checklist audit iso 22000

7/24/2019 Checklist Audit ISO 22000

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CHECKLIST AUDIT ISO 22000

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Clause Requirement Doc ref

Conformance

Observations & objective evidenceY N

5 MANAGEMENT RESPONSIBILITY

5.1. MANAGEMENT COMMITMENT

5.1 Evidence of top managementcommitment to the FSMS and itscontinual improvement: objectives (5.3) communicating (5.6.2.) policy (5.2) management review (5.8.) resources(6)

5.2. FOOD SAFETY POLICY

a) Appropriate to the role in the food chain

b) Commits to comply with statutory,

regulatory and customer FSrequirements

c) Communicated and understood withinthe organization (5.6.)

d) Reviewed for continued suitability (5.8)

e) Supported by measurable objectives

5.3. FOOD SAFETY MANAGEMENTSYSTEM PLANNING

a) To meet the objectives

b) To maintain the FSM integrity whenchanges are implemented

5.4. RESPONSIBILITY AND AUTHORITYR&A are defined and communicatedwithin the organization

Identified person(s) to receive reportsproblems with the FMS

Designated personnel to initiate andrecord actions


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5.6. COMMUNICATION

5.6.1. External communication

Implemented effective arrangements forcommunicating with :

a) Suppliers and contractors

b) Customers / Consumers:

product information (see7.3.3.2)

enquiries

contracts / order handling

customer feedback / complaints

c) Food authorities

d) Other organizations that could beaffected

Provided information on FS aspects ofproducts that may be relevant to otherorganizations, especially to hazards thatneed to be controlled. Recordsmaintained.

Legal and customer FS requirementsrecorded

Designated personnel to manage the

external communication


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5.6.2. Internal communication

The Top management hascommunicated to the organization theimportance of meeting this standard,legal and customer FS requirements

Implemented effective arrangementsfor communicating with relevantpersonnel in FS:

FST is informed of changes, especially:

a) Products or new products

b) Raw materials, ingredients and

servicesc) Production systems and equipment

d) Production premises, location ofequipment, surrounding environment

e) Cleaning and sanitation programs

f) Packaging, storage and distributionsystems

g) Personnel qualification level / allocationof responsibilities and authorizations

h) Regulatory requirements

i) Knowledge regarding food safetyhazards and control measures

j) Customer, sector and otherrequirements

k) Relevant enquiries from externalinterested parties

l) Complaints indicating hazardsassociated with the product

m) Any condition which have an impact onfood safety


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5.8. MANAGEMENT REVIEW

5.8.1. At planned intervals

Records maintained

5.8.2. Inputs:

a) Follow-up actions from previousreviews

b) Verification activities (see 8.3.3)

c) Changes related FS (see 5.6.2)

d) Emergency situations, accidents (see5.7) and recalls (see 7.10.4)

e) System up-dating activities (see 8.5.2)

f) Communication activities includingcustomer feed-back (see 5.6.1)

g) External audits or inspections

5.8.3. Outputs:

a) Assurance of food safety (see 4.1.)

b) Improved effectiveness of the FSMS(see 8.5.)

c) Resource needs (see 6.1)

d) Revisions of the FSP and objectives(see 5.2).


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6 RESOURCE MANAGEMENT

6.2. HUMAN RESOURCES

6.2.2 For personnel relevant in FS

a) Identify necessary competencies

b) Training

c) Specific training for personnelresponsible of monitoring, corrections,and corrective actions

d) Evaluation of implementation andeffectiveness

e) Awareness of contribution to FSf) Awareness of need for effective

communication

g) Records of training and other actions

6.2.1. Agreement or contracts with externalexperts involved in FSM

6.3. INFRASTRUCTURE (see 7.2.3.)

6.4. WORK ENVIRONMENT (see 7.2.3.)


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7 PLANNING AND REALIZATIONOF SAFE PRODUCTS

7.2. PRPs

7.2.2. PRPs shall be

a) Appropiate to the organizational needs

b) Appropiate to the size and type ofoperation and product

c) Implemented across:

