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PRE-ASSESSMENT QUESTIONNAIRE

FSMS SYSTEM CERTIFICATION SCHEME


GUIDELINES FOR COMPLETING THE QUESTIONNAIRE
(1)

A separate questionnaire shall be completed for each location for which certification is
required.

(2)

Any information detailed in the FSMS document are not required to reproduce in the
questionnaire but reference to the FSMS document must be made.

(3)

The SLSI will ensure the confidentiality of all information furnished by the applicant in this
questionnaire. This information is only disclosed to the designated auditors who are required
to sign a confidentiality agreement. The names of auditors and a copy of their confidentiality
agreement will be sent to the applicant prior to audit.

(4)

Please tick the relevant box given under each question.

(5)

Upon completion questionnaire shall be returned with any other additional information to
system Certification Division of the Sri Lanka Standards Institution.

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1.0

1.1

COMPANY PROFILE

Name of the Applicant :

Postal Address :

Tel : Phone :
Fax
: ...

GENERAL REQUIREMENT

Position in the food chain


Yes

No

Farming (Breeding) ?
Farming (Growing) ?
Processing (Animal perishable product) ?
Processing (Vegetable perishable product) ?
Feed production ?
Processing (Stable products) ?
Catering/Retail ?
Services ?
Equipment manufacture ?
(Bio) chemical manufacturer ?
Packaging material manufactures ?
Yes

No

Has the organization established, documented, implemented and maintained an


effective food safety management system and updated it when necessary in
accordance with ISO 22000 :2005 standard?
Has the scope of the food safety management system defined covering the
products or product categories, process and production sites that are addressed
by food safety management system?
Are the food safety hazards identified, evaluated and controlled in such a manner
that the products of the organization do not directly or indirectly harm the consumer?
Has the appropriate information regarding safety issues related to its products
been communicated through out the food chain?

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Has the information concerning development, implementation and updating


of the food safety management system been communicated through out the
organization?
Does the organization evaluate periodically, and update when necessary, the food
safety management system to ensure that the system reflects the organizations
activities and incorporate the most recent information on the food safety hazards
subject to control?
Does the organization outsource any process that effects product
conformity?
If yes, has the organization identified and documented such process and established
adequate controls?

1.2

Documentation Requirements
Does the food safety management system documentation include the following:
Yes

1.3

Statement of food safety policy and related objectives?

HACCP Manual

Documented procedures and records required by ISO 22000 : 2005

Documents needed to ensure effective development Implementation and


updating of the food safety management system

Have the documented procedures been established, Implemented


and maintained?

No

Control of documents
Yes

No

Are there written down procedures for control of documents?


Does procedure demand approval of documents for adequacy prior to issue?
Are there revision status clearly shown in all documents?
Are these documents maintained in a legible and readily identifiable manner
Do provisions exist to review & re-approve of documents?
Does the control of documents ensure that relevant versions of
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applicable documents are available at points of use?


Does the food safety team leader have a track of all controlled documents?
Are controlled copies of HACCP Manual available with each divisional head?
Is there a mechanism to control external origin documents?
Do the controls exist to prevent the unintended use of obsolete documents and
to apply suitable identification to them if such documents are retained?
1.4

Control of Records
Yes

No

Is there a written procedure for maintaining and control of records?


Does the procedure specify the controls needed for the identification, storage,
protection & retention of records?
Are these records easily retrievable?
Are these records maintained in such a manner so as to provide evidence of
Conformity to requirements and the effective operation of the Food Safety
Management System?
2.

MANAGEMENT RESPONSIBILITY

2.1 Management Commitment


Has the top management provided evidence of conformity to the development, implementation
and continual improvement of the Food Safety Management system by :
Yes

Showing food safety supported by the business objectives of the


Organization?

Communicating to the organization the importance of meeting the


requirement of ISO 22000 : 2005, any statutory and regulatory
requirements as well as customer requirements ?

Establishing the food safety policy ?

Conducting management reviews ?

Ensuring the availability of resources ?

No

2.2 Food Safety Policy


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Has the Top management ensured that the food safety policy;
Yes

Is appropriate to the role of the organization ?

Confirms to both statutory and regulatory requirements and with


mutually agreed food safety requirements of customers ?

Is communicated, implemented and maintained at all levels of the


Organization ?

Is reviewed for continuing suitability ?

