Food Safety Management System Certification

Audit Summary Report

Organization:

Address:

Standard(s):

Representative:

Date(s) of audit(s):

This report is confidential and distribution is limited to the audit team, audit attendees client representative and the Certification Body office.

1.  Audit objectives

The objectives of this audit were:

To determine conformity of the management system, or parts of it with audit criteria and its:

 -ability to ensure applicable statutory, regulatory and contractual requirements are met,

-effectiveness to ensure the client can reasonably expect to achieve specified objectives, and

-ability to identify as applicable areas for potential improvement.

2.  Scope of certification

Has this scope been amended as a result of this audit?

This is a multi-site audit and an Appendix listing all relevant sites and/or remote locations has been established (attached) and agreed with the client.

For integrated audits, confirm the current level of the client’s IMS integration:

3.  Current audit findings and conclusions

The audit team conducted a process-based audit focusing on significant aspects/risks/objectives required by the standard(s). A sampling process was used, based on the information available at the time of the audit.  The audit methods used were interviews, observation of activities and review of documentation and records. The structure of the audit was in accordance with the audit plan included as an annexe to this summary report.

The audit team concludes that the organization

established and maintained its

4.  Previous Audit Results

The results of the last audit of this system have been reviewed, in particular to assure appropriate correction and corrective action has been implemented to address any nonconformity identified. This review has concluded that:

5.  Audit Findings

The audit team conducted a process-based audit focusing on significant aspects/risks/objectives. The audit methods used were interviews, observation of activities and review of documentation and records.

1-The management system documentation demonstrated conformity with the requirements of the audit standard and provided sufficient structure to support implementation and maintenance of the management system.

2-The organization has demonstrated effective implementation and maintenance / improvement of its management system and is capable of achieving its policy objectives, as well as and the intended results of the respective management system(s).

3-The organization has demonstrated the establishment and tracking of appropriate key performance objectives and targets and monitored progress towards their achievement.

4-The internal audit program has been fully implemented and demonstrates effectiveness as a tool for maintaining and improving the management system.

5-The management review process demonstrated capability to ensure the continuing suitability, adequacy and effectiveness of the management system.

6-Throughout the audit process, the management system demonstrated overall conformance with the requirements of the audit standard.

7-Certification claims are accurate and in accordance with CB guidance and the organization is effectively controlling the use of certification documents and marks.

6.  Significant Audit Trails Followed

The specific processes, activities and functions reviewed are detailed in the Audit Planning Matrix and the Audit Plan. In performing the audit, various audit trails and linkages were developed, including the following primary audit trails, followed throughout:

Relating to Previous Audit Results:

GUIDE TO AUDITORS

• The standard chapters marked with * must be checked during a surveillance audit at random, parts of the remaining chapters will be examined, depending on the time available.
• In the case of multi-site assessment MSA, the proofs per location must be explicitly stated.
  This usually concerns chapter 8.

Color legend:
Black        = Clause applicable for ISO 9001 + ISO 14001 + ISO 45001

Blue          = Clause applicable for ISO 9001

Green       = Clause applicable for ISO 14001

Red          = Clause applicable for ISO 45001 (In the case of migration from OHSAS to ISO 45001, checklist must be used)

Food Safety Management System Processes

4.CONTEXT OF THE ORGANIZATION

4.1 Understanding the organisation and its context

The organization has determine external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended safety management system.

4.2 Understanding the needs and expectations of the interested parties

The organization has determined the interested parties and their needs and expectations and monitors and reviews the information about the interested parties and their requirements.

4.3 Determining the scope of the food Safety management systems

The organisation has determined the (geographic) boundaries and applicability of the management system – considering the external and internal issues, the requirements by the interested parties and their product and services.

When determining this scope, the organization shall consider:

The external and internal issues referred to in 4.1

The requirements referred to in 4.2

The scope shall be available and maintained as documented information.

4.4 Food Safety Management System Performance of Laboratory Activities

The organization has establish implement, maintain, update and continually improve a food safety management system including the processes needed and their interactions, in accordance with the requirements of document.

