Tag Archives: food safety plan

How GFSI Schemes Align With FSMA Compliance

By Food Safety Tech Staff
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With publication of the first set of final rules for FDA’s Food Safety Modernization Act (FSMA) expected any day now, food safety teams are busy strategizing as to how they are going to prepare for compliance and be “FSMA-ready” on Day 1.

Across industry, it is generally agreed that being certified to a GFSI scheme is a solid foundation for FSMA compliance. In a new three-part online series,  “GFSI in the Age of FSMA: How GFSI Schemes Align With and Prepare You for FSMA”, the North American leaders of the three major GFSI schemes – SQF, BRC and FSSC 22000 – will discuss the following topics:

  • How certification to their scheme prepares a company for FSMA compliance in terms of alignment with:
    • Supplier Controls
    • Building a food safety plan
    • Migrating from HACCP to HARPC
    • Being audit ready all the time
    • Environmental monitoring … human & animal food rules … and much more
  • What changes to the scheme have been made (or are planned) to better align with FSMA
  • Gaps the leaders see in FSMA that are filled by their scheme
  • What companies who are, or plan to be, GFSI certified should be doing now for Day 1 FSMA compliance

The series, which launches September 25 is complimentary. Learn more and register at: http://www.safetychain.com/GFSI-Webinar-Series

SafetyChain webinar series
(left to right) John Kukoly of BRC, Jacqueline Southee of FSSC 22000, and Robert Garfield of SQFI are the featured speakers of the GFSI series.

Food company teams working in Regulatory, Food Safety & Quality Assurance, Operations, C-Suite, Legal and other related positions in companies who are – or are planning to become – certified in a GFSI scheme are encouraged to attend one, two or all three sessions.

The series is being sponsored by SafetyChain Software with media partner Food Safety Tech.

Top 3 Things to Know about President Obama’s FY 2016 Food Safety Budget Proposal

By Miranda Peguese
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Knowing the government’s increased focus on food safety means companies must continually be audit ready with program sustainability as a focus for management and employees alike. Commitment to food safety and a sound preparation plan is key for facilities as they navigate through the increasing food safety regulatory oversight.

Food safety funding has been a major focal point for the FY 2016 budget proposed by President Obama. Primarily due in support of the fact that all major Food Safety Modernization Act (FSMA) rules are scheduled to take effect by the end of FY 2016, the increased focus will impact each of the agencies governing food safety within the US and all entities which fall under their jurisdiction.

Here are three things to know about the proposed food safety funding allocation for FY 2016:

1. There will be a sizeable increase in the allocation of food safety funding.

President Obama’s $3.99 trillion FY 2016 budget proposal allocates $1.6 billion for food safety, a significant increase in food safety funding over previous years. This would include increases of $301 million for the U.S. Food and Drug Administration (FDA) to support new measures under the Food Safety Modernization Act (FSMA), resulting in a $109 million increase over the previous year as well as an additional $2.1 million increase to the Centers for Disease Control and Prevention (CDC) over FY 2015’s $48 million allocation going towards food safety.

USDA budget requests would decrease slightly for FY 2016, requesting $1.012 billion vs. $1.016 billion for the previous year’s budget as a result of program related cost savings and correlated efficiencies and expects that a portion of the $2.9 billion for agricultural research and extension activities would support additional food safety requirements set forth by FSMA.

2. The proposed increase in food safety funds would include a prioritized food safety spending plan.

The increases to the allocated funding for food safety do not come without guidance. The funding increase includes a detailed plan for spending to include the following allocation:

  • $32 million for Nation Integrated Food Safety System
  • $25.5 million for New Import Safety Systems
  • $25 million for Inspection Modernization Training
  • $11.5 million for Industry Education and Technical Assistance
  • $4.5 million for Risk Analytics and Evaluation
  • $4 million for Technical Staffing and Guidance Development

The top three funding allocations noted are for integration, import, and inspection. These allotments directly reflect the directives set forth in FSMA

3. The plan also includes a proposed single food safety regulatory entity.

In addition to the increase in funding, the new plan outlined by President Obama also asks for Congress to combine several programs overseeing US food safety into a single agency under the Department of Health and Human Services (HHS). Advocates of the plan state that the combination would provide “focused, centralized leadership, a primary voice on food safety standards and compliance with those standards, and clear lines of responsibility and accountability”, citing the current food safety system as being fragmented and outdated. Currently, a total of 12 agencies enforce 30 different laws. An alternate proposal has also been put forth by two members of congress which would suggest the formation of a new food safety agency independent of HHS.

How does this affect your facility? Knowing the government’s increased focus on food safety means companies must continually be audit ready with program sustainability as a focus for management and employees alike. Commitment to food safety and a sound preparation plan is key for facilities as they navigate through the increasing food safety regulatory oversight.

