents or records must be updated as part of your change management and then our training. If you do not communicate the new way of doing things, the people on the shop floor will not understand how to how to accept the new way of working. So the training what we see one of the biggest challenge we bring the changes but we don't communicate or we don't train the people on the floor they are not always aware of the changes happening at the management level or the equipment level or process level. So they have very limited knowledge in terms of what you call the change management. So they have to be brought up to speed to understand what are the change coming and what is their role as part of the new change management process. And finally you got to verify you got to verify and validate where necessary.

You know that there's a big difference between a verification and a validation and depending upon your requirement depending upon the situation you may have to determine do I need to verify or I need to validate the changes are properly implicated and finally your effectiveness check before you once you go live and this is where I think most of the change management process fails that we implement a change, we go live, then we do not track is the change effective, is the change still effective. So maybe six month back it was effective but tomorrow it might not be effective anymore. So those that's the last step that during your management review if you can add include your change management effectiveness check process that will be a good KPI to understand all the changes whatever you have implemented are effectively controlled through your change control and finally you have to close your change management process formally sign up and close the process. Okay. So now moving to the next slides. What is the role of the quality manager or SQF practitioner?

Because as I said SQF practitioner or quality manager do not do not own the entire everybody thinks they own the program but technically everybody owns the program. So what is the role of a quality and food safety manage manager in the whole change management process? Number one, you are the risk owner. You understand the risk assessment, impact assessment better than anybody in the organizations. So your input in terms of assessing the impact and assessing the risk could be could be one of the crucial role number one gatekeeper. You got to make sure that the change control plans, your training plan, your effectiveness check, your verification check are happening as planned on the due date.

So compliance gatekeeper you do training and the coaching got to make sure that the respective department respective people are trained and educated on the change management process. You got to verify you own the data and then continuous improvement. You are the one who driving the continuous improvement from a food safety perspective and you got to be your continuous improvement leads. So these are the role of a change owner or food safety manager in the change management process. Next slides. Okay.

So now let's take a practical example. So I was giving this practical example allergen. Why I said allergen? Because you know the allergen is one of the most what you call critical food safety risk in the in the in the industry. Now let's say if you would like to add a new tree nut allergen to the ingredient line. Now let's follow the 11 steps of change management process.

So your problem statement is that you are adding a new tree nut to the ingredient line. And you want to understand how would this impact. Let's talk about the impact assessment. The impact assessment is starting from the storage. You are going to bring the new allergen to the plant. You have to store somewhere.

Then you have to handle that allergen. Then your equipment which is going to be coming in contact with the tree nut allergen. It has to be clean. So that means your impact impacting area is your storage, your production and your sanitation. And what is the risk? We all know that the risk of allergen is very high.

We cannot have any traces of not allergen in the plant. So you have to assess the risk and impact assessment. Then comes to mind control planning. What are the control plans needed to introduce a new allergen to the to the to the plant? Number one, as I said, your storage segregation. Do you have a dedicated area for your tree nuts or can it cross-contaminate to your other ingredients?

That has to be a control plan in the storage your production. Do you need to change your production scheduling logic so that you do not cross-contaminate a tree nut to the next production or do you have to include a what do you call in between shift cleaning or do you want to include your cleaning verification or do you want to include the your verification of your effectiveness verification of your cleaning program or your trainer allergens. So these are the control plans, sample control plans you must put in place and more importantly your procedure, your process you have to change your cleaning procedure. You have to change your storage proc receiving procedure. You have to change your production planning procedure. You may have to change your production checklist to include your tree nut allergy.

So before you go into the full-fledged production, you may want to do a trial on the new production line to understand where this change when you order a tree nut allergen. Do you still have any risk of cross-contamination or leftover tree nut allergen in the in the production line or in the plant or in the process? And once that trial run goes successfully then you need to maintain the continuous monitoring or your recurrence check that to confirm your controls are holding in the in the operations. What are the common mistakes happens in the food industry from a change management perspective? I'm pretty sure you will agree to this that we make changes verbally. We do not make the changes documented.

