Posts Tagged ‘recordkeeping’

Avoiding The Pitfalls Of FSMA’s Recordkeeping and Sanitation Rules

By Pamela Sweeten, Owner & Founder, P. Sweeten Consulting

Two cornerstones of FSMA’s final rule on Preventative Controls for Human Food are record keeping and sanitation. Food manufacturers and processors, along with companies importing goods into the U.S., are now being held to a much higher standard of sanitation, documentation, and compliance to better protect the health of the U.S. public.

Food Safety Records
It is not just that demand for record keeping has increased dramatically in scope, the FDA now has more legal authority to access and audit your records. This makes knowing and following the changes to Part 117 of the Current Good Manufacturing Practice (cGMP), Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food essential.

Record Requirements
There are general requirements for all records that must be followed. All records must:

  • Be kept as original or electronic records or true copies
  • Contain factual observations and values
  • Be legible, permanent, and accurate
  • Must be done in real time
  • Include the detail required to create a history of performed work
  • Standard details including identifying the facility or plant, date/time of the activity being documented, signatures and initials of the person who performed the activity, and when applicable the identity and lot code of the product

Record Retention Requirements

  • You must store and retain your records for a minimum of two years
  • Any documentation relating to supporting the status of a facility as being a qualified facility should be kept as long as necessary to support the status of the facility
  • Records that have been discontinued (records related to changes) must be kept for a minimum of two years
  • Records, other than the Food Safety Plan, must be able to be present at the facility within 24 hours of being requested by an official for review.
  • The Food Safety Plan may only be transferred to another accessible location only if the facility is closed for an extended period. The document still must be able to be obtained and given to an official at the facility within 24 hours of an official review request

Food Safety Plan

  • Must be kept on-site at the plant or facility
  • Upon completion of the food safety plan, the owner, operator, or agent in charge of the plant or facility is required to sign and date the plan. Any changes to the plan must also be signed and dated by this person of authority.

Three Categories Of Records To Keep
There are three categories of records you may need to keep, depending on your hazard evaluation. The records needing to be kept reflect the entire supply chain process and potential hazards from prior to receiving at the facility through to the customer carrying the product.

First are hazards controlled by the supplier (prior to delivery to the receiving facility). Once the hazard evaluation has been completed, if it is determined that a hazard will be controlled by the supplier, then a written supply chain program (or Foreign Supplier Verification Program for facilities that are importers) is required.

Documentation in this program includes but is not limited to:

  • Approval of the supplier
  • Supplier verification
  • Sampling and testing
  • Suppliers food and safety records
  • Procedure for receiving ingredients and raw materials
  • Reanalysis documentation

Next come hazards controlled at the receiving facility. If the receiving facility will control the hazards, then the receiving facility will be required to develop, implement, and document preventative controls.

Documentation requirements include, but are not limited to:

  • Preventative control monitoring and verification of monitoring
  • Any corrective measures that were taken and verification of actions taken
  • Environmental monitoring
  • Product testing
  • Training documentation
  • Reanalysis documentation

Finally, there are hazards controlled by the customer. If the receiving facility relies on a customer or another first receiver to control a hazard, then there are some records that must be developed and kept.

Documentation requirements include but are not limited to:

  • Written disclosure (included in the food’s shipping documents) that an identified hazard was not controlled by the facility
  • A written assurance (submitted annually) that contains the established procedures the customer must follow to prevent (or drastically reduce) the identified hazard

Sanitation Controls
A large part of controlling hazards is creating sanitation regulations that will drastically reduce or prevent hazards before they can occur. The environment, equipment, and employees should all be part of the sanitation control solution. Sanitation controls should include:

  • Food contact surfaces (including utensils, equipment, and food packaging)
  • Food handling
  • Cross contamination
  • Food allergens

Sanitation can be costly, but you could lose so much more if your product quality or shelf life is affected by unsanitary facility conditions. The best sanitation departments audit their facility and then create a structure for consistency. When creating this structure, a facility should consider the type of soil that needs to be cleaned, what the chemical needs to do when used (dissolving, emulsification, wetting agents etc.), and the state of the plant’s water.

