Case study 


Cap Presence control of sensitive 

beverages in 2010


Introduction

milk aseptic filling med hr

  Over 250 different food- and beverage-borne diseases have been described.  Mostly infections, caused by a variety of bacteria, viruses or parasites

“Y” is a great dairy filling and packaging plant. Here it has been installed a standalone Full Bottle Inspector in a new Aseptic filling Line for PET-bottled dairy products.  The equipment devoted to assure Safety to dairy products, say the most dangerous existing and thinkable beverages, being an Electronic Inspector visible in the figure below:

  • operating standalone, rather than in-the-Machine,
  • no automated Visual inspection by camera, of the Caps’ height,
  • no automated Visual inspection by camera, of the Caps’ inclination, 
  • no automated Visual inspection by camera, of the Tamper Evident Ring, 
  • no Leakage control by squeezing.  

To inspect bottles' sealing and leakage gives relatively poor results for an Inspector with two cameras, but no squeezing leakage control.   Imagine what is necessary to guarantee dairy products


heuftr basic

  The real electronic inspector referred to in the present RCA Case Study.  Operating standalone.  Also, no camera check of the plastic PET caps closing the bottles.  Just Cap's Presence digital (on-off) inspection.  An equipment unadapt to the task to assure that bottles open because of malpositioned caps, do not systematically reach people.  Bottles filled with milk or other dairy derivates or juices, in Aseptic conditions, without added preservatives protecting humans.  These beverages cannot be inspected by an Electronic Inspector with the only “cap Presence” inspection, if the goal is to limit the ingestion of contaminated beverages.  Also, the fact that an Aseptic Bottling Line runs 23000 bph or less, does not add anticontaminant Preservatives to the sensitive beverages


Did they existed safer technologies in 2010 ?










Yes, they did.   The safe solution was in 2010 and is today:

  • in-the-machine approach, where the Electronic Inspector has its own electromagnetic inspection cooperating with tens of others whose measurements are independent, lying in the Capper and Filler machines.    An approach where each one container having lost its own originally attributed identity, has to be mandatorily rejected, also if the visual inspections of the Electronic Inspector saw it correctly capped;   
  • a thorough inspection for the Cap conditions (height, inclination, tamper evident ring) with at least two cameras.

An example of the in-the-machine configuration of an Electronic Inspector from which they can be expected much higher hit ratios also for small Caps’ defects, with two cameras and no squeezing, is depicted in the figure below.  The figure refers itself to a device we system-integrated at Nestle’ Yinlu® (at Jinan, China).


nestle yinlu 2800x2100@1x













“...malpositioned caps, open bottles with preservatives-free milk or juices are just the tip of the iceberg of Projects not fulfilling the Bottler’s Order in terms of Food and Beverage Safety.   

Then, Root Cause for contaminated persons is at least: 

willingful negligence

 The Case Study hints to an Aseptic Beverage Bottling Line, compelled to produce sensitive dairy products with only a Cap Presence Inspection.  A safety level nearly opposite than what can be reached, as an example, by the installation depicted on right side.  Here, similar dairy bottled products are controlled by a couple of cameras, assuring a full 360º coverage of the cap and of the tamper evident ring. The electromagnetic-only measurement approach is not the optimal solution.  But, in the Case Study here presented, each individual Cap results independently controlled in the Capper by mean of mechanic systems sensible to the Torque.  All the measurements correlated to a uniquely identified bottle (in-the-Machine operation mode).  Imaged one of the Bottling Lines of Nestle’-Yinlu at Jinan, China, installed and started by our Staff


It features a proprietary design of the interfacing toward the Aseptic Bloc Filler + Closer.  Interfacing three different Machines (Filler + Capper + Inspector) to let each one bottle be rejected on the base of the joint probability of several independent measurements of a random variable.   A theorem defines such probability much lower than that possible to an Inspector configured standalone at the Capper out feed.   Without such kind of technical solutions, also the best existing Aseptic Filling Bloc and the most cared process, terminates in contaminations, simply because of leaking bottles whose cap is not closed.    


Root Cause

If the safer technologies, whose original application should have prevented or however greatly limited the occurrence of contamination of final Customers exist, then it is possible to restrict to just two cases the Root Cause for such an event.   Place yourself in the position of the Plant, Quality Control and Production Managers, after news circulating in the Press and other media like the TV or Internet, showing final Customers hospitalised with what they appear symptoms of foodborne poisoning, after having drinked their beverages.   The Case Study outlined a Project ignoring that an Aseptic Bottling Line running 23000 bph or less, surely does not add anticontaminant Preservatives to the sensitive beverages.   The Aseptic filling remains without preservatives at 7200 bph as much as at 72000 bph.    An Aseptic Bottling Line is more expensive than one for common non-Aseptic nor Ultraclean-filled beverages, also because it has to assure additional Quality to the Product.    “It has to assure” meaning that malpositioned caps, say open bottles with preservatives-free milk or juices, are one of the ways to represent Projects not fulfilling the Bottler’s Order in terms of Food and Beverage Safety.    Then, front of cases of contaminated persons the Root Cause is at least, willingful negligence.    Quite clear, but ...willingful negligence of Whom ? 