So when you make a verbal changes there's no evidence what was discussed what was changed what was what are the implications. So this is one of the most common pitfall that verbal change request. Second pitfall what we what here oh it's not a critical control point so we will not do a change management we our focus always goes into the into critical control point if it's risky if it's not a CCP there's no implication to food safety that most common the what you call the mindset that has to be that's the most common pitfall second thing training you know what we will train people once you go live that is something we see a lot but that's too late you are already too late because your changes when they go live onto the plant floor it must be people must know what's happening and changes are never revisited after launch you do the initiation you do whole the change management process then you once you close it you don't revisit and as I was explaining that your management review could be a good vertical tool to revisit your changes is throughout the year. So, how do you how do you fix these problems? You got to have a change control process, change control form and the sign up. Sign up because when you initiate a change, when the changes is completed or controls are completed, people are trained and before you go live, you could have a sign up process in the change control form so that everybody are aware of the changes and we don't miss a step.

Okay. So now when you would be getting audited or the new change management process, what does the auditor wants to look when they come to audit you? They would definitely look at your change request records. They will ask, hey, show me all the change management records you have since last one year. They'll definitely look at is the change management process properly documented, properly signed off and properly communicated or implemented. So that is a part they will definitely go for the change management records and they will take those change management examples and when they go on the floor they will definitely interview the people on the floor if they are aware of the changes happened throughout the last one year.

So they will definitely go and interview people to understand if they are aware of the changes and what additional expectations or additional measures they are supposed to do when the change is happening. That is something definitely they are going to interview during the on floor interviews and they are definitely going to observe what changes you said you'll be doing is it truly happening on the floor or it is only on the binder. They'll definitely go and audit the changes on the floor so that the program what the change management program says or whatever the change record says that these are the changes and I'm going this are truly implemented on the floor to recap you got to document the whole change management process so that when the audit happens you are ready with your change management record you got to communicate and train your respective people so that when they're interviewed they have the answer and finally the change management process should be visible on the floor so that when the auditor goes and audit they can see the changes on the floor. Now how can we automate the change management process so that we are not heavily relying on a on a change management paper-based or Excel-based record. How can you make it a more automated efficient change management process? The so the answer is let's go digital.

There are benefits of digital tools which can help you stay compliant with your change management process throughout the or throughout the change implementation. What are the tools we have available? Workflow. So whenever a change has to go through a approval process, we could have a built-in workflow built into the change management system so that it automatically direct to the change management owner or change management approver. We could also have workflow for assigning when you assign a change, you don't have to verbally communicate, hey you are responsible for this part of the change or communicate by email. Can you please make sure do it?

You could assign a change control action plan through a digital platform so that the actual assigned user gets notified when the task is assigned gets notified if the task is not completed gets notified when the task is past the due date so that you don't have to do the change management repet reminders by email. So digital tools can help you various ways to bring your entire change management process not only from the workflow. It could be a one place where every stakeholders can visualize what are the changes coming up and how the changes progressing throughout the process and what are the reminders what are the what are the KPIs where the change is not happening or change process not happening and it can also foster a stronger food safety culture because everybody own a part of the change management process and it's visible to everybody in the organizations. Now how can we go digital as Tammie mentioned that by no means we are trying to present our digital tools here. We wanted to present that there are digital tools available in the marketplace which can help you to manage your change management process very effectively. So whenever you want to initiate a change management process, you could go and have a structured record where the change management can be purely documented and reporting is a very important part of any change management process.

And if you want to have a structured reporting, your data quality should be structured. So if you have a equipment list of the equipment you can put a drop down so that tomorrow if you're doing a reporting on where does the change request coming from in the plant which area or which equipment you could do that through a reporting. So for that your change initiation data should be structured and that can be done through a digital tool by having those structured data in a drop-down for you. So you'll go and initiate a change by creating a change request. You could also add objective evidence of your change. If you are if you have a camera or if you are taking your mobile app, you could upload images, could upload documents of your changes.

Once the change is done, then impact assessment. So your impact assessment could be also more structured. Currently if you're doing impact assessment, you're assuming okay you know what it might impact my product, might impact my process. But that can be automatically preconfigured based on the change type. Your associate area for impact can be automatically pulled in such as your quality, product safety, health and safety, regulatory, environmental. So you'll be able to have this predefined based on your change type.

So that means your impact assessment can be more organized in a digital tool. Next comes our feasibility study. Is the change feasible? Is there any financial implication? Is there any constraint from the procurement side? Is there any constraint from the manufacturing side?

