Practical steps toward due diligence.

Editor's Note:

From time to time, the Journal will feature articles from international environmental health journals not only to inform you of problems/solutions in other parts of the world, but also to relate to you situations that offer insight and perhaps solutions to those you may confront in your day-to-day operations.

The introduction of the due diligence defense in the Food Safety Act demanded that intricacies of a food business should be considered by food enforcement officers, its costs, its operational management, and any constraints that are imposed upon it.

The defense was designed to provide a balance between the strict liability offense and one where it might be possible for a defendant to establish that all reasonable precautions had been taken and all due diligence exercised. Any business, company, or individual defending a charge has to ensure that both of these component parts have been satisfied if they are to mount a successful defense.

The concept embodied in this defense is not new to EHOs. The term "reasonably practicable" is in the Health and Safety at Work Act and "best practicable means" and "without reasonable excuse" are in the Environmental Protection Act; investigations of offenses relating to these statutes would follow a similar protocol.

The Practicalities

While it is the role of the accused to raise the defense, the prosecution should always consider the defendant's chances of success, before recommending that a prosecuting should go forward. In doing so, they should address the demonstrable elements of the procedures constituting reasonable pre-cautions; under no circumstances should such a decision be reliant on instinct.

As Blake, et al. (1) emphasized, due diligence draws on the facts of a particular case, rather than some fixed formula or standard. It focuses on what is reasonable in the circumstances; no one can claim a blanket due diligence defense and, unlike quality assurance accreditation, it cannot be awarded.

In deciding whether a business has taken all reasonable precautions, the inquiry is fundamentally examining the management information and control systems of that business in relation to a specific incident. It is therefore of paramount importance that the inquiry itself is conducted efficiently, not only because the ability of the local authority may be questioned by a whole host of critics, but more specifically to allow the business to properly defend itself should any proceedings be brought.

Initial Steps

Before beginning an investigation of contamination, there are a number of essential steps which must be addressed without delay. These include:

* establishing details of the complainant, the point of sale, and making an evaluation of the complainant's qualities as a witness;

* agreeing with the complainant that their identity can be revealed and that they would be willing to attend court;

* deciding how the complainant has been prejudiced or how the food has apparently failed to comply with the Food Safety Requirements;

* notifying the Home Authority of the details as soon as possible;

* gathering evidence where possible, through photographs, sketches, and measurements of the complaint upon receipt; and

* making details available as soon as possible to the business, including the name of the complainant, in order that a business can properly initiate its own investigation of the complaint (see Daventry District Council v. Ollins (2)).

In preparing for an investigation, it is (the London Borough of) Enfield's practice to offer the manufacturer the opportunity to view the product. This is a matter of courtesy, forming no part of the Authority's investigation, but it gives the manufacturer a chance to begin their own internal investigation. An appointment is made, usually within five days of receiving the complaint, unless its deterioration is likely to hamper any analysis, in which case the manufacturer is advised when the product will be submitted for analysis and given the opportunity to view it first.

The manufacturer is not cautioned at this stage. However, if any remarks are made at that meeting a note should be made of them, because in any subsequent interview under PACE(Police and Criminal Evidence Act) these matters may be properly put to the person being interviewed.

Lacots have recently indicated certain information which the Home Authority might provide for the Enforcing Authority, as follows: previous convictions; response to advice; reasonable precautions taken; any quality or HACCP systems relating to the complainant; and results of inspections/audits.

Complaint details

Inquiries of when the Home Authority conducted an indepth inspection or audit should be made, as this may coincide with the production of the complaint article.

It is suggested by the authors that no formal interview takes place until after all necessary documentation has been examined and the production process has been inspected. It is good practice to carry out as many inquiries as possible before inviting the defendant or a representative of the defendant company to attend a formal interview.

Before Inspection

Before undertaking an inspection of the source premises, it is important to have an understanding of the production process associated with the manufacture of the complaint item. This is best achieved by obtaining a thorough description of the operation from the manufacturer.

