Illness, OUTBREAK, Death, RECALL???

Illness, OUTBREAK, Death, RECALL???.

Illness, OUTBREAK, Death, RECALL???

Illness, OUTBREAK, Death, RECALL

Why do we see these words in headlines?

Are producers, packers, shippers and stores doing the best they can to ensure a safe reliable food supply to the consumer?

I just got done reading a whitepaper, headline “When does a cantaloupe cost $55.53?”

The paper was written to highlight the risks taken when people do not follow processes that are in place.  At the end of the day a person dying from complications of eating a cantaloupe are not worth the risk.

Suppose you were able to isolate a product all the way back to 10 feet of where the harvest occurred… would it be a better process for the consumer?  With the technology available today, it simply is not worth the risk of labeling a pallet of goods or products when you can label each item in the box.  With the technology available from Advanced Traceability Solutions, you’re able to choose how to limit your risk.

Why would you do this?  This process allows you to limit your risk and protect your brand name.  Consumers are the ONLY reason you have a brand.  If the consumer loses confidence in your product, it could ruin your business and cripple your industry.

At the root of the compliance requirements are simple checklists and inspections. In sophisticated systems, at high cost, a lot of the data collection is automated. However, the standards and requirements for ISO, SQF, OSHA, FDA and others have a footprint way beyond the scope of these automated systems. Those areas, such as simple safety, sanitation, and security inspections are ‘blind spots’ for those systems and are typically addressed with paper documentation.

Convergence has created the opportunity to address many of these ‘blind spot’ requirements currently ineffectually met by paper based ‘systems’. The paper-based system is faulty at best, costs an inordinate amount to maintain, and its veracity is easily faulted, negating its very purpose – reducing cost, improving visibility for management and above all reducing risk.  I what every business should be doing.

Why use paper when the cost is as high as $0.85 per piece of paper?  That means a filing cabinet with four drawers will cost about $25,000 to fill and that isn’t the cost involved when a paper or report is misfiled or missing completely.

Moving to electronic recordkeeping is cost effective and efficient.  Keeping records is essential to every business how you keep them and minimize cost is up to you.

Advanced Traceability Solutions

Advanced Traceability Solutions.

Advanced Traceability Solutions

Advanced Traceability Solutions

Recalls expand for River Ranch.

Today River Ranch has expanded recall to National Levels and multiple products.

While this isn’t a surprise it is concerning.

The voluntary recall by the Salinas, Calif. based grower initially included lettuce shipped to California and Colorado. The bagged salads are sold under the names River Ranch, Farm Stand, Hy-Vee, Marketside, Shurfresh, The Farmer’s Market, Cross Valley, Fresh n Easy, Promark and Sysco.

The recalled retail and food service salad bags have “best by” dates between May 12 and May 29 or Julian dates of 118 and 125. The code date is typically located in the upper right hand corner of the bags.

A full list of recalled retail salad bags can be found here, and a full list of recalled food service bags can be accessed here.

Consumers with questions can contact River Ranch 24-hours per day at 1-800-762-7708.

Symptoms of Listeria infection, or listeriosis, include high fever, diarrhea, headache, convulsions and neck stiffness. Older adults, pregnant women, and people with a weakened immune system are considered high-risk for the infection. Unlike many pathogens, Listeria monocytogenes bacteria can grow at room temperatures or refrigerator temperatures, and can linger long after the source of the contamination is gone.

How does someone get listeriosis?

You get listeriosis by eating food contaminated with Listeria monocytogenes. Babies can be born with listeriosis if their mothers eat contaminated food during pregnancy. However, healthy persons may consume contaminated foods without becoming ill. Persons at risk can prevent listeriosis by avoiding certain high-risk foods and by handling and storing food properly.

Listeria monocytogenes is commonly found in soil and water. Animals can carry the bacterium without appearing ill and can contaminate foods of animal origin, such as meats and dairy products.

Most human infections follow consumption of contaminated food. Rare cases of nosocomial transmission have been reported.

When Listeria bacteria get into a food processing factory, they can live there for years, sometimes contaminating food products. The bacterium has been found in a variety of raw foods, such as uncooked meats and vegetables, as well as in foods that become contaminated after cooking or processing, such as soft cheeses, processed meats such as hot dogs and deli meat (both products in factory-sealed packages and products sold at deli counters), and smoked seafood. Unpasteurized (raw) milk and cheeses and other foods made from unpasteurized milk are particularly likely to contain the bacterium.

Listeria is killed by pasteurization and cooking; however, in some ready-to-eat foods, such as hot dogs and deli meats, contamination may occur after factory cooking but before packaging. Unlike most bacteria, Listeria can grow and multiply in some foods in the refrigerator.  This is what we are seeing in the River Ranch case.  NOTE River Ranch discovered this in routine testing of product. 

When will the food processing industry change to a test and ship mentality vs. ship and pray as it is now?

Until that time arrives using a data collection, consolidation and organization system is vital.  Advanced Traceability Solution specializes in knowing who received product and when.  This is vital to saving lives, time and resources.

