Wednesday, March 12, 2014

ISO 22000: WHAT IS ISO 22000 GAP ANALYSIS? – Section IV

Gap Analysis IV
In ISO 22000 food safety management systems (FSMS), prerequisite programs (PRPs) provide the foundation for hazard analysis and critical control point (HACCP) to function. Food safety experts have found that well-functioning PRPs simplify and strengthen the HACCP plan within the ISO 22000 FSMS. The PRPs are based on good manufacturing practices or good hygienic practices.

Some of the most common PRPs of ISO 22000 which are basically belong to GMP includes:

  1. Facilities, including construction and layout of buildings, associated utilities, premises, work space and employee facilities.
  2. Supporting utilities including air, water and energy.
  3. Supporting services including waste and sewage disposal.
  4. Suitability of equipment and accessibility of equipment for cleaning and maintenance.
  5. Management and control of purchased materials.
  6. Prevention of cross contamination.
  7. Cleaning and sanitizing.
  8. Pest control.
  9. Personal health and hygiene.
  10. Environmental monitoring.
  11. Chemical control.
  12. Glass and hard plastic control.
  13. Product trace and recall.
  14. Complaint investigation.
  15. Labeling.
  16. Employee training and competencies.
However, we are going to discuss ISO 22000 focused PRPs more comprehensively at a later stage after discussing about the Gap Analysis because this process is happens before company has a ISO 22000 FSMS, where it will compromise your thought process if you focus on ISO 22000 requirements instead of GMP. 

Section IV: Distribution Facilities
4.1 General (GMP and Codex Requirement)
Where necessary, conveyances and bulk containers should be designed and constructed so that they:
Do not contaminate foods or packaging;
Can be effectively cleaned and, where necessary, disinfected;
Permit effective separation of different foods or foods from non-food items where necessary during transport;
Provide effective protection from contamination, including dust and fumes;
Can effectively maintain the temperature, humidity, atmosphere and other conditions necessary to protect food from harmful or undesirable microbial growth and deterioration likely to render it unsuitable for consumption; and
Allow any necessary temperature, humidity and other conditions to be checked.
Conveyances and containers for transporting food should be kept in an appropriate state of cleanliness, repair and condition. Where the same conveyance or container is used for transporting different foods, or non-foods, effective cleaning and, where necessary, disinfection should take place between loads.
Where appropriate, particularly in bulk transport, containers and conveyances should be designated and marked for food use only and be used only for that purpose.

Compliance Criteria
Closely inspect the given points to identify the extent of the existing design and recommend to improve or to maintain the current model. Concentrate on the given points to evaluate more thoroughly and systematically.  

The Control Points
  1. Vehicles used for the primary distribution of chilled or frozen foods should be capable of maintaining the specified temperature ranges, which have been agreed with the manufacturer.
  2. Temperatures at the point of dispatch and during transit, must be monitored and recorded and must comply with those agreed.
  3. Loading of such vehicles must take place through sealed docks, from a temperature-controlled environment.
  4. Prior to loading, all delivery vehicles must be internally inspected to ensure that they are clean, free from moisture, foreign objects and pests that could cause product contamination or damage to the packages. This check should be recorded.
  5. It is essential where vehicles are used to transport different products e.g raw material, final products, and by products then the vehicles should be free from odours, which could cause taint problems, and that this is checked and recorded.
  6. Delivery of products must always be within closed vehicles to prevent contamination from external sources.
  7. The driver of the vehicle must comply with relevant aspects of the GMP requirements at the factory and at the depot or store.
  8. Where the services of a contract distribution company are commissioned their vehicles and administrative procedures must be vetted and deemed acceptable prior to a contractual agreement being made.
  9. For chilled products, a designated person should check the internal temperature of the product by placing temperature recording device in gills, for all vehicles. Dispatched frozen or chilled product must be maintained at correct temperature and monitored at the airport prior to release. The QA team should be aware of these checks. It is recommended that external digital temperature recorders are on trucks delivering to the port of exit e.g airports, seaports.
  10. The internal condition of delivery vehicles must be inspected prior to unloading deliveries or loading finished product, to ensure that vehicles are clean, well maintained and free of foreign bodies, pests and odours.
  11. Where, for whatever reason the use of a vehicle is rejected by the Quality Assurance department, the reasons for rejection must be recorded, dated, signed and appropriate corrective action taken. Where contract distribution companies are used, this will mean talking to them directly.

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