Tag Archives: foreign supplier

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Failure to Have Foreign Supplier Verification Plan a Common Inspection Observation

By Maria Fontanazza
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Food accounts for one-third of the 42 million products imported into the United States each year, according to Andrew J. Seaborn, supervisory consumer safety officer, division of import operations, ORA, FDA. FSMA’s risk-based FSVP rule places responsibility on importers to ensure their food is safe, yet since the rule was implemented, the most common Form 483a observation has been a failure to develop an FSVP. In fact, from FY 2017 to present, the observation was cited 552 times, outweighing any other observation, said Seaborn at the recent Food Safety Supply Chain Conference, as he shared some of the latest trends in compliance and enforcement related to FSVP.

Thus far, common citations include:

  • No written hazard analysis to identify and evaluate known or reasonable foreseeable hazards
  • No written procedures that ensure appropriate foreign supplier verification activities are occurring related to imported food

Seaborn noted several additional “significant observations” related to FSVP inspections, including incorrect entry data, and the absence of documentation in the following areas:

  • Approval of a foreign supplier
  • Evaluating foreign supplier performance, along with related risks
  • Establishing written procedures to ensure foreign supplier verification activities are performed
  • Review and assessment of another party’s evaluation of foreign supplier performance
  • Ensuring food was produced in compliance with low acid canned foods regulations
  • Related to meeting the definition of a very small importer, when applicable
Main Points of FSVP FSVP Inspections (Completed)
U.S.-based importers responsible to ensure safety of imported food FY 2017 285
Risk-based (hazards, importers and suppliers) FY 2018 792
Align with PC supply chain provisions FY 2019 (as of 5/28/19) 458 (FDA is planning for 880)
FDA oversees compliance via importer inspection
Foreign suppliers can help importers comply

 

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The Results Are In: FSMA Supply Chain IQ Test (Part II)

By Food Safety Tech Staff
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Thank you to everyone who participated in our latest FSMA IQ test, which focused on the supply chain. This series was developed by Kestrel Management. If you have any questions about the results, we encourage you to leave a comment.

We also invite you to learn more about important supply chain issues at our Food Safety Supply Chain Conference later this month, May 29–30. You can attend in person or virtually.

If you haven’t taken Part II yet, take the Supply Chain IQ Test now.

And now for the results!

  1. Control limits must be included within the hazard analysis and preventive controls for HACCP.
    • FALSE. More clarification is needed here, as 96% of respondents said this is true.
  2. CCPs previously established under HACCP or previous hazard analysis may be a preventive control under FSMA.
    • TRUE. 91% got this right.
  3. Product testing for pathogen or indicator organism is not addressed under FSMA verification and reevaluation.
    • FALSE. 87% answered correctly.
  4. You must document justification of records not required by a food safety plan in a food operation under FSMA.
    • TRUE. Just 44% responded “true”.
  5. You must implement corrective actions and corrections properly, including procedures to address the presence of organizations in ready-to-eat as a result of product testing.
    • TRUE. Congratulations, 100% got this one right!
  6. Under section 117.150, you must implement corrective actions based on your determined response for all affected food as evaluated.
    • FALSE. This seems to be another area that needs clarity: Just 13% answered “false”.
  7. Under FSMA supply chain requirements, you must document approved suppliers.
    • TRUE. Once again, great job—100% answered correctly!
  8. A foreign supplier of food to the U.S. must ensure that all the requirements of a FSMA Food Safety Plan under cGMP117.126 be met for the manufacture of the food being exported to the United States.
    • TRUE. 91% knew this one.
  9. A food broker of foreign-supplied product to the U.S. does not have any responsibility of meeting the FSMA requirements.
    • FALSE. 91% answered correctly.
  10. Data sets must be shared between shippers, carriers, loaders & receivers to ensure rules are properly implemented.
    • TRUE. 74% answered correctly.
  11. Only the personnel of the carriers transporting food product require training and training records.
    • FALSE. 96% got this one right.
  12. Shipper & carrier can agree to a condition & temperature monitoring mechanism for foods that requires temperature control for safety.
    • TRUE. 91% answered correctly.

Canadian Poultry Products Recalled for Lack of Import Inspection

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The products subject to recall bear the establishment number “Canada 591”. These products were shipped to retail locations in Washington.

Sunrise Poultry Processors of Lethbridge, Alberta, is recalling approximately 2,705 pounds of poultry products that were not presented at the U.S. point of entry for inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The following poultry items, produced on Feb. 2, 2015, are subject to recall:

  • 40-lb. bulk cases of “Sunrise Poultry CHICKEN THIGHS.”
  • 25-lb. cases of “Sunrise Poultry CHICKEN THIGHS BONELESS.”
  • 25-lb. cases of “Sunrise Poultry BONELESS CHICKEN BREAST.”
  • 2.5-lb. cases of “Sunrise Poultry CHICKEN WHOLE FRYER.”
  • 4-lb. cases of “Sunrise Poultry CHICKEN WHOLE FRYER.”
  • 3.25 to 3.75-lb. cases of “Sunrise Poultry CHICKEN WHOLE FRYER.”