5-LEADERSHIP

5.1 Leadership and commitment

Top management has demonstrate leadership and commitment with respect the food safety management system by:

Ensuring the integration of food safety management system requirements into the organization's business process:

Ensuring that the resource needed for the food safety management system are available;

Communicating the importance of effective food safety management and of confirming to the food safety management system requirements, statutory/regulatory requirements and mutually agreed customer requirements related to food safety;

Ensuring that the food safety management system is evaluated and maintained to achieve it intend outcome(s) results (see4.4)

Directing and supporting persons to contribute to the effectiveness of the food safety management systems;

Promoting continual improvement;

Supporting other relevant management roles to demonstrate their food safety leadership as it applied to their areas of responsibility.

Refers to” business” in this document can be interpreted broadly to mean those activities that are core to the purpose of the organization existence.

5.2 Food Safety Policy

5.2.1 Establishing The Food Safety Policy

Top management has establish, implement, and maintain a food safety policy that:

Is appropriate to the purpose and context of organization;

Provides a framework for setting n reviewing the objectives of food safety management system;

Includes a commitment to satisfy applicable food safety requirements including statutory/regulatory requirements and mutually agreed customer requirements related to food safety;

Address internal and external communication;

Includes a commitment to continual improvement of the food safety management system;

Address the need to ensure competencies related to food safety.

5.2.2 Communicating The Food Safety Policy

The food safety policy:

Be available and maintained as documented information;

Be communicated, understood, and applied at all levels within the organization;

be available to all relevant interested parties, as appropriate.

5.3 Organizational roles, responsibilities and authorities

Top management makes sure the responsibilities and authorities for relevant roles are assigned, communicated, and understood within the organization.

Top management makes sure the responsibility and authority for:

Ensuring that the food safety management system conforms to the requirements of this document;

Reporting on the performance of the food safety management system to top management;

Appointing the food safety team and the food safety team leader;

Designation person with defined responsibility and authority to initiate and document action(s).

5.3.2 The Food Safety Team Leader Shall Be Responsible For:

Ensuring the food safety management system is established, implemented, maintained and updated;

Managing and organizing the work of the food safety team; and

Ensuring relevant training of food and competencies for the food safety team (see 7.2)

Reporting to top management on the effectiveness and suitability of the food safety management system.

All person makes sure have responsibility to report problem(s) with food safety management system to identified person(s).

6-PLANNING

6.1 Actions to address risks and opportunities

The organization has determine the risks and opportunities that need to be addressed to:

assurance that the FSMS can achieve its intended result(s) enhance desirable effects prevent, or reduce, undesired effectsachieve continual improvement.

Plan include actions to address these risks and opportunities.

integrate and implement the actions into its FSMS processes.

evaluate the effectiveness of these actions.

6.1.2 The organization Risk plan:

Actions to address these risks and opportunities;

How to:

Integrate and implement the actions into its food safety management system processes;

Evaluate the effectiveness of these actions.

6.1.3 The actions taken by the organization to address risks and opportunities shall be proportionate

The potential impact on food safety requirements, and;

The conformity of food products and services to customers, and;

Requirements of interested parties in the food chain.

With reference to the note 1 in 6.1.3

Options to address risks and opportunities can include: avoiding risks, taking risks in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risks, or accepting the presence of risk by informed decision.

With reference to the note 2 in 6.1.3

Opportunities can be lead to the adoption of new practice (modification of products or processes), using new technology and other desirable and viable possibilities to address the organization's or its customer's food safety needs.

6.2 Objectives and planning to achieve them

6.2.1 The organization has establish objectives of the food safety management system at relevant functions and levels.

The objectives of the food safety management:

Be consistent with food safety policy; authorization of results

Be measurable (if practicable);

Take into account applicable food safety requirements including statutory/regulatory and customer requirements

Be monitored and verified;

Be communicated;

Be maintained and updated as appropriate.

The organization shall retain documented information on the objectives of the food safety management system.

