GFSI Re-certification audits: Maximize preparedness minimize stress

Irwin Pronk, principal advisor, HACCP By Design, has over 35 years of experience in the food processing, animal feed and packaging industries, has worked with over 400 companies and trained over 10,000 individuals.

In 2005, Irwin was recognized by the Ontario Food Protection Association as Sanitarian of the Year.

Irwin writes, worried about your upcoming GFSI* audit? Scrambling? Stressing about possible non-conformances that may arise unexpectedly? Concerned about the potential reaction of senior managers? Customers?

The best approach is always to be prepared, principled, open and transparent. By identifying and addressing potential issues up front, and keeping your key players involved at every stage, you will not only help your audit go smoothly, you will have an increasingly solid foundation for achieving your long-term goals by developing broad-based awareness and participation. That is the cornerstone of a culture of safe food production.

In this series of 7 articles, you will learn how to:

  • Ensure your Food Safety and Quality programs are effective and efficient.
  • Be ready for all audits and be able to present your plant, managers, programs, and procedures in the best possible light.
  • Continually improve yourself, your system, your staff, and your senior managers to be more preventive and proactive.

(Irwin wanted to do a 7-part series, but I edited it into one, especially since I’ve sat on the piece for so long).

The food safety programs themselves are intended to produce a calm confidence, though that is rarely the case. How do we keep them running at 100%, and even improving? As well, dealing with the re-certification audits is complicated requiring a great deal of thought and energy. The primary issue being consumers’ food safety but we can’t forget our customer’s requirement that certification is maintained, all the while we have a busy food processing plant to run.

What is the best way to prepare for your upcoming re-certification audit? We want to foster a food safety culture. An audit can also be a good way for us to get a second opinion on how the system is designed and how effective it is. For this to be more likely to occur, choose your Certification Body (auditing firm) carefully, not just based on price, so you can be more confident to get helpful insights from the auditor! Easy audits are a waste of time and money, accomplishing far too little.

The biggest pressure we feel at the time of the audit is the customer’s requirement to maintain certification. No one wants to be cut off or have people wonder about what’s going on at your company.

So how can you and your team walk into the audit in a positive frame of mind, clear on where the strengths and weaknesses are and having a plan in-place to deal with them. It is possible, and I’d like to go through a number of suggestions to help you!

I do want to say up front that the approach being suggested is ‘the high road’, a principled approach that is open and transparent. I have found it works best. Hiding things and covering up issues gets everyone nervous and if auditors get the impression that anyone is deceiving them, they will react and there is no predicting how they will handle it.  When we are well prepared, open and transparent, it builds confidence and diffuses potentially explosive issues.  

Experience has found the following six factors to be most helpful.

  1. Be sure previous audit non-conformances are resolved and potential Major or Critical non-conformances are addressed.
  2. Audit the plant for the obvious GMP issues.
  3. Rigorous Internal Auditing.
  4. Communicate potential non-conformances. to Senior Management
  5. Manage the audit.
  6. Don’t do this by yourself! Get a second opinion.

The best approach is always to be prepared, principled, open and transparent. By identifying and addressing potential issues up front, and keeping your key players involved at every stage, you will not only help your audit go smoothly, you will have an increasingly solid foundation for achieving your long-term goals by developing broad-based awareness and participation. That is the cornerstone of a culture of safe food production.

  1. Be sure previous audit non-conformances are resolved and potential Major or Critical non-conformances are addressed.

You will likely have a long list of things to accomplish. Ensuring the non-conformances from the previous audit are closed, should be at the top. Minor non-conformances that are identified a second time automatically move up to a Major non-conformance level, and one of our goals will be no Majors.

What happens too often after an audit is we make promises about completing minor non-conformances, with the best of intentions, but life and work get in the way and we lose track. Don’t let that happen. Schedule follow-ups, in fact, consider scheduling internal audits of those non-conformances after 2 months and again after 6 months to ensure they are completed and working effectively. Having the larger Internal Audit team involved, and reporting monthly to Senior Management, keeps everyone accountable and on their toes, including us.

Some jobs are complicated, involve a lot of people (sometimes Corporate folks, IT or HR, not to mention the sometimes long and drawn out process of capital requests), are a lot of work and take a great deal of time. For example, fixing a Preventive Maintenance program that was designed and issued by Corporate will be difficult and slow. Even when things take much longer than expected we have to remember that a year later, we can’t be talking of progress, we must show completion. You may need to put in place a manual, paper-heavy process in the meantime, but the issue must be addressed and there must be proof.

During the last audit when the auditor found the non-conformance, it would have occupied quite a bit of their time and very likely prevented them from looking further into other aspects of the program. So rather than just addressing the non-conformance, look at all the other parts of the requirement, and your program, and be sure they are complete.

Maintenance is an example. The issue identified by the auditor may have been a worn, frayed belt, but the underlying problem may have been that the belt was not identified in the Preventive Maintenance system. Be careful to look more broadly. Are all the product contact surfaces included as Preventive Maintenance (PM) checks and are they highlighted as food safety priority PM’s. Examples are pump impellors, blenders, conveyors, depositors and fillers. Is the status of the PM program reviewed on a weekly basis? Have any incomplete PM’s that relate to Food Safety been highlighted, discussed and corrective action been determined and documented? Are records kept of these meetings?

Major & Critical Non-conformances

While we must prevent non-conformances from recurring we must also ensure that there are no Major or Critical non-conformances. Examples of Major non-conformances could be;

  • Ingredients in the receiving or production areas that are not approved through the Supplier Approval Process.
  • A new processing line installed but the HACCP plan has not been updated to include it.
  • A new allergen introduced with the controls at Product Development and the HACCP Team failing.
  • Ongoing environmental Listeria positives in the processing or wash-up areas.
  • Out of specification micro tests of finished product without any documented corrective action.
  • Foreign materials findings / complaints not investigated thoroughly.

