DOC : FSMS-F6. 28 Adequacy Audit R… · Web viewDOC : FSMS-F6.2-01. ISSUE : 01. DATE : JAN 2007. PAGE : 1 OF 17. ... packaging, storage and distribution systems; personnel qualification

DOC : FSMS-F6.2-01ISSUE : 01DATE : JAN 2007PAGE : 1 OF 17APPROVED BY: ADG

ADEQUACY AUDIT REPORT FOR FOOD SAFETY MANAGEMENT SYSTEM (FSMS)

1. Auditor's Name and Designation :

2. Date(s) of the Adequacy Audit :

3. Application No. :

4. Firm’s Name & Address :

5. Site(s) where FSMS implemented : (attach sheet, if required)

6. Product/Service Description & CPA Code:

7. FSMS Manual/Document(s) of firm :

i) Title:

ii) Issue No. and date of issue, including : Number of amendments (if any):

8. Adequacy Report (see Annexure) : 9. Product/Product Group(s) not included:

under FSMS (with justification) 10. Whether non-conformities found :

11. Additional information, if any

Signature Name & DesignationMSCO( ) Date:Recommendation and Points for Action:

Sign. of MSCO( )DDG ( ) Date


ANNEXURE (Findings of the Adequacy Audit, Clause 6 of Report)

Clause of IS/ISO 22000

Requirement(s) of standard Clause Reference to firm’s document

Yes/No Details of Nonconformity, if any

44.1

Food Safety Management Systems General requirements

a) Has the organization established, documented, implemented and maintained an effective food safety management system and updated it when necessary?

b) Is the scope of the food safety management system defined?

c) Does the scope specify the products or product categories, processes and production sites addressed by the food safety management system?

d) Are food safety hazards identified, evaluated and controlled?

e) Whether appropriate information regarding safety issues related to products communicated through out the food chain?

f) Whether information concerning development, implementation and updating of the FSMS communicated throughout the organization?

g) Whether FSMS evaluated periodically, and updated when necessary and whether most recent information on the food safety hazards incorporated?

h) Whether the organization has chosen to outsource any process(s)? and If so,

i) whether control(s) exercised over such process(es)?ii) whether such control identified & documented within FSMS?

j) Does the organization ensure control over its outsourced processes?

4.24.2.1

Documentation RequirementsGenerala) Does FSMS documentation include

i) statement of food safety policy and related objectives ii) procedures and records required by the standard iii) documents needed by the organization to ensure effective development, implementation and updating of FSMS?

4.2.2 Control of documentsa) Are the documents required by FSMS controlled?b) Whether documented procedure has been established to i) approve documents for adequacy prior to issueii) review, update and re-approval of documentsiii) identify changes and current revision status of documentsiv) ensure availability of relevant versions of documents at

place of usev) identification and distribution control of documents of

external originvi) prevent unintended use of obsolete documentsvii) identify obsolete documents retained for any purposeviii) ensure documents remain legible & readily identifiable

DOC : FSMS-F6.2-01ISSUE : 01DATE : JAN 2007PAGE : 3 OF 17

APPROVED BY: ADG Clause of IS/ISO 22000



4.2.3 Control of Recordsa) Does the organization establish and maintain FSMS records?

b) Whether records are legible, identifiable & retrievable?

c) Whether the organization has established a documented procedure to define controls needed for records w.r.t. their

i) identificationii) storageiii) protectioniv) retrievablev) retention timevi) disposition

5.5.1

Management ResponsibilityManagement commitment

Does the top management provide evidence of its commitment towards FSMS by

i) showing food safety is supported by business objectives of the organization

ii) communicating importance of meeting customer, statutory and regulatory requirements

iii) establishing of food safety policyiv) conducting management reviewv) ensuring availability of resources

5.2 Food Safety Management Policy

a) Has the top management defined, documented & communicated its food safety policy?

b) Is the food safety policy i) appropriate to the role of the organization in the

food chainii) conforms with statutory & regulatory requirements

and with mutually agreed food safety requirements of customers

iii) communicated, implemented and maintained at all levels of the organization

iv) reviewed for continued suitabilityv) supported by measurable objectives vi) adequately addresses communication

5.3 Food Safety Management System Planning

a) Whether planning of FSMS have been carried out to food safety management?

i) to meet requirements of the standardii) to meet objectives of the organization that support

food safety

b) Whether integrity of FSMS is maintained when its changes are planned and implemented?