6.2.2 The organization has planning how to achieve its objective of the food safety management system, the organization shall determine:

What will be done;

What resources will be required;

Who will be responsible;

When it will be completed;

How the results will be evaluated.

6.3 Planning of changes

the organization has determine the need for change to the food safety management system, including personnel changes, the changes shall be carried out and communicated in planned manner.

The organization shall consider:

The purpose of the changes and their potential consequence for supply and maintenance of safe food production;

The integrity of the food safety management system;

The availability resources to effectively implement the changes;

The allocation or re-allocation of responsibilities and authorities,

7. SUPPORT

7.1 Resources

7.1.2 People

 7.1.3 Infrastructure; 7.1.4 Environment for the operation of processes

The organization has determined, makes available and maintains the necessary infrastructure (machines, EDP systems, buildings, etc.) and environment for the functioning of its processes in order to guarantee the conformity of the products/services provided.

 7.1.5 External developed elements of the food safety management system

the organization has establishes, maintains, and continually improves its food safety management system by externally developed elements of a food safety management system including PRPs and the hazard control plan

 7.1.6 Control of externally provided processes, products, or services

the organization has Establish and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers of processes, products, or services.

7.1.2 People

7.2 Competence

7.3 Awareness

The organization has identified and empowered people who are necessary for the effective implementation of the Management System (MS) and for the realization and management of its processes

The organization has determined the necessary competences for the personnel who carry out work activities under its control and verifies that the personnel satisfy them or has undertaken the appropriate actions to guarantee their acquisition (including the ability to identify hazards).

Personnel who work under the control of the organization are aware of the policy and objectives set by the organization, as well as the contribution they can make to the effectiveness of the MS, as well as the consequences of not complying with the requirements of the MS.

7.4 Communication

The organization has established and maintains a concept about internal and external communication.

(including contractors and visitors to the workplace).

In establishing its communication modalities, the organization has considered the aspects of diversity and opinions of interested parties and these modalities allow workers to contribute to the improvement of the FSMS-Management System.

7.5 Documented information (Create and update, steering documented information)

The documental structure of the Management System is adequate to the complexity of the organization, its processes / products / services and the skills of the people and includes the documented information required by the applicable reference standard.

The documented information, incl. those of external origin, are identified, reviewed, approved, kept under control (distribution, access, retrieval, updating, storage and preservation, retention and elimination) and protected (confidentiality, integrity and maintenance of legibility), as appropriate.

8. OPERATION

Comment: Please report about all shifts which have been audited

8.1 Operational planning and control

The organization has established and monitors the processes identified as relevant of its FSMS Management System (incl. the outsourced processes) in order to implement the actions necessary to address risks and opportunities and governs these processes by implementing the necessary controls.

8.2 Prerequisite programmes (PRPs)

The organization has establish, implement, maintain and update PRP(s) appropriate to the organization and its context with regard to food safety appropriate to the size and type of the operation and the nature of the products being manufactured and/or handled; implemented across the entire production system, either as programmes applicable in general or as programmes applicable to a particular product or process; approved by the food safety team. ensure that applicable statutory, regulatory and mutually agreed customer requirements.

8.3 Traceability system

The organization has able to uniquely identify incoming material from the suppliers and the first stage of the distribution route of the end product ensure that applicable statutory, regulatory and customer requirements are identified. Documented information retained for a defined period to include, as a minimum, the shelf life of the product. verify and test the effectiveness of the traceability system.

8.4 Emergency preparedness and response

8.4.1 General

The organization has ensure procedures are in place to respond to potential emergency situations or incidents that can have an impact on food safety which are relevant to the role of the organization in the food chain.

8.4.2 Handling of emergencies and incidents

The organization has determine respond to actual emergency situations and incidents to reduce the consequences of the emergency situation review and, where necessary, update the documented information.

8.5 Hazard control

8.5.1 Preliminary steps to enable hazard analysis

8.5.1.1 General

The organization food safety team carry out the hazard analysis, preliminary documented information to collected, maintained and updated.