The products subject to recall bear the establishment number “Canada 591”. These products were shipped to retail locations in Washington.

The problem was discovered when the import facility reported to FSIS that product with an estimated date of arrival of Feb. 4, 2015, had not been received at that location.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSVP: What Has Changed in the Re-proposed Rule?

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

In a recent FSMA Fridays webinar, Dr. David Acheson, and Melanie Neumann of The Acheson Group covered some of these changes and its impact on the food industry. Food Safety Tech presents some excerpts:

What is FSVP all about?

Dr. Acheson: The foreign supplier verification program is supply chain risk control for imported foods. Following the melamine in pet foods scandal that originated in China, the legislation was aimed at tightening preventive controls for imported foods. The rule concerns companies that import food from foreign manufacturers, and requires them to ensure that those suppliers are complaint with FDA requirements in the U.S. and thus, you are addressing risks along the supply chain.

How did the re-proposals change FVSP rules?

While there are several changes proposed, the entire substance of the FSVP rules haven’t changed as whole. Overall the changes seem to align the FSVP rule closer to the preventive controls rule in terms of wording and intent. Some of the changes include:

  • Approved Suppliers: As long as an importer can demonstrate that they have a process to approve suppliers, and that they follow it, there is no need for them to maintain a list of approved suppliers. However, this raises a question: If you don’t have a list of suppliers, do you know if your supplier is approved or not?
  • Supplier Risk: FDA now requires an evaluation of supplier risk along with product risk. Factors that should be considered include regulatory compliance, the history with the supplier (including test results and their willingness to correct problems), and any other relevant factors.
  • Audit requirements: In the original rules, FDA asked whether or not an initial audit and subsequent annual audits should be required when an importer identifies hazards that could cause serious adverse health consequences or death to humans or animals. In the supplement, FDA has basically said that yes, audits should be required under these circumstances, but has also given the flexibility in stating that if an importer can demonstrate that the risk can be managed in some other way, and that suppliers can be just as effectively verified through other means, then the importer is free to use other tools, or to decrease frequency of the audits.
  • Duplication of efforts: FDA will not require food manufacturing facilities who are subject to preventive controls (and who rely on suppliers to control significant hazards) to keep a whole additional plan in place to comply with FSVP.
  • Definition of very small importer: In the re-proposed rule, FDA has set $ 1 million in annual sales as the definition for very small importer, which aligns with the definition in the Preventive Controls rule.

Will food and beverage importers be expected to do onsite audits of foreign suppliers?

As described above, importers are supposed to do onsite audits, but only for significant hazards. Earlier FDA had provided two options. In the re-proposal, FDA seems to going with Option 1, which requires an annual audit for those supplier with significant hazards, but had added flexibility, by which the importer can determine another way of determining risk, or a less frequent audit schedule in lieu of that annual audit. But here’ the concern: While I embrace flexibility and decision making power at the industry or importer level, but there’s no objective bar set. The new requirement seems to say, ‘You have to do this, but you don’t have to do this, if you think you don’t have to do it!’ As a lawyer, looking at this in writing, it raises some flags about enforcement.

Click here for more on this exciting and evolving topic, including answers on where GFSI audits fit in, and what should U.S. importers be doing now to be ready to comply with FSVP requirements.

Holly Mockus, Product Manager, Alchemy Systems

Real Training Needs – Time and Resources

By Holly Mockus
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Holly Mockus, Product Manager, Alchemy Systems

With the announcement on September 19, 2014 of the released re-proposals to the main FSMA-related rules – Preventive Controls for both Human and Animal Food, the Produce Safety Rule, and the Foreign Supplier Verification Program – it is time to take another look at the real need within the food industry related to training and education.

The word ‘train’ in some form or format appears over 100 times in the Produce Safety rule and the Preventive Controls for Human Food documents. One Hundred Times! This is clear indication that it’s time to take another look at the training programs in place today.

When asked, managers and supervisors responsible for training today typically respond that their biggest challenges or needs are having the time and resources available to conduct meaningful training for the workforce. Gone are the days where a ‘good’ training program consisted of shoehorning a training session into a segment of line downtime and hoping for enough time to cover all the learning objectives. As regulatory and customer emphasis on employee empowerment and engagement continues to escalate – food industry training programs must grow and evolve.

Here are some basic areas that need the proper time and resource dedication for maximum impact:

  • An analysis to determine gaps in the current training program should be very robust. Don’t skimp on the resources needed to do an effective job here. The use of this data is the first steps on the training journey and becomes the cornerstone as you build employee expertise.
  • The development of content should not be under resourced at any step in the process. Content is critical in providing the ‘How’ and the ‘Why’ (Who, Where, and When too). Worry less about fitting the material into a specific time slot and more about the quality and applicability for the specific workforce audience.
  • Partnering with a Subject Matter Expert or a content provider is an investment that will pay dividends as employees soak in the knowledge and ask for more.
  • Delivering the content in an environment that is conducive to group training where there are now distractions, all questions and answers can be heard by the participants in another resource that is critical to the success of a robust and effective program. Learning labs for more one-on-one self-directed learners are another means of providing knowledge to the workforce without having to incur line downtime. An investment that will pay for itself in a relatively short period of time.
  • Coaching employees for success in one of the best gifts that a supervisor or manager can provide. Constructively correcting incorrect behaviors and positively reinforcing good behaviors may take good people skills and a little extra time. Making it a habit costs very little and will provide a clear concise roadmap throughout the training process.