APPROVED BY: ADG




5.4 Responsibility and authority

a) Are the responsibilities and authorities are defined and communicated within the organization?

b) Whether all personnel have the responsibility to report problem with the FSMS to identified person(s)?

c) Whether responsibility and authority of the designated personnel defined to initiate and record actions?

5.5 Food Safety Team Leader

a) Whether the top management has appointed a food safety team leader?

b) Whether responsibility and authority of the food safety team leader defined?i) to manage a food safety team and organize its workii) to ensure relevant training and education of the food

safety team membersiii) to ensure that the food safety management system is

established, implemented, maintained and updated, andiv) to report to the organization’s top management on the

effectiveness and suitability of the food safety management system

c) Liaison with external parties on matter related to FSMS5.65.6.1

CommunicationExternal Communication

a) Whether the organization has established, implemented and maintained effective arrangements for communicating with

i) suppliers and contractorsii) customers or consumers, in relation to

- Product information (including instruction regarding intended use, specific storage requirements and, as appropriate, shelf life)- Enquiries- Contracts or order-handling including amendments- Customer feedback including customer complaints

iii) statutory & regulatory authorities, andiv) other organizations that have an impact on, or will

be affected by, the effectiveness or updating of FSMS

b) Does the communication provide information on food safety aspects of the organization’s products that may be relevant to other organizations in the food chain?c) Whether records of communications maintained?d) Whether the food safety requirements from statutory & regulatory authorities and customers are available?e) Whether responsibility and authority of designated personnel defined to communicate externally any information

concerning food safety?f) Whether information obtained through external

communication included as input to system updating and management review?


APPROVED BY: ADG




5.6.2 Internal Communication

a) Whether arrangements established, implemented and maintained effectively for communicating with personnel on issues having an impact on food safety?

b) Does the organization ensure that the food safety team is informed in a timely manner of changes, including the following:

- products or new products;- raw materials, ingredients and services;- production systems and equipment;- production premises, location of equipment,

surrounding environment;- cleaning and sanitation programmes;- packaging, storage and distribution systems;- personnel qualification levels and/or allocation of responsibilities and authorizations;- statutory and regulatory requirements;- knowledge regarding food safety hazards and control

measures;- customer, sector and other requirements that the

organization observes;- relevant enquiries from external interested parties;- complaints indicating food safety hazards associated

with the products;- other conditions that have an impact on food safety.

c) Whether food safety team ensures that above information is included in the updating of the FSMS?

d) Whether top management ensures that relevant information is included as input to the management review?

5.7 Emergency Preparedness and Response

Whether procedures established, implemented and maintained to manage potential emergency situations and accidents that can impact food safety and which are relevant to the role of the organization in the food chain?

5.85.8.1

Management ReviewGenerala) Whether FSMS reviewed at planned intervals?b) Does the review include

i) assessing opportunities for improvementii) need for change to the FSMS including the food safety

policyiii) whether records of management reviews maintained?

5.8.2 Review Inputa) Whether input to management review include,

i) follow-up actions from previous management reviews,ii) analysis of results of verification activitiesiii) changing circumstances that can affect food safetyiv) emergency situations, accidents and withdrawals

(including recalls)v) reviewing results of system updating activitiesvi) review of communication activities, including customer

feed-backvii) external audits or inspections

b) Presentation of data to facilitate proper review of stated objectives


APPROVED BY: ADG




5.8.3 Review Outputa) Whether output from the management review include decisions and actions related to

i) assurance of food safetyii) improvement of the effectiveness of the FSMSiii) resource needs, andiv) revisions of the organization’s food safety policy

and related objectives6.6.1

Resource ManagementProvision of Resources

Whether the organization provides adequate resources for the establishment, implementation, maintenance and updating of the FSMS?