Critical non-conformances are even more significant as they can stop the audit and result in a failure. Examples of Critical non-conformances could be;

  • Allergen cross-contamination,
  • Mislabeling involving allergen-containing products,
  • Condensation falling onto Ready To Eat (RTE) product,
  • Gear oil dripping onto product
  • Blender paddles heavily worn with loose burrs of metal.

In summary, your top priorities are “Major” and “Critical” non-conformances. Be especially careful to have previous non-conformances completely closed. This will be the auditor’s first task. Be sure the non-conformances are completely closed, not just improved and consider if there are weaknesses in any other areas of the program.

  1. Audit the plant for the obvious GMP issues

Don’t get caught with straightforward, easily prevented non-conformances. There will always be a handful of minor non-conformances, but if you want to consistently get a low number of Minors you must prevent this type of non-conformance from popping up (especially if you are shifting to an unannounced audit). This kind of non-conformance is where the entire plant management team rolls their eyes, as if to say “I can’t believe we missed that!”

Here are some examples:

A cabinet, in the production area, contains a can of non-food grade solvent, plus a squeeze bottle of ink jet cleaner that is not labeled.

Other examples to watch out for are packaging containers used for purposes other than food, such as a pen holder at a Supervisor’s work station, or maintenance parts stored in jar in the Shop.

Because floors can harbour dangerous bacteria like Listeria and Salmonella we need to be making repairs promptly and regularly. Scheduling the repairs takes time. If we begin early enough, it can be done at standard hourly rates, but waiting until the last minute results in us having to pay overtime rates. Cracks in the warehouse should be caulked, whether saw cuts or stress cracks.

The most sensitive areas are typically packaging and finished product handling, then the processing area, raw material preparation, then the warehouse.

Additional examples include;

  • A column was getting damaged from bulk sacks being lifted up beside it. The bumping over time was causing paint to flake and even concrete to be chipped off. It was skinned with stainless steel, but even that took two attempts to get it right. The first version was knocked loose.
  • Condensation dripping due to cold air from outside, for example, may a very expensive ventilation, humidity reduction or increased air flow. Condensation can become a critical non-conformance if in falling from the ventilation hood, cold water line or ceiling, the water drips onto cooked, Ready To Eat product.

Beware of auditors’ demands. One example recently was some wood ceilings where the auditor had found a couple of localized mold problems and stated that all the ceilings be ‘sealed’ or coated. The actual cause of the problem were two cooling units that were spattering droplets of water, wetting the ceiling. Why was water spattering? The drain pan was dirty and the drain was plugged. We had the pan and drain cleaned and the entire unit put on a cleaning schedule. The ceiling was then cleaned and the mold never returned. Many problems have simple solutions.

You will likely find temporary repairs. Tape around air lines, ‘pigs’ soaking up leaking oil, and more. They may be as simple as a piece of plastic used to divert a cool breeze or a piece of cardboard used to help product move around a corner.

There are times when a repair cannot occur until the line is down. A better options for handling situations like this include using a C-Clamp or vise-grip to hold a broken weld, but put a Maintenance tag on it. As well, open a Work Order.

On a production line of packaging film, picture a number of fast running bearings that leak oil very slowly, with no known solution. Many options had been tried though none had worked. In the meantime, the Operator had been given a daily checklist to inspect for oil, and wipe as necessary. Observing the piece of equipment the day I was visiting, it was found that oil was dripping. The checklist was found behind all the paperwork on the Operator’s desk, incomplete. Was the checklist missed in the daily review of records? Why? Was this process audited (or followed up)? This could have become a critical non-conformance if oil was found to be dripping onto the film.

Finding these types of problems takes time. It requires walking up and down each line and around the outskirts of each department. You need to be the one to find a burr on the edge of a blender scraper blade, cracked Lexan or the worn flashing. It could be as simple as a few dead flies or ants in a corner, or over-greased bearings that cause a minor non-conformance. Figure out where they came from and solve the problems. Rather than have the Quality department do all these inspections, have Operations identify a key Supervisor in each department to do the inspections, with the help of Quality, and the support of Maintenance. This gets the job done, but more importantly teaches the Operations team and keeps responsibility where it belongs.

  1. Rigorous Internal Auditing

Along with the program Corrective Action Preventive Action, Internal Auditing is one of the most important management tools you could possibly use to promote food safety. To make the most of it, use the best auditors you can find, and develop your team so that they will learn to audit even more rigorously than a 3rd party auditor. This is possible, because you know your plant best.

Your internal audit process should find far more non-conformances than any 3rd party auditor will. Let’s consider how many recalls we have had in our country from plants that had been recently audited. What does that say of programs and the third-party process? Weakness on both fronts! Don’t forget Peanut Corporation of America! Many of the plants having recalls lately have been GFSI certified. Don’t rely heavily on any kind of 3rd party audit, especially for a supplier who provides you an important ingredient. If you’ve got a lot at stake, get over there and check them yourself! The same principle holds true in your plant. No one knows your plant better than you do.

To do a great Internal Audit you need a great team of people.

One large production site has 3 of their site’s 4 Directors on the team, and the Internal Audit team of 23 persons audits their integrated program of ISO9001, ISO14000, OHSAS18000 and FSSC22000 at the same time. At another site the Internal Audit team includes a Purchasing Manager and Financial Controller. These are unique team members but their focus is typically on higher level programs, ‘systems’ audits, like Supplier Management, Corrective Action or Management Review. Because the Finance department, for example, is audited regularly themselves, their staff make good auditors. Also, more and more often, plants are asking a consultant to participate in their company’s internal audits, having them visit 3-4 times per year.

