S. Dix, Tesco Stores plc, Welwyn Garden City
V. McEachern, A. Bungay, S. Bray Ippolito and
4.5 Regulatory verification of industry food safety and
carrying out activities, and observing the application of in-plant control activities are used by inspectors when performing a regulatory verification. In addition, traditional inspection techniques can be used to focus on areas where a non-compliance is identified or simply to verify that the control measures are effective. The regulatory verification approach is a comprehensive in-depth assessment of industry’s controls and outputs that applies to both audit and inspection methods. It allows the inspector to evaluate information and data gathered over time by the company, to perform inspections of the product and the plant environment and to focus his or her verification efforts based on risk and compliance. This allows the decisions of the inspector to be based on a greater amount of information than in the past and gives more flexibility in assessing industry controls.
4.5 Regulatory verification of industry food safety and
In order to assist industry in this step, regulators can develop checklists based on the regulatory requirements. Self-verification checklists should be concise and easy to use. Checklists can be used by the companies to plan the development of the FSCS, as well as a final checking process for completion.
The process for industry use is fairly simple. Upon completion of the FSCS, a business member – preferably independent of the system development team – should use the checklist to verify that the components are all present prior to submission of the documented plan to the regulatory agency for acceptance. The checklist would then accompany or precede the FSCS submission to the regulatory agency.
Some may regard the industry self-verification as a ‘‘paper exercise’’ but this is a false perception. From the viewpoint of the food industry, the self-verification checklist is a useful tool for development and completion. For regulators, the industry self-verification process promotes industry ownership of the FSCS. The self-verification checklist can be an important communication tool, and regulators should design the checklist to provide the relevant industry progress data that is needed for government planning in this type of initiative.
For example, checklists should be created in order to determine if the industry FSCS is sufficiently developed to proceed to the next stage – the system verification.
4.5.2 System verification
The objective of the system verification is to assess the written FSCS against the reference standard to determine if the written document is complete, and technically and scientifically sound.
The system verification is done on the first written FSCS and on subsequent amendments. The process of system verification can be discussed in several distinct stages: planning the system verification; conducting the system verification; and communicating the system verification results.
Planning the system verification
In order to assess and acknowledge any written FSCS, it is essential that a set of criteria be prepared which will serve as the basis for assessment. The criteria must be developed from the reference standard and should interpret the requirements of the reference standard for the written FSCS. The criteria can be developed in the form of a checklist and assessment report to be used by the regulator. Every effort should be made to balance ease of use of the report with the need for sufficient criteria to conduct a comprehensive assessment of the written FSCS.
The system verification is a well organized process. Regulators will not begin a system verification until the industry self-verification indicates that the written FSCS is complete and ready for assessment. It is important to remember that each FSCS is unique, and the regulator must remain open to different approaches in meeting the system verification criteria.
Conducting the system verification
In conducting the system verification, the process begins with the establishment of a system verification team, including technical or scientific resource people when required. It will be necessary to have all relevant documents available (i.e.
the FSCS, the system verification report, applicable product hazards references and any relevant industry guidance documents).
The system verification is a paper review of all major components of the FSCS. It includes the prerequisite programs and flow diagrams, hazard analysis, control measures, corrective action plans, etc., but would not include very detailed procedures such as specific work instructions. This checklist is used to assess the completeness and soundness of the written FSCS. In making this determination, it is essential that the regulator consider the interaction between various parts of the FSCS, for example the prerequisite programs and the HACCP plan. These sections cannot be assessed independently of one another.
A common difficulty in conducting the system verification is determining the level of detail that should be satisfied to find the written document complete and sound. It is important to differentiate between ‘‘complete and sound’’ and the ideal written FSCS that individual regulatory personnel may envisage.
The system verification should be closed when the regulator has sufficient evidence to believe the written program is complete and sound. The system verification does not attest to the effective implementation of the FSCS, only that the system is found to meet the requirement of the reference standard.
It should be expected that it will take time for industry to create an effective documented FSCS. Specifically, time to analyze and develop the first draft of the written system, to test the procedures through implementation and to revise the written procedures, at least once but more likely over several system generations. The regulatory system should facilitate, and even encourage, this test and revise approach.
Communicating the results
The company should be provided with a written report indicating any deficiencies found in the written FSCS. Regulators are cautioned to avoid the opportunity to suggest ways to revise the written system for two reasons:
industry authorship of the document will improve its workability; and if regulators are involved in developing the system, it may create conflict when the system is being assessed during implementation.
4.5.3 Compliance verification
The compliance verification is the on-site assessment of the implemented FSCS. It has a twofold objective: to verify that the FSCS is implemented as written and to ensure that the system is effective in meeting the requirements set out in the reference standard. It also has planning, opening, investigating and closing phases.