There are many products designed to properly manage each type of sanitation control. Depending on the type of food a facility is working with or the equipment utilized, the needs may be different. For example, facilities handling meat, poultry, or seafood should include in their sanitation controls antimicrobial treatments to maintain product quality and yield. And, depending on the type of conveyor a facility has, a wet or dry lubrication system is required to both lubricate and sanitize the conveyor.

Working with an experienced cleaning and sanitation company can ensure that a company’s unique needs are covered. Working with the sanitation department to identify the hazards, a sanitation company will implement a customized program and routinely test to ensure you are meeting food safety standards. These results should be kept in your records as evidence your facility has taken preventative measures and taken steps to control the environment.


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This is an example of a farm record that will follow the commodity throughout the supply chain. Complete and secure.



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Cost effective FSMA Compliance: Recordkeeping, labeling and field barcoding applications

Why Should You Attend:

Recent federally-adopted rule mandates that FDA is able to detain for up to 30 days food products it believes may be adulterated or mis-branded. Such foods would be kept out of the marketplace until the agency determines whether there is a need for further enforcement actions, such as seizure or an injunction to prevent the suspect products from being distributed.

This webinar will discuss mitigate your risks of having detainment of or recall of products With proper record-keeping, labeling and barcoding applications. While these requirements mandate FDA’s action in the area of food safety, and despite the activity in this area, the Agency has had difficulty in adopting a final rule to date.

This session is designed for growers, shippers, carriers, packers, producers, retail grocers and wholesalers and it is focused towards helping both domestic and foreign entities in ensuring compliance with FDA regulations. The presenter will highlight FSMA, and offer solutions for all levels of the supply chain. She will share and highlight a solution that encompasses everything necessary to meet, 2002 Bio-Terrorism Law, Food Defense, Country of Origin, GAP’s, SSOP, HAACP, USDA-FSIS and EU trace back laws for all food handlers.

Areas Covered in the Webinar:

  • Brief overview of FSMA.
  • Highlighting law pertaining to recordkeeping documentation.
  • Choosing a system to properly document recordkeeping.
  • Why field label?
  • When choosing a barcoding system what to look for and why.
  • Regulatory status of FSMA as the law is currently written and timeline of FDA action
  • What FDA expects to gain with FSMA

Who Will Benefit:

Food manufacturers and facilities responsible for packaging/labeling food products will benefit from this training. Titles include:

  • Regulatory affairs
  • Food packaging suppliers and manufacturers
  • Labeling
  • Documentation
  • Food technologists
  • Food safety
  • Food inspectors
  • Marketing
  • QA/ QC
  • Growers
  • Shippers

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Does FSMA scare you? Is being compliant a daunting task?

FSMA Recordkeeping is needed now.

I have seen contracts where by signing you acknowledge your aware of The Food Safety Modernization Act.

Please ask questions and become informed. TrackMyCrop

For as little as $10 less than lunch out, you’re getting a database recordkeeping system that meets FDA compliance.

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Using ScoringAg’s unique SSI-EID traceback product codes, RFID codes, or 2-D barcodes printed on each clamshell or product, handlers at all levels of the distribution chain including buyers can learn about each product’s Country of Origin.

ScoringAg runs a web-based computer database system that offer’s all retailers access to extensive traceback records, pictures, and or video information for origin traceability, of individual item’s, clamshell’s, case’s, bins, containers, fruits, vegetables, meats, and all other grocery products and ingredients. This gives retailers Country of Origin (COOL) law compliance labeling, traceability, and consumer’s peace of mind with the speed of a mouse click to search for each unique SSI-EID item’s code that displays real time product data for required audit traceback.

Using ScoringAg’s unique SSI-EID traceback product codes, RFID codes, or 2-D barcodes printed on each clamshell or product, handlers at all levels of the distribution chain — including buyers — can learn about each product’s Country of Origin, certifications, good agricultural practices performed, and audits via a store or home computer or internet cell phone in real time. There is no need to wait for audit or certification information for traceability from producers or food chain suppliers and handlers as information can be recovered within seconds by each store. ScoringAg records enable wholesalers, retailers, restaurant chefs, and buyers to decide what country of origin, and quality of purchases they want. As the records can’t be falsified or changed once data is entered into the worldwide database, as there is documentation and a source verification of all movement and document records using the principals of the US . code 21 CFR part 11.