Before you even go onto the actual change management, your feasibility study can be automated. And if you need let's say you need to have capex and you need an approval for the capex it could be automatic automatically rooted to your finance team or your for capex approval. So the feasibility study can be automated in the digital tools. Then your risks assessment. The risks assessment the is one important tool you could configure your decision tree. If you have your own decision tree to determine the risk that can be configured in the platform or you could use any standard likelihood, severity and detectability, two-dimensional or three-dimensional risk assessment tools to objectively assess your risk.

One feature also can be included your recurrence check. Did we initiate similar change in the past? If the change is reoccurring means what your past change was not effective. So recurrence check also very important feature in our in our overall risk assessment process to understand am I initiating new due change or there could be reoccurring changes. Next comes action planning. Your action planning could be included in the in the change management process where you would be able to add an action item to an internal or external user.

You could also verify if the action has been completed or not. Once the action has been assigned, the system can automatically remind them to complete the task on time. And you could also add a review of your action planning so that once the ask action is completed somebody can review it. So if let's talk about some of the action planning and how a digital tool can help you. Now let's say you want to update your procedure. If you have a document management software, you could directly link a procedural change to the document management and make the changes in the document management and bring it back to our change management as an evidence the action has been completed.

If you want to conduct an internal audit because of the change, if you have audit management software, you could initiate an audit to your to your internal users. You could also initiate a supplier approval. You could also initiate a CAPA, initiate a learning. If you're training, if you have to train somebody, if you have a learning management software, you could create a corrective action plan or action plan that conduct these trainings. So all the action plans can be digitally done in the platform. If you have got softwares where your document management, CAPA management, supply management, audit management, training management can be integrated or interconnected to a one-stop change management solutions.

Now, next step is effectiveness check. So, effectiveness check is something based on your periodic. Now let's say as I said if you want to include that every year on December 31st I would like to bring my effectiveness check or I would like to conduct an effectiveness check 6 month from the day I implemented. So after 6 month it is going to create a reminder for you that it's time for you to go back and then look at your effectiveness check and I could we could include your recurrence check if you have any reoccurring incident that means you it's not effective whatever changes you did. Finally if you want to initiate a change cost because everything is a cost right? If you want to include hey what is my change cost?

You could also have your own internal cost center built into the system where every aspect of your change implication can be taken into consideration for your cost of the change and finally your KPIs your trend analysis. If you would like to build your own trend analysis, how are the changes happening? How are the corrective actions happening? How are the recurrence happening? You could definitely have those kind of structured reporting in a change management software. That brings to Smart Food Safe.

We as a software solution provider we have our own change management software where you could have a built-in effectiveness or recurrence check. It has got its own configurable workflow. So change can be rooted to the appropriate person. It has got automated escalation. Now let's say you have a deviation change action. It's 10 days past due and it's not been completed.

The system sending reminder but it's not getting completed. So we could have that escalated to the level one, level two, level three. That means if you're on the level three and you are receiving an escalation notification that means something is not happening. We have got other modules so that the change management software can be interconnected to document management audit management. This module is compliant with 21 CFR part 11. So that your data integrity and your data requirements from the 21 CFR is already met.

It has got its own real-time dashboards and it has also automated risks and impact assessment tools available. With that note, the key takeaway from this webinar before you initiate any change request understand the change. What is the change? What are the implication? What are the what are the risk to the change? Make sure you build a process where the change is change management is documented properly from a procedure standpoint and from a record standpoint.

And finally, digital tools will definitely help you to make your life easier to stay up to date because your job as a quality manager or food safety manager should not be correcting mistakes should be focusing on preventing mistake and that can be done with digital tools or change management. And finally we at Smart Food Safe we have a comprehensive digital solutions available and if you are interested to learn about us you'll have my email id at the end but by no means we are trying to promote our software here we are here to educate that digital tools should be the way forward if you're looking to manage your change management process and with that note I'm pretty sure you guys Now SQF unites 2027 has been announced. So March 23rd to 25th it's happening in Takan and more information can be given by Tammie in this in this presentation. Thank you once again. I'm pretty sure you may have some questions. I see some questions are popping up.

I'll be happy to take any questions if you have.

Tammie Van Buren: All right. So thank you Prasant very much. One of the things I do want to emphasize we are seeing a lot of people in the chat asking about who's using what and different softwares and so feel free to put in the chat what you are using as we've you know indicated Prasant has a software program it is you know he took a you know 30 second brief you know hey here's who we are but there are many others and so feel free to type in the chat what you're using and share with each other. So Prasant if you want to unshare your screen then you and I will kind of go through yeah let's go through some questions. So we had several and thank you all very much. So the first big question that came in is, you know, we're talking change.