Adequately addresses communication ?

No

2.3 Food Safety Management System Planning


Has the Top Management ensured that;
Yes

Planning of the Food Safety Management System is carried out to


meet requirements given in 4.1 of the standard and the objectives of
the organization that support food safety ?

The integrity of the food safety management system is maintained


during changes ?

2.4

No

Responsibility and Authority


Yes

No

Yes

No

Has the Top Management defined the Responsibilities and Authorities


Are these Responsibilities and authorities communicated within the
organization ?
Have all personnel made responsible to report problems with the food
Safety management system to identified person(s) ?
Has designated personnel made responsible and authorized to initiate
and record actions
2.5 Food safety team leader
Has the Top Management appointed a Food Safety Team Leader
Does the Responsibilities & Authorities of Food Safety Team Leader
include provisions:

To manage a food safety team and organize its work

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To ensure relevant training and education of the food safety team


member ?

To ensure that the food safety management system is established,


implemented, maintained and updated ?

To report to the organizations top management on the effectiveness and


suitability of the food safety management system?

To Liaise with external parties on matters relating to the food safety


management system ?

2.6 Communication
2.6.1 External Communication
Yes

No

Has the Top Management ensured that sufficient information on issues


Concerning food safety is available through out the food chain ?
Has the organization established, implemented and maintained effective
Arrangements for communicating with ?

Suppliers and contractors ?

Customers or consumers, in relation to product information ?

Safety and regulatory authorities ?

Other organizations that have an impact on, or will be affected by, the
effectiveness or updating of the food safety management system ?

Does such communication provide information on food safety aspects


of the organizations products that may be relevant to other organizations
in the food chain ?

Are the records of communication maintained ?

Has designated personnel been made responsible and authorized to


communicate externally ?

2.6.2

Internal Communication
Yes

No

Has the organization established, implemented and maintained effective


arrangements for communicating with personnel ?
Has the organization ensured that the food safety team is informed in a timely
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manner of changes, including but not limited to ;

Products or new products ?


Yes

Raw materials or 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 enquires from external interested parties ?

Complaints indicating food safety hazards associated with the product ?

Other conditions that have an impact on food safety ?

2.7

No

Emergency preparedness and response


Yes

No

Has the top management established implemented and maintained procedures


to manage potential emergency situations and accidents ?
2.8

Management Review

2.8.1

General

Has the Top Management reviewed the organizations Food Safety


Management System at planned intervals, to ensure its continuing
suitability, adequacy and effectiveness
Yes

No

Has the review assessed the opportunities for improvement and the need
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for changes to the food safety management system including the food safety
policy ?

2.8.2

Review input

Has the input to Management Review included information on;

Follow-up actions from previous managements reviews ?

Analysis of results of verification activities

Changing Circumstances that can affected food safety ?

Emergency situations, accidents and withdrawals ?

Reviewing results of system updating activities ?

Review of communication activities including customer feed-back ?

External audits or inspections

2.8.3

Yes

No

Yes

No

Review output

Has the outputs of the Management Review actions related to the following;

Assurance of food safety ?

Improvement of the effectiveness of food safety management system ?

Resource needs ?

Revisions of the organizations food safety policy and related objectives ?

3.0

Resource Management

3.1

Provision of resources
Yes

3.2

No

Has the organization provided adequate resources for the establishment,


implementation, maintenance and updating of the food safety management
system?
Human Resources

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3.2.1

General
Yes

Are competent personnel assigned to work affecting food safety?

Does the organization consider the education, training, skills and experience
in assigning personnel?

Does the organization maintain records of agreement or contacts defining the


Responsibility and authority of external experts

3.2.2

No

Competence, awareness and training


Has the organization;

3.3

Identified the necessary competencies for personnel whose activities have an


Impact on food safety ?

Provided training or take other actions to satisfy these needs

Ensured that personnel responsible for monitoring, corrections and corrective


actions are trained ?

Evaluated the implementation and the effectiveness ?

Ensured that personnel are aware of the relevance and importance of their
Individual activities ?

Ensured that requirements for effective communication is understood by all


personnel whose activities have an impact on food safety ?

Maintained appropriate records of training and actions taken ?