8.5.1.2 Characteristics of raw materials, ingredients and product contact materials

The organization ensure that all applicable statutory and regulatory food safety requirements identified for all raw materials, ingredients and product contact materials maintain documented information concerning all raw materials, ingredients and product contact materials to the extent needed to conduct the hazard analysis.

8.5.1.3 Characteristics of end products

The organization ensure that all applicable statutory and regulatory food safety requirements are identified for all the end products intended to be produced concerning the characteristics of end products to the extent needed to conduct the hazard analysis.

8.5.1.4 Intended use

The organization expected handling of the end product any unintended use but reasonably expected mishandling and misuse of the end product groups of consumers/users identified for each product.

8.5.1.5 Flow diagrams and description of processes use

8.5.1.5.1 Preparation of the flow diagrams

The organization establish, maintain and update flow diagrams by Food Safety Team clear, accurate and sufficiently detailed to the extent needed to conduct the hazard analysis via Flow diagrams the sequence and interaction of the steps in the operation; any outsourced processes; where raw materials, ingredients, processing aids, packaging materials, utilities and intermediate products enter the flow; where reworking and recycling take place; where end products, intermediate products, by-products and waste are released or removed.

8.5.1.5.2 On-site confirmation of flow diagrams

The organization confirm on-site the accuracy of the flow diagrams update the flow diagrams retain as documented information.

8.5.1.5.3 Description of processes and process environment

The organization existing PRPs, process parameters, control measures (if any) and/or the strictness with which they are applied, or procedures that can influence food safety ; describe the extent needed to conduct the hazard analysis the layout of premises, including food and non-food handling area processing equipment and contact materials, processing aids and flow of materials; external requirements (e.g. from statutory and regulatory authorities or customers) that can impact the choice and the strictness of the control measures.

8.5.2 Hazard analysis

8.5.2.1 General

The organization conduct a hazard analysis, based on the preliminary information to determine the hazards that need to be controlled.

8.5.2.2 Hazard identification and determination of acceptable levels

The organization identify and document all food safety hazards expected to occur in relation to the type of product, type of process and process environment identification based on the preliminary information and data collected , Experience, internal and external information including, to the extent possible, epidemiological, scientific and other historical data; information from the food chain on food safety hazards related to the safety of the end products, intermediate products and the food at the time of consumption, statutory, regulatory and customer requirements.

8.5.2.2.2 Hazard identification and determination of acceptable levels

The organization identify step(s) (e.g. receiving raw materials, processing, distribution and delivery) at which each food safety hazard can be present, be introduced, increase or persist. the stages preceding and following in the food chain the stages preceding and following in the food chain the process equipment, utilities/services, process environment and persons.

8.5.2.2.3 Hazard identification and determination of acceptable levels

The organization has determine the acceptable level in the end product of each food safety hazard identified ensure that applicable statutory, regulatory and customer requirements are identified consider the intended use of end products consider any other relevant information maintain documented information determination of acceptable levels and the justification for the acceptable levels.

8.5.2.3 Hazard assessment

The organization conduct a hazard assessment for each identified food safety hazard prevention or reduction to an acceptable level evaluate each food safety hazard with regard to: the likelihood of its occurrence in the end product prior to application of control measures the severity of its adverse health effects in relation to the intended use identify any significant food safety hazards described used methodology.

8.5.2.4 Selection and categorization of control measure(s)

Based on the hazard assessment select an appropriate control measure or combination of control measures capable of preventing or reducing the identified significant food safety hazards to defined acceptable levels categorize the selected identified control measure(s) to be managed as OPRP(s) For each of the control measures selected an assessment of the following the likelihood of failure of its functioning; the severity of the consequence in the case of failure of its functioning the effect on identified significant food safety hazards the location in relation to other control measure(s) whether it is specifically established and applied to reduce the hazards to an acceptable level whether it is a single measure or is part of combination of control measure(s).

