Are Unannounced Food Safety Audits (Investigations) The Way To Go?

There goes another beautiful theory about to be murdered by a brutal gang of facts.” – Francois VI, Duc de la Rochefoucauld, French writer and moralist, (1613-1680)

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I walk with a slight hitch with my left foot because of a Forrest Gump type of impairment when I was super-young.

Years later, I was actually accused by some plants, that my prevailing left foot glitch was really caused by all of the colonoscopies received during food safety audits in the capacity of a consultant.

In retrospect, they might be right.

Since 2002, I’ve been on the receiving end of at least 75 National School Lunch Program (NSLP) audits/investigations east and west of the Mississippi.

I have no idea the number of other USDA, FDA, GFSI, GMP, humane handling, OSHA food safety audits/investigations I’ve been at the receiving end of.

And note, please..., there are many other food safety consultants that can claim twice as much as I just did.

Through all of the receiving audits, starting from the late 1980’s through 2017, I'm convinced that unannounced audits/investigations are thee way to go.

Why?

Because unannounced audits/investigations shall unequivocally expose each food plant’s actual, blue-diamond truth; their food safety/quality systems, infrastructure, top management commitment, and processing operations – as they really R

Plain and simple.

Before you position me like the Romans did Spartacus - read me out.

As a consultant (2000-2017) representing USDA/FDA plants and insurance companies, I've gone through produce, pharmaceuticals, chain restaurants, food, beverage, flour mills, confectionary, GFSI audits, red meat, poultry, seafood, feed animals, birds and alligator audits – and - a good number of unannounced OSHA audits both north and south of the 65th parallel.

 Lets scrutinize 2017’s levels of difficulty concerning USDA/FDA commercial/governmental food safety audits/investigations.

I subjectively and arguably rated this myself – from the easiest food safety audits in 2017 - to the very toughest.

So if you must, aim yours arrows over here to Doheny Beach, California.

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Simple Rating Scale: Level 1 being the easiest and Level 12 being the hardest.

Level 1

Type: State, county, and city food/health safety Inspections

Audits performed by: Pre-qualified governmental employees

Auditors: Same as above

Frequency: Normally once a year audit. Unannounced audits.

Level 3

Type: 3rd Party Good Manufacturing Practice (GMP) Audit

Audits performed by: Silliker, AIB, SAI Global, etc.

Auditors: Performed by qualified full-time and subcontracted auditors

Frequency: Once a year audit. Announced audits

Level 6 

Type: Governmental audits - The National School Lunch Program (NSLP)

Audit performed by: Agricultural Marketing Service (AMS) of the USDA

Auditors: Agricultural Marketing Service (AMS) qualified auditors

Frequency: Monthly audits. Announced audits

Level 11

Type: Global Food Safety Initiative (*GFSI) audit (*SQF, BRC & FSSC 22000)

Audits performed by: Performed through qualifying certification bodies that employs qualified full-time and sub-contracted auditors

Auditors: Qualified contracted auditors and sub-contracted auditors

Frequency: Once a year audit. Announced audit

Level 12

Type: GFSI audit. FDA inspection with form 483 – (not counting pathogen specific swabs).

Audit performed by: Same as level 9 for GFSI. Qualified FDA inspectors.

Auditors: Same as level 9 for GFSI auditors. Qualified FDA auditors.

Frequency: Once a year audit. Optional GFSI unannounced audit. FDA unannounced.

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Level 1’s

These food/health inspectors employed by states, counties, and cities nationwide are getting tougher and can be harbingers of unpleasant late night phone calls.

Don’t underestimate these Simba’s turned feral lions.

For a crystal clear example concerning food/health inspectors/investigators that I was involved in a decade ago, let’s start our story with a hermetically sealed 85 percent lean fine grind ground beef that’s positioned within a meat case at a retail store.