ScoringAg is the only worldwide standardized record keeping system where the records move with the product through its coded PIDC location and labeling code system.

HACPP, GAP’s, BMP’s, FDA Bio-Terrorism rules, field and handling audits, and other food safety quality control systems, helps conventional, natural, and organic grown products with all kinds of certifications, mostly at the producer, processor levels, but doesn’t prevent recalls as recent events have shown. Certifications, lot numbers, and branded labels do not provide an item level traceback of documents for products from shelves to the field or the original source production site in real time. Third party certification’s, BMP and GAP field audit’s with the ScoringAg’s audit trail verification record-keeping system has regained consumer confidence while providing full item level traceability in seconds to retailers no matter the number of mixed lots in produce bins.

Recalls if needed are site-specific, time-specific, handler-specific and item-specific as to not disrupt the total food chain supply as to what happened in the spinach, melon, and the latest meat and food product recalls. This record-keeping and database system allows all trade buyers to purchase anywhere with safety and to use the recall system anytime it’s deemed necessary. The web-based recordkeeping system can also archive records as equired by the COOL law by retailers for 1 year after the sale of all covered commodities sold within the regulatory requirements.

The industry does not need more food safety laws, government regulations and inspectors, what is needed is ScoringAg’s time stamped activity database with daily documentations by each food handler to prove compliance throughout all the complete food supply chain of activities, including transportation as built and provided by ScoringAg for COOL. The secure barcode and SSI-EID label system can be printed directly from the database in real time anywhere. Field stickers on product can be printed where ever product is located or handled using standard label printers whether RFID or not from plain sticker tape directly from the web-based database.

Having a traceback record keeping system in place provides traceback information within seconds by knowing the audit path of handlers whether from the initial production field or from commingling other fields or products in retailers display cases to the final package that the consumer buys. Food growers, buyers, importers, and processors with retailers will now face the toughest questions of food origin and quality, and their biggest challenges now is the Country of Origin Labeling requirements and renew loyalty in their customers food purchases by having full traceability to prove COOL on each packaged or loose product.

ScoringAg’s traceback and trace up system for all agriculture products, featuring Site-Specific Recordkeeping and PIDC location codes, is one of the many divisions of ScoringSystem, Inc., located in Bradenton , Florida USA . The company specializes in providing solutions with mobile data, via wireless PDA’s, laptops, and Semacode programmed internet ready Nokia, Siemens, and Sony Ericsson cell phones. SSI-EID Food code searches can be done thru these other web sites, Traceback.com and ScoringRestaurants.com to display product origin records and also directly from grocery store websites. ScoringAg.com and ScoringContainers.com makes managing data easier and does it in an extremely low cost effective manner.

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Listen to FDA officials on March 19, 2013 explaining, who is exempt or not for registration, handling, shipping, and packing:

Exemptions for which small farms
Exemptions by products
Exemptions on labeling
Exemptions for Tester users
Non exemptions for Farmers Markets
Non exemptions for roadside markets
Non exemptions for CSA’s
Non exemptions for grower/packers

ScoringAg, the industry partner for food safety, recordkeeping, sanitation, and complete traceback has the inexpensive solution for any size of operation. For small and midsize operations we have Recordkeeping solutions for FSMA for $100 or less.

The data can be stored and accessed as long as needed for many years on a secure 256-bit encrypted dedicated server. We are not using a Cloud data storage computing system, as there is no security and the information in the cloud is owned by the US Government.

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The Food and Drug Administration is asking for feedback on a food traceability report released on Monday. The 300-page report, which looks at two pilot projects that were mandated by the Food Safety Modernization Act, along with the comments the agency receives, will inform a future rule on recordkeeping requirements that could vastly improve traceability in the food chain.

