The term documented information relates to both how to operate a process procedure, work instruction, etc. A documented Food Safety Manual is no longer required. Requirement made applicable to all types of documented information including records. Documented information of external origin determined by the organization to be necessary for the planning and operation of the FSMS shall be identified, as appropriate, and controlled.
A written procedure for controlling documents and records is no longer required. The requirements originally included under 7. Includes reference to control of changes 6.
How does the organization ensure food safe product is consistently realized through each step in the process each hand off? How do they control the actions put in place to address the risks and opportunities determined in section 6.
What process es do they have in place to control planned changes? How do they learn from changes that unintendedly impact their FSMS?
How do they control outsourced processes — external design company, transportation, warehousing, production competitor used for overflow orders, etc.
Wording has been changed slightly and appropriateness of the PRP linked to the context of the organization. PRP's Documented information shall now also specify their selection, applicable monitoring and verification. Did results of verification activities show a PRP should be updated? Ask for documented evidence of this planned change. Section 8. Wording has been changed, minimum requirements when establishing a traceability system have been added including reworking.
Requirement for verification and testing of the effectiveness of the traceability system has been added. Now includes requirements for taking rework into account and ensuring retention time of records related to the shelf life of the products. Reconciliation of quantities of end products with the quantity of ingredients should be considered. Is the organization tracking scrap? The organization MUST verify and test the effectiveness of the traceability system.
A requirement for documented information regarding the management of these situations has been included. Documented information shall be established and maintained to manage situations and incidents that have occurred.
Documented information must be reviewed and, where necessary, updated after the occurrence of any incident, emergency situation or test. The organization should periodically test procedures, where practical.
An annual fire drill is not good enough. Was the test a success, or did it reveal an unintended impact that requires a revision to procedures? Description of process steps and control measures 7. Requirements related to the competence of the Food Safety Team have been relocated to Clause 7. General: Minimum relevant information to be considered when conducting the Hazard Analysis has been added. Characteristics Raw Material: Source e.
Characteristics end product: wording such as Methods of distribution and delivery has been added. Flow Diagrams: Inputs and Outputs to be detailed in the flow diagrams have been extended and the on-site verification requirements described separately 8. Clarification Notes have been added. Recommendation to consider hazards in sufficient detail has been added.
Requirement to use the pre-defined flow diagram has been added in alignment to the Codex. Hazard Assessment: The word elimination of food safety hazards has been removed. Requirement to identify significant food safety hazards has been included. Selection of control measures: The word elimination re food safety hazards has been removed and the wording significant food safety hazards has been added to scope of application of this sub-clause.
External requirements that can impact the choice and strictness of control measures shall be documented. Wording has been changed to clarify that validation applies to both single control measures and combinations of control measures. Requirement to maintain the validation methodology and evidence of capability has been added. Action Criteria definition has been included as a requirement for OPRP as well as specific requirements to define them.
The input of monitoring methods has been added as an additional option next to monitoring devices. For OPRPs, equivalent methods of verification of reliable measurements are now permitted in place from calibration methods. Requirements for actions to be taken are not only applicable for when critical limits are not met but also when action criteria is not met.
The scope of application of 8. Requirements for validation of software used in monitoring and measuring within the FSMS have been added, including documented information in validation activities. Requirement for impartiality of person conducting the verification has been added not the same person that performs the monitoring. Application of corrective actions has been included in case potentially unsafe product is detected via the verification activities.
Person performing verification activities can not be a person who is involved in the monitoring of that PRP. Handling of potentially unsafe products: Requirement clarified for evaluating each lot of affected product. Requirement added for not releasing product affected by failure to meet critical limits at a CCP, leaving the evaluation for release only applicable to products that fail to comply with the action criterion of an OPRP.
Requirement added to retain as documented information the results of the evaluation of release. When nonconformity of a product is related to critical limits at CCPs that product is potentially unsafe and shall not be released. When nonconformity of a product is related to action criteria for oPRPs that product may be released, provided the requirements of 8.
Documented information must be retained! General: organization must determine what, when and how they will monitor and measure, and who and when will these results be analyzed and evaluated. Results must be retained as documented information. Importance of the Processes: these vary but may include management review, corrective action, internal audit, actions to address risks and opportunities, operational planning, and objectives.
Changes Affecting Organization: Unique situations could warrant additional audits. High turnover - competence and awareness. MR Inputs: The structure and number of inputs for the management review have been amended. NOT just a listing. Did actions to address risks and opportunities from section 6 achieve intended results? If they did, how was it documented in MR minutes? If they did not, how were actions updated and revised?
New clause specifying requirements to deal with non-conformities within the organization, including the requirement to determine if similar non conformities could potentially occur preventive actions. Three types of evidence for you to review: 1 Does the action relate to the root cause?
How is site management reviewing the effectiveness of the corrective action s? This is NOT a verification that the action was implemented i. Requirement extended to include the improvement of the suitability and adequacy of the FSMS, not just the effectiveness.
What Opportunities for Improvement are site management working on? Did these Continual Improvements achieve the intended result s?
If so, how did site management update the FSMS focus on section 9. If not, how has management adjusted their planning section 6? Open navigation menu. Close suggestions Search Search. User Settings. Skip carousel. Many of them are also animated. The majority of foods entering Saudi Arabia are subjected to rigorous inspection.
Manufacturers and distributors must conform to several requirements to sell their products in the Middle East market. Applying for ISO certification in Saudi Arabia can be highly beneficial to people in the food industry. PowerPoint PPT presentation free to view. This provides customer confidence in the product. ISO Certification - FSMS - ISO Certification is the overall sanitation the executives framework standard for the whole nourishment supply arrange, from cultivators and creators to processors and bundling, transport and motivation behind deal.
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The standard spotlights on stock system confirmation, has the board structure norms embedded, and is agreed with HACCP principles. It helps corporate professional to establish good food safety management system in organization. It is one of the most widely recognised standards when it comes to food safety regulations. It helps give to ISO training to teach food safety requirements, steps for FSMS implementation as well as food safety system advantages to the performance of organization.
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Manufacturers and distributors must conform to several requirements to sell their products in the Middle East market.
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