To learn more about the food safety allocations within the proposed FY 2016 budget, visit http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm432576.htm and http://www.usda.gov/wps/portal/usda/usdahome?navid=BUDGET.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Top 5 FSMA Challenges

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

The year 2015 is almost two months in, and the U.S. Food and Drug Administration has got its head down looking at the comments to the re-proposed rules under the Food Safety Modernization Act (FSMA), with the first of several deadlines – August 31, 2014 – looming ahead.

Against this backdrop, food safety experts Dr. David Acheson, and Melanie Neumann, at The Acheson Group, discussed the Top 5 Challenges for becoming FSMA Compliant with SafetyChain Software’s Barbara Levin.

The top 5 challenges were identified as:

  1. Determining exactly which rules apply to you and what compliance will involve;
  2. Building a food safety plan – migrating from HACCP to HARPC;
  3. If you are a registered firm – building a supply chain management program;
  4. Determining what testing you will need to do; and
  5. Determining recordkeeping requirements for FDA.

Why have the above been identified as the top 5?

FSMA has thrown out a number of different rules, and for food companies, figuring out where you should fit can be difficult. For instance, should you be looking at Preventive Controls, or Foreign Supplier Verification Program? The language in the Produce Rule is complicated, so if you are a mixed type facility, it can be challenging. While most companies are familiar with Hazard Analysis at Critical Control Points or HACCP, the concept of migrating into Hazard Analysis and Risk-based Preventive Controls or HARPC is not that easy.

Getting a handle around your supply chain and its various components is just difficult, and just understanding what this requirement will involve will be a huge challenge.

While testing of agricultural water was addressed in the initial Produce Rule, the re-proposed Preventive Controls rule included environmental monitoring and finished product testing as requirements for compliance. It will be a challenge for companies to determine what kind of testing they will need to do.

Keeping track of the variety and volume of records that FDA will need to for FSMA will be a huge challenge.

While we could have picked up many more than five, these were the top five that we think will be the most challenging.

To determine what rules will apply to you and what will compliance involve, what are the top things you should be doing now?

Firstly, if you are not starting already to see what applies to you, then you are already behind. Do a FSMA readiness assessment and look at all the rules to determine which ones apply to you. For instance, if you are a company that makes cereal and cookies, then you probably don’t need to worry about the produce rule.

Once you determine the rules that are applicable to you, then the heavy lifting begins. You need to do a gap analysis to see where you are now and where you need to get to. Drawing out this road map to compliance then becomes critical, and that’s what companies need to do be doing now.

Building a food safety plan and migrating from HACCP to HARPC, what are the top things that you should be doing?

The goal of the preventive controls rule is to encourage food companies to start thinking much more about prevention. While HACCP principles are a great start, in some areas, it could be limited in scope, and focused only on critical control points that we can measure. But HARPC expands our thinking to risks that we can control that are beyond classic HACCP thinking, and don’t fit nicely into the seven steps of HACCP. For instance, hand washing – we may not be able to measure this, but this would still be a critical step to control risk. So it will be a challenge for food companies to take their HACCP program and elevate it to HARPC thinking.

If you are a registered firm, building a supply chain management program has been identified as the third challenge. How do you know if you have to register? What can you do now to build a supply chain management program? And would you consider this the biggest challenge for FSMA compliance?

The requirement for food companies to register has nothing to do with FSMA; it was included as part of Bioterrorism Act. According to this, if you are packing, holding, processing or manufacturing food, you need to register with FDA. FSMA added the requirement that this registration would need to be updated every two years. This requirement is now important as several of the supply chain management program rules, which are part of the Preventive Controls rule, apply to companies that need to register.

The requirement to have a supply chain management program was in very early versions of FSMA and then got pulled out, and then now it’s back. And it’s not going away. What can you do to prepare for this rule? Look at all your suppliers, look at who they are, what they are shipping to you – do a hazard analysis of all their products, know their risks and understand what they are doing to control that risk.

For instance, your supplier Mr. Smith is supplying you ground black pepper, which you are using in a variety of products. We have determined that ground black pepper has a potential for Salmonella risk and has been historically linked to Salmonella. So you need to do a hazard analysis and determine if it is a risky food and who is controlling that risk. Is it you or Mr. Smith, and that depends on what you are using that ingredient for. If you use it as a garnish in based potato chips, then there is no cooking or kill-step involved, so the risk should be controlled by Mr. Smith. Thus, FDA will expect you to figure out that Mr. Smith is indeed controlling that risk, which you can do through site visits and data.

Another scenario is that you get that pepper from Mr. Smith, but you are using it in soup, and thus, have your own kill step to control that risk. So you don’t need to pay that visit, put have your own procedures to address risk with that ingredient.

While ground black pepper is a straightforward example, where it gets tricky is when you have to do this will ALL your ingredients. Companies typically have hundreds of suppliers and thousands of ingredients. So start NOW to understand how this little part of the preventive controls rule will affect you; you only have about 18 months to figure this out. And for that reason, I think this will be a huge challenge.

How can companies determine what testing they will need to do? What should companies starting doing now?