Yes

No

Yes

No

Infrastructure

Has the organization provided the resources for the establishment and Maintenance
of the infrastructure needed to implement the requirements of ISO 22000 : 2005 ?
3.4

Work Environment
Yes

No

Has the organization provided the resources for the establishment and
maintenance of the work environment needed to implement the requirements of
ISO 22000 : 2005 ?
4.0

Planning and realization of safe products

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4.1

General
Yes

No

Yes

No

Yes

No

Has the organization planned and developed the process needed for the realization
of safe products ?
4.2

Pre-requisite Programmes (PRPs)

Has the organization established, implemented and maintained PRP(s) to assist


in controlling :

The like hood of introducing food safety hazard to the product through the
work environment ?

Biological, chemical and physical contamination of the product(s) including


cross contamination between products

Food safety hazard levels in the product and product processing environment ?

Are the PRP(s) appropriate to the organizational needs 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 operational line ?

Approved by the food safety team ?

Has the organization identified statutory and regulatory requirements related


to the PRP(s) ?

Does the organization consider and utilize appropriate information when


selecting and/or establishing PRP(s) ?
(Eg. Statutory and regulatory requirements, customer requirements,
recognized guidelines codex principles and codes of practices, national,
international or sector standards)?

Does the organization consider the following when establishing PPR programmes;

Construction and lay-out of buildings and associated utilities ?

Lay-out of premises, including workplace and employee facilities ?

Suppliers of air, water, energy and other utilities ?


Yes

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No

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Supporting services, including waste and sewage disposal ?

The suitability of equipment and its accessibility for cleaning, maintenance


and preventive maintenance?

Management of purchased material supplies, disposals and handling of


products?

Measures for the prevention of cross contamination ?

Cleaning and sanitizing ?

Pest control ?

Personnel Hygiene ?

Other aspects as appropriate ?

Has the PRP(s) planned and verified as necessary ?

Are the records of verification and modification maintained ?

Does the documents specify how activities included in the PRO(s) are
managed ?

4. 3

Preliminary steps to enable hazard analysis

4.3.1

General
Yes

No

Yes

No

Yes

No

Does the organization collect, maintain update and document all relevant
information needed to conduct the hazard analysis ?
4.3.2

Food Safety team

Has the organization appointed a multi disciplinary knowledged and experienced


food safety team in developing and implementing food safety management system ?

Does the organization maintain records to demonstrate that the food safety team
has the required knowledge and experience ?

4.3.3

Product Characteristics

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4.3.3.1 Raw materials, ingredients and product contact materials


Has the organization described all raw materials, ingredients and product contact
materials including the following, as appropriate;

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 ?

Has the organization identified statutory and regulatory food safety


requirements related to the above ?

Yes

No

Yes

No

4.3.3.2 Characteristics of end products


Has the organization described in documents, the characteristics of end products
to the extent needed to conduct the hazard analysis including information on the
following, as appropriate ?

Product name or similar identification ?

Composition ?

Biological, Chemical and physical characteristics relevant to food safety ?

Intended shelf life and storage conditions ?

Packaging ?

Labeling relating to food safety and/or instructions for handling, preparation


and usage ?

Methods(s) of distribution ?

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4.3.4

Has the organization identified the statutory and regulatory food safety
requirements Related to the above ?
Intended use
Yes

No

Has the organization described in documents, the reasonably expected handling


of the end product, and any unintended but reasonably expected mishandling
and misuse of the end product ?
Has the organization identified, 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 ?
4.3.5

Flow diagrams, process steps and control measures

4.3.5.1 Flow diagrams


Has the organization prepared clear, accurate and sufficiently detailed flow diagrams
for the products or process categories including the following as appropriate ?
Yes

The sequence and interaction of all steps in the operation ?

Any outsourced process 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 ?

Verify the accuracy of the flow diagram by on-site checking ?

Availability of records of verified flow diagrams ?

No

4.3.5.2 Description of process steps and control measures


Has the organization described;
Yes

No

The existing control measures, process parameters and/or the rigorousness


with which they are applied or procedures that may influence food safety ?
External requirements that may impact the choice and the rigorousness of
the control measures ?
(eg. From regulatory authorities or customers)

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4.4

Hazard analysis

4.4.1

General
Yes

No

Yes

No

Yes

No

Yes

No

Does the food safety team conduct a hazard analysis to determine which hazards
need to be controlled, the degree of controls required to ensure food safety, and
which combination of control measures is required ?
4.4.2

Hazard identification and determination of acceptable levels

4.4.2.1 Has the organization identified and recorded all food safety hazards that
are reasonably expected to occur in relation to the type of product, type
of process and actual processing facilities ?
Is the identification based on the following ?