The key point here is that you need to know your own issues. My motto is “Surprises are great at birthdays and Christmas, but at work they stink.” So, even when good things happen, it shouldn’t be a surprise, it’s the result of concerted effort in a prescribed direction.

It is strongly recommended that Internal Audits happening more often than less, at least every month, and findings reported to senior management monthly, reporting non-conformances, corrective action and whether the Internal Audit team is on schedule or not.

Be sure the Internal Audit team has good tools to work with. Use a checklist and be sure the audit standard is available to them so they are thorough. Check the details. When interviewing, don’t take people’s word for it, ask for evidence.  You need objective evidence of conformance or non-conformance and each department’s staff need to held accountable for the details of their program. Take the time necessary to be thorough. When they have had problems, check the communication and follow-up to make sure that the corrective action ‘loop’ is closed and everything is well documented.

When there are Minor, Major or Critical non-conformances, open a Corrective Action (CAR, NCR, CAPA etc.). This documents the issue and gets people’s attention! But, be sure everyone involved follows through so they are resolved and signed off (complete). No one wants to get a non-conformance for a corrective action program.  Do your best to avoid that embarrassment.

A rigorous Internal Audit program can not only find problems but with practice and skill, find more subtle indicators of weakness and even identify negative trends so we catch them before they become a problem, building an environment where we anticipate and prevent.

  1. Communicate potential non-conformances. to Senior Management

As you approach a re-certification audit, be careful to be realistic and admit that there will be problems that won’t be completed in time for the audit. Don’t just hope they won’t be noticed or simply worry over what will be observed by the auditor. Create a list of the issues at your facility, and prioritize them. Which of these issues have the potential Critical, Major or Minor non-conformances? Some issues may have just recently arisen and others have been difficult to resolve over an extended period of time.  Also, be sure senior management knows the risks. Do not leave them unaware, and don’t tell them at the last minute. With their understanding, you are more likely to have their support.

Once you have prioritized and communicated, think about how to deal with these areas of weakness during the audit. My advice is to consider documenting them using a Corrective Action (e.g. CAR, CAPA, NCR etc.). There are a number of reasons why this approach is strongly suggested. Trying to hide the problem or waiting to see if the auditor sees it is nerve-wracking, plus the auditor’s reaction is much too hard to predict. My experience is that being honest and transparent does a lot of good.  Not that you will tell the auditor all of your issues at the start of the audit, but if they do see the problem during the audit, you can be prepared to calmly respond by saying “Yes, we’ve observed that as well. We are working on it and here is what is happening.” Show the auditor the Corrective Action document that would include a description of the problem, root cause analysis and the corrective action plan. Years of experience has shown this brings calm to a difficult situation, it also builds the auditor’s confidence and trust in you. In more than one situation, a non-conformance that could potentially have become a Major, become a Minor. In other situations a Minor became an Opportunity for Improvement (OFI) or just a note in the audit report.

Here are a few specific examples:

  1. Positive Listeria or Salmonella results in a Cooler or Wash-up Room: Be ready to show the history of the problem and the current corrective action activities including capital requests and work orders.
  2. Recurring sanitation problems such as high ATP results or microbiological swabs: Be sure you can show communication from the Lab (QA) to Sanitation and Operations, and well documented corrective actions reported back to QA and management.
  3. Preventive Maintenance behind schedule, or perhaps the Internal Audit program or the Master Cleaning Schedule: Open a Corrective Action to document the current status, clearly state the priorities (e.g. food contact equipment PM’s) and how we are in the process of getting back on track.
  4. Perhaps not all suppliers are approved or some files are incomplete: Be very clear on the actual status. For example, only 70% of suppliers are approved. Be ready to show Emails following up with the other 30% of suppliers, planned visits, the status of the higher risk ingredients and clarifying that they are the first priority. In preparing for the presentation to the auditor, my suggestion is to have, for example, four files to show. Choose three which are complete and the fourth partially complete. Rather than wait for the auditor to choose suppliers randomly, prepare an honest representation of your situation ahead of time because you already know what questions they will ask. You have the standard.
  5. An ingredient or two has been out of specification but the plant was able to use it: Be sure to document the issue in something like a Specification Deviation. The extension of an ingredient’s shelf life could also be documented this way. Other examples of this include finished product quality (e.g. viscosity).
  6. A metal detector producing more kick-outs than normal (perhaps even linked to consumer complaints). Document the incident in a Corrective Action Preventive Action document, investigate the root causes carefully. Investigation and corrective action must be very convincing and may include machine overhauls or even the rental of an X-Ray unit.

Senior Managers do not like surprises. If Senior Managers are being apprised of issues on a monthly basis then they should have all the information they need. If this is not your normal approach yet, at least provide them with a list of what you see as potential issues and do this as soon as possible. This should be at least three months prior to the audit.

  1. Manage the audit

The auditor leads the audit process, yet, you can manage a great deal of it if you plan carefully. This is not about being sneaky or devious, but intentional, planning your presentations and talking points so things don’t get missed and each department knows what their role is, able to articulate their programs and procedures, and shouldering their responsibility. It is important to have every department involved and this is a way to encourage it. One underlying goal is for each department to weave food safety and quality into their programs and procedures, not QA to run it. This planning process encourages this. What follows are some examples

Plan the agenda.

Prior to one recent audit, a month before the audit, no agenda had been sent by the Certification Body. The plant requested it. When the agenda arrived a few days later, it was obvious that many changes were needed. Because of the size of the plant and the way responsibilities were shared between departments too much time would be wasted. For the auditor’s sake it was rewritten, organized by department rather than audit standard sections. Each department was consulted to be sure it suited their schedules. Waiting until the day of the audit to correct it would have been confusing. Remember that even though the auditor may have been there a year before they likely only have a vague memory of the plant, people and situation.