8.5.2.4.2 In addition, for each control measure, the systematic approach shall include an assessment of the feasibility of:

for each control measure an assessment of the feasibility of: establishing measurable critical limits and/or measurable/observable action criteria; monitoring to detect any failure to remain within critical limit and/or measurable/observable action criteria; applying timely corrections in case of failure. documented information of decision-making process and results of the selection and categorization of the control measures and External requirements (e.g. statutory, regulatory and customer requirements).

8.5.3 Validation of control measure(s) and combinations of control measures

The food safety team validate that the selected control measures are capable of achieving the intended control of the significant food safety hazard(s) When the result of validation shows that the control measures(s) is (are) not capable of achieving the intended control, the food safety team modify and re-assess the control measure(s) and/or combination(s) of control measure(s). maintain the validation methodology and evidence of capability of the control measure(s) to achieve the intended control as documented information.

8.5.4 Hazard control plan (HACCP/OPRP plan)

8.5.4.1 General

The organization has establish, implement and maintain a hazard control plan hazard control plan include the following information for each control measure at each CCP or OPRP: food safety hazard(s) to be controlled at the CCP or by the OPRP; critical limit(s) at CCP or action criteria for OPRP; monitoring procedure(s); correction(s) to be made if critical limits or action criteria are not met; responsibilities and authorities; records of monitoring.

8.5.4.2 Determination of critical limits and action criteria

Specify CCPs and action criteria for OPRPs Ensure that the acceptable level is not exceeded(Critical limits at CCPs ) Action criteria for OPRPs (measurable or observable ).

8.5.4.3 Monitoring systems at CCPs and for OPRPs

established monitoring system for each CCP , control measure or combination of control measure(s) to detect any failure to remain within the critical limits include all scheduled measurements relative to the critical limit(s).established monitoring system for each OPRP , the control measure or combination of control measure(s) to detect failure to meet the action criterion At each CCP, the monitoring method and frequency capable of timely detection of any failure to remain within critical limits, to allow timely isolation and evaluation of the product For each OPRP, the monitoring method and frequency proportionate to the likelihood of failure and the severity of consequences. OPRP is based on subjective data from observations (e.g. visual inspection) the method supported.

8.5.4.4 Actions when critical limits or action criteria are not met

specify corrections and corrective actions to be taken when critical limits or action criterion are not met ensure that the potentially unsafe products are not released, the cause of nonconformity is identified the parameter(s) controlled at the CCP or by the OPRP is (are) returned within the critical limits or action criteria; recurrence is prevented.

8.5.4.5 Implementation of the hazard control plan

implement and maintain the hazard control plan, and retain evidence of the implementation as documented information.

8.6 Updating the information specifying the PRPs and the hazard control plan

The organization has Update hazard control plan the following information, if necessary: characteristics of raw materials, ingredients and product-contact materials; characteristics of end products; intended use; flow diagrams and descriptions of processes and process environment.

8.7 Control of monitoring and measuring

The organization specified monitoring and measuring methods and equipment in use are adequate for the monitoring and measuring activities related to the PRP(s) and the hazard control plan. The results of calibration and verification retained as documented software updated in a timely manner validity of the previous measurement results when the equipment or process environment is found not to conform to requirements.

8.8 Verification related to PRPs and the hazard control plan

8.8.1 Verification

The organization establish, implement and maintain verification activities define purpose, methods, frequencies and responsibilities for the verification activities ensure that verification activities are not carried out by the person responsible for monitoring the same activities. Verification results documented and communicated. verification is based on testing of end product samples or direct process samples.

8.8.2 Analysis of results of verification activities

The food safety team conduct an analysis of the results of verification that shall be used as an input to the performance evaluation of the FSMS.

8.9 Control of product and process nonconformities

The organization ensure that data derived from the monitoring of OPRPs and at CCPs are evaluated by designated persons who are competent and have the authority to initiate corrections and corrective actions.

8.9.2 Corrections

The organization ensure that when critical limits at CCP(s) and/or action criteria for OPRPs are not met, the products affected are identified and controlled with regard to their use and release. When critical limits at CCPs are not met, affected products shall be identified and handled as potentially unsafe products action criteria for an OPRP are not met describe corrections made on nonconforming products and processes, documented.