6.26.2.1

Human ResourcesGeneral

a) Whether the food safety team and the other personnel carrying out activities having an impact on food safety are competent and have appropriate education, training, skills and experience?

b) Whether records are available for of agreement or contracts defining the responsibility and authority of external experts if utilized for development, implementation, operation or assessment of FSMS?

6.2.2 Competence, Awareness and Training

a) Whether necessary competencies for personnel whose activities have an impact on food safety identified?

b) Whether training or other action to ensure personnel have the necessary competencies provided?

c) Whether personnel responsible for monitoring, corrections and corrective actions of the FSMS trained?

d) Whether implementation and effectiveness of a), b) and c) implemented?

e) Whether awareness of the relevance and importance of individual activities in contributing to food safety ensured?f) Whether understanding of the requirement for effective communication by all personnel whose activities have an

impact on food safety ensured? g) Whether records of training and actions described in b) and

c) are maintained?6.3 Infrastructure

Whether resources are provided for the establishment and maintenance of the infrastructure needed to implement the requirements of the Standard?

6.4 Work Environment

Whether resources provided for the establishment, management and maintenance of the work environment needed to implement the requirements of the Standard?


APPROVED BY: ADGClause of IS/ISO 22000



7.7.1

Planning and Realization of Safe ProductsGeneral

a) Whether the processes needed for the realization of safe products planned and developed?

b) Whether the organization implements, operates and ensures the effectiveness of the planned activities including PRP(s) as well as operational PRP(s) and/or the HACCP plan and any changes to those activities?

7.27.2.1

Prerequisite Programmes (PRPs)Whether PRPs established, implemented and maintained to assist in controllingi) the likelihood of introducing food safety hazards to the

product through the work environmentii) biological, chemical and physical contamination of the

product(s), including cross contamination between products, and

iii) food safety hazard levels in the product and product processing environment

7.2.2 a) Whether the PRP(s) appropriate to thei) organizational needs with regard to food safetyii) size and type of the operation and the nature of the

products being manufactured and/or handledb) Whether the PRPs implemented across the entire production

system as applicable in general or particular production or operational line?

c) Whether the PRPs approved by the food safety team?d) Whether the statutory and regulatory requirements related to the above identified?

7.2.3 a) When selecting and/or establishing PRP(s), does the organization consider and utilize appropriate information given in statutory & regulatory requirements, customer requirements, relevant standards etc.?

b) When establishing PRPs, does the organization consideri) construction and lay-out of buildings and associated utilitiesii) lay-out of premises, including workspace and employee

facilitiesiii) supplies of air, water, energy and other utilitiesiv) supporting services, including waste and sewage disposalv) the suitability of equipment and its accessibility for

cleaning, maintenance and preventative maintenancevi) management of purchased materials, supplies, disposals and

handling of products vii)measures for the prevention of cross contamination

viii) cleaning and sanitizingix) pest controlx) personnel hygienexi) other aspects as appropriatec) Whether verification of PRP(s) planned?d) Whether records of PRP(s) verifications and modifications

maintained?e) Whether documents specify management of activities

included in the PRP(s)?7.37.3.1

Preliminary steps to enable hazard analysisGeneral

a) Whether all relevant information needed to conduct the hazard analysis collected, maintained, updated and documented? b) Whether the records of the above information maintained?





7.3.2 Food Safety Team

a) Whether a `food safety team’ has been appointed?

b) Is the food safety team a combination of multi-disciplinary knowledge and experience?

c) Whether records maintained to demonstrate that the food safety team has the required knowledge and experience?

7.3.37.3.3.1

Product CharacteristicsRaw materials, ingredients and product-contact materials

a) Whether description of all raw materials, ingredients and product-contact materials needed to conduct the hazard analysis documented?b) whether the description includes- biological, chemical and physical characteristics- composition of formulated ingredients, including additives and processing aids- origin- method of production- packaging and delivery methods- storage conditions and shelf life- preparation and/or handling before use or processing- food safety-related acceptance criteria or specifications of

purchased materials and ingredients appropriate to their intended uses

c) Does the organization identify statutory and regulatory food safety requirements related to the above?d) Whether the descriptions kept up-to-date?