Plan each department’s ‘presentation’

Everyone gets very nervous during audits and don’t always represent themselves and their programs very well.

As well, auditors also can use terminology that unfamiliar to people. Because of the confusion, too often, managers assume they don’t do what has been asked for, or don’t have that program. Very often they just call it something different. Meeting with each department, reviewing their sections of the standard will allow you to help them plan their presentation. Most plants try to avoid this problem by having QA answer as many questions as possible since they know the standard best and understand the auditor’s terminology. This causes a long term problem that negatively affects the food safety culture of the plant. With this approach other department managers are not likely become familiar with the programs expectations and thereby fail to shoulder their responsibilities.

As well, planning will help each person present their case honestly, and in the best possible light. Similar to an example in the last article, if there are 62 supplier files but only 25 complete ones. Do not just present your best ones and hope the auditor does not ask for more. If they do, and review a file that is incomplete they will not trust anyone in the plant. Consider showing two complete ones and 3 that are in process. All programs are in some state of improvement.

In the example below is an excerpt from a Recertification Audit Plan, an introductory paragraph and one example from the Human Resource department, one of ten department-specific plans for the site.

General notes for all departments:

  • If there are any disagreements with the Auditor, do not argue. Ask to see the requirement in the standard.
  • Don’t accept non-conformances too easily. Bring all the relevant information you can think of to the Auditor to help them make the right decision.
  • Rather than pulling original documents to show the auditor, consider making photocopies, preparing the examples in a series of folders, then after the audit, the paper can be recycled, and no re-filing needs to be done.

Human Resources – Training

  1. Start by showing the training procedure (be sure to highlight how the site verifies the effectiveness of training).
  2. Show how the Training Matrix works.
    1. Have some examples of ‘competence’ or qualifications ready. The obvious ones are likely the Quality Manager and Lab Technician.
    2. Production training. Have the training files ready for about 5 people across the various departments and including a Temporary employee, a Contract person as well as Full Time staff members.
      1. Be sure the evidence shows that the effectiveness of the training has been checked.
    3. Annual Training
      1. Show what subjects were covered.
      2. Show how attendance was taken, and how those that missed the main sessions were later trained.
    4. Give a couple of examples of the two people who have been noticed working in production, having excellent qualifications we were not aware of, and were subsequently transferred to the office (more responsible positions). Perhaps introduce them as you walk through the office. Also mention examples of potential problems that were noticed by staff, communicated to their Supervisors and prevented.

Other departments that need similar coaching are;

  • Purchasing
  • Lab
  • Maintenance & Utilities
  • Senior Management
  • Operations
  • Warehouse
  • Security
  • Quality Assurance

Preparing examples of training records, for example, keeps you in the drivers seat. Waiting for requests for records from auditors, then scrambling to find the information quickly can easily result in forgetting something important. As mentioned before, we know the standard so we also know what questions the auditor will ask. If you have 30 minutes with the auditor, have a presentation ready to more than fill that time slot. Not with filler but will a clear review of the programs and procedures.

This may sound like a time-consuming process but so is responding to non-conformances, and this feels much better.

A brief word about disagreements with auditors. First of all don’t get mad. Most people loose their powers of reasoning when they are angry. Be careful there are no disparaging remarks when difficulties are encountered. If someone is loosing their temper they should leave the room.

If the auditor seems to be off-base, and you don’t understand why they find an issue so important, or they don’t seem to be understanding your explanations ask them to explain further. Thankfully this is a rare situation. Ask where that requirement is in the standard and the guidance documents. Minor non-conformances do get assigned that should just be OFI’s and Major non-conformances that should only be Minors, but in order to wisely appeal a decision we need to know the standard thoroughly.

Judgments can always be appealed through the Certification Body if we are sure the auditor is off base. The important thing is that we are ‘right’.

Have the auditor interview each department in their own area.

Auditors are typically placed in the main boardroom (as far away from the plant as possible and near the coffee pot) or in a QA meeting room.  First of all, we want to dispel the notion that the food safety program is run by QA. Our intent should be to have each department integrate the food safety and quality elements into their programs and procedures. Make every effort to accomplish this. It is best for the overall food safety of the product and consumers. The culture of food safety has to permeate every corner of the plant and this is one way to encourage that.

Include supervisors and staff as the auditor is touring the building, a different supervisor in each area. There should not be too large a group, but include nearby people and introduce them. They can then overhear the questions and answers, thereby learning and becoming more comfortable with the process. They will see the same things as the auditor and if there is an issue, will better understand why.

The auditor does need a home-base. Make is comfortable. Have lots of good snacks, especially your own products if possible.

Another point to consider is conducting what could be called a ‘first impressions audit’. While it sounds odd, pretend you are the auditor first driving up to the plant and arriving in the lobby. Drive to the plant from both directions so see how it looks from the road. What needs to be cleaned up? Park in the visitor’s spot. Are there weeds? Walk to the front reception area. A snow shovel or broom in the reception area all reflect poorly on the organization. Excellent housekeeping, even in the meeting room, communicates attention to detail. Walk from the office to the plant, and decide which route is best to take.

There are many objectives that need to be achieved. What effort will you make to improve the culture of food safety, engage management and get closer to achieving zero non-conformances? The details are important!

