Monday, October 30, 2017

Today’s Inspection and Audit Reality: The New Normal

Industry’s “new reality” for inspection and audit readiness pivots on evolving its programs based on the expectations of today’s – and tomorrow’s – inspectors, auditors and customers alike.

Food industry inspection and audit protocols are evolving at a rapid pace, and rightly so. This is not surprising given today’s regulatory, audit and ever-changing risk landscapes, which are driving further complexity and expansion of requirements to ensure the industry is, “audit ready, all the time.”

This evolution of inspections and audits has been primarily triggered by newer regulations such as FSMA and private standards, such as GFSI and its certification programme owners (CPO’s, fka Scheme Owners) like SQF, BRC, FSSC 22000, IFS, etc. Heightened customer demand and consumer visibility into food safety incidents –many thanks to mainstream and social media– and the resulting increased demand for information has also fueled this evolution, compelling industry to focus on higher levels of transparency, both internally and throughout the supply chain.

The changes above are driving the food industry to face a new reality. One where the following questions continue to rise to the surface:

  • How have “yesterday’s” inspection and audit expectations changed from what companies are experiencing today?
  • Based on this evolution, how will “tomorrow’s” inspection and audit expectations change?
  • In short, what does the new reality or the “new normal” look like now for inspection and audit readiness?

We will take a look at what some of the first inspections are shaping up to look like under the Preventive Controls for Human Food (PCHF) Rule and the Foreign Supplier Verification Program (FSVP) Rule. Some common themes and some tips to successfully manage regulatory inspections as well as audit readiness tips are set forth below.

More Inspectors
Roll out the welcome mat because more inspectors are coming to the party. We are seeing an average of three to upwards of six regulatory inspectors performing the inspections under the PCHF rule. This may cause an initial shock wave but when you stop to consider the rationale it has a certain level of reasonableness to it. Industry has invested in its personnel for nearly two years in updated training to meet new FSMA regulations such as preventive controls qualified individual (PCQI) training, updated current GMP training and perhaps qualified auditor training, if applicable. It makes sense that FDA needs to make a similar investment in its people to ensure its inspectors are prepared to knowledgeably perform FSMA-related inspections.

FDA has implemented a robust training program for its inspectors. Regarding PCHF inspections for example, only inspectors who have successfully completed the PCQI training plus FDA’s internal training will lead other inspectors through the facility inspections as an in-field training exercise. So, the good news is at least one inspector is fully trained under FDA’s training program standards. This said, with more inspectors, there are more eyes, and with more eyes, more opportunities to see risk through different perspectives. It’s best to be on your game, with a tested playbook so you have confidence you are prepared when the team of inspectors arrive at your facility. Conduct a mock inspection against your policies, procedures and food safety plan that have been updated for the new PCHF and other applicable FSMA requirements. You will be thankful you did.

Digging Deeper
Into Records: FSMA and the seven rules that comprise it requires more controls, monitoring and verification activities by the food industry, thus naturally giving inspectors more records to access and review. Further, FDA received expanded records access authority upon the signing of FSMA. FSMA allows FDA to access records relating to articles of food for which there is a reasonable probability that the use of, or exposure to, the article of food will cause serious adverse health consequences or death to humans or animals. Before FSMA the standard FDA had to meet to access records was “credible evidence”; now its “reasonable probability”—a standard that is far lower and subjective—allowing access to more types of records than before. Another new addition is FDA now may access records beyond those relating to the specific suspect food if the agency reasonably believes that other food articles are likely to be affected in a similar manner.

Example: If you have a potential problem on production line 1, and you firmly believe the issue is contained to line 1, but that line is in even arguably close physical proximity to line 2, depending on the issue an inspector may invoke this new authority and ask for all records associated with line 2 in addition to line 1 for the same time period to be sure that the situation indeed did not spread or otherwise impact line 2. (e.g. confirm no risk for cross contamination or allergen cross-contact).

This should not mean it’s open season on all your records, but it certainly means more records are open to review and scrutiny, so having a robust record retention and management system becomes mission-critical. How sound is yours? Record-keeping and document management have long been important to GFSI / CPO’s. However, many food companies do not have a certification from one of these entities, which begs the question whether the scope of your third-party audit, or that of a supplier you are currently evaluating for approval, adequately evaluates this important area.