7.3.3.2 Characteristics of end productsa) Whether description of the characteristics of end products needed to conduct the hazard analysis documented?

b) Whether the description includes

- product name or similar identification- composition- biological, chemical and physical characteristics

relevant for food safety- intended shelf life and storage conditions- packaging- labeling relating to food safety and/or instructions for handling, preparation and usage- method(s) of distribution

c) Does the organization identify statutory and regulatory food safety requirements related to the above?d) Whether the descriptions kept up-to-date?

7.3.4 Intended Use

a) Are the intended use, the reasonably expected handling of the end product and any unintended but reasonably expected mishandling and misuse of the end product considered and described in documents to the extent needed to conduct the hazard analysis?

b) Does the organization identify groups of users and, where appropriate, groups of consumers for each product, and consumer groups known to be especially vulnerable to specific food safety hazards?

c) Whether the descriptions kept up-to-date including, when required, in accordance with 7.7 of the standard?





7.3.57.3.5.1

Flow diagrams, process steps and control measuresFlow diagrams

a) Does the organization prepare flow diagrams for the products or process categories covered by the food safety management system?b) Does the flow diagram provide a basis for evaluating the possible occurrence, increase or introduction of food safety hazards?c) Are flow diagrams clear, accurate and sufficiently detailed?d) Does the flow diagrams include the following as appropriate:

- the sequence and interaction of all steps in the operation- any outsourced processes and subcontracted work- where raw materials, ingredients 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

e) Does the food safety team verify the accuracy of the flow diagrams by on-site checking?f) Whether the verified flow diagrams maintained as records?

7.3.5.2 Description of process steps and control measures

a) Does the organization describe the existing control measures, process parameters and/or the rigorousness with which they are applied, or producers that may influence food safety to the extent needed to conduct the hazard analysis?

b) Does the organization describe external requirements (e.g. from regulatory authorities or customers) that may impact the choice and the rigorousness of the control measures?

c) Whether the descriptions updated?7.47.4.1

Hazard AnalysisGeneral

a) Whether hazard analysis conducted by the food safety team?b) Whether hazard analysis is done to determine which hazards

need to be controlled, the degree of control required to ensure food safety, and which combination of control measures is required?

7.4.2

7.4.2.1

Hazard Identification and Determination of Acceptable Levelsa) Whether all food safety hazards identified & recorded?

b) Whether the identification is based on

- the preliminary information and data collected - experience- external information including, to the extent possible

epidemiological and other historical data - information from the food chain on food safety hazards that

may be of relevance for the safety of the end products, intermediate products and the food at consumption

c) Have all the step(s) (from the raw materials, processing and distribution) indicated at which each food safety hazard been

introduced?


APPROVED BY: ADG




7.4.2.2 Whether consideration given to the following when identifying the hazards?- The steps preceding and following the specified operation- The process equipment, utilities/services and surroundings - The preceding and following links in the food chain

7.4.2.3 a) Whether for each of the identified FS hazard, the acceptable level of FS hazard in the end product has been determined?

b) Does the organization taken into account established statutory and regulatory requirements, customer food safety requirements, the intended use by the customer for determining acceptable levels?

c) Whether the justification for, and the result of, the determination recorded?

7.4.3 Hazard Assessmenta) Does the organization conduct a hazard assessment to determine the following for each FS hazard identified?

- Whether its elimination or reduction to acceptable levels is essential to the production of a safe food - Whether its control is needed to enable the defined acceptable levels to be met

b) Does the organization evaluate each food safety hazard according to the possible severity of adverse health effects and the likelihood of their occurrence?

c) Does the organization described the methodology used?

d) Are the results of food safety hazard assessment recorded?7.4.4 Selection and Assessment of Control Measures

a) Does the organization select appropriate combination of control measures which is capable of preventing, eliminating or reducing these food safety hazards to defined acceptable levels?b) Whether each of the control measures as described in 7.3.5.2 of the standard reviewed with respect to its effectiveness against the identified food safety hazards?c) Are the control measures categorized as to whether they need to be managed through operational PRP(s) or by the HACCP plan?d) Does the organization carry out the selection and

categorization using a logical approach that includes assessments with regards to- its effect on identified food safety hazards relative to the

strictness applied- its feasibility for monitoring- its place within the system relative to other control

measures- likelihood of failure in functioning of a control measure- severity of consequence(s) in case of failure in its

functioning- whether control measure is specifically established and

applied to eliminate or significantly reduce the level of hazard(s)

- synergistic effects (i.e. interaction that occurs between two or more measures resulting in their combined effect being higher than the sum of their individual effects)

e) Are the methodology and parameters used for this categorization documented?

f) Are the results of the assessment recorded?