Don’t do this by yourself! Get a second opinion

Yes, you know your plant best, but a calm, second opinion from someone who has done this countless times can help with a broader perspective and even positively influence your senior managers when things need to get done. The second opinion can help you sharpen your priority list especially because the list can be very long and you could use some help to separate the A priorities from the B’s and C’s. Be sure the person you bring in knows your industry well but also understands the broader food processing industry and even other standards for a more complete perspective. As an aside, although a plant is certified to one standard it is beneficial to be knowledgeable of the other standards. Each has its own unique perspective and requirements. Incorporating them will benefit your food safety program. Keep copies of the most commonly used standards such as BRC, FSSC22000 and SQF.

Yes, the big audit is coming but don’t loose sight of the fact that the point of the program, and being certified, is protecting the consumer. An audit is supposed to be constructive feedback and we want to make the most of that. Hope for some great insights from the auditor! Easy audits are a waste of time and money.

It is possible for you and your team to walk into the audit in a positive frame of mind, clear on where the strengths and weaknesses are and having a plan in-hand in dealing with them. You can do it, and hopefully the suggestions in this series of articles are helpful.

It bears repeating, in dealing with the audit and the auditor, take ‘the high road’.  Take a principled approach that is open and transparent. It works best. Hiding things and covering up issues makes everyone nervous and if auditors get the impression that they are being deceived, they will be very upset and there is no predicting how they will handle it. When we are well prepared, open and transparent, it builds confidence and diffuses potentially explosive issues.  

How do you spell stress? GFSI? Here is the list of 6 areas that in my experience have been most helpful in reducing that stress.

  • Be sure previous audit non-conformances are resolved.
  • Audit the plant for the obvious GMP issues.
  • Rigorous Internal Auditing.
  • Communicate potential non-conformances.
  • Manage the audit.
  • Get a second opinion.

Your certification and re-certification audits can be a constructive and positive event, encouraging the production of high quality, safe food.

Audits and inspections are never enough: French inspectors missed Salmonella at baby milk plant

French food safety inspectors failed to detect salmonella contamination at a plant belonging to dairy giant Lactalis, three months before the company carried out a major recall of baby milk, a report said Wednesday.

Lactalis, one of the world’s largest producers of dairy products, discovered the bacteria at its factory in Craon, northwest France, during tests in August and November.

It did not however report the find to the authorities.

Officials from the food safety department carried out a routine inspection of the site in September and gave it a clean bill of health, the Canard Enchaine investigative weekly reported.

It was only three months later, after around 30 infants being fed Lactalis powdered milk fell sick, that the health ministry sounded the alarm.

Officials from the national anti-fraud bureau swooped on the site on December 2 and found the assembly line where liquid milk is transformed into formula to be contaminated.

Lactalis issued two major recalls covering all production from the site from February 15, blaming the contamination on renovation work.

The plant has been at a standstill since December 8.

Lactalis is under investigation over the affair.

It could face charges of causing involuntary injuries and endangering the lives of others.

Market food safety at retail so consumers can choose.

Audits and inspections are never enough: A critique to enhance food safety

30.aug.12

Food Control

D.A. Powell, S. Erdozain, C. Dodd, R. Costa, K. Morley, B.J. Chapman

http://www.sciencedirect.com/science/article/pii/S0956713512004409?v=s5

Internal and external food safety audits are conducted to assess the safety and quality of food including on-farm production, manufacturing practices, sanitation, and hygiene. Some auditors are direct stakeholders that are employed by food establishments to conduct internal audits, while other auditors may represent the interests of a second-party purchaser or a third-party auditing agency. Some buyers conduct their own audits or additional testing, while some buyers trust the results of third-party audits or inspections. Third-party auditors, however, use various food safety audit standards and most do not have a vested interest in the products being sold. Audits are conducted under a proprietary standard, while food safety inspections are generally conducted within a legal framework. There have been many foodborne illness outbreaks linked to food processors that have passed third-party audits and inspections, raising questions about the utility of both. Supporters argue third-party audits are a way to ensure food safety in an era of dwindling economic resources. Critics contend that while external audits and inspections can be a valuable tool to help ensure safe food, such activities represent only a snapshot in time. This paper identifies limitations of food safety inspections and audits and provides recommendations for strengthening the system, based on developing a strong food safety culture, including risk-based verification steps, throughout the food safety system.

Jazz is music in hell: Odwalla founder finds second life in Califia almond and plant-based beverages

Geoffrey Mohan of the LA Times writes that Greg Steltenpohl, 63, heads Califia Farms, an almond and plant-based beverage company he co-founded in 2010. With about $100 million in annual sales, the company is something of a redemption for the Stanford graduate, whose first lightning strike in the beverage business, Odwalla, started as a way to fund his avant-garde jazz band, and ended with a fatal food poisoning and recall that eventually left the company in the hands of Coca-Cola.

“Odwalla got started because I didn’t really have a plan. I was focused on music and just thought, ‘Hey, I can make some juice on the side, play music and all that.’”

The band’s eclectic mixtures of unpasteurized juice were far more popular than the band’s music and, by 1993, Steltenpohl and his partners took Odwalla public.

Accidental success met accidental fall in 1996, the year Odwalla hit its peak sales of $59 million. An E. coli outbreak traced to Odwalla’s raw apple juice sickened dozens and killed a child in Colorado. Federal criminal charges, fines, lawsuit settlements and a precipitous drop in sales left the company so short of cash it wound up controlled by new investors who eventually sold the brand to Coca-Cola.

Steltenpohl tried his hand at several other businesses before getting a call from Berne Evans, the head of Sun Pacific packing, who had helped pioneer easy-peeling mandarins — trademarked Cuties.

Steltenpohl blanches at the idea that he has some knack for catching food preference waves just as they crest — with Odwalla, then with almond milk, and now with a line of almond-based cold brew coffee drinks.