Into your Hazard Analysis: Inspectors are spending significant time reviewing the adequacy of the hazard analysis performed as part of the requirement of the food safety plan under the PCHF Rule and as part of the foreign supplier verification plan requirement under the FSVP rule. If facilities do not identify all the hazards of concern that require a preventive control associated with their facility and foods they produce, then the rest of the food safety plan falls apart. If you work with peanuts to produce peanut butter and identify Salmonella as a hazard requiring a preventive control but not aflatoxin or peanut allergen you have likely missed the mark.You may not have the appropriate preventive controls, monitoring, verification activities, validations and corrective actions identified in your hazard analysis and food safety plan to control for the most significant hazards your facility / the finished food is facing from a food safety risk perspective. (note the identification of hazards requiring preventive controls is highly dependent on the food, facility, processing methods of the manufacturer, upstream supplier and will vary if products are RTE or nRTE)

How are auditors tackling this issue? Many third-party audit firms have invested in providing PCQI training for its auditors so they are better prepared to evaluate the sufficiency or gaps in the hazard analysis. It is a good idea to ask your audit firm what updated skills and training have been given to its auditors to ensure you are getting the assistance you need.

Lasting Longer:
It makes a certain amount of sense that inspections would take longer to conduct and complete since there are more inspectors accessing and reviewing more records than pre-FSMA.§117.190 of the PCHF Rule alone contains a laundry list of implementation records required to meet only the risk-based preventive controls requirements of subpart C (the food safety plan requirements). These records include:

  • Documentation identifying the hazards requiring one or more preventive controls
  • Documentation for not establishing a preventive control
  • Records that document monitoring preventive controls
  • Records that document corrective actions
  • Records that document verification, as applicable, including:
  • Validation
  • Verification of monitoring
  • Verification of corrective actions
  • Calibration of process monitoring and verification instruments
  • Product testing
  • Environmental monitoring
  • Records review
  • Reanalysis
  • Records that document the supply chain program
  • Records that document training for PCQI and the qualified auditor

There are other record requirements relating to other sections of this rule, (e.g. if a facility meets Modified Requirements or Qualified Facility requirements, and subpart F relating to how records must be kept, who must sign, how long they must be retained, etc.).

Needless to say by reviewing the above list, record and document management will be key in today and tomorrow’s inspection and audit reality, in order to produce requested documents quickly, accurately and in compliance with regulations and customer expectations (lets not forget the 24 hour reporting requirement of the Reportable Food Registry (RFR) and increasing contractual requirements by customers, particularly in private label situations, where 2-4 hours is the “new normal” to report to a private label customer if a co-manufacturing facility may have a suspect or actual food safety incident at hand). For those still on manual/paper-based systems, now may be the time to consider technology as a means for managing risk.

Leveraging Technology:
Even the FDA is embracing technology folks (and no, this isn’t meant to be a slam, but rather a statement of fact). Case in point, although the first inspections are being conducted onsite for training purposes, inspections under the FSVP (Foreign Supplier Verification Rule) are intended to move to virtual inspections where relevant documents subject to inspection are requested via email by FDA and transmitted electronically from the FSVP food importer. Another example is the RFR, which requires the reporting of a “reportable food” to an online portal within 24 hours upon meeting certain criteria. If the government can embrace technology why does industry seem a bit slow to the party?

Some companies have done a stellar job of embracing this 21st century technological evolution, or as some may describe, revolution, in which we now live and work. Others, I am sorry to report, are woefully behind in leveraging technology to manage risk. GFSI recently released its new version 7.1 with new and modified standards. For example, V7.1 adds a couple of new clauses for each scope under Food Safety Management Requirements, such as purchasing from non-approved suppliers. The ripple effect is the CPO’s are in turn updating and releasing new versions of their own respective private standards. Layer on FSMA and the seven new rules that comprise it, which includes expanded records access authority by the agency, and companies are facing an exponential increase in the number of records to manage.

Simply put, it is becoming progressively more difficult to manage all required records and documentation in a paper-based system. As a result, more companies are evaluating software systems that can help manage key supply chain, production, traceability and distribution data so they can put their finger on the pulse of information when auditors and inspectors request information. Wise choice.

Not only should an electronic document management system help with speed to identify and access documents -it should also help with data trending (to the extent applicable). For example, if you are storing PC/CCP monitoring data on oven cooking temperatures, can the electronic system track and trend the data captured so that it can alert designated users when a PC/CCP goes out of limits? The best systems can, and the best-in-class companies are finding ways to reduce the human error factor by leveraging technology to better manage their risks and transforming the data into information through dashboards and trending reports so they can see where deviations or near misses may be arising. Yes, technology involves a capex request. But the ROI is almost always cheaper than a recall and certainly is less costly than the brand reputation damage that could result.

