Crítica a la noción de la autonomía como soberanía individual

It should be undertaken initially and as needed thereafter

monitoring, to determine compliance with the HACCP plan. Therefore verification procedures are intended to check the effectiveness of the HACCP system.

Verification refers to activities undertaken to check compliance with the plan and its implementation. These activities should be planned ahead, because they should be approved by the responsible person in the establishment at the same time as all other results of the HACCP study.

Originally the producer did verification to check the effectiveness of the HACCP system. However, since HACCP has been incorporated into legislation and recommended by Codex Alimentarius, the authorities have seen verification as their task.

Although internationally accepted definitions of the tasks of regulators or law enforcement officers have not been established yet, it is believed that the food handler, should do verification in accordance with the HACCP plan. That activity doesn’t exclude necessarily the authorities from checking the verification procedures performed by the handler in particular or the plan in general.

Taking under consideration that “Food Hygiene” means all measures necessary to ensure the safety and wholesomeness of foodstuffs, then, “Food Hygiene Monitoring System” is the main tool to prevent foodborne disease. Secondary, this system permits to detect and prevent the causes responsible for the spoilage of food. An inefficient monitoring system leads to economic losses, reduces credit by consumers in food hygiene control system and also reduces credit in international trades.

In order for the monitoring system to be effective, measures shall cover all stages after primary production (the latter including, for example, harvesting, slaughter and milking), during preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling and offering for sale or supply to the consumer.

According to Article 1³², of 94/356/EC: Commission Decision of 20 May 1994, {this can be achieved by ‘Own-checks’, that means all those actions aimed at ensuring and demonstrating that a fishery product satisfies the requirements of that Directive. Those actions must correspond to an approach internal to the establishment; they must be developed and implemented by the persons responsible for each production unit, or under their management, in accordance with the general principles set out}.

The documentation must include two types of information to be kept for submission (upon request) to the competent authority:

A. A detailed and comprehensive document including:

- description of the product,

- description of the manufacturing process indicating critical points, identified hazards, assessment of risks and control measures,

- procedures for monitoring and checking (at each critical point), with indication of critical limits for parameters that need to be controlled

- corrective action to be taken in case of loss of control, - procedures for verification and review.

B. Records

- of the observations and measurements, - results of the verification activities,

32 94/356/EC: The Commission Decision of 20 May 1994 is laying down detailed rules for the application of Council Directive 91/493/EEC, as regards to its own health checks on fishery products (Text with EEA relevance), Official journal NO. L 156 , 23/06/1994 P. 0050 – 0057, Article 1

- reports and written accounts of decisions relating to corrective action taken in the past An appropriate document management system must be provided, in particular, for the easy retrieval of all documents relating to an identified production batch.

18. AUDIT

18.1.1. The Audit and it’s role

Audit is a systematic and functionally independent examination in order to determine whether activities and related results comply with planned objectives (Codex Alimnentarius1997).

The term “Audit” is used for a variety of activities. Normally, independent auditors perform an audit which involves an in-depth examination of the production site and of how the HACCP plan was established and implemented. This definition is given because the word audit is frequently used in the context of verification or regulatory assessment.

18.1.2. Third part Auditing

It is good practice to let “another pair of eyes” scrutinise the HACCP study and the implementation of a HACCP plan. This scrutiny or “audit” can be performed by people working already at the factory or industry to which the factory belongs, or by professional auditors working for an independent accredited auditing organisation.

Since most processing lines are quite complicated, both HACCP teams and Audit

“teams” should include members with different expertise. However, the auditors should have some advantages, which the HACCP team may not have. The reason for this is that the HACCP team may overlook certain things because of a well known “familiarity blindness” due to its professional affiliation with the company. Therefore the Audit team should be able to identify possible week points of the HACCP plan proposed by a HACCP team.

Very often auditors are acting on behalf of a customer who has specific requirements, and they may recommend improvements to satisfy their customer’s specific needs.

Taking under consideration that audit is a tool through which the operations of the HACCP system are formally monitored and conformance with the documented system is assured, we may say that through audit it is possible to:

ƒ confirm that the written procedures (prerequisite programme and HACCP plans) are up to date;

ƒ to review the HACCP system for its conformity³³ with the written procedures (implemented as described);

ƒ measure the effectiveness of the HACCP system in meeting the objectives set in the written procedures. Furthermore audit has to assure uniform and consistent actions, to guarantee the objectiveness of the evaluation, to maintain records and enhance their use and maintenance in the plant.

Now taking under consideration that audit is consistent with the ISO 10011 we can apply to it the following definition:

“Audit is a systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives”.