“It sounds like that,” he admitted with a laugh. “But you figure I’ve been doing it for 37 years. You could say I hit the waves, but there’s a lot of paddling in there.”

“It’s not always the important thing to be the first,” Steltenpohl said. “I think it’s more important to solve a number of other problems.… The way we talk about it is: something different, something better — that’s kind of the hurdle we have to pass internally. If we can’t answer to ourselves why is it different, why is it better, how does it move the bar higher, then why are we doing it?”

Too bad you didn’t apply that to juice business.

 In late Oct. 1996, an outbreak of Escherichia coli O157:H7 was traced to juice containing unpasteurized apple cider manufactured by Odwalla in the northwest U.S.Sixty-four people were sickened and a 16-month-old died from E. coli O157:H7. During subsequent grand jury testimony, it was revealed that while Odwalla had written contracts with suppliers to only provide apples picked from trees rather than drops – those that had fallen to the ground and would be more likely to be contaminated with feces, in this case, deer feces — the company never verified if suppliers were actually doing what they said they were doing. Earlier in 1996, Odwalla had sought to supply the U.S. Army with juice. An Aug. 6, 1996 letter from the Army to Odwalla stated, “we determined that your plant sanitation program does not adequately assure product wholesomeness for military consumers. This lack of assurance prevents approval of your establishment as a source of supply for the Armed Forces at this time.”

Why would anyone brag about AIB? Oh, it’s Missouri: Ozarks Food Harvest Bank earns superior food safety rating

According to the West Plains Daily Quill, Ozarks Food Harvest received high marks on its food safety inspection from AIB International. For six years, southwest Missouri’s only regional food bank has held this superior food safety certification.

Except AIB – based in Manhattan, Kansas – has given superior plus plus ratings to some of the worst food offenders in the past decade: Peanut Corporation of America (which supplied the idiots at Kelloggs), DeCoster eggs and dozens more.

When Ozarks Food Harvest first received this certification in 2012, it was only the sixth Feeding America food bank of 200 in the country to do so.

The auditing tragedy is bad people taking money from people trying to do good.

Audits and inspections are never enough: A critique to enhance food safety

2012, Food Control

D.A. Powell, S. Erdozain, C. Dodd, R. Costa, K. Morley, B.J. Chapman

http://www.sciencedirect.com/science/article/pii/S0956713512004409?v=s5

Abstract

Internal and external food safety audits are conducted to assess the safety and quality of food including on-farm production, manufacturing practices, sanitation, and hygiene. Some auditors are direct stakeholders that are employed by food establishments to conduct internal audits, while other auditors may represent the interests of a second-party purchaser or a third-party auditing agency. Some buyers conduct their own audits or additional testing, while some buyers trust the results of third-party audits or inspections. Third-party auditors, however, use various food safety audit standards and most do not have a vested interest in the products being sold. Audits are conducted under a proprietary standard, while food safety inspections are generally conducted within a legal framework. There have been many foodborne illness outbreaks linked to food processors that have passed third-party audits and inspections, raising questions about the utility of both. Supporters argue third-party audits are a way to ensure food safety in an era of dwindling economic resources. Critics contend that while external audits and inspections can be a valuable tool to help ensure safe food, such activities represent only a snapshot in time. This paper identifies limitations of food safety inspections and audits and provides recommendations for strengthening the system, based on developing a strong food safety culture, including risk-based verification steps, throughout the food safety system.

Auditors and public health: a request

I still can’t say no to students.

Beth Driscoll, MA, CPHI(C), CHA, PMP (I’m not sure what all those initials mean) and PhD Candidate, Policy Studies, at Ryerson University (that’s in Toronto, which is in Canada) writes:

My name is Beth Driscoll, and I am inviting you to participate in a brief, online survey.  This survey will take approximately 15 minutes to complete, and investigates the perceptions of Global Food Safety Initiative (GFSI) auditors’ role in public health.  This survey is being conducted for my doctoral research project at Ryerson University.

To participate in this project, you must:

•]be fully certified to conduct GFSI audits for at least one benchmarked scheme;

• have completed at least five GFSI audits of that scheme; and,

• be fluent in English.

The survey is not intended to investigate or assess the GFSI, a GFSI benchmarked Food Safety Scheme, Certification Body, Accreditation Body, government or other organization.  Should the responses to the survey questions contain information that would identify one of these organizations, the identifying information will be anonymized prior to use.

Conflict of interest declarations: I am a contract employee for NSF International.  This information is being collected solely for my researcher’s graduate degree, and is not being collected for any organization associated with the GFSI or NSF International, nor do I conduct GFSI audits. 

If you choose to participate, you will be asked to complete an online survey about your professional identity and your understanding of your role in public health through the audits you conduct to a Global Food Safety Initiative (GFSI) benchmarked Food Safety Scheme.  The survey is confidential is using Opinio, Ryerson University’s Online Survey Program, and all data is stored at Ryerson University.  This study has undergone review through the Ryerson University Research Ethics Board and if you have questions about your rights as a research participant, you may contact the Ryerson Research Ethics Board at rebchair@ryerson.ca.  If you have any questions about the survey please contact the researcher, Beth Driscoll, at edriscol@ryerson.ca  or Dr. Richard Meldrum at  meldrum@ryerson.ca before continuing.

Please feel free to forward this email to anyone you feel may be qualified to participate.

To participate, please go to the following website: https://survey.ryerson.ca:443/s?s=6004

How the hell could we know? Kellogg hopeless at food safety and accountability

In 2008, peanut butter thingies with the nut part sourced from Peanut Corporation of America killed nine people and sickened at least 700 with Salmonella.

traci_lind_and_matthew_broderick_in_the_road_to_wellville_2In March 2009, Kellogg’s CEO David Mackay did an outstanding impersonation of Kevin McDonald’s, “How the hell should I know” skit (below) in front of a U.S. Congressional committee.