sensitive food and beverage


“Oasis Brands, Inc. Recalls Products Lacteos Santa Martha Because of Possible Health Risk

Contact
Consumer:
305-599-0225

FOR IMMEDIATE RELEASE - October 16, 2014 - Oasis Brands, Inc. of Miami, FL is recalling select lots of various Lacteos Santa Martha products with Best by dates of 07/01/14 through 12/31/14, because the products has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The recalled products were distributed in Florida, Georgia, Tennessee and North Carolina from April 1st thought October 14, 2014 to distributors and retail stores. The products can be identified by the batch ID code (best used by date) sticker on the label of the plastic bag of 07/01/14 through 12/31/14.  

FDA is investigating illnesses associated with the product.

The recall is the result of routine sampling by The Virginia Department of Agriculture and Consumer Services Food Inspectors and subsequent FDA environmental samples that revealed the presence of Listeria monocytogenes. The company ceased production and distribution of the product as FDA and the company continue their investigation as to what caused the problem.

Consumers who have purchased the Lacteos Santa Martha products are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at (305) 599-0225 Monday thru Friday 9:00 am - 4:30 pm EST.

U.S. Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993, USA

 1-888-INFO-FDA (1-888-463-6332)”

Willingful Negligence of Whom ?

...of the OEM or Vendor of the Machinery or the inspection equipment, or of some of the Staff of the Bottler of Aseptic beverages in charge of that Project during its early Design phase ?    In the following we’ll examine two different scenarios:


1.  Of the Bottler ?

The juridical “divide” deciding the nature of the Root Cause and its attribution is the existence of an official written, undersigned (Contractual) communication of the OEM or Vendor on a date before the Order of the Bottler.   A technical communication explaining that Cap Presence inspection is not a technology compatible with Food and Beverage Safety.   If such a communication existed, then the Bottler preferred a cheap and risky technology.   He has freedom to choose a Food and Beverage Low Safety Policy, if he wants.   The eventual negative outcomes included.   No doubt if he preferred the cheapest and riskier technologies, the annual premium he’ll have to pay to an Insurance Company in exchange for the coverage (Product Liability Insurance) of the risk to produce in those Conditions, shall be higher than with expensive technologies yet worldwide recognised as Quality standards.


2.  Of the OEM and/or Vendor ?

But, what if the official written Contractual technical communication about the fact that that Equipment cannot assure the safety of dairy products, filled in an Aseptic ambient without preservatives added, never happened ?   Then the Root Cause has to be ascribed to the Machinery's OEM (or, inspection equipment’s Vendor).   Not to write openly about such well known risks to a prospected Customer, presenting him alternative, also if more expensive technologies, can let artificially gain an Order for an entire multi-million dollars Beverage Bottling Line.  “Artificially” because the Competitors’ Offers to that same Bottler for that same Project shall look “artificially” more expensive.   

Clearly, such economy corresponds to missing basic Food and Beverage Safeties, then being an intentional falsification, and not a good-faith mistake.

One allowing to enrich someone at the expense of others, leaving to the others consequences that, if they’d have been warned before to sign a Contract, they’d have never accepted.    In this case, nearly wherever in the World and following the negative outcomes of the intentional falsifications, Tribunals shall decide this is much more than Machinery's OEM or inspection equipment’s Vendor willingful negligence.   Any doubt ?   As an example, Google the keywords: 

                                                    “food scandals” 

                                                    “soft-drinks contamination” 

and you’ll be presented many results.  So many results that a human-life is not long enough to read: millions of web pages.  In the meantime, you’d discover plenty of Procurement Dept. and Project Management Dept. staff, convinced that their “Company has no responsibility if did not passed technical guarantees to the prospected or actual Customer”.    Thus forgetting that the fact they did not passed Guarantees (that, in the reality, they received by the Vendor) could be later interpreted as proof of a scheme which can be resumed as: ...to increase the profits at whatever price, also endangering Others’ health.   The fact that the Vendor passed them these Guarantees in a confidential way or secret, does not impede today the legally enforced retrieval of the data.   If this second scenario is the Root Cause, is something with effects just between Bottler and OEM/Vendor.   Bottler’s responsibility toward his final Customers remains always and however.   The fact that the Bottler has the capability to show his good faith was betrayed by statements or missing statements of the OEM/Vendor, does not reduce substantially his liability.    Why not ?      Because He continues to have the duty toward his Customers to take all cares to prevent things like these from happening, and not the OEM or Vendor.    


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