So people are getting ready to change from Edition 9 to Edition 10. Is that a change that we need to document and run through our change management process and procedure?

Prasant Prusty: Tammie, we are bringing a new change management process. We are bringing a new EMP process. That itself it's a change. So you have to document every changes going to impact your food safety practices. So yes you have to document again you have to go through the risks assessment go through the impact assessment and you may not require further action if your program already comply to the edition 10 or you may require to take additional action if you're not complying to the changes.

Tammie Van Buren: Yeah, absolutely. No, I would agree totally that you know for some aspects of Edition 10 it is going to be a big change. So you do need to follow aspects of a change management process. I will say that you know I love the 11step process. So that 11step process is not necessarily a code requirement. But it does organize it what Prasant has said to you today.

That 11step process kind of brings it all in and covers everything that you need. You will get a copy of this presentation as well as the slides. So you will get to see his 11step process on how to address change management. But let's go back to another question. So our operators make routine adjustments to keep the process centered. Well, first of all, that statement, that's a problem.

[laughter] you know, coming from a quality person, we should not be making, we call it tinkering or tweaking the process to try to keep it on center that if you are quality code certified, and I do encourage everybody to get quality c code certified, that's one of the things you learn in process control is your operator shouldn't be messing with the process constantly making adjustments trying to target center. But that's a side note. Back to our question on change management. Would we need to consider these as changes? And sometimes auditors seem to be considering these as breakdowns. So I guess I would need to understand how significant the change is.

But how do we communicate that these are not changes that require a change management process but instead it's just routine or pro part of the process. So what are your thoughts on that?

Prasant Prusty: So again Tammie without going into the details of the change because we don't have the background. Yeah. You got to ask yourself what's the risk? Yeah. Do you see a food safety risk here? If there's a food safety risk, yes, you got to you got to take care of the risk cuz ultimately a change management process address any potential or any future risk which may potentially come into the process because of the changes.

So since we are not seeing their process they have to ask themsel do I have a if you don't know do a risk assessment look at identify all the potential risk do a risk assessment what's the likelihood and what's the probability and what's the detectability and if it makes sense of course you need a change management process yeah

Tammie Van Buren: If your organization already has a management of change process do you need to create a different one just for Edition 10

Prasant Prusty: You don't need if your organization has already a process that means you are already capturing the 11 steps what I explained in the presentation but if you if you see that you have your current change management process is not meeting the requirement of SQF says it has been verified and validated if it's not verified or validated you have a gap yeah absolutely agree on that one 100%.

Tammie Van Buren: So, just compare it to the code, see if it's already meeting it. When does notifying the customer land in the process of big changes such as an introduction of a new allergen? So, you covered that as an example. So, where would you notify the customer within that 11step process there?

Prasant Prusty: Okay. So if the customer product is getting impacted by the new allergen which might require your label change you have to notify the customers. So it's between you and your customer what kind of agreement you have but if you want to change a label or change a process which may implicate the customer product. I'm pretty sure every customer wants to know what changes we're bringing.

Tammie Van Buren: Yeah. And for that one I would go back to the code too. So that very last sentence in the code requirement says changes shall be confirmed or validated, documented and communicated as necessary in a time frame that ensures food safety is maintained. So I'm kind of in the sooner rather than later camp. You know, the sooner you get customers involved in the process and notifying them of the change, then I think the easier it is for them to adjust or get their questions answered before it's, oh my gosh, I'm sending you product today that has, you know, tree nuts in it. So I like the sooner rather than the later, but we specifically put in the code, I led the technical working group to write, the food manufacturing code, and we specifically put in there in a time frame, that ensures food safety is maintained.

So, it's not a situation where it's one set time frame for every change. So, it's not a one and, you know, done. I notify my customer 7 days before the change takes place. I think I think you have to evaluate and as you've said Prasant go back to that risk assessment. What is the risk of not communicating to the customer in a timely manner? So this is kind of similar to what somebody asked already about if we are already doing change management process do we need to create different specifically but this question is we're already under Edition 9 and we've said change management is in Edition 9.