Considering Culture:
How strong is your food safety culture? How polished are your internal team’s “soft skills?” Be prepared to jump on the collaboration train with FDA—the paradigm is shifting from FDA acting as the “police” to becoming a “partner”. Specifically, FDA is taking initiative to learn more about food safety culture- a topic growing in importance to industry and one FDA historically had not fully understood or placed inspection metrics around. Public-private partnerships have formed including conference calls with FDA and industry to learn more about how industry is assessing and implementing food safety culture, as well as discussions with CPO’s to understand how these private standards are measuring this emerging topic. The net takeaway is that FDA is now looking at and assessing your food safety culture.

How is it being used? Food safety culture is factored into the scope of preventive controls inspections, according to Joann Givens, deputy regional food and drug director with the FDA, during a speech given at the Process Expo conference in September 2017. Further, Givens says regulators are receiving soft skills training to better interact with industry to create a spirit of collaboration and partnership. This level of training investment at the agency level clearly conveys the importance of providing the same type of training to industry– to ensure that we aren’t the ones with the poor “bedside” manner and poor interpersonal skills when FDA shows up on our doorsteps, and to ensure we are continuously striving to mature our food safety cultures.

Final Thoughts:
The “new reality” is that industry’s preparation for inspections and audits needs to evolve based on the expectations of today’s – and tomorrow’s – inspectors, auditors and customers alike. FDA is learning along-side industry during this first year or so of PCHF and FSVP inspections. Some may be skeptical of the FDA mantra “educate before and while we regulate”. However, it does appear through some of the first inspections that this is truly a mantra that is being embraced by the agency, and as such, industry is encouraged to work collaboratively and openly with the agency in this spirit of learning and collective mission of protecting public health and safety. It is a unique time of evolution and transformation in the food industry. Every player in the supply chain must find ways to transform to a new reality wherever they may be in the supply chain, and define a new normal to keep up with this evolution, or risk the cruel reality of being left behind as a memory of yesterday.

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Friday, October 27, 2017

Final Available Class for 2017

GFCP Gluten Free Certification Program
November 6th, 2017 Dallas, TX


SQFI in conjunction with the Allergen Control Group (ACG) is pleased to provide an opportunity for interested auditors to achieve approved auditor certification at the SQF Conference

The Gluten-Free Certification Program (GFCP) is a management system and facility certification used by ingredient and processing manufacturers to demonstrate their commitment to the implementation of responsible practices, related to the safe and reliable production of gluten-free foods.

GFCP is endorsed by the Beyond Celiac (formerly the National Foundation for Celiac Awareness) in the USA and the Canadian Celiac Association. GFCP standard is an incremental core set of fundamental operating requirements that provide a facility with the preventative gluten management systems needed to demonstrate a commitment to gluten controls and social compliance. Successfully, implementing these requirements ensures the facility have the tools in place to meet or exceed regulatory outcomes and avoid dependency on random end-product testing.

Course Description:
The objective of this course is to provide the food industry and internal auditors with the knowledge about the ANAB Accredited Gluten-Free Certification Program, Standard Policies and Procedures, as a necessary step for a facility to successfully complete a third-party audit. The course is based on the auditing methodology documented in ISO 17021 and the technical skills necessary to train and implement the GFCP standards. A Certificate of Attendance will be issued indicating the participant has completed GFCP Industry Training as one of the competencies recommended to acquire a GFCP Certificate of Recognition for the facility and or becoming an approved GFCP auditor. Retailers, consultants and supplier organizations are also welcome to attend this training, to learn about the GFCP Standard and how the auditor will audit in the standard.

Although there are no set requirements to sit for this course, there are specific pre-requisite competencies in order to become a certified GFCP approved auditor.

The goals of this one-day course are:
Gain a clear understanding of the GFCP standard.
Comprehend the requirements to be an approved GFCP internal or third-party Auditor
Learn the GFCP Standard Certification Assessment Requirements

Oscar Camacho, President Superior Food Safety Inc., SQF License Training Center & SQF Certified Consultant – High Risk and SQF Certified Trainer
Paul Valder, President, Allergen Control Group Inc.

Date: Monday, November 6, 2017
Time: 7:00 am – 5:00 pm
Cost: USD $375.00 per person (includes course materials and lunch)

Tuesday, October 24, 2017

On-site PRIVATE classes in English & Spanish and Consulting Services


  • HACCP Workshop
  • Implementing SQF Training - Version 8.0 - English and Spanish
  • FSMA Preventive Controls for Human Foods
  • FSPCA For Human Food Compliance
  • Produce Safety Rule Training Official Program
  • SQF Quality Systems For Food Manufacturers
  • Internal and External GFSI Audits
  • Crisis Management
  • Gluten Free Certification Program
  • SQF Advance Practitioner Course
  • Prerequisite Programs


  • Food Safety Consulting Services

Please visit our website or send us an email for more information!