This 85 percent fine grind lean ground beef within the package at this penultimate end of the food chain was *possibly exposed to the following:

- A validated beef harvesting HACCP and SSOP systems (with at least two CCP’s)

- *Tested for generic E. coli while hanging on a rail as a carcass

- *Tested for E. coli O157:H7 while hanging on a rail as a carcass

- *Tested for indicative organisms just prior to making its way via a overhead rail system for the carcass breaking saw

- A validated raw not ground beef HACCP and SSOP systems (with at least one CCP)

- A validated raw ground beef HACCP and SSOP systems (with at least one CCP)

- *Further tested for indicative organisms and specific pathogenic testing before and after grinding operations and sent FED-EX to an ISO 17025 accredited laboratory that carbon emulates USDA’s microbiological testing methodology and sensitivities.

The multiple micro testing for our story all came back negative for O157:H7 - including low results for indicative organisms.

So is this 85 percent lean raw ground beef, pathogen free?

Oh Darling, please believe me!

Those O157:H7’s and their kissing cousins the six NONE O157:H7 STECS can be as elusive as Harry Houdini once was.

The toxins emitted from those H7’s and six STECS are virulent and nasty microorganisms.

The package of the fine grind lean ground beef that the food/health inspector grabbed and tested - by pure serendipity - popped a positive for E. coli O157:H7.

Back up samples – same.

Recall time.

Lights, cameras, social media, lawsuits, action! Sue me, sue you.

HACCP reassessment time.

Possible/likely visit by a USDA NOIE and a time consuming Food Safety Analysis (FSA).

Further investigations unveiled that approximately 20,000 pounds of frozen 90 percent lean beef trimmings that were imported from abroad that was included within our 85 percent fine grind lean ground beef package, had a certificate of analysis that was also negative for O157:H7.

So everybody’s specific pathogenic testing were negative - except for - the food/health inspector’s samples.

Poop happens.

Especially with raw or frozen ground beef – it doesn’t matter.

The lot of 85 percent lean raw ground beef that was recalled caused no illnesses with a just small portion of the lot of lean ground beef being returned to the USDA plant.

That’s usually the norm these days. The lean raw ground beef was already consumed by the time the recall was finally caught and announced by the plant and USDA.

However, this story hasn’t yet ended.

This USDA establishment that produced the 85 percent lean ground beef lost some good paying customers.

Why?

Because it had been previously stipulated, within written contract(s) with customer(s), that “fresh domestic only” beef trimmings were only to be used for 85 percent fine grind raw ground beef.

A classic case of modern day ... food fraud?

You bet.

And trust me, it happens a lot, regardless of product(s) or country. 

I thought that only happens in China and … Brazil…and …?

Level 3’s

So tell me, should USDA/FDA plants only be in ‘tip-top-hip-hop sparkling audit shape’ for only one or two days a year that adheres to all of the contents of food safety audits --- and then un-wind like Hawkeye and Colonel Klink always did - the remaining 363 days of a fiscal year?

A lot of USDA and FDA plants do this, not all, but many.

I know.

Level 3’s are doing a good job and have a history of producing safe and wholesome products for the general commerce. However, the depth and width of level 3 audits are not near the ‘deep-depth charges’ of the AMS, GFSI and FDA 383 levels.

‘Nooo way baby’ – as Theodore Kojak so aptly used to quip with his lollipop on a stick.

Level 6’s

The NSLP doesn’t offer such exquisite luxuries as level 3’s.

The AMS performs announced monthly audits to pre-qualifying companies.

Selected AMS auditors have an inclination to dig deep and wide - now and then. One never knows really when.

Level 6 plants have their act together and are well managed. Have to be or you’ll be booted out the fed’s program in a nanosecond. And yes getting disqualified happens a lot … I know. And I’m not referring to the Westland/Hallmark debacle of 2008.

Management at level 6’s has seen the “*Steve Olson Light,” (*Steve Olson is credited by many, myself included, of developing today’s NSLP remarkable ISO based technical proposal format), and many of these diamond spanking sparkling plants are GFSI certified at level 11.

Level 11’s

 Unless plants are falsifying their documents, GFSI accredited plants have things to do 365 days a year.