The report, which involved numerous stakeholders, was crafted by the Institute of Food Technologists (IFT) over the past couple years. The organization conducted two pilot projects — one on tomatoes and one on chicken, peanut butter and spices used in processed food — designed to look at how food can be rapidly tracked and traced, what types of data are needed and how the data can be made available to FDA.

On top of being chock-full of information on food tracing, the IFT report also makes several recommendations to FDA. IFT suggests, among other things, that the agency establish a uniform set of recordkeeping requirements for all all FDA-regulated foods, with no exemptions based on risk, and that each member of the food supply be required to develop a product tracing plan. The document also calls on FDA to be more clear in communicating what it needs from industry to conduct food tracing investigations and says FDA should considering adopting a technology platform that would allow “efficient aggregation and analysis” of data submitted to FDA on request.

“We’re looking for input on where we should go with this information,” said Sherri McGarry, Senior Adviser to the CORE Network in the Office of Foods at FDA. McGarry noted that under FSMA, FDA is limited to requiring recordkeeping for high-risk foods, not all FDA-regulated foods. She said FDA would consider eventually issuing a guidance aimed at improving traceability for other low-risk foods not covered by the future rule.

McGarry said that the agency has high hopes for improving traceability in the coming years. With improved technology and recordkeeping and data requirements, the FDA could one day visualize food supply chains and actually see how they interconnect and overlap during a foodborne illness outbreak, enabling investigators to hone in on the problem quickly.

“[The report] is really encouraging,” said McGarry. “It gives us more specifics on what can be improved, both in the industry and at FDA.”

FDA requested the information to help the agency form its own recommendations on improving traceability, which it will ultimately offer in a Report to Congress, as mandated by FSMA.

“The produce industry has been looking forward to these traceability recommendations to make sure that we can move confidently with the traceability best practices that we have collectively developed in the [Produce Traceability Initiative],” said Mike Agostini, Senior Director of Produce at Wal-Mart Stores and co-chair of the PTI Leadership Council, in a statement on Monday. “Our industry community is excited to have the opportunity to delve into the details of the report and provide feedback to FDA.”

FDA invited those interested in submitting comments to do so over the next 30 days. To submit comments electronically, go to http://www.regulations.gov and enter docket number FDA-2012-N-1153.