“When you look at Kellogg, we have 3,000 ingredients and 1,000 suppliers, I think it’s common industry practice to use a third party” (to verify safety).

Not common enough for Nestle North America, which rejected Peanut Corporation of America’s Blakely plant as a supplier in 2002 after it found the plant had no plans to address hazards like salmonella.

The Atlanta Journal-Constitution reported that in January 2006, Nestle also rejected the company’s Plainview, Texas, plant after finding dozens of dead mice rotting in and around the plant, dead pigeons near a peanut receiving door and live birds roosting inside the plant.

Congressional types also heard that auditors AIB — also known as the American Institute of Baking based in Manhattan (sigh, Kansas) — were hired and paid by Peanut Corp. of America, notified the company in advance when they were coming, how to prepare for inspections and then gave its plants glowing reviews.

An inspector with AIB wrote to the manager of Peanut Corp.’s Blakely, Ga., in a December 2008 e-mail produced by the committee, “You lucky guy. I am your AIB auditor. So we need to get your plant set up for any audit.”

Mackay told the committee a version of, “how the hell could we know?” and that AIB is the most commonly used inspector by food companies in America.

48_the_road_to_wellvilleHe also wanted food safety placed under a new leader in the Health and Human Services department, called for new requirements that all food companies have written safety plans, annual federal inspections of facilities that make high-risk foods, and other reforms.

Mackay whined that Kellogg’s had to recall more than 7 million cases of crackers and cookies, at a cost of $65 million to $70 million, and that “Audit findings reported no concerns that the facility may have had any pathogen-related issues or any potential contamination.”

Kellogg’s is a multi-billion dollar company asking for a government handout to do what Kellogg’s should be doing – selling a safe product. Kellogg’s helped create the paper albatross that is third-party audits instead of having its own people at plants that supply product which Kellogg’s resells at a substantial profit.  Kellogg’s crapmeister told Washington how to strengthen food safety when he couldn’t keep shit out of his own company’s peanut cracker thingies.

aib-audit-eggsThis is a company founded on fairytales and colonic cleansing in Michigan, making its money selling sugar-sweetened treats to kids and their parents, and using a sliver of those profits to sanctimoniously fund so-called research and training, using Michigan State University as their willing vessel.

With this background, it’s not surprising that, as reported by Dan Flynn of Food Safety News, that, “In mid-2007, Michael collaborated with his brother, Stewart Parnell, who was the President and CEO of Peanut Corporation of America, a peanut processing and manufacturing company, to provide peanut paste to Kellogg.”

P.P sales “was a small operation with two tanker trucks and one customer: Kellogg Company.

From mid-2007 to 2008, Michael shipped peanut paste from PCA’s Blakely, Georgia plant (PCA Blakely) to a Kellogg production facility in Cary, North Carolina.”

P.P.’s tanker trucks, filled with peanut paste, during those months were making 1,200 round-trips to provide the product Kellogg’s needed to put a little dab of peanut paste on all those Keebler PB sandwich crackers.

When anyone from Kelloggs talks about food safety, have a chuckle and move on; or tell them what dickshits they are and how they know nothing about food safety.

Audits and inspections are never enough: A critique to enhance food safety

30.aug.12

Food Control

D.A. Powell, S. Erdozain, C. Dodd, R. Costa, K. Morley, B.J. Chapman

http://www.sciencedirect.com/science/article/pii/S0956713512004409?v=s5

Abstract

Internal and external food safety audits are conducted to assess the safety and quality of food including on-farm production, manufacturing practices, sanitation, and hygiene. Some auditors are direct stakeholders that are employed by food establishments to conduct internal audits, while other auditors may represent the interests of a second-party purchaser or a third-party auditing agency. Some buyers conduct their own audits or additional testing, while some buyers trust the results of third-party audits or inspections. Third-party auditors, however, use various food safety audit standards and most do not have a vested interest in the products being sold. Audits are conducted under a proprietary standard, while food safety inspections are generally conducted within a legal framework. There have been many foodborne illness outbreaks linked to food processors that have passed third-party audits and inspections, raising questions about the utility of both. Supporters argue third-party audits are a way to ensure food safety in an era of dwindling economic resources. Critics contend that while external audits and inspections can be a valuable tool to help ensure safe food, such activities represent only a snapshot in time. This paper identifies limitations of food safety inspections and audits and provides recommendations for strengthening the system, based on developing a strong food safety culture, including risk-based verification steps, throughout the food safety system.

 

 

Will fewer people barf? FSMA and audits, especially third party, still suck

Allen L Mozek, MPH, a Fellow of the International Food Protection Training Institute (IFPTI) and public health advocate for prevention of areca nut diseases, writes in this (as yet unpublished) letter to the editor of Food Safety magazine that the October/November 2016 issue sings “Kumbaya” about the Food Safety Moderization Act (FSMA)  – let’s step back and be politically incorrect:

barf-o-meter-dec-12HACCP was never supposed to be a regulation but “an approach to inspection” – per Dr. Frank L. Bryan – HACCP pioneer.

Ready-to-eat produce and sprouts, due to outbreaks and lack of CCP, would not be permitted if not for Salinas CA producers and sprout association lobbying.

Preventive controls is “another regulation” that will mitigate hazards but not provide the conventional 5 log reduction of pathogens with these products.