APPROVED BY: ADG




7.5 Establishing the Operational Prerequisite Programmes (PRPs)a) Are the operational PRPs documented?b) Does the operational PRPs include

- food safety hazard(s) to be controlled by the programme

- control measure(s)- monitoring procedures that demonstrate that the operational PRPs are implemented- corrections and corrective actions to be taken if

monitoring show that the operational PRPs are not in control

- responsibilities and authorities- record(s) of monitoring

7.67.6.1

Establishing the HACCP PlanHACCP Plana) Are the HACCP plan documented?b) Does the HACCP Plan include- food safety hazard(s) to be controlled at CCP- control measure(s)- critical limit(s)- monitoring procedure(s)- corrections and corrective action(s) to be taken if critical

limits are exceeded- responsibilities and authorities- record(s) of monitoring

7.6.2 Identification of Critical Control Points(CCPs)

Does the organization identify CCPs for each hazard that is to be controlled by the HACCP plan?

7.6.3 Determination of Critical Limits for Critical Control Points

a) Does the organization determine critical limits for each CCP?b) Whether critical limit established to ensure that identified

acceptable level of FS hazard in the end product is not exceeded?

c) Are the critical limits measurable?d) Is the rationale for the chosen critical limits documented?e) Are the critical limits based on subjective data (such as visual

inspection of product, process, handling, etc.) supported by instructions or specifications and/or education and training?

7.6.4 System for the monitoring of critical control points

a) Whether monitoring system for each CCP been established?b) Does the monitoring system include all scheduled

measurements or observations relative to critical limit(s)?c) Does the monitoring system consist of relevant procedures,

instructions and records that cover measurements or observations that provide results within an adequate time frame

- monitoring devices used- applicable calibration methods- monitoring frequency

responsibility and authority related to monitoring and evaluation of monitoring results

- record requirements and methods

d) Are the monitoring methods and frequency capable of determining when the critical limits have been exceeded in time for the product to be isolated before it is used or consumed`?


APPROVED BY: ADG




7.6.5 Actions when monitoring results exceed critical limits

a) Whether planned corrections and corrective actions, to be taken when critical limits are exceeded in the HACCP plan, have been specified?

b) Whether the cause of nonconformity identified?

c) Does the organization establish and maintain documented procedures for the appropriate handling of potentially unsafe products so that they are not released unless evaluated?

7.7 Updating of preliminary information and documents specifying in the PRPs and the HACCP plan

a) Does the organization update the following information w.r.t operational PRPs and/or the HACCP Plan:

- product characteristics- intended use- flow diagrams- process steps- control measures

b) Whether, if necessary, the HACCP plan and the procedures & instructions specifying PRPs amended based on above information?

7.8 Verification planning

a) Does the verification planning define the purpose, methods, frequencies and responsibilities for the verification activities?

b) Whether the verification activities confirm that- the PRP(s) are implemented- input to the hazard analysis is continually updated

the operational PRP(s) and the elements within the HACCP plan are implemented and effective

- Hazard levels are within identified acceptable levels- other procedures required by the organization are

implemented and effective

c) Is the output of this planning in a form suitable for the organization’s method of operations?

d) Whether verification results recorded and communicated to the food safety team?

e) Whether verification results provided to enable analysis of the results of the verification activities?

f) Whether system verification is based on testing of end product samples?

g) In case samples show nonconformity, whether the affected lots of the products handled as potentially unsafe?

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7.9 Traceability systema) Whether a traceability system that enables the identification

of product lots and their relation to batches of raw materials, processing and delivery records established and applied?

b) Whether the traceability system is able to identify incoming material from the immediate suppliers and the initial distribution route of the end product?

c) Are traceability records maintained for a defined period for system assessment to enable the handling of potentially unsafe products and in the event of product withdrawal?

d) Whether the records are in accordance with statutory and regulatory requirements and customer requirements and based, for example, on the end product lot identification?

