mdi ConsultantsFood Services Update: September, 2010
Many food suppliers and/or manufactures are being brought into the 21 Century. For the past 30 years the pharmaceutical and medical device industries had to comply with a whole set of complex regulatory requirements both from the US FDA and/or foreign governments. There is the FDA cGMPs, FDA QSR/cGMP, ISO 9000 and ISO 13485.
Well, now the worldwide food industry is looking to upgrade the demands needed to complete in this complex and inter connecting world. The large chain stores are pushing this agenda and forcing it down to their suppliers and thus down to even the smallest suppliers.
First it was just a “third party” audit for a recognized sourced. Companies had to meet the requirements of this auditor.
Now, this has move one step higher and this is to achieve either the BRC (British Retail Consortium) standards or the ISO22000 certification.
What are these new standards that are being voluntarily being imposed on the food industry? Basically, the BRC and the ISO standards are a combination of the ISO9000 requirements and the HACCP program.
So why is this new standard for the food being “demanded” at this time?
Maybe it is because in the past few years of the major product recalls: spinach and salads, peanuts, and most recently the salmonella in eggs.
As you may have known the ISO (International Organization of Standardization) has extensive experience in developing standards for many different types of applications. You are probably very familiar with the ISO 9000 (Quality Management System) and the 13485 (Quality Management System for Medical Device Manufactures). These standards was developed to provide a uniform standard worldwide for quality management.
These standards provide a buyer in one part of the world would have a degree of confidence in the quality practices of a registered company in another part of the world. These standards have been used as the basis for other more specific standards for quality management in the automotive industry, and the aerospace industry, as well.
Now this approach has been taken for Food Safety Management. This is a major change for the food industry that had had its quality policies under regulatory scrutiny but not reviewed by a voluntary standards group.
Now the ISO and its member countries used the Quality Management System approach, and tailored it to apply to Food Safety. This standard will be incorporating the widely used and proven HACCP principles into the quality management system. This new standard is called ISO 22000.
WHAT DOES ISO 22000/BRC REQUIRE?
If you are familiar with the ISO 9000 and the HACCP, the ISO22000 standard will now be incorporate both of these well understood requirements and systems into one standard.
ISO 22000 requires that you design and document a Food Safety Management System (FSMS). The standard contains the specific requirements to be addressed by the FSMS. Generally the standard addresses:
- Having an overall Food Safety Policy for your organization, developed by top management.
- Setting objectives that will drive your companies efforts to comply with this policy.
- Planning and designing a management system and documenting the system.
- Maintaining records of the performance of the system.
- Establishing a group of qualified individuals to make up a Food Safety Team.
- Defining communication procedures to ensure effective communication with important contacts outside the company (regulatory, customers, suppliers and others) and for effective internal communication.
- Having an emergency plan.
- Holding management review meetings to evaluate the performance of the FSMS.
- Providing adequate resources for the effective operation of the FSMS including appropriately trained and qualified personnel, sufficient infrastructure and appropriate work environment to ensure food safety.
- Following HACCP principles.
- Establishing a traceability system for identification of product.
- Establishing a corrective action system and control of nonconforming product.
- Maintaining a documented procedure for handling withdrawal of product.
- Controlling monitoring and measuring devices.
- Establishing and maintaining and internal audit program.
- Continually updating and improving the FSMS.
What is required for 22000 Registration?
Besides the above requirements for achieving ISO22000 certification, your quality system would be required include a HACCP program as part of your Food Safety Management Systems Standards?
HACCP
Your food safety team will need to create and implement a Hazard Analysis and Critical Control Point plan (HACCP Plan) for each product or process. The HACCP plan starts with some preliminary steps such as identifying product characteristics, describing intended use, preparing flow diagrams and describing process steps. The team uses this information to identify hazards that can be expected to occur, determine acceptable levels of the hazard and select control measures.
The team identifies the control point where the hazard can be controlled, and the specific step that needs to be taken to successfully control the hazard. The plan for controlling the hazard must be documented and include the hazard to be controlled, the control measure, critical limits, how the control point will be monitored, corrections and corrective actions to be taken if limits are exceeded, responsibilities and authorities and required records.
Verification
The food safety team will also establish a plan for verification activities to ensure that the PRPs are implemented, inputs to hazard analysis are updated, the operational PRPs and HACCP plan are implemented and effective and the hazard levels are within limits. Verification activities make sure the HACCP system is in compliance.
Traceability
A system of traceability of product must be in place. Make sure that you can perform an effective recall if necessary. You must also be able to control any nonconforming product. Document your process to control affected product when critical control limits are exceeded. Include taking action to identify and eliminate the cause of nonconformity and prevent nonconforming product from entering the food chain.
Internal Audits
Once the system is implemented you will be verifying that it is working on an ongoing basis. The verification will include internal audits by your own audit team and food safety team evaluation of the verification activities.
If you are already in the food industry, and providing a safe food product or service, you most likely have many of these practices in place even though they may not be formally documented.
Adding the effectiveness of a documented food safety management system will provide your company not only the benefits of recognition of having a management system in place, but also the benefits of quality management and the security of producing safe product for your customers.
To discuss how the Food Services Third Party Certification will affect your business, e-mail us at [email protected] and reference “Food Services – ISO 22000”.