Annotated flow charts are an effective form in which to receive this information. If available, HACCP documentation is ideal for this purpose. A good HACCP will not only provide a description of the process but will also identify any associated hazards identified by the manufacturer and give details of suggested remedial action.

From this preliminary information, the investigating officer will make a judgment, based on common sense criteria, as to the most likely source of the contaminant and hence limit the scope of the investigation. It is extremely important to define the scope at an early stage to prevent the manufacturer, either wittingly or unwittingly, from overloading the investigating officer by providing volumes of unnecessary information.

Once the scope of the investigation has been identified, detailed documentation should be requested relating to specific processes or pieces of equipment for the date of production of the complaint item. Such documentation may include procedures for the operation, maintenance, and cleaning of equipment and any associated records to demonstrate that these procedures were in place at the time of the complaint. Relevant training procedures and records should also be examined, noting their relevance, clarity, effectiveness, and enforcement.

Procedures and records should be cross-referenced with any HACCP documents to ensure that all identified hazards have been addressed.

In addition to product-specific documentation, general documentation relating to the premises should be requested, such as cleaning schedules and hygiene and foreign body policies. Any Codes of Practice relevant to the manufacturer should be considered; details of these can be obtained from the Institute of Food Science and Technology (IFST).

As it is the Enforcing Authority which is responsible for ensuring a proper investigation is undertaken, this Authority should provide clear guidance on the nature and scope of the investigation if the inspection is to be carried out by the Home Authority.

The Inspection

Experience at Enfield has favored the use of two officers for such inspections, each having defined roles. One officer should be charged with the responsibility to take samples, documents, photographs, and sketches. The other should concentrate on the technical operation of the premises and the application of procedures and policies. It is important, however, that both officers act as a team, taking detailed notes of their observations and each

other's actions.

Equipment for such inspections should include cameras, sample bags, and security tags and a receipt pad. An inquiry before the inspection will confirm the extent to which specialist clothing, such as safety shoes and a hard hat, are provided.

The following format is suggested, for conducting the inspection:

* Pre-inspection meeting with the Home Authority

If the inspection is to be carded out in another Authority, it is important to discuss the format of the inspection with the Home Authority and establish ground rules, either by telephone or through a meeting at the Home Authority's offices. It is usual for the investigating officers to confine their inspection to the matters relating to the complaint and refer their written comments, as soon as possible after the inspection, regarding the operation of the premises to the Home Authority for any appropriate action. The food business should be informed that these comments have been referred to the Home Authority.

* Pre-inspection meeting with the factory management

The purpose, format, and scope of the investigation should be explained to the factory management. Again, this may be by way of a telephone discussion, or when the investigating officers arrive at the factory.

* Informal Tour

This should be carried out to familiarize the inspection team with the production process.

* Detailed Inspection

This should concentrate on the areas identified before the visit.

Management

* Cost of the investigation

Due diligence investigations can be extremely time consuming, due to the documents which need to be examined. Where at all possible, these should be looked at away from the premises to allow the officer to become familiar with them, to seek further clarification as necessary from the Home Authority or other professionals, or to request additional documentation.

The location of the factory may lead to further costs. An overnight stay and considerable journey times are factors in the Enforcing Authority undertaking the inspection. For this reason, the officers must be thoroughly prepared concerning the scope of the investigation and the appropriate roles of the inspection team.

* Abuse of process

Investigating officers should be aware of this issue and must ensure that their inquiries are not conducted in such a way that it could be held that the manufacturer was prejudiced in defending themselves.

* Planning the formal interview

If the Authority is considering proceedings against the business, they should always give them the opportunity of attending a formal interview, which would be conducted under the provisions of the Police and Criminal Evidence Act.

At Enfield this is normally conducted at the Departmental Offices and the investigation is by letter, which would advise them that they may have their solicitor present. Experience has shown that it is also wise to indicate the nature of the investigation and which documents require further amplification.

It is at the formal interview that information can be put to the defendant, which has been gathered by way of letters, documentation and visual observation or as a result of staff at the factory giving verbal answers.