The preliminary information and data collected according to 4.3 of this


questionnaire ?

Experience ?

External information including. to the extent possible, epidemiological and


other historical data ?

Information of 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 ?

Are the step(s) (from raw materials, processing and distribution) at which
each food safety hazard may be introduced indicated) ?

4.4.2.2 Has the organization considered the following when identifying the
hazards;

The steps preceding and following a specified operation ?

The process equipment, utilities/services and surroundings ?

The preceding and following links in the food chain ?

4.4.2.3 For each of the food safety hazards identified has the organization
determined;
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Yes

The acceptable level of the food safety hazard in the end product?

The established statutory and regulatory requirements ?

Customer food safety requirements ?

The intended use by the customer ?

Other relevant data ?

4.4.3

Hazard assessment

No

Does the organization conduct hazard assessment for each food safety hazard
Identified to determine;
Yes

Whether its elimination or reduction to acceptable level is essential ?

Whether its control is needed ?

No

Has the organization evaluated each food safety hazard according to;

Severity of adverse health effects ?

The likelihood of their occurrence ?

Has the organization described the methodology used for hazard


assessment ?

Does the organization record the results ?

4.4.4

Yes

No

Yes

No

Selection and assessment of control measures

Has the organization selected an appropriate combination of control measures


which is capable at preventing eliminating or reducing food safety hazards to
defined acceptable level?
Does the organization review each at the control measures described in 4.3.5.2
with respect to its effectiveness ?
Has the organization categorized the control measures as to whether they need
to be managed through operational PRP(s) or by the HACCP plan
Has the categorization carried out using a logical approach that includes assessments
with regard to the following;

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Yes

Its effect on identified food safety hazards relative to the strictness applied ?

Its feasibility for monitoring (Eg. Ability to be monitored in a timely manner


to enable immediate corrections)?

Its place within the system relative to other control measures ?

The likelihood of failure in the functioning of a control measure or


Significant processing variability ?

The severity of the consequence(s) in the case of failure in its functioning ?

Whether the control measure is specifically established and applied to


eliminate or significantly reduce the level of hazards(s)

Synergistic effects (i e interaction that occurs between two more measures


Resulting in their combined effect being higher than the sum of their
individual effects)?

Has the methodology and parameters used for categorization described in


Documents and the results of the assessment recorded ?

4.5

No

Establishing the operational pre-requisite programmes (PRPs)

Do the operational PRPs documented include the following information


for each programme;
Yes

4.6

Food safety hazards(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, shows


that the operational PRPs are not in control?

Responsibilities and authorities ?

Records of monitoring ?

No

Establishing the HACCP plan

4.6.1 HACCP plan


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Does the HACCP plan documented include the following information for each identified
critical control point (CCP);
Yes
No
Food safety hazard(s) to be controlled at the CCP ?

Critical limits ?

Monitoring procedures ?

Corrections and corrective action(s) to be taken if critical limits do exceed?

Responsibilities and authorities ?

Records of monitoring ?

4.6.2

Identification of Critical control points (CCPs)


Yes

No

Has the organization identified control measures for each hazard that is to be
controlled by the HACCP plan ?
4.6.3

Determination of critical limits for critical control points


Has the organization;
Yes

Determined the critical limits for each CCP established?

Established critical limits to ensure that the identified acceptable level


of the food safety hazard in the end product is not exceeded ?

Established measurable critical limits ?

Documented the rationale for the chosen critical limits ?

Determined the critical limits based on objective data (such as visual


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

4.6.4

No

System for the monitoring at critical control points


Yes

No

Has the organization established a monitoring system for each CCP to


Demonstrate that the CCP is in control ?
Does the monitoring system consist of relevant procedures, instructions and
records that cover the following;
Yes
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No

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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 ?

Does 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 ?

4.6.5

Actions when monitoring results exceed critical limits


Yes

No

Does the HACCP plan specify the planned corrections and corrective actions
to be taken when critical limits do exceed ?
4.7 Updating of preliminary information and documents specifying the
PRPs and the HACCP plan
Does the organization update the following information, if necessary ;
Yes

Product characteristics ?