8.9.3 Corrective actions

The organization Evaluated corrective actions when critical limits at CCP(s) and/or action criteria for OPRPs are not met. identify and eliminate the cause of detected nonconformities, to prevent recurrence, and to return the process to control after a nonconformity is identified retain documented information on all corrective actions.

8.9.4 Handling of potentially unsafe products

8.9.4.1 General

The organization take action(s) to prevent potentially unsafe products from entering the food chain retain products that have been identified as potentially unsafe under its control until the products have been evaluated and the disposition has been determined If products that have left the control of the organization are subsequently determined to be unsafe, the organization shall notify relevant interested parties and initiate a withdrawal/recall The controls and related responses from relevant interested parties and authorization for dealing with potentially unsafe products.

8.9.4.2 Evaluation for release

The organization Evaluation Each lot of products affected by the nonconformity Products affected by failure to meet action criterion for OPRPs only be released as safe when any of the following conditions apply: evidence other than the monitoring system demonstrates that the control measures have been effective; evidence shows that the combined effect of the control measures for that particular product conforms to the performance intended (i.e. identified acceptable levels); the results of sampling, analysis and/or other verification activities.

8.9.4.3 Disposition of nonconforming products

Products that are not acceptable for release reprocessed or further processed within or outside the organization to ensure that the food safety hazard is reduced to acceptable levels; or redirected for other use as long as food safety in the food chain is not affected; or destroyed and/or disposed as waste.

8.9.5 Withdrawal/recall

The organization ensure the timely withdrawal/recall of lots of end products that have been identified as potentially unsafe, by appointing competent person(s) having the authority to initiate and carry out the withdrawal/recall. use of appropriate techniques (e.g. mock withdrawal/recall or practice withdrawal/recall) and retain documented information verify the implementation and effectiveness of withdrawals/recalls.

9. PERFORMANCE EVALUATION

9.1 Monitoring, measurement, analysis and evaluation

The organization has implemented a monitoring & measurement program including analysis and evaluation of the data as evidence of management system efficiency.

9.1.2 Analysis and evaluation

The organization analyse and evaluate appropriate data and information arising from monitoring and measurement, including the results of verification activities related to PRPs and the hazard control plan, the internal auditsand external audits.

9.2 Internal audit

The organization has established and implemented an internal audit program including frequency, methods, responsibilities, planning and reporting requirements which takes into consideration:

1. Objectives
2. Importance of the processes concerned
3. Customer feedback
4. Changes impacting on the organization
5. Results of previous audit
6. The results are reported to Top Management

9.3 Management Review

Top Management perform some review of the effectiveness of the management system at planned intervals; the content of the management review meets the standard requirements.

10. IMPROVEMENT

10.1 Nonconformity and Corrective action

The organization systematically collects all findings arising from audits, complaints & appeals, failures; it evaluates the root causes, defines some corrective actions and controls their effectiveness.

10.2 Continual improvement

The organization brings evidence that it continually improves the adequacy and effectiveness of the management system.

10.3 Update of the food safety management system

The organization ensure that the FSMS is continually updated the food safety team evaluate the FSMS at planned intervals it is necessary to review the hazard analysis , the established hazard control plan and the established PRPs.

7.  Nonconformities

Number NCRs were raised as the result of this visit.

Next visit will be on

Nonconformities detailed here shall be addressed through the organization’s corrective action process, in accordance with the relevant corrective action requirements of the audit standard and shall include actions to analyse the cause of the nonconformity and prevent recurrence, and complete records maintained.

Note: - Initial, Re-certification and Extension audits – recommendation for certification cannot be made unless check box 4 is completed. For re-certification audits the time scales indicated may need to be reduced in order to ensure re-certification prior to expiry of current certification.

Note: At the next scheduled audit visit, the CB audit team will follow up on all identified nonconformities to confirm the effectiveness of the corrective actions taken.

8.  General Observations & Opportunities for Improvement

9.  Opening and Closing Meeting Attendance Record

3 Year Audit Programme:

Appendix A - Opening and Closing meeting agenda