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So began the letter to Sunland Inc. on November 26, 2012. Many groups have written about this topic already, however, I wanted to provide some thoughts on what this means to the rest of the food industry under FDA’s jurisdiction.
It began as a voluntary suspension of operations during the height of the recall, but when the facility decided to reopen its doors, FDA invoked its new FSMA authorities to keep them closed.
FDA’s first use of its new authority in the forced suspension of operations at the peanut-product manufacturing plant of Sunland Inc. is bringing to fruition the words that have been repeated for the last two years: Be prepared, and Don’t Wait. And now, despite the number of pending, unissued rules … the time has come. FDA is enforcing this impactful part of the Food Safety Modernization Act.
What food facilities should take critical note of is that, not only were FSMA provisions invoked to enforce the suspension itself (under Section 102), but several of the 483 Inspectional Observations and cited infractions related to various new FSMA requirements were noted in order to substantiate the suspension.
Some of these observations focused on several requirements under Section 103 Preventive Controls, including:
A lack of records to document the cleaning of the production and packaging lines after Salmonella was detected in peanut and nut butters between 2009 and 2012. We could give Sunland benefit of the doubt, and say the company may have done the required cleaning but just didn’t document it – or maybe it didn’t do it at all. Either way, in the eyes of the agency, if it isn’t documented, it didn’t happen. FSMA will require heightened record-keeping requirements which Sunland clearly did not keep. (Section 103)
Distribution of certain lots of peanut butter and nut butters that were positive for Salmonella per Sunland’s internal testing. One must question whether Sunland had, or used, a test-and-hold program. This citation would lead one to believe that no such practice was in place, because if it were, the contaminated products would have still been in Sunland’s control when the test results were in. If, on the other hand, Sunland really shipped product that they knew was positive for Salmonella and did not institute a recall, it will only be a matter of time before we hear about activity from the Office of Criminal Investigation at FDA and then possibly the Department of Justice.
Distribution of products in which Sunland tests detected allergens but did not label them as containing the peanut, almond, and soy. Again, perhaps the company had already distributed the products prior to receiving the test results … but if that’s the case, the company should have recalled those products due to undeclared allergens.
A lack of preventive food safety for employees, including inadequate hygiene and lack of hand-washing sinks in the production or packaging areas. This one is hard to extend any benefit of the doubt when employees were observed working bare-handed, where no hand-washing sinks were available.
A similar lack of preventive pest control practices was observed, with effective measures not being taken to exclude pests from the processing areas.
Storage of raw ingredients was not adequately controlled, allowing for birds to land on open bed trailers of exposed peanuts and for exposure to rain, providing an enhanced growth opportunity for Salmonella.
Finally, FDA concluded that there was reasonable probability that Sunland products “are contaminated with Salmonella, or are at risk for such, based on the conditions in your facility.”
If we stop and think about timing, I have speculated in the past that the first time FDA uses the
“Suspension of Registration,” authority it will be with a big bang. I think this situation proves me correct. However, I do wonder why FDA waited until the company was just about to re-open. That alone is indicative of the “Big Bang Theory” from the regulators.
The next very important lesson is that, according to the letter from FDA, Sunland did put a corrective action plan together, but the FDA did not like what they saw and thus suspended the facility’s registration. The critical lesson here is to work very closely with the regulators in response to situations like this. However closely the company and its consultants may think they worked with FDA, the response that the corrective plan was not adequate tells me that that they did not work closely enough.
With its history of recorded contamination, Sunland provides a strong example of the value of FDA’s new authority. Records showed that the company had placed contaminated product in the market since 2009. Prior to FSMA, however, FDA did not have authority to mandate a recall or suspend/revoke facility registration. In the past, it was the game of voluntary recall followed by FDA requested recall along with some ugly press, and finally the complex process of seizing products. But if FDA had had these authorities back in 2009, would the plant have been shut down long before – preventing the distribution of a great deal of contaminated product, and an unknown number of illnesses between then and now? It can be expected that the answer is probably yes – if the FDA had done the inspections on a regular basis. But that is something that requires the one thing FDA does not have, which is resources. This case demonstrates the importance of FSMA and the additional enforcement powers granted under it to FDA in order to better protect consumer health and safety.
Some may read the letter from the FDA Commissioner and the 483 and conclude that testing product gets you in trouble – so don’t test. I hope that FDA is vocal about this and points out that is not testing that gets you in trouble, it is testing and not reacting appropriately to the results that gets you in trouble.
I hate to say I told you so, but … If you haven’t been preparing for the record-keeping and preventive controls rules of FSMA over the last two years, be ready for the consequences if FDA shows up at your door. The specifics of the provisions have not been released, but it certainly appears that FDA is stepping up the consequences of being out of compliance. They have now stepped off first base with a suspension of registration and have achieved the big bang.
There are lessons in this for all of us to avoid getting a letter from the FDA Commissioner that starts with “The U.S. Food and Drug Administration (FDA) hereby suspends the registration for your food facility.” So let’s make the best of those lessons as we interpret the FDA actions, and, at the same time, urge FDA to be vocal about the expectations that they have, so we all benefit from these unfortunate situations.

Did you know…

In a November newsletter, we made a call to industry to pick up its role to educate consumers, citing the French GMO study that linked genetically modified corn to cancer was, at first, highly cited by the media, and then began being declaimed as fraud. Last week the European Union’s food safety agency (EFSA), definitively rejected the report, stating that it did not meet “acceptable scientific standards.” The agency’s assessment listed weaknesses of the study as “unclear study objectives, the low number of rates used in each treatment group, a lack of detail on the feed and treatment formulation, key information missing on the statistical methods employed.”

For more information about Leavitt Partners Global Food Safety Solutions, click here.

The U.S. Food and Drug Administration (FDA) hereby suspends the registration for your food facility… by David W. K. Acheson is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License.