Bennett, et al. (3) gives further information on the gathering of evidence by interview.

With the advent of the due diligence defense it is essential that investigating officers try to anticipate those matters which might be raised as part of the defense. It is too late to gather further evidence when such a defense is raised in the course of a trial, because the defendant has no duty to provide evidential disclosures to the prosecution.

Also, once an accused is charged, no further questions may be put except in accordance with PACE, which does make limited allowances for subsequent questioning.

Officers must avail themselves of all relevant manufacturing procedures and be clear as to the scope of their inquiries. Although such investigations are time consuming, consideration of what precautions are reasonable and whether all due diligence has been exercised at the investigation stage has the overall effect of strengthening one's case and making a successful conclusion more likely.

References

1. Blake, L., R. Malcolm, and J. Pointing (Consulting Editor, Double P), Prosecuting Food Safety Act Offenses.

2. Daventry District Council v. Olins (1990); 1990 RTR 228; Criminal Law Review 568.

3. Bennett, C., R. Halford, and M. Steward (1991), "Gathering Evidence by Interview," Environmental Health, September 1991, pp. 216-221.

Example of a due diligence investigation: Foreign body found in an apple pie 

The Complaint: An apple pie containing a piece of black rubber-like material approximately 22mm x 74mm x 64mm was presented to the Authority for investigation. On examination the material appeared to be a section of a large circular item. The pie was pre-packed and the complainant discovered it as she bit into the product. It was therefore decided that the initial investigation should concentrate on the manufacturing process.

Home Authority Involvement: The manufacturers declined to view the product and so the foreign object was forwarded to the Home Authority by recorded delivery. Their preliminary investigations revealed that the piece of rubber appeared to be part of the seal used in pipe work feeding the apple pie filling to the depositor and that there appeared to be no specific precautions in place to avoid such an occurrence. The Home Authority was not able to carry out the due diligence inspection due to resource difficulties, so in this instance the Enforcing Authority undertook the inspection.

Pre-Inspection Planning: Detailed product specification and detailed flow diagrams of the production method for apple pies were requested. The following documents relating to the manufacture of apple pies were requested by the Enforcing Authority from the manufacturer: operating instructions; training procedures; training records; cleaning schedules; production records; maintenance procedures. The equipment which was of particular interest included; the fruit washing and inspection process; apple filling manufacture; pastry manufacture; and depositor.

Copies of any procedures, records, and associated training documents for the following were also requested; visual inspection of final product; HACCP or other risk assessment of production process; general factory cleaning schedule; foreign body policy; and other quality control procedures.

The Inspection: An inspection of the factory was undertaken by the Enforcing Authority whose officers were accompanied by the Quality Systems Manager and the Production Manager.

Informal Tour: A short guided tour of the mini-pie production line included the dispensing area, scaling area, mixing area, sieving room, pumping area, filling line, baking, and packing areas.

Detailed Inspection: From information supplied before the inspection and during the tour, it was decided that the most likely points at which the foreign object entered the product was in either the dispensary, scaling, and pumping areas or the filling line, and so the indepth investigation concentrated on these areas.

Dispensary Area: Both powdered and liquid ingredients were weighed out in the dispensary areas. Two stainless steel pipes with integral dosing pumps were used to dispense bulk liquid ingredient, such as liquid glucose, into plastic buckets ready for production. Both these pipes contained a number of joints which were made using stainless steel pipe fittings. One of these pipes was approximately three inches in diameter, the other two inches. Seals for the fittings of both pipes were produced by the management. The two-inch seal was similar to the foreign object that had been found in the fruit pie.

Scaling Area: The dry ingredients for the fillings were dispensed into a Collett scale system from overhead hoppers and mixed together with the other ingredients in a Collett mixer. To the rear of this machine was a stainless steel down pipe approximately two inches in diameter, which had a number of compression pipe fitting joints. These joints required rubber seals of a similar nature to the fragment discovered in the apple pie.