The audit has to assure uniform and consistent actions and objectiveness of the evaluation. All these information should be kept in records (Audit Records).

33 The word “conformity” is used in reference to industrial activities; the word “confirmation” refers to a regulatory situation.

The business management and the competent authorities are responsible, each for his own competence, to guarantee the efficacy and efficiency of the check system implemented.

Specifically the role of the industry is to develop, implement and maintain prerequisite programmes and HACCP plans, to maintain the necessary records and ensure an appropriate training programme for the staff.

On the other hand the competent authorities should verify the compliance³⁴ with planned measures and their efficiency to assure the safety of food. By doing so, the audit target is to evaluate the effectiveness of the measures described in HACCP plans and their efficiency to achieve the objective.

An official reference about a regulatory system audit that explains in details, how to develop own-checks system verification does not exist. The European Union has not elaborated any procedures for “Auditory field activities” and has not defined any tools to gather and record information during an own checks system verification.

18.1.3. Types of Audit (a) First party audit

It’s the tool by which the “business” is monitoring adherence to the documented HACCP system. It provides detailed information about failures of the system and highlights the potentiality of improvement. The auditors are chosen within the company but not strictly related to the area, function or procedures being audited.

(b) Second party audit

It is the tool through which the customer can directly evaluate if the process/product of his supplier satisfies its request. In this case the auditor usually belongs to the customer’s staff.

Sometimes the supplier can choose one person among the personnel who can act as a

“representative” of the customer. In many cases the customer is hiring an independent expert to do the Auditing for him.

(c) Third party audit

It is performed by agencies, independent of both customer and suppliers, recognised as competent to assess system against a standard. For quality management system, third party audit is carried out by internationally recognised agencies; it’s volunteer and the company will achieve certification related to the quality standard met.

Regulatory Audit complies with this type of audit.

(d) Vertical audit

It is used to look in depth a particular function or department. It permits to monitor the use of all relevant procedures as they are used to support this function or department.

(e) Horizontal audit

It is used to follow a process from the start to the end. This kind of audit would look at procedures as they support the process itself and is likely to span many different functions or departments. Audits or assessment leading to certification are likely to be horizontal.

34 In definitions both of conformity and compliance, it is mentioned that they refer not only to HACCP, but also to its prerequisites. Foods in international trade have to be produced according to General Principles of Hygiene and HACCP. Even for foods, which are intended for domestic use, GHP should be the basis;

HACCP is complementary to the system, but cannot stand-alone. For this reason the word “prerequisites” has been introduced.

(f) Partial audit

It consists of an assessment of a part of the system. The partial audit goal may be focused on:

- selected components or areas of HACCP system;

- follow-up to previous full or partial audit;

- concerns detected through consumer complaints;

- company’s HACCP system changes;

(g) Full audit

It consists of an assessment of both, prerequisite programmes and HACCP systems

18.1.4. Auditor³⁵

An auditor generally should be a person with abilities and deep knowledge on the subject. It is important that he will be able to show tact and ability to put Auditees at ease. He should also be a good listener and aware questioner. From the technical point of view he should have a suitable technical background to really understand the process being audited and of course some knowledge of quality management.

The above specifications rarely come together in one person. Therefore it’s necessary a - on job - training together with a specific training course in order to achieve the necessary familiarity with the audit system.

The best HACCP plan in the world will not work if the people who implement it are not properly trained. Training is very important for people responsible for the development of the HACCP plan, as well as people who have to assess its implementation and maintenance.

18.1.5. Audit procedure

The audit procedure and the related forms belong to the HACCP system documents. It will include surveillance activities and checks on monitoring data to assure the respect of critical limits as well as systematic and independent measures (control and test on products and processes). The reason for that is to achieve objective evidence that the food processing plant own-checks-system complies with the standards.

All the results will be filed in order to qualify and assure that the audit will be conducted on the basis of previously established rules, which will define methods, tools, frequency, responsibility and proper record keeping.

18.1.6. Frequency of auditing

The frequency of auditing has to assure that the System will not loose efficacy with time. Therefore special audits out-of-schedule, should take place when there are changes related to raw material (new supplier for example) or to the product (changes in processing conditions, purchase of new equipment, new packaging material, extra cleaning and sanitising, etc).

Other reasons for extra (out-of-schedule) audits are: change in storage conditions, consumer use, receipt of any information on a new hazard associated with the product, evidence or suspect of non compliance, previous audit findings, etc.

Frequency is strictly related to the risks presented by a product and processes and to the ability of the establishment to adhere to its HACCP system. The risks of the establishment can be classified under three categories:

Category I: includes all the factories whose process includes a “kill step” or