Intended use ?

Flow diagrams ?

Processes steps ?

Control measures ?

No

4.8 Verification planning


Yes

No

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


Does 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 level ?

Other procedures required by the organization are implemented and


effective ?

Does the output of this planning is in a form suitable for the organizations
method of operations ?

Are the verification results recorded and communicated to the food safety team

Yes

No

Yes

No

Yes

No

4.9 Traceability system

Has the organization established and applied a traceability system that enables
the identification of product lots and their relation to batches of raw materials
processing and delivery records ?

Is the traceability system able to identify incoming material from the


immediate suppliers and the initial distribution route of the end product ?

Are the 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 ?

Are the records in accordance with statutory and regulatory requirements


and customer requirements (eg: based on the end product lot identification) ?

4.10 Control of nonconformity


4.10.1 Corrections

Does the organization ensure that when critical limits for CCP(s) are
exceeded or there is a loss of control of operational PRP(s), the products
affected are identified and controlled with regard to their use and release ?
Is there a documented procedure established and maintained defining the

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Identification and assessment of affected end products to determine their


proper handling and a review of the corrections carried out ?

Are all corrections approved by the responsible person(s) ?

Are all corrections recorded together with information on the nature of the
nonconformity, its cause(s) and consequence including information needed
for traceability purposes ?

4.10.2 Corrective actions


Yes

Are 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 ?

Are the corrective actions initiated when critical limits exceeded or when
there is a lack of conformity with operational PRP(s)

Is there a documented procedure available to identify and eliminate the


cause of detected nonconformities, to prevent recurrence, and to bring the
process or system back in to control after nonconformity is encountered ?

No

Are these actions include;

Reviewing nonconformities (including customer complaints) ?

Reviewing trends in monitoring results that may indicate development


towards loss of control ?

Determining the causes(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 ?

Are the corrective actions recorded ?

4.10.3 Handling of potentially unsafe products


4.10.3.1

General

Yes
No
Does the organization handle nonconformity products by taking
action(s) to prevent the nonconformity product from entering the food
chain ?

Does the organization ensure that ;


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Yes

The food safety hazard(s) of concern has(ve) been reduced to the defined
acceptable levels ?

The food safety hazard(s) of concern will be reduced to identified


acceptable levels prior to entering into the food chain ?

The product still meets the defined acceptable level(s) of the food safety
hazard(s) of concern despite the nonconformity ?

No

Are the all lots of product that have been affected by a nonconforming
situation held under control of the organization until they have been
evaluated ?

Does the organization notify relevant interested parties and initiate a


withdrawal if products that have left the control of the organization are
subsequently determined to be unsafe ?

Does the organization maintain documents regarding the controls and


related responses and authorization for dealing with potentially unsafe
products ?

4.10.3.2

Evaluation for release ?

Does the organization take actions to release each lot of product affected
by the nonconformity, when any of the following conditions apply ;

Evidence other than the monitoring system demonstrates that the control
measures have been effective ?

Destruction and/or disposal as waste ? Evidence shows that the combined


effect of the control measures for that particular product complies with the
performance intended ?

The results of the sampling, analysis and/or other verification activities


demonstrate that the affected lot of product complies with the identified
acceptable levels ?

4.10.3.3

Disposition of nonconforming
products

Does the organization evaluate, if the lot of product is not acceptable for release is
it handled by one of the following ?

Yes

No

Reprocessing or further processing within or outside the organization to


ensure that the food safety hazard is eliminated or reduced to acceptable
levels ?
Yes

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No

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Destruction and/or disposal as waste ?

4.10.4 Withdrawals

Has the top management appointed personnel having the authority to


initiate a withdrawal and personnel responsible for executing the
withdrawal ?

Is there a documented procedure for ;

Notification to relevant interested parties


(eg:- statutory and regulatory authorities, consumers and/or consumers) ?

Handling of withdrawn products as well as affected lots of the products


still in stock ?

The sequence of actions to be taken ?

Yes

No

Yes

No

Are the withdrawn products ;

Held under supervision until they are destroyed ?

Used for purposes other than originally intended ?

Determined to be safe for the same (or other) intended use ?

Reprocessed in a manner to ensure they become safe ?

Are the cause, extent and result of a withdrawal record and report to the
top management as input to the management review ?

