Pre Assessment Questionnaire-Fsms

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.
Doc No: FSMS F 11.0 02A
Issue: 04
Date of Issue: Aug. 2011
Page 1 0f 26
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?
Issue: 04
Page 2 0f 26
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
Issue: 04
Page 3 0f 26
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

Issue: 04
Page 4 0f 26
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
Issue: 04
Page 5 0f 26
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
Issue: 04
Page 6 0f 26
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
Issue: 04
Page 7 0f 26
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
Issue: 04
Page 8 0f 26
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
Issue: 04
Page 9 0f 26
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
Issue: 04
No
Page 10 0f 26
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
Issue: 04
Page 11 0f 26
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 ?
Issue: 04
Page 12 0f 26

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)
Issue: 04
Page 13 0f 26
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;
Issue: 04
Page 14 0f 26
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;
Issue: 04
Page 15 0f 26
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

Issue: 04
Page 16 0f 26
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
Issue: 04
No
Page 17 0f 26
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
Issue: 04
Page 18 0f 26
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
Issue: 04
Page 19 0f 26
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 ;

Issue: 04
Page 20 0f 26
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
Issue: 04
No
Page 21 0f 26
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?
Issue: 04
Page 22 0f 26
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
Issue: 04
No
Page 23 0f 26
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 ?
Issue: 04
No
Page 24 0f 26
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
Issue: 04
No
Page 25 0f 26
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 ?
Issue: 04
Page 26 0f 26

Pre Assessment Questionnaire-Fsms

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Pre Assessment Questionnaire-Fsms

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PRE-ASSESSMENT QUESTIONNAIRE

FSMS SYSTEM CERTIFICATION SCHEME

Please tick the relevant box given under each question.

Doc No: FSMS F 11.0 02A

Date of Issue: Aug. 2011

Name of the Applicant :

Position in the food chain

Has the organization established, documented, implemented and maintained an

Doc No: FSMS F 11.0 02A

Date of Issue: Aug. 2011

Has the information concerning development, implementation and updating

Statement of food safety policy and related objectives?

Documented procedures and records required by ISO 22000 : 2005

Documents needed to ensure effective development Implementation and

Have the documented procedures been established, Implemented

Are there written down procedures for control of documents?

Date of Issue: Aug. 2011

applicable documents are available at points of use?

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

2.1 Management Commitment

Showing food safety supported by the business objectives of the

Communicating to the organization the importance of meeting the

Establishing the food safety policy ?

Conducting management reviews ?

Ensuring the availability of resources ?

2.2 Food Safety Policy

Date of Issue: Aug. 2011

Is appropriate to the role of the organization ?

Confirms to both statutory and regulatory requirements and with

Is communicated, implemented and maintained at all levels of the

Is reviewed for continuing suitability ?

Adequately addresses communication ?

2.3 Food Safety Management System Planning

Planning of the Food Safety Management System is carried out to

The integrity of the food safety management system is maintained

Responsibility and Authority

Has the Top Management defined the Responsibilities and Authorities

To manage a food safety team and organize its work

Doc No: FSMS F 11.0 02A

Date of Issue: Aug. 2011

To ensure relevant training and education of the food safety team

To ensure that the food safety management system is established,

To report to the organizations top management on the effectiveness and

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

Has the Top Management ensured that sufficient information on issues

Suppliers and contractors ?

Customers or consumers, in relation to product information ?

Safety and regulatory authorities ?

Does such communication provide information on food safety aspects

Are the records of communication maintained ?

Has designated personnel been made responsible and authorized to

Has the organization established, implemented and maintained effective

Date of Issue: Aug. 2011

manner of changes, including but not limited to ;

Products or new products ?

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

Statutory and regulatory requirements

Knowledge regarding food safety hazards and control measures ?