The contents of the mixing bowl were then placed into a stainless steel "wheely" or fruit bins. The wheel assembly of one bin was worn and a rubber seal had become damaged so that a section approximately three inches was hanging down. The inspection team thought that this could be a potential contamination hazard which had not been observed by the factory management.

Pumping Area: The contents of the fruit bins were discharged to the production hall by means of a fruit pump in order to convey the mixed apple fillings to the filling machine. An operator was seen connecting the outlet pipe of a fruit bin onto the fruit pump pipe work. He tightened the pipe fittings, which contained a rubber seal, with a 'C' spanner exerting maximum force on the fittings. This was considered bad practice as it may have placed the seal inside under undue pressure and caused damage.

Filling Line: The Asser machine was used to dispense the mixed pie fillings into pastry cases contained within foil dishes, and the pastry lids were applied. There was a length of stainless steel pipe with six pipe connectors along its length which ran directly above the uncovered pie cases, containing filling, directly prior to the pastry lid applicator. This pipe was connected to the Oakes machine which was used to deposit custard to selected varieties of pipes.

Loose Seals: During the inspection, a two-inch 'H' pipe seal, similar to the complaint article, was found on a piece of machinery and was subsequently surrendered to the investigating officer by the management. The machine was not in use at the time of the inspection and a section of piping had been disconnected from one end and a rubber pipe seal was left loose on top of the discharge valve associated with this pipe. Also a two-inch rubber pipe seal was left on a stainless steel table at the foil tray infeed end of the Asser machine, and a two-inch pipe seal hooked over the top of a fire hose tap. These seals were later produced as evidence.

Documentation: The breakdown sheet contained a number of pre-start checks for all machines in the bakery, including details of the start-up, stop, and clean of the fruit pump. This document did not specify any requirements to check the integrity of rubber pipe seals of give any details regarding the replacement and disposal of the seals.

The HACCP document was dated November 1992, a month before the production of the complaint pie, and identified a number of critical control points relating to the quality and safety of mini-pie production. However, no regard was given to the potential risk of contamination of products by rubber pipe seals, despite the ubiquitous use of these seals in the factory.

The Good Manufacturing Practice Document contained a small section on foreign body control. No reference was made to any precautions that should be taken to prevent the contamination of products by rubber pipe seals.

During the inspection, it was apparent that the surplus pie fillings were subject to rework, i.e. removed from the Assar machine and returned to the fruit bins to be reused. No documentation, procedures, or records relating to the control of reworked products could be produced.

Were reasonable precautions taken?

Having inspected the documents and the production process, it was felt that the business had not taken all reasonable precautions or exercised all due diligence in relation to this incident for the following reasons:

1. The inspection revealed that rubber pipe seals, which were similar in nature to that discovered in the apple pie, were used throughout the factory. The nature of some of the pipes required that they were frequently disconnected/reconnected by staff, involving the use of rubber seals. Procedures were not available to ensure that these operations were carried out in such a manner as to prevent damage to the seals and the subsequent contamination of products. The position of some of the pipe fittings such as the delivery pipework from the Oakes machine; the dispensary downpipes; the Collet scales; and the pipework associated with the fruit pump was such that open products were in close proximity and as such precautions would be required to be taken to prevent contamination. There were no procedures relating to the use, removal, or disposal of these pipe seals. The risk of product contamination by these items was not identified and hence not addressed by the HACCP.

2. A number of pipe seals were found left on pieces of equipment in areas where product contamination could occur. As such, it was apparent that these items were not placed under sufficient control.

3. No written procedures were available for the use and control of reclaimed product destined for rework. There was no evidence that precautions were taken during the recovery of unused product and subsequent reintroduction of this product into the mixing process to prevent foreign body contamination.

4. Deterioration of rubber seals on the wheel assemblies of fruit bins was noticed. No documentation was available to demonstrate that the potential hazard associated with this had been identified and addressed.

Conclusion

The case was prosecuted in the magistrates court and convicted with a fine of [pounds]500. Full prosecution costs were awarded.

Colin Bennett, Andy Bowles, and Miranda Steward are all employed with the London Borough of Enfield.