Second, food fraud is intentional adulteration for economic gain and not amenable to either HACCP or preventive controls but is rather an ethical problem. See the essay:

Market Economies With Churches and Market Economies Without Churches, by Zhao Xiao

Third, I would like to see thorough answers to three questions (courtesy of economist Thomas Sowell):

1.     What is the empirical evidence for this legislation?

2.     Compared to what will this legislation be an improvement?

3.     What is the cost?

Fourth, please answer the charge of “conflict of interest” and “sham”, regarding third party auditors, exclaimed by renowned foodborne illness attorney Bill Marler and barfblog.com editor Doug Powell.

83 sickened: Long list of food safety failures identified at Adelaide InterContinental, source of Salmonella outbreak

Katrina Stokes of The Advertiser reports that documents released under the freedom of information act highlighted numerous potential problems with the Intercontinental’s cooking practices, which left 83 people ill with salmonella poisoning after eating at the Riverside restaurant on Sunday, July 31. These include the known safety risk of using the same whisk in both cooked and raw eggs.

scrambled-eggs_An Adelaide city council report, obtained by The Advertiser from Duncan Basheer Hannon, confirms the common link between the affected individuals was the consumption of scrambled eggs. Test results identified Salmonella Typhimurium.

An investigation led by the council in early august concluded a long list of “issues” with cooking processes at the hotel.

They included:

A whisk used throughout the (scrambled egg) cooking process from a raw egg mix to a cooked mix.

Scrambled eggs were continually topped up and not fully replaced between the hours of 6.30am and 9.15am.

Serving spoons were replaced only when deemed necessary, posing a potential risk for cross-contamination.

The stick blender used to mix raw eggs was inadequately sanitised.

The nightshift chef responsible for preparing the raw-egg mix did not adequately understand correct cleaning and sanitising processes.

Scrambled egg reheat temperatures were not recorded on July 31 and there was no thermometer to record temperatures because it was “lost three months ago.”

A plastic container storing raw egg slurry had a damaged lid and rough internal surfaces, which were identified as difficult to clean and sanitise.

Intercontinental Adelaide general manager Colin McCandless said the report was a “hypothesis.”

Mr McCandless said the hotel had produced a score of “100 per cent” in a recent external audit of food safety procedures.

Audits often mean little.

That’s the same McCandless who in early Augest said it was ‘absolutely safe’ to eat at the hotel.

The hotel’s $37 full breakfast buffet at the Riverside restaurant includes scrambled eggs.

 

Collaboration collaborationists: Trust us is terrible soundbite for food safety

Last night, I chatted in my terrible French with our host and his far better English, with Amy there to mediate the difficult parts, about his parents’ emotional shit-fest during Nazi occupation in World War II.

gfsi.collaboration.bs.jun.16The short version: his father had been chosen to be killed by Germans in retaliation for the killing of a German soldier, and while awaiting death, American troops rolled into town, post-Normandy, and his father was spared.

The son showed me a photograph of the German boss being transported out of town on the front of an American Jeep, hands on his head.

That’s one of the reasons this lovely French family loves Amy: she’s American.

Collaboration, which has been touted for decades as essential in the academic enterprise and yesterday ad nausea in the food safety world, also has a different meaning: Collaborationists.

Selling out.

I’ve covered this before, but food safety collaboration is over-rated, especially if it’s driven by a top-down organization.

Just because a lot of salaries from the United Nations Industrial Development Organization (UNIDO) and the Global Food Safety Initiative (GFSI) signed a memorandum of understanding on jointly developing food safety capacity building projects, means nothing (upper right, propaganda image).

Will fewer people barf?

Yet the collaborationists falling over themselves to follow is at once both nauseating and vomit-inducing.

Philippe Scholtes, Managing Director at UNIDO, said, “The World Health Organization estimates that up to 600 million people fall ill every year after eating contaminated food. Our collaboration with GFSI will further strengthen and promote multiple benefits of safe food for social inclusiveness, sustainability and industrial development.” 

Will fewer people barf?

Mike Robach, Chair of the GFSI Board of Directors, added, “We are very enthusiastic about the potential to have a bigger impact in these key regions, thanks to this collaboration with UNIDO. Multi-sector collaboration is the way forward in achieving food safety across borders and barriers. Our joint efforts within this partnership will take us further and faster towards our vision of safe food for consumers, everywhere.”

collaboration.german.trustWill fewer people barf (lower left, propaganda image)?

Individuals create and innovate, and bring others to the table.

Individuals who are steady and focused need someone to take them out of their comfort zone, as much as the erratic need steadying support.

That is the challenge of any collaboration, bringing those elements together, and being better than the individual.

Otherwise, it’s just a collaborationist following a paycheck.

Olympic-sized food safety issues for Rio

Lina Tran of Eater writes that Rio de Janeiro 2016 kicks off in less than three months, and everyone knows feeding Olympic athletes is one of the most exciting aspects of the Games.

chapman.auditRio has constructed a kitchen the size of a football field (American football, that is) and a dining room two times that, the Associated Press reports. The kitchen will prepare 60,000 meals each day for over 18,000 athletes, coaches, and staff.

The dining hall will house five all-you-can-eat buffets accommodating different tastes and diets: Brazilian, Asian, International, Pasta and Pizza, Halal and Kosher. Diners have a spectrum of international breakfast options, including congee, miso soup, and natto.

Food safety is a crucial strategy for an operation of this size, and steroids in animal meat, meant to improve lean growth, can cause false positives in drug testing of athletes. “To assure that our ingredients are free of steroids and other kinds of chemicals, we are making sure our suppliers have all the certificates that are demanded by our national food and drug agency,” says Marcello Corderio, Rio’s director of food and beverages.

Certificates? Paperwork? Really? Do better. You can’t test your way to safe food, but any program requires some sort of verification, whether it’s testing or a pair of eyes on the production facility. Not just paperwork.