Saturday, October 21, 2017

Superior Food Safety Training Classes

  • HACCP Workshop
  • Implementing SQF Training - Version 8.0 - English and Spanish
  • FSMA Preventive Controls for Human Foods
  • FSPCA For Human Food Compliance
  • Produce Safety Rule Training Official Program
  • SQF Quality Systems For Food Manufacturers
  • Internal and External GFSI Audits
  • Crisis Management
  • Gluten Free Certification Program
  • SQF Advance Practitioner Course
  • Prerequisite Programs

Food Safety Consulting Services

Please visit our website or send us an email for more information!

Sunday, October 15, 2017

Napa Valley Grape Harvest

Each year at the end of summer, the Napa Valley comes alive with the excitement and rush of harvest. After months of careful nurturing and observation, winemakers all over the valley finally give the word, "it's time."

The Stages Of Harvest In Napa Valley

Grapes for sparkling wines are the first to be picked, usually in early August, marking the start of "crush". Next, most of the white wines make their way from the vineyard to the crush pad.

Harvest continues through late October - sometimes early November - for red varieties, as they take a bit longer to reach full maturation. Harvesting of Cabernet Sauvignon grapes in the Napa Valley begins later than most other varieties and typically lasts the longest.

Late-harvest wines are made from grapes left on the vine longer than usual, allowing them to get riper and produce more highly concentrated sugars. Harvesting of these grapes can last until December.

To learn more and for a list of Harvest Parties and Interactive Harvest experiences please visit this link:

Thursday, October 12, 2017

SQF Quality Systems For Manufacturers

If you want to better understand the benefit of implementing quality systems in your Food processing facility, I invite you to read this article.

Many times companies take into consideration pricing factor without considering the pros and cons of low cost vs. high, or sub-contracting labor overseas vs. domestically.

At Superior Food Safety we find the implementation of effective quality systems in the USA food industry as one of the biggest opportunities to reduce waste and impact the bottom line and cash flow. An effective quality system focuses on compliance with finished product specifications while reducing all kinds of waste such as product, labor, excess of inventory, downtime and loss of opportunity among others.

The SQF Quality Systems for Manufacturers Edition 8.0 training will equip you with the tools you need to learn in order to put in place controls to track and reduce waste and improve your operations as a result.

Monday, October 9, 2017

FDA Extends Nutrition Facts Deadline

The FDA today (Sept. 29) announced a delay in the implementation date for the new Nutrition Facts panel, from July 26, 2018, to Jan. 1, 2020, for food processors with $10 million or more in annual food sales. Manufacturers with less than $10 million in sales have an extra year to comply — until Jan. 1, 2021.

The extension has been rumored for a while, as the Trump administration has been revisiting many "burdensome" rules imposed by the previous administration. There also remain some key vacancies at FDA and USDA, necessitating some delays.

The delay also involves the final rules (and implementation dates) for Supplement Facts and Serving Size.

Back in May of 2016, the FDA announced the new Nutrition Facts label for packaged foods to reflect new scientific information, including the link between diet and chronic diseases such as obesity and heart disease. "The new label will make it easier for consumers to make better informed food choices," the agency said at the time. That gave the food industry two years to prepare for the changes.

The biggest changes were calling out added sugars, increasing many serving sizes and making calories bigger and bolder. "After those rules were finalized, industry and consumer groups provided the FDA with feedback regarding the compliance dates," the agency wrote today. "After careful consideration, the FDA determined that additional time would provide manufacturers covered by the rule with necessary guidance from FDA, and would help them be able to complete and print updated nutrition facts panels for their products before they are expected to be in compliance.

"As a result, the FDA intends to extend the compliance dates to provide the additional time for implementation. The framework for the extension will be guided by the desire to give industry more time and decrease costs, balanced with the importance of minimizing the transition period during which consumers will see both the old and the new versions of the label in the marketplace."

Article Source:

Superior Food Safety Training Classes

  • HACCP Workshop
  • Implementing SQF Training - Version 8.0 - English and Spanish
  • FSMA Preventive Controls for Human Foods
  • FSPCA For Human Food Compliance
  • Produce Safety Rule Training Official Program
  • SQF Quality Systems For Food Manufacturers
  • Internal and External GFSI Audits
  • Crisis Management
  • Gluten Free Certification Program
  • SQF Advance Practitioner Course
  • Prerequisite Programs

Food Safety Consulting Services

Please visit our website or send us an email for more information!

Friday, October 6, 2017

Yesterday's Internal and External Audits GFSI Workshop

Superior Food Safety's Oscar Camacho gave a workshop about "Internal and External Audits GFSI" at TORANI facilities. 