The compliance verification is based on audit principles. The process is designed to conduct a meaningful assessment in an efficient manner. In order to
accomplish this, regulators are tasked to evaluate a ‘‘thin slice’’ of the company system (i.e. a comprehensive, but narrow, review of the company‘s control system). For example: for a large food production facility, a regulator could limit the compliance verification to an in-depth investigation of the controls in place for only one of many products produced.
Planning the compliance verification
The first step in the compliance verification is the development of a compliance verification checklist. This is prepared using the company’s FSCS and in advance of the on-site verification.
Checklists are devised to address the scope and objectives of the verification.
The checklist creates a guided structure for each assessment process. Depending on the nature of the verification, the checklist may take on different, yet similar shapes. Lines of inquiry for the checklist are set up using the reference standard and its structure. The checklist should contain specific activities to be conducted to test the application and effectiveness of the FSCS. Appropriate activities include: conducting interviews with key personnel; observing specific operational procedures; reviewing records; monitoring testing procedures; and sampling materials for analyses.
The checklist may be expanded during the course of the compliance verification, if required, in order to determine compliance to the reference standard. The scope of the compliance verification is established using the plant’s compliance history and any risk factors of the product and process.
The compliance verification checklist is an important record of an individual assessment. With each successive compliance history, the previous checklist should be reviewed during the creation of the new checklist.
Opening the compliance verification
The compliance verification begins with an opening meeting with the plant management. At this meeting, the regulatory personnel should explain the scope and objectives of the verification. At this time, industry representatives should pose any questions regarding the compliance verification. Industry management should be encouraged to provide a person to accompany the regulatory personnel during the compliance verification.
When an industry representative accompanies the regulator, a number of benefits are realized:
• Industry witnesses the regulator’s observations in real time.
• The industry representative can provide answers to questions immediately.
• The presence of a company representative can facilitate interviews with plant personnel (alternatively, it may hinder interviews).
• The transparency of the regulatory process can be improved, which can also improve communications.
• Industry may benefit in terms of a learning process.
Wrap-up meetings should be held with the processor each day that the compliance verification continues, and the plant management should be informed of the verification progress. Of course, when any issue of critical significance is found (i.e. relating to the safety of a food product) the plant management must be informed immediately.
The investigation
To conduct the compliance verification, the regulator follows the plan established by the compliance verification checklist and proceeds with the investigation. The investigation is a series of planned activities to collect objective evidence in support of the inquiry. The results of all findings are recorded.
Objective evidence is qualitative or quantitative information, records or statements of fact pertaining to the implementation of a quality management program, and is based on observation, measurement or tests. Examples of objective evidence include:
• information contained on company records
• facts related during an interview with a plant employee
• inspector observations
• laboratory results
• product inspection results, and
• measurements made by an inspector.
When a regulator has reason to believe that the FSCS has failed (i.e. it is not being implemented as designed or it is not effective), then objective evidence should be gathered as supporting evidence. An instance of system failure is called a non-conformity. Non-conformities may be either procedural or performance related, and minor or critical with respect to food safety concerns.
Closing the compliance verification
The regulator’s findings, including any non-conformities and supporting objective evidence, are documented in the compliance verification report and presented to the company at the closing meeting. Since the regulator has a daily wrap-up meeting with the company, the contents of the final report should not be a surprise to the company. The purpose of the closing meeting is to discuss the findings of the compliance verification with all relevant levels of company management to ensure there is an understanding of the results.
During the closing meeting, the company will be asked to initiate corrective action plans for each non-conformity addressed. When the company has provided corrective action plans (at the meeting or at a later date) these will be reviewed, and if satisfactory, will be accepted by the regulator. The regulator will also verify at a later time that the corrective action is implemented by the company.
4.5.4 Common barriers to regulatory verification
Government agencies may encounter difficulties in moving from a traditional inspection approach to a regulatory verification approach. It is important for regulatory agencies to recognize barriers and develop the appropriate strategies to overcome them. Common challenges to instituting regulatory verification follow.
Cost of change
Over the long term, a regulator verification approach to assessing industry control systems will cost less and provide greater assurance of safety in the food system than a traditional approach. However, the transition period between programs will be a burden on both monetary and human resources. Governments should expect to go through several years of implementation before realizing cost savings. In assessing the cost of introducing a systems approach to food inspection, government should not exclude the cost of failing to move in this direction.
People
In contrast to the standards and pass–fail criteria associated with traditional inspection methods, the regulatory verification approach may be uncomfortable for some regulators. Regulatory personnel may indicate a resistance to change, which can be attributable to moving from known to unknown territory. For example, the movement to regulatory verification is accompanied by the need for new skills, such as audit techniques. Resistance to change may be overcome by communicating to the public, industry, and regulatory personnel the benefits of using a systems approach.
Regulatory personnel may feel uncomfortable with the new knowledge and expertise required when using the industry system verification approach. They will need a good understanding of the hazards associated with food products, food processes, and controls.
Regulatory verification relies on the personal judgement of trained, experienced personnel. The approach recognizes human experience, memory, perception, and cognitive thinking as perhaps the most powerful assessment tools available.