Food litigation is the new tobacco

Three days in Washington at the 2012 Food Safety Summit had us scouring the exhibition floor for innovations, innovators and food safety news worth spreading, and taking in as many workshop sessions as possible. 

A standout was a panel of lawyers presenting on “How To Protect Your Company with an Effective Food Liability Program.”

“Food litigation is the new tobacco,” said Joseph Fasi, one of the speakers. “Litigation is starting to explode,” he continued, “and lawyers can smell the money. They’ll be digging through your records for gold nuggets.”

Which was why there was considerable discussion about how recordkeeping has the potential to bury a company or save its life.

Emails are forever, so negative off-the-cuff comments about the quality of a company’s safety responsibilities is verboten. Communications showing that a company has undertaken only a minimum level of preventative controls will be taken to mean that it doesn’t care adequately about food safety.

Litigation lawyers and their teams will pounce on any comments showing a culture of callousness or admonishments for ineptitude or any expression of employee disregard. Any statements making reference to trimming costs is particularly dangerous.

Conversely, what you don’t say is as important as what you do say. If your company has taken extra preventative or regulatory-sanctioned activities, you should say so in your communications.

The other subject that sent some chills down the spines of company representatives in the audience was the warning that, if a company has been hit with damages for a food safety issue where the culprit was an imported product or ingredient, the company should not expect to recoup damages from the exporter, because the exporter may not have sufficient assets.

In a case where the exporter does have the resources, jurisdiction could be a hindrance. An exporter could refuse to pay because the other country doesn’t recognize the verdict.

A domestic company is ultimately responsible for all imported food. “A company wants the right to decide the rigour of certification based on risk,” summarized Fasi.

 

Tina Brillinger, President

Global Food Safety Resource

 

HOW YOU KEEP RECORDS IS VITAL.  ELECTRONIC RECORDKEEPING IS SAFE AND SECURE.

What system are you using?

How Processors are Affected by the FSMA

The passage of the FSMA has ushered in a new era of oversight in the food industry. Processors will be required to develop comprehensive written food safety plans that document their facilities’ preventive controls. The main requirements are as follows:

• Programs are in place to ensure food is produced safely.
• Hazard analyses identify all potential risks throughout all processing steps.
• Preventive controls are implemented to mitigate risks.
• These controls are monitored to ensure they are properly implemented.
• The controls have been analyzed to verify they achieve the intended
reduction in risk.
• The hazards and preventive controls are re-analyzed whenever there are
significant changes to the process, or at least every three years.

While the FDA has not yet determined how the new requirements will be implemented, leading food processors have already begun improving their food safety plans and controls. They are making use of Hazard Analysis and Critical Control Point (HACCP) programs, current good manufacturing practices, and systems technologies that ensure the accuracy and accessibility of data and documentation.

As the industry shifts focus from reacting to food safety issues to preventing them in the first place, processors that proactively introduce improved safety plans and programs will not only survive, but thrive.

Overall Approach to Part 11 Requirements

Narrow Interpretation of Scope
We understand that there is some confusion about the scope of part 11. Some have understood the scope of part 11 to be very broad. We believe that some of those broad interpretations could lead to unnecessary controls and costs and could discourage innovation and technological advances without providing added benefit to the public health. As a result, we want to clarify that the Agency intends to interpret the scope of part 11 narrowly.
Under the narrow interpretation of the scope of part 11, with respect to records required to be maintained under predicate rules or submitted to FDA, when persons choose to use records in electronic format in place of paper format, part 11 would apply. On the other hand, when persons use computers to generate paper printouts of electronic records, and those paper records meet all the requirements of the applicable predicate rules and persons rely on the paper records to perform their regulated activities, FDA would generally not consider persons to be “using electronic records in lieu of paper records” under §§ 11.2(a) and 11.2(b). In these instances, the use of computer systems in the generation of paper records would not trigger part 11.
Definition of Part 11 Records
Under this narrow interpretation, FDA considers part 11 to be applicable to the following records or signatures in electronic format (part 11 records or signatures):
Records that are required to be maintained under predicate rule requirements and that are maintained in electronic format in place of paper format. On the other hand, records (and any associated signatures) that are not required to be retained under predicate rules, but that are nonetheless maintained in electronic format, are not part 11 records.
We recommend that you determine, based on the predicate rules, whether specific records are part 11 records. We recommend that you document such decisions.
Records that are required to be maintained under predicate rules, that are maintained in electronic format in addition to paper format, and that are relied on to perform regulated activities.
In some cases, actual business practices may dictate whether you are using electronic records instead of paper records under § 11.2(a). For example, if a record is required to be maintained under a predicate rule and you use a computer to generate a paper printout of the electronic records, but you nonetheless rely on the electronic record to perform regulated activities, the Agency may consider you to be using the electronic record instead of the paper record. That is, the Agency may take your business practices into account in determining whether part 11 applies.
Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities. We recommend that you document this decision (e.g., in a Standard Operating Procedure (SOP), or specification document).
Records submitted to FDA, under predicate rules (even if such records are not specifically identified in Agency regulations) in electronic format (assuming the records have been identified in docket number 92S-0251 as the types of submissions the Agency accepts in electronic format). However, a record that is not itself submitted, but is used in generating a submission, is not a part 11 record unless it is otherwise required to be maintained under a predicate rule and it is maintained in electronic format.
Electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signings required by predicate rules. Part 11 signatures include electronic signatures that are used, for example, to document the fact that certain events or actions occurred in accordance with the predicate rule (e.g. approved, reviewed, and verified).

