Tuesday, November 20, 2018

ISO 22000:2018 Structural Changes – IV


Performance Evaluation
The ISO 22000:2018 revision has changed much on the structure where it has introduced a new section which is called performance evaluation base on the Annex SL format. Since, ISO 22000 is applicable to all organizations in the food and feed industries, regardless of size or sector it needs more integrity to work with combination of other standards. Hence, following the same High-Level Structure (HLS) as other ISO management system standards, such as ISO 9001 (quality management), it is designed in a way that it can be integrated into an organization’s existing management processes but can also be used alone, where integration of performance evaluation has collapse several areas together which are differently considered before. Therefore, following topics has been considered in the given order under performance evaluation.

9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review

Monitoring, Measurement, Analysis and Evaluation
The section specifically discussed on the major requirements of;
a) What needs to be monitored and measured?
specific areas needs to be considered by the management according to the identified food safety hazards, PRPs, OPRPs and CCPs as well as any other requirements specified by interested parties.
   
b) The methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results;
The specific methods to be employed and the requirements to ensure valid results obtained during the operation as to the pre-specified requirements

c) When the monitoring and measuring shall be performed;
The time lines, intervals for specified activities

d) When the results from monitoring and measurement shall be analyzed and evaluated;
Time line for decision making from the outcome

e) Who shall analyze and evaluate the results from monitoring and measurement.
The responsibilities and authorities for decision making

The objective of the section is to prepare documented information of the procedures to be followed during the course of action against predetermined requirements with appropriate methods and practices. The evidence of the results will be collected in a specified manner to support the next steps of the process such as analysis and evaluation, internal audits as well as management review. Thus, section has completely focus on the system performance while connecting each other in a sequential manner. In the previous version of the ISO 22000:2005, management review was one of the first things which came first before anything, but in the new version it has come out at last because after the initial meeting to set up a food safety management system, it is come as a review meeting where you need information, results and outcomes to manage a review. 

Analysis and evaluation
As it is specified in the standard “The organization shall analyze and evaluate appropriate data and information arising from monitoring and measurement including the results of verification activities related to PRPs and hazard control plan (8.8 and 8.5.4), the internal audits (9.2) and external audits”. Thus, section should specify the relevant methods that are used evaluate and analyze obtained results as explained in the above section which will be applied here to make decisions based on the system performance. Hence, it further explains where analysis shall be carried out in order to:
a) Confirm that the overall performance of the system meets the planned arrangements and the FSMS requirements established by the organization;

b) Identify the need for updating or improving the FSMS;

c) Identify trends which indicate a higher incidence of potentially unsafe products or process failures;

d) Establish information for planning of the internal audit program related to the status and importance of areas to be audited;

e) Provide evidence that any corrections and corrective actions are effective.

The results of the analysis and any resulting activities are documented as specified and kept for further references during internal or external audits, management reviews as well as to improve the FSMS while identify trends for future considerations.

Internal Audit
As of internal audits, there is no much difference to the scope of the activities from the previous version, most of the standard audit practices are included as the previous version. Hence, if you have a previous audit procedure which can be used in the new system with minimal changes where you should consider anything if you have missed in the following areas given in the standard.

As it explains the organization shall conduct internal audits at planned intervals to provide information on whether the FSMS is conforms to the organization’s own requirements for its FSMS and the requirements of this document, as well as if it is effectively implemented and maintained.

Nonetheless, organization also need to have to plan, establish, implement and maintain an audit program(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes in the FSMS, and the results of monitoring, measurement and previous audits. The program must define the audit criteria and scope for each audit while selecting competent auditors and conduct audits to ensure objectivity and the impartiality of the audit process. Ensure the results of the audits are reported to the food safety team and relevant management while retaining the documented information as evidence of the implementation of the audit program and the audit results. The evidence should further specify the necessary correction and corrective action taken within agreed time frame, to determine if the FSMS meets the intent of the food safety policy (5.2), and objectives of the FSMS (6.2).
In addition, follow-up activities by the organization should include the verification of the actions taken and the reporting of the verification results.

Management Review
As of previous version, management review has no much difference where your previous procedure can be reused with slight modifications. It requests top management to review the organization’s FSMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. Hence, the management review input and the output has no much difference either where your company specifications based on the product manufactured and the requirements of the interested parties may add few more specific requirements to the scope. Thus, only difference is the scope has been widened than the previous version including monitoring, measuring analysis, evaluations and audits.    

Management review input
The management review request you to include consideration of:
a) The status of actions from previous management reviews;
b) Changes in external and internal issues that are relevant to the FSMS including changes in the organization and its context (4.1);
c) Information on the performance and the effectiveness of the FSMS, including trends in:
1) Result of system updating activities (4.4 and 10.3);
2) Monitoring and measurement results;
3) Analysis of the results of verification activities related to PRPs and the hazard control plan (8.8.2);
4) Nonconformities and corrective actions;
5) Audit results (internal and external);
6) Inspections (e.g. regulatory, customer);
7) Performance of external providers;
8) Review of risks and opportunities and of the effectiveness of actions taken to address them (6.1);
9) Extent to which objectives of the FSMS have been met.
d) The adequacy of resources;
e) Any emergency situation, incident (8.4.2) or withdrawal/recall (8.9.5) that occurred;
f) Relevant information obtained through external (7.4.2) and internal (7.4.3) communication, including requests and complaints from interested parties;
g) Opportunities for continual improvement.               

Considering the above factors it is basically the same management review model without major differences, where it further requests you to present data in a manner that enables top management to relate the information to stated objectives of the FSMS.

Management review output
As usual management output also similar to its predecessor which request to include decisions and actions related to continual improvement opportunities as well as any need for updates and changes to the FSMS, including resource needs and revision of the food safety policy and objectives of the FSMS. The relevant information must be retained as documented information for evidence of the results of management reviews.

While adapting to the new format, the performance of the system is being evaluated and organized under a single section where it has given greater opportunities for merging any ISO standard manufacturer intended to follow. Thus, inclusion of additional audit requirements to a single procedure has been possible with reduction of complexities while adapting a single format.

Reference: ISO 22000:2018 Standard 

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