7.107.10.1

Control of nonconformityCorrectionsa) Whether it is ensured that when critical limits of CCP(s) are

exceeded or there is a loss of control of operations PRP(s), the products affected are identified and controlled with regard to their use and release?

b) Whether a documented procedure established and maintained - Defining the identification and assessment of affected end

products to determine their proper handling- Defining a review of the corrections carried out

c) Whether products manufactured under conditions, where critical limits have been exceeded, handled in accordance with 7.10.3?

d) Whether products manufactured under conditions where operational PRP(s) have not been conformed with evaluated with respect to the cause(s) of the nonconformity and to the consequences thereof in terms of food safety and in accordance with 7.10.3?

e) Whether the records of the evaluation maintained?f) Whether all corrections approved by responsible person(s)

and recorded together with information on the nature of the nonconformity, its cause(s) and consequence(s), including information needed for traceability purposes related to the nonconforming lots.

7.10.2 Corrective actionsa) Whether the data derived from the monitoring of operational

PRPs and CCPs evaluated by designated person(s) with sufficient knowledge and authority to initiate corrective actions?

b) Whether corrective actions initiated when critical limits are exceeded or when there is a lack of conformity with operational PRP(s)?

c) Whether a documented procedure established and maintained that specify appropriate actions to

- identify and eliminate the cause of detected nonconformities- prevent recurrence- bring the process or system back into control after

nonconformity is encounteredd) Whether the corrective actions include- reviewing nonconformities (including customer complaints)- reviewing trends in monitoring results that may indicate

development towards loss of control- determining the cause(s) of nonconformities- evaluating the need for action to ensure that nonconformities

do not recur- determining and implementing the actions needed- recording the results of corrective actions taken- reviewing corrective actions taken for ensuring effectiveness

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7.10.37.10.3.1

Handling of potentially unsafe productsGenerala) Whether the nonconforming products handled by taking

action(s) to prevent the nonconforming product from entering the food chain?

b) Whether all lots of product, that may have been affected by a nonconforming situation, held under control of organization until they have been evaluated?

c) Whether relevant interested parties notified and withdrawal (including recalls) initiated, if products that have left the control of the organization are subsequently determined to be unsafe?

d) Whether the controls and related responses and authorization for dealing with potentially unsafe products documented?

7.10.3.2 Evaluation for ReleaseWhether each lot of product affected by nonconformity released as safe only 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 complies with the performance intended

- the results of sampling, analysis and/or other verification activities demonstrate that the affected lot of product complies with the identified acceptable levels for the food safety hazard(s) concerned

7.10.3.3 Disposition of nonconforming productsWhether the organization handles the lot of product which is not acceptable for release, by any of the following activities?

a) reprocessing or further processing within or outside the organization to ensure that the food safety hazard is eliminated or reduced to acceptable levels?

b) Destruction and/or disposal as waste?7.10.4 Withdrawals

a) Whether the top management has appointed personnel having the authority to initiate a withdrawal and personnel responsible for executing the withdrawal, of lot of end products which have been identified as unsafe?

b) Whether documented procedure has been established and maintained a for

- notification to relevant interested parties - handling of withdrawn products as well as affected lot of the

products still in stock- the sequence of actions to be taken

c) Does the organization secure or hold withdrawn products under supervision until they are destroyed, used for purposes other than originally intended, determined to be safe for the same (or other) intended use, or reprocessed in a manner to ensure they become safe?

d) Whether the cause, extent and result of a withdrawal recorded and reported to top management as input to the management review?

e) Whether the organization verifies and records effectiveness of the withdrawal programme through the use of appropriate techniques?