Approach to Specific Part 11 Requirements
Validation
The Agency intends to exercise enforcement discretion regarding specific part 11 requirements for validation of computerized systems (§ 11.10(a) and corresponding requirements in § 11.30). Although persons must still comply with all applicable predicate rule requirements for validation (e.g., 21 CFR 820.70(i)), this guidance should not be read to impose any additional requirements for validation.
We suggest that your decision to validate computerized systems, and the extent of the validation, take into account the impact the systems have on your ability to meet predicate rule requirements. You should also consider the impact those systems might have on the accuracy, reliability, integrity, availability, and authenticity of required records and signatures. Even if there is no predicate rule requirement to validate a system, in some instances it may still be important to validate the system.
We recommend that you base your approach on a justified and documented risk assessment and a determination of the potential of the system to affect product quality and safety, and record integrity. For instance, validation would not be important for a word processor used only to generate SOPs.
For further guidance on validation of computerized systems, see FDA’s guidance for industry and FDA staff General Principles of Software Validation and also industry guidance such as the GAMP 4 Guide (See References).
Audit Trail
The Agency intends to exercise enforcement discretion regarding specific part 11 requirements related to computer-generated, time-stamped audit trails (§ 11.10 (e), (k)(2) and any corresponding requirement in §11.30). Persons must still comply with all applicable predicate rule requirements related to documentation of, for example, date (e.g., § 58.130(e)), time, or sequencing of events, as well as any requirements for ensuring that changes to records do not obscure previous entries.
Even if there are no predicate rule requirements to document, for example, date, time, or sequence of events in a particular instance, it may nonetheless be important to have audit trails or other physical, logical, or procedural security measures in place to ensure the trustworthiness and reliability of the records.6 We recommend that you base your decision on whether to apply audit trails, or other appropriate measures, on the need to comply with predicate rule requirements, a justified and documented risk assessment, and a determination of the potential effect on product quality and safety and record integrity. We suggest that you apply appropriate controls based on such an assessment. Audit trails can be particularly appropriate when users are expected to create, modify, or delete regulated records during normal operation.
Legacy Systems7
The Agency intends to exercise enforcement discretion with respect to all part 11 requirements for systems that otherwise were operational prior to August 20, 1997, the effective date of part 11, under the circumstances specified below.
This means that the Agency does not intend to take enforcement action to enforce compliance with any part 11 requirements if all the following criteria are met for a specific system:
The system was operational before the effective date.
The system met all applicable predicate rule requirements before the effective date.
The system currently meets all applicable predicate rule requirements.
You have documented evidence and justification that the system is fit for its intended use (including having an acceptable level of record security and integrity, if applicable).
If a system has been changed since August 20, 1997, and if the changes would prevent the system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 records and signatures pursuant to the enforcement policy expressed in this guidance.
Copies of Records
The Agency intends to exercise enforcement discretion with regard to specific part 11 requirements for generating copies of records (§ 11.10 (b) and any corresponding requirement in §11.30). You should provide an investigator with reasonable and useful access to records during an inspection. All records held by you are subject to inspection in accordance with predicate rules (e.g., §§ 211.180(c), (d), and 108.35(c)(3)(ii)).
We recommend that you supply copies of electronic records by:
Producing copies of records held in common portable formats when records are maintained in these formats
Using established automated conversion or export methods, where available, to make copies in a more common format (examples of such formats include, but are not limited to, PDF, XML, or SGML)
In each case, we recommend that the copying process used produces copies that preserve the content and meaning of the record. If you have the ability to search, sort, or trend part 11 records, copies given to the Agency should provide the same capability if it is reasonable and technically feasible. You should allow inspection, review, and copying of records in a human readable form at your site using your hardware and following your established procedures and techniques for accessing records.
Record Retention
The Agency intends to exercise enforcement discretion with regard to the part 11 requirements for the protection of records to enable their accurate and ready retrieval throughout the records retention period (§ 11.10 (c) and any corresponding requirement in §11.30). Persons must still comply with all applicable predicate rule requirements for record retention and availability (e.g., §§ 211.180(c),(d), 108.25(g), and 108.35(h)).
We suggest that your decision on how to maintain records be based on predicate rule requirements and that you base your decision on a justified and documented risk assessment and a determination of the value of the records over time.
FDA does not intend to object if you decide to archive required records in electronic format to nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file format (examples of such formats include, but are not limited to, PDF, XML, or SGML). Persons must still comply with all predicate rule requirements, and the records themselves and any copies of the required records should preserve their content and meaning. As long as predicate rule requirements are fully satisfied and the content and meaning of the records are preserved and archived, you can delete the electronic version of the records. In addition, paper and electronic record and signature components can co-exist (i.e., a hybrid8 situation) as long as predicate rule requirements are met and the content and meaning of those records are preserved.