While the original produce rule included testing requirements for water, the other testing requirements mandated by FSMA are mostly new. The preventive controls rule now requires food companies to have an environmental monitoring program in place. FDA has also laid out a strategy in which finished product testing can be used as a risk control system. It’s not mandated per se, but it may be a way to exercise the preventive controls rule. Companies need to plan right now to determine what kind of testing they will need to do, how to document it etc. The environmental monitoring program and product testing requirements are new. So start looking at these programs, understand the rules to determine which of these rules apply to you, and do the gap analysis and FSMA readiness assessment now.

You have identified that record keeping requirements for FDA will a major challenge. How can companies prepare for this?

Record keeping will be an area where companies are most likely to struggle. There will be mounds and mounds of documents that will be generated because of the FSMA rules. The days of filing cabinets are over, and it will be really hard to do this in a manual environment. Companies need to look at technology and automation to manage all this data. If companies happen to be regulated by dual agencies, we are talking about even more information that they need to collect and keep track of. So automate NOW.

We often notice that companies are keeping track of the right data and documentation, but are unable to prove this, and retrieve the information when needed. With FSMA, the agency is going to say, ‘if you can’t prove it, it didn’t happen.’ So companies need to get smart about having effective document retrieval systems.

Are there any additional challenges that FDA isn’t talking about that companies need to look out for?

While the above challenges broadly capture the most significant challenges, we think the following may also be something that companies would need to prepare for:

  1. High-risk list: This year, we expect FDA to announce some rules regarding this.
  2. Traceability requirements: FDA may reveal more about this and how his will link to the high-risk list.
  3. Voluntary Qualified Importer Program or VQIP: The needs and requirements for this are still not clear. We expect some rules to be proposed this year.
  4. Additionally, while we don’t expect it to happen, if FDA makes any radical changes with the final rules, that could generate some new challenges.

For more on this discussion, click here.

Top 10 GFSI Non-conformances, and How to Avoid Them

By Michael Biros
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Are you ready for audit? Gary Smith, Director of training and improvement solutions at SAI Global, talks about the top 10 GFSI non-conformances for SQF & BRC audits.

1. Business Continuity Plan Components/Annual Testing and Review

Many companies do not know what a business continuity plan is. It is not a recall and performing a mock recall will not count as an annual test and review. It is the continuing of business with a disruption in the supply chain. What are your plans for a key supplier going out of business or being affected by a natural disaster? If there is a fire or accident at one of your facilities, how are you going to ensure that your customers will still get delivery of your product? 

2. Food Safety Plan

HACCP has been around for years, but this is still a major area of focus. HACCP must be implemented and individuals must be properly trained in HACCP. All Critical Control Points (CCPs) must be validated. Review supporting documents during annual check. Is the flow chart current? Is the hazard analysis still correct? Question your employees during your internal audit. Get your employees used to and comfortable with answering questions about the food safety plan. 

3. Equipment and Utensil Condition

Utensils (scoops, shovels, belts, etc), equipment, and all food contact surfaces must be designed and in good condition so as not to be a food safety risk. Implement a foreign material control plan. Have a preventative maintenance schedule. Focus the internal audit program on equipment, not just employees. Use a flashlight when conducting internal audits. Train, empower, and reward production employees to identify equipment defects. Do not have temporary repairs. 

4. Allergen Management

Allergens are the number one cause of recalls. You must have a good allergen control program and this program must be validated. Identify ingredients as allergens at receiving and have a label inspection program. Specific allergen proteins must be validated with surface testing and product testing. Allergens must be listed as hazards in hazard analysis with the control as the allergen management program. 

5. Internal Audit

Have a strong internal audit program that emphasizes proactive solutions to avoid non-conformances. Manage non-conformances with a corrective action program. Take photos of all findings during internal audits. Make the process as formal as possible. Dress like the auditor would and ask employees questions. 

6. Condition of Walls, Doors, Floors, and Ceilings

Tape, cardboard, and construction plastic sheeting must not be used as these surfaces cannot be cleaned. Doors and windows must be properly closed. 

7. Product Traceability and Mock Recalls

If an auditor asks you about a product, you must be able to list all the raw materials, where they came from, and how they were processed to create your product. Keep the recall team current. Have procedures for a mock recall and always perform it. Make the mock recall a real test. Include ingredients and packaging in all traceability programs. Perform product trace exercises during the internal audit. 

8. Records

Make sure that your records are legible, authorized, and that demonstrated activities are taken. 

9. Procedures for Product Disposition when Calibration is Out

This is a new standard. Companies are now required to have documented procedures in place for when calibration equipment is down. 

10. Stay Vigilant!

If you’ve achieved food safety certification, congratulations! However maintaining certification takes commitment and dedication. Be sure to maintain a strong food safety culture within your organization. Communicate well across all levels of the company. Have a strong internal audit program and don’t be afraid to identify issues and focus on corrective action management.