Training is a journey, not a destination. Teaching ‘how’ starts the journey – ‘why’ builds the culture. Spending time and resources for training should be a no-brainer for the food industry today. Stop looking at training as time spent losing operational effectiveness and start looking at training as the best investment you can make in your people, products and brands!

Hear the author speak more on Food Safety training at the Food Safety Consortium, November 17-18, 2014, Schaumburg, IL. Click here for more details and to register.

 

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSMA 2nd Review Cycles: A Q&A on Preventive Controls

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

On Friday September 19, 2014, FDA finally released re-proposals to four of the main FSMA-related rules: Preventive Controls for both Human and Animal Food, the Produce Safety Rule, and the Foreign Supplier Verification Program. The 75-day comment period will close around mid-December, after the proposals are officially published in the Federal Register.

At a recent FSMA Fridays webinar, presented by SafetyChain, Dr. David Acheson and Jennifer McEntire, Ph.D., of The Acheson Group focused on changes proposed to the Preventive Controls rule (for Human and Animal Foods). We present below some excerpts:

Q: What is the further definition of situations where environmental testing will be required?

Dr. Acheson: This is one of three very predictable components of the reproposals coming out. We have been saying for a long time to expect environmental monitoring to come back into the regulations. We all wish we have environmental monitoring everywhere, but this is not practical, feasible or environmentally focused. So what FDA has done now is to say we expect you to look at your environment, especially if it’s ready-to-eat products, and require you to conduct environmental monitoring in those specific areas. The change proposed is not fully prescriptive, and facilities need to conduct environmental monitoring as appropriate to their food products, the facility etc. It is required it specific circumstances where ready-to-eat product is exposed post-processing, and before packaging. Under this reproposed rule, the agency requires you to have strong environmental monitoring procedures as needed, records of these methods, and proof that you have corrective actions built in, when needed.

Q: What is the role of finished product testing in verification of food safety plans?

McEntire: When FSMA rules were initially announced, there was a lot of uncertainty whether FDA would require finished product testing, as in many cases, this would be like looking for a needle in a haystack. Now FDA is asking you to do finished product testing as necessary, as a verification activity to check if your overall food safety system is working well. Companies will need to look at the types of preventive controls that in place, at areas such as sanitation, employee hygiene (hand washing) etc., aspects that FDA does not require to be validated, and use finished product testing as a way to make sure that these are being done the way they are supposed to be. If you think it’s appropriate and if you choose to have finished product testing as part of your verification, make sure to have written procedures, documentation, corrective actions etc.

Q: What are the requirements and responsibilities for controlling suppliers along a company’s supply chain?

Dr. Acheson: Everybody recognizes that controls supply chain risk is an important part of controlling brand risk, AND it is a huge challenge. So it makes logical sense, and we know from experience, that suppliers have and will continue to send out food and ingredients that are not suitable, cause problems and cause recalls. Another reason is based in the Foreign Supplier Verification Program, which is essentially a different take on Supply Chain control. The only difference is that FSVP is a risk control requirement for imported, FDA-controlled foods. It looks at who you are getting food from, is there a hazard in it, and how is that hazard controlled? With the FSVP, we had set a different bar for imported foods than for foods sourced domestically. So this new addition rule tries to align Preventive Controls rule with the FSVP, by adopting a similar approach. So now it doesn’t matter if you source domestically, or from outside, you need to have a strong supplier controls program, and this has to be risk-based.

So look at your ingredients or materials. Do they contain a significant risk? If so, who’s controlling that risk – you or the supplier? For instance, if you are sourcing an ingredient like an herb, which has been associated with a Salmonella outbreak, then yes, there is a risk associated with it. So this ingredient that you are sourcing from different places is a significant hazard, but what you are doing with it is putting it in a blend and then cooking it in a product. So you are controlling that risk, and you don’t need to document that from the suppliers. However, the same ingredient, if you are just using it as a garnish, without a kill step, the control falls back on the supplier. And you as the user, have to make sure that the supplier is controlling that risk. The agency is giving some options, such as audits, testing, verification of supplier programs etc. to manage this requirement. For instance, if your analysis says there’s a significant risk, and it can lead to a significant adverse effect or death, Class 1 type situation, if that ingredient poses that level of risk and you are not controlling it, then an annual audit will have to be conducted of that supplier.

Where does GFSI fit into this? In my view, GFSI will align with this. So if you have a GFSI audit of the supplier, then you are going to be in pretty good shape.