For information about our upcoming classes and workshops please visit our website: 

Tuesday, October 3, 2017

The Changing Landscape of a Foodborne Illness Outbreak Response

New tools like online reporting allow health departments to better mitigate risks of foodborne illness.

Recent high-profile foodborne illness outbreaks appear to have an enduring impact for the entire industry – from when and how health departments respond to alleged illness to how a single tweet wreaks havoc. The bar for when a comprehensive response is required is lower and the extent and nature of the required response has changed.

Here’s what we’ve learned:

Health departments are receiving more complaints from consumers. Although much of this is believed to be related to the high-profile outbreaks, some are a result of health department websites making it easier to report illness. A few years ago, guest illness reporting required calling the health department during business hours, working your way through complex voicemail options until you reached a recorded line to leave a message about your illness. Today, most health departments in large cities and many in smaller counties, have simple on line reporting systems available 24/7. So when someone isn’t feeling well at midnight, and is sure it’s from the last thing they ate, they go online and report the illness.

Health departments are now more often following up on single reports of illness and reports of illness that are inconsistent with most foodborne illness incubation periods. This is creating a large burden for already short-staffed departments, but in response to what the public now expects. In the past, they might have replied to the ill guest and explained that they’d received no other reports, that most foodborne illness has a longer incubation period and refer the illness to personal physicians if a follow up is clinically appropriate. But today, we’re finding many health departments dispatching inspectors for even a single complaint that doesn’t appear consistent with incubation periods for that meal.

There’s increasing pressure on health departments to go public with illness events – even if the illness is no longer ongoing or creating a public health risk. The foodborne illness legal community has made it clear that they believe the public has the right to know about any and every foodborne illness. And some health departments are responding to that pressure – without their being an on-going public health risk; which would have been the trigger in the past.

Guest complaints about illness are occurring more frequently. Every single one of our clients is reporting an on-going uptick in guest reports of illness. We’re not clear if it’s that consumers are more aware of illness, more concerned or more likely to associate it with a restaurant or food service provider. But the entire industry is seeing an increase in guest reports of illness. And every guest assumes it was the last meal they ate.

How you handle any guest complaint about illness is even more critical than it was a few months ago. Here’s why: if you don’t’ respond to the guest quickly and listen with authentic empathy, that guest is far more likely than ever before to tweet about you, write a bad review, post on social media or contact the media. You need to act quickly and it doesn’t matter if it’s a weekend or holiday. Waiting until Monday morning is not an option.

Noro season is year-round now… it’s no longer the winter vomiting disease like it is called in some places. Noro virus outbreaks continued in California (and elsewhere) until after the school year ended. We need to be alert to Noro all of the time.

Employees continue to work sick. There are so many reasons that employees work sick and it has little or nothing to do with paid sick time. They work sick because they’re not very sick, they don’t understand that any gastrointestinal upset may be a sign of foodborne illness, they don’t want to disappoint their manager or they don’t want to let their team down. They’re working sick for altruistic reasons without understanding the potential ramifications. We have a long way to go in educating managers and employees about what “sick” looks like, what can happen from working sick and why we need to work together long term to change this set of behaviors.

Employee Exclusion Policies need to be revisited. Someone is shedding the Noro virus for twenty-four hours prior to become symptomatic and then at very high levels for three days after symptoms end. Sick employees need to be excluded for much longer than they currently are in most restaurants and food service establishments to control Noro outbreaks.

Employee Illness on Days Off are as critical to crisis prevention and response as illness on work days. You need to know if an employee was sick on a scheduled work day or on a day off. As we discussed previously, they were shedding the Noro virus before they got sick and for days after. Your illness response plan needs to include a very robust tool for employee illness reporting – one that is as easy to use seven days a week and raises an alert to management when there are two or more sick employees.

It’s time to redraft and recommunicate the definition of a potential crisis in your organization. In the past, we previously used the following definitions of what defined a potential crisis for a restaurant or foodservice group:

  • Two or more employee illness reports (for same time period and symptoms)
  • Two or more guest complaints (from different parties for same time period)
  • One confirmed employee illness (with a communicable disease)

Your new definition must be broader and reflect the lower trigger points for action. It may include one guest complaint from a large party, illness in a neighboring school, social media buzz about illness from your location and / or a health inspection in response to a guest complaint of alleged illness.

The takeaway: the lessons learned continue to evolve and new ones emerge with each new outbreak. Making sure we identify and share these lessons across the industry and your organization is critical for being prepared to first identify and then quickly respond to the next threat that comes your way.

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