Does the organization verify and record the effectiveness of the withdrawal
programme through the use of appropriate technique (eg: mock withdrawal
or practice withdrawal)

5. Validation, verification and improvement of the food safety management system


5.1 General
Yes

No

Does the food safety team plan and implement the processes needed to validate
control measure combinations, and to verify and improve the food safety
management system?

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5.2 Validation of control measure combinations


Prior to implementation of control measures to be included in operational PRP(s)
and the HACCP plan and after any changes, does the organization validate that;

The selected control measures are capable of achieving the intended


control of the food safety hazard(s) for which they are designated ?

The 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?

Are the control measures and/or combinations modified and re-assessed


the if the result of the validation shows any deviation ?

Yes

No

Yes

No

5.3 Control of monitoring and measuring

Does the organization capable of providing evidence so that the specified


monitoring and measuring methods and equipment are adequate to ensure
the performance of the monitoring and measuring procedures ?

Are monitoring and measuring equipment calibrated or verified at specified


intervals, or prior to use, against measurement standards traceable to
international or national measurement standards ?

Is the basis used for calibration recorded when traceability to international


Or national standards cannot be done, since no standards exist ?

Are monitoring or measuring equipment;

Adjusted or re-adjusted as necessary ?

Identified to enable the calibration status to be determined ?

Safeguarded from adjustments that would invalidate the measurement


results ?

Protected from damaged and deterioration ?

Does the organization;


Yes

Maintain records of the results of calibration and verification ?

Assess the validity of the previous measurement results when the


equipment results when the equipment or process is found not conform

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to requirement ?
Yes

Take appropriate action for the equipment and any product affected, if the
Measuring equipment id nonconforming ?

Maintain records of such assessment and resulting actions ?

Confirm the ability of computer software to satisfy the intended application


when used in the monitoring and measurement of specified requirements ?

No

5.4 Food safety Management System verification


5.4.1

Internal audit

Yes

Does the organization conduct periodic audits of the food safety


management system ?

Do the periodic audits evaluate the conformity of the food safety


managements of ISO 22000:2005 ?

Do the periodic audits evaluate the degree to which the food safety
management system has been effectively implemented and updated ?

Does the organization plan the audit programme taking into consideration
the importance of the process and areas to be audited ?

Does the organization plan the audit programme taking into consideration
the updating actions resulting from previous audits ?

Are the audit criteria, scope, frequency and methodology defined ?

Does the audit process and auditor assignment ensure objectivity and
Impartiality ?

Is there a documented procedure that includes the responsibilities


and requirements for conducting audits ?

Is there a documented procedure for reporting results and marinating


records ?

Is timely corrective actions taken on deficiencies found during the audit ?

Do follow-up actions include the verification of the implementation of


corrective action ?

Do follow-up actions include the reporting of verification results ?

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5.4.2

Evaluation of individual verification results


Yes

Does the food safety team systematically evaluate the individual results
of planned verification ?

Does the organization take action to achieve the required conformity,


if verification does not demonstrate conformity with the planned
arrangements ?

5.4.3

Analysis of results of verification activities


Yes

No

No

Does the food safety team analyze the results of verification activities,
including the results of the internal audits and external audits ?

Are the analysis carried out in order;

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

To identify the need for updating or improving the food safety management
system ?

To identify trends which indicate a higher incidence of potentially unsafe


products ?

To establish information for planning of the internal audit programme


concerning the status and importance of areas to be audited ?

To provide evidence that any corrections and corrective actions that


have been taken are effective ?

5.5 Improvement
5.5.1

Continual Improvement
Yes

Does the organization plan and manage processes necessary for the
continual improvement of the Food Safety Management System ?

Does the organization use communication, management review, I


internal audit, evaluation of verification results, audit, evaluation of
verification results, analysis of results of verification activities,
validation of control measure combinations corrective actions and

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food safety management system updating to facilitate the continual


improvement of the food safety management system ?
5.5.2

Updating the food safety management system


Yes

Does the top management ensure that the food safety management system
is continually updated ?

Does the food safety team evaluate the food safety management system at
planned intervals?

No

Are the updating activities based on;

Input from other information concerning the suitability, adequacy and


effectiveness of the food management system ?

Output from the analysis of results of verification activities ?

Output from the management review ?

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