It's just kind of that hidden requirement there. So we're under Edition 9. So what's the additional things that I need to do when I implement Edition 10 that's not currently in Edition 9. So do you want so I guess I guess the Edition 10 requires you to have a documented change management process. That's the starting point. It has to be documented based on the code requirement and then every changes has to be also go through the risk assessment implication what do you call the accurative action planning and effectiveness verification that whole process you may have before in the past but it has to be more structured based on the code requirements

Tammie Van Buren: That's what I was going to say too you have to have that documented process so I like how you said more structure. So this next question, everything is already covered in the code in some way. The example of introducing a new allergen would be assessed in the ingredient supplier approval, an allergen management program, and those programs are validated regularly. Are we just supposed to summarize everything we're already doing into a change and quotation change management form now? So going back to your example of adding an allergen.

Prasant Prusty: So Tammie, it's the same thing you go back to the change management form. Did you capture all the requirements of the SQF code what we was explaining 11 step in the change management form you may be meeting or you may not be. For example, signing up. Let's say you have to sign up a change approval. Are you already capturing or it's only saying that hey it's not it's not a documented. So that part is very important to make sure that the requirements it's already what do you call in your change management process already capturing all the requirements.

Yeah. Absolutely. I mean, the person that asked the question mentioned a few things. Approved supplier, the and the allergen management program, but change management is going to make you look at the receiving process. You're receiving a new allergen. It's going to make you look at your storage.

So, how are you going to store it? Where are you going to store it? So, it encompasses the entire process. The intention behind a change management procedure. So will we be able to have a written plan that directs to other programs as long as these processes fulfill the change management requirement? So, and then somebody followed up, yes, that's a great question.

Can my change management procedure refer to other existing program processes? Kind of the same I think that several people have been asking. So, I'm already doing all of these things, but now for Edition 10, it specifically says change management process. So, can I just say see allergen program, see approved supplier program, can I just reference things when I'm putting my change management procedure together or do I need to do more? So tell me one thing I would I would say you yes you may be doing part of the this but if you look at the code 2.3.5.1 2.3.5.2 into it has a very clear expectation what has to be done and if you are already meeting that of course you can make a reference okay see this is it but change management does not restrict to one element it restrict your overall food safety program and by referring to pro supply approval referring to allergen you are limiting the scope to those areas what about unplanned chains which may initiate a food safety risk you will We solved that one. Yeah, absolutely.

The last one's not really a question, but there were several discussions within the chat about, you know, weighing the pros and cons of going a digital change management process versus a manual process and handwritten and Excel spreadsheets and things like that. You know, one of the things that someone did point out is that, you know, regardless of which digital platform you use and SQF does have several that were, you know, associated with or, you know, that do come to our conference every year such as yourself. But having that online presence to where it kind of lines things up to make the SQF audit, I don't want to say easier, but I but I will say more efficient, right? So, any other parting words on what are some of the other benefits besides just audit day? I can line up all my documents. So any parting thoughts on that?

Well Tammie SQF is a tool to bring you the continuous improvement on your food safety program and the continuous improvement does not happen on the day of the audit. It has to be happen every single day and for you to find out if it's happening every single day auditing is not the best tool. You need to have a KPI which take into consideration your data, your corrective action, your change initiation on a daily basis, on a hourly basis, on a minute basis. So that means you got to be ready every minute. So and you cannot have that saying that yes, I did my audit. I got a great score.

I my program is good. Yes, that is good on the day of the audit. But what happened after the audit? Yeah, absolutely. Okay, last question. We had it kind of slide in here at the end.

Introducing a new raw material from an already approved supplier. So, can we just do our approved supplier program? And is that sufficient to meet the change management requirement? New material approved supplier already. Okay. So the supplier may be approved but the material may bring some inherent risk if you're talking about cantaloup which has inherent risk.

So you have to understand if this new material you are trying to bring from the supplier does contain in inherent risk. Number two does your process have the capability to address this inherent risk? If your process does not have the capability, you have to go through a change management process. All right. Well, thank you all for joining us. We are back up at the top of the hour.

As Coup has posted in the chat, you all will get the presentation. You will get the recording. Please reach out if you have any questions about change management and the clarification on the code requirements. Compliance atsqfi.com is where you get me and I'm happy to u provide you with code clarifications u point you to resources that would help you in your journey in Edition 10 which is coming up in just a few months. So again thank you all thank you prant such a pleasure to present with you today. 1:00:04 1 hour, 4 seconds Thank you.

Thank you everybody. Thank you Tammie. Bye-bye. Bye-bye.