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Q. Why are accurate record keeping and traceability programs critical?

A. If an operation can’t demonstrate, through record keeping, that they’ve done all the right things and complied with their own food safety plan, then they won’t be able to defend themselves if someone alleges that their product was contaminated or, worse, caused an illness. For most companies, 99.99% of the food safety records they keep will probably never be reviewed again. But for that one lot where it really matters, having the records might save them from a very expensive recall.

Another important point: Don’t bother keeping records unless they are kept consistently and they are accurate. If there is any indication that any of the records may not be complete or accurate, none of the records will be believed.

Record keeping is something that growers and handlers have not done enough of, so it will be more work and take more time than they are doing today. But record keeping does not have to be burdensome. Understand what is important to record and find ways to record, retain, and be able to access that information accurately and simply.

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by David Acheson on May 24, 2012 in Food Safety FDA would like food/feed facilities to voluntarily submit additional profile information through the Food Facility Registration Module – and wants to know what you think.

In a Federal Register Notice, FDA announced the opportunity for public comment on the information collection provisions of FDA’s program of voluntary submission of food facility profile information and new electronic form (FDA 3797).

The voluntary profile information is intended to help FDA determine whether a firm is high-risk or non-high-risk, and, from that, determine the frequency at which the firm would be inspected. Additionally, FDA noted that submission would benefit a food facility by enabling FDA to prepare for an inspection in advance “through interaction with better-informed investigators and potentially reduced inspection time.”

Firms will be offered the opportunity to complete or update a food/feed facility profile after electronic registration with FDA and anytime they access the Food Facility Registration Module. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States may also submit or update information at any time through a direct URL (to be provided by FDA).

The proposed information, to be submitted in English only, includes:

the facility type (e.g., manufacturer/processor, repacker/ packer, or warehouse/holding facility); the products and hazards (e.g., biological, physical, chemical) and preventive control measures associated with those products, where either there is a regulation in place requiring identification of hazards and preventive control measures (e.g., seafood and juice), or the firm, as a matter of its own business practices, voluntarily identifies hazards and implements preventive control measures; other facility information (such as food safety training, facility size, operational schedule, and number of employees).

Assuming that approximately half the registering firms will choose to provide profile information, FDA estimates annual submission of 6,780 domestic and 11,685 foreign firms. Information submission is estimated to take about 15 minutes by an average domestic facility and 45 minutes by a foreign facility (taking into account a potential lack of fluency in English.) In 2011, the Food Safety Modernization Act (Section 102) added to the mandated food facility information, requiring that registrations contain the facility/U.S. agent contact e-mail address and an assurance that FDA would be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Additionally, if determined necessary by FDA, registrations are required to contain information regarding other applicable food categories, as determined appropriate by FDA, for foods manufactured/processed, packed, or held at registering facilities.

FSMA also added a renewal clause, requiring that all facilities renew their registrations between Oct. 1 and Dec. 31 of each even-numbered year, beginning this year. With comments on the voluntary profile submission proposal due by July 10, its timing is undoubtedly due to this upcoming renewal period.

While the request and voluntary aspect of the proposal seems fairly straight forward, it does bring to mind a few questions, specifically that since the form is voluntary, how will the information be evaluated? Will it move a facility that supplies information to a better spot – ostensibly penalizing those who do not fill it out? Or might a facility put itself in the cross hairs based on its responses?

Will the input data be electronically analyzed or will a person review it? Because the forms include the naming of hazards and preventive controls, it seems that it must be subject to some sort of human evaluation – which raises a few more questions in and of itself, including the availability of resources to do so.

And, while FDA states that it expects only half of those registering to complete the profile information, does it actually see the voluntary aspect as a precursor or trial to mandated submission of profile information?

Comment can be submitted electronically or by mail (Division of Dockets Management/HFA-305, Food and Drug Administration,5630 Fishers Lane, Rm. 1061,Rockville,MD20852). All comments should be identified with the docket number FDA-2012-N-0430. Comment is due by July 10, 2012.

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