Level 11’s should just take that leap of faith and go on up to the tip-top that is level 12.

Level 11’s may still have some questionable gaps to fix that haven’t yet been unearthed during an audit, which may be holding them back, I suspect. Get ‘em fixed and take that jump - minus the bungee cord … you’re ready.

?Level 12's

Level 12’s, I think all of you rock like Neil Young rocks.

Level 12’s senior management – on down the pecking order - are fully cognizant that manufacturing consistently safe and high quality products requires 24/7/365, GFSI, FDA-FSMA preventive pro-active themed vigilance. Whew…

True Level 12’s expect that their operations can take on an unannounced audit because they’re both confident and convinced that their operations can meet thou - Food Safety, Food Quality, Continuous Improvements and all prevailing governmental agency requirements that’s mandatory of a 2017 GFSI certified food establishment.

What can be said about FDA? What a thriller-in Manila these unannounced inspections shall and will reveal...

Announced audits since the late 1980’s have always bothered me.

Always.

Global Food Safety Initiative (GFSI) audits that are announced make me moan like the millions of fans did when baseball great and my childhood super idol Tony Conigliaro was tragically beaned.

More and more FDA/USDA plants are choosing (yes, they are) the GFSI unannounced audit option(s) because they’ve worked their GMO infested sesame buns off getting and maintaining their operations and are truly executing what the standard is demanding of them on a quotidian basis.

I know.

FDA plants - it’s a done deal since late 2015 and you shall be experiencing increasing unannounced inspections exponentially as the clock ticks on.

Complacency is not in level 12’s lexicon.

Execution is.

Nothing, nothing wrong with that. That's what it takes!

So what’s all the fuss?

Because your food plant - in reality - isn't really executing, on a daily basis, what it should be doing regarding food safety and quality 7/24/365?

Not good.

Would you tell that to an auditor?

Would you tell that to your customer(s)?

Shame, shame we had a good thing ‘a going.

I know that many USDA/FDA companies are surprised when an unannounced OSHA auditor instantaneously materializes at their plants doorsill, and then issues, like a grocery cashier does when giving you back low five(s), one-by-one-by-one hand delivered paper citations with daisy-chained associated fines, and then calls out to others for some OSHA help.

The above would be D-I-T-T-O, if, ... selected food plants had an unannounced food safety audit today.

The schemes of GFSI are expanding the food safety/quality landscape just like the revolutionary Spinning Jenny changed and sped things up for the clothing sector eons ago - the folks at GFSI are currently spinning and stretching north and south of current GFSI benchmarks.

In particular - GFSI is heading north to the corrals and farms and then south-bound to the distributors and retailers, where everyone knows the wild and untamed West starring Cisco Kid still reigns in live living 2017 ‘too-numerous-to-count’ color.

With the FDA’s mighty and remarkable 2011 FSMA steam-rolling ahead and picking up implementation speed - selected environments of FDA and USDA plants may start seeing ---

-  A Marshal Rooster Cogburn appearing at their plants doorsill

- Closely followed by an expensive Perry Mason

- Then a date with a stern Judge Judy - and finally -

- A ‘Share-A-Cell’ with Steve McQueen and Dustin Hoffman on Papillon’s Devils Island - not Gilligan’s.

This is all already happening.

I’m telling you all, it’s all heading towards GFSI and FDA F-S-M-A’s.

The FDA implemented selected GFSI benchmarks for todays FSMA’s.

Look it up, if you didn’t know. GFSI and FSMA are nearly one of the same.

I know that along the long and winding road that unannounced food safety audits will be common.

Food safety is thee responsibility (and accountability) of the original supplying purveyor – it’s not the governmental regulatory agencies or GFSI’s responsibility.

They'll just cite and bite.

Food safety audits should be like a box of chocolates - you should never know who, what, or when you're going to get.

Get to level 12, be ‘proactively ready’ before you get a right-foot glitch like Forrest and I both inherited thee hard and emotional way.