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8.8.1

Validation, verification and improvement of the FSMSGeneral

Whether the food safety team plan and implement the processes needed to - validate control measures and/or control measure

combinations - verify and improve the food safety management system

8.2 Validation of control measure combinationsa) Whether the organization validates that the

- selected control measures are capable of achieving the intended control of the food safety hazard(s) for which they are designated

- control measures are effective and capable of, in combination, ensuring control of the identified food safety hazard(s) to obtain end products that meet the defined acceptable levels

b) Whether the control measure and/or combinations thereof are modified and reassessed if the result of the validation shows that one or both of the above elements cannot be confirmed?

c) Whether modifications include changes in control measures?8.3 Control of monitoring and measuring

a) Whether, organization provides evidence that the specified monitoring and measuring methods and equipment are adequate to ensure the performance of the monitoring and measuring procedures?

b) Where necessary to ensure valid results, whether the measuring equipment and methods used are:

- calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards?

- adjusted or re-adjusted as necessary?- identified to enable determination of calibration status?- safeguarded from adjustments that would invalidate the

measurement results? - protected from damage and deterioration?

c) Whether records of the results of calibration and verification maintained?

d) Whether validity of the previous measurement results when the equipment or process is found not to conform to requirements assessed?

e) Whether appropriate actions taken for the equipment and any product affected, if the measuring equipment is nonconforming?

f) Whether records of assessment and resulting actions maintained?

g) When used in the monitoring and measurement of specified requirements, whether the ability of computer software to satisfy the intended application confirmed?





8.48.4.1

Food Safety Management System VerificationInternal audit

a) Whether internal audits conducted at planned intervals to determine whether the FSMS

- conforms to the planned arrangements? - conforms to the organization’s established requirements? - conforms to the requirements of IS/ISO 22000? - is effectively implemented and updated?

b) Whether the audit programme is planned taking into consideration the importance of the processes and areas to be audited, as well as any updating actions resulting from previous audits?

c) Are the audit criteria, scope, frequency and methods defined?

d) Whether the selection of auditors and the conduct of audits ensure the objectivity and impartiality of the audit process?

e) Is there a documented procedure defining the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records?

f) Does the management responsible for the area being audited ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes?

g) Whether follow-up activities include the verification of the actions taken and the reporting of the verification results?

8.4.2 Evaluation of individual verification results

a) Whether the food safety team systematically evaluates the individual results of planned verification?

b) Whether actions taken to achieve the required conformity, if verification does not demonstrate conformity with the planned arrangements?

c) Whether such actions include review of:

- existing procedures and communication channels?- the conclusions of the hazard analysis, the established

operational PRPs and the HACCP plan- the PRPs- the effectiveness of human resource management and of

training activities

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8.4.3 Analysis of results of verification activities

a) Whether the food safety team analyses the results of verification activities including the results of the internal audits and external audits?

b) Whether the analysis is carry out in order to:

- confirm that the overall performance of the systems meets the planned arrangements and the food safety management system requirements established by the organization

- identify the need for updating or improving the food safety management system

- identify trends which indicate a higher incidence of potentially unsafe products

- establish information for planning of the internal audit programme concerning the status and importance of areas to be audited

- provide evidence that any corrections and corrective actions that have been taken are effective

c) Whether the results of the analysis and the resulting activities recorded and reported, in an appropriate manner, to top management as input to the management review?

8.5

8.5.1

Improvement

Continual Improvement

Whether the effectiveness of the FSMS continually improved through the use of

- communication- management review- internal audit- evaluation of individual verification results- analysis of results of verification activities- validation of control measure combinations- corrective actions- food safety management system updating

8.5.2 Updating the food safety management system

a) Whether the FSMS continually updated?

b) Whether the food safety team evaluates the FSMS at planned intervals?

c) Whether the FS team considers to review the hazard analysis, the established operational PRP(s) and the HACCP plan?

d) Whether the evaluation and updating activities based on- input from communication, external as well as internal?- input from other information concerning the suitability,

adequacy and effectiveness of the FSMS?- output from the analysis of results of verification activities- output from management review

e) Whether system updating activities recorded and reported, in an appropriate manner, as input to the management review

Documents

DOC : FSMS-F6. 28 Adequacy Audit R… · Web viewDOC : FSMS-F6.2-01. ISSUE : 01. DATE : JAN 2007. PAGE : 1 OF 17. ... packaging, storage and distribution systems; personnel qualification