General programmes

Specific programmes

d) Approved by FST

7.2.3. According to

Legal requirements

Customer requirements

Recognized guidelines

Codex Alimentarius

Codes of practices

Specific documents to manage PRPs

7.5. Establishing the operational PRPs

Documentation for each programme:

a) Hazards controlled

b) Control measure(s)

c) Monitoring procedures

d) Corrections/ corrective actions

e) Responsibility & Authority

f) Records of monitoring

7.2.3. Elements of PRPs

a) Lay-out, design and construction of buildings and facilities:

Location

Perimeter and grounds

Walls

Floors

Ceilings

Windows

Doors

Lighting

Ventilation


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b) Lay/out of premises, includingworkspace and employee facilities:

Process flow

Working space and storage

Segregation Low/High riskareas/process

Segregation design

Washing and cleaninglocations

Changing facilities

Hand washing facilities Toilets

Catering facilities

c) Supplies of air, water, energy and otherutilities

d) Supporting services including wasteand sewage disposal

e) Equipment including its preventativemaintenance, sanitary design andaccessibility for maintenance andcleaning for each unit

f) Management of purchased materials,

disposals and handling of products: Raw materials

Ingredients

Packaging

Chemicals

Waste

Sewage

Storage of raw materials /packaging / in process / endproducts

Transportation

g) Measures for the prevention of crosscontamination


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h) Cleaning and sanitizing:

Cleaning practices

Cleaning schedules

Control and verification ofeffectiveness

Documented procedures /records

i) Pest control:

Competent pest control

Documented procedures /

records Physical measures: drains,

hermetically sealed doors,screens, security perimeter forinspection in storage, etc,.

Location of all measures

Plan/diagram for electric flykillers / baits / traps

Risk of product contaminationwith chemicals

j) Personnel hygiene:

GMPs

Protective clothing

Jewellery

Cuts and grazes

Hand cleaning

Notification of relevantinfectious disease orconditions

Medical screening

Training


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7.3. PRELIMINARY STEPS TO ENABLEHAZARD ANALYSIS

7.3.1. General

Relevant information needed toconduct the hazard analysisdocumented, collected, maintained andupdated

7.3.2. Food Safety Team (FST) (5.5.)

FST Leader appointed by TopManagement with responsibility:

a) To manage the FST

b) Training & education of FST members

c) To ensure that FSMS is established,implemented, maintained and updated

d) To report to Top Management aboutFSMS

Multi-disciplinary knowledge andexperience

Records demonstrate the requiredexpertise for all team members

7.3.3. Product characteristics

7.3.3.1. Raw materials, ingredients andproduct-contact materials

Specifications with:

a) Biological, chemical and physicalcharacteristics

b) Ingredients including additives andprocessing aids

c) Origin

d) Method of production

e) Delivery methods and packaging

f) Storage conditions and shelf life

g) Preparation and/or handling before use

or processingh) Food safety related acceptance criteria

or specifications of purchasedmaterials and ingredients appropriateto their intended uses

Relevant legislation/ regulationsdocumented

Specifications updated


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7.3.3.2. Characteristics of end products

Specifications with:

a) Name

b) Composition

c) Biological, chemical and physicalcharacteristics

d) Intended shelf life and storageconditions. Intended use (see 7.3.4.)

e) Packaging

f) Labelling relating to food safety and/or

instructions for handling, preparationand usage

g) Method(s)of distribution

Relevant legislation/ regulationsdocumented

Specifications updated

7.3.4. Intended use

Identified & documented appropriateinformation about :

The reasonably expectedhandling of the product

Any unintended but

reasonably expectedmishandling and misuse of theproduct

Group of consumers identified,specially vulnerable groups ofpopulation

Descriptions updated

7.3.5. Flow diagrams, process steps andcontrol measures

7.3.5.1. Flow diagrams

For each product / process categorycovered by the FSMS

Sufficient detail / schematic overview

Including

a) Sequence / interaction of steps

b) Outsourced processes andsubcontracted work

c) Inputs (raw materials, ingredients,intermediate products)

d) Reworking and recycling

e) Outputs (end, intermediate, by-products, waste)

Verified by FST (records)


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7.4.4. Selection and assessment of controlmeasures

Identified & document controlmeasures that are to be applied,selected from the control measuresdefined in 7.3.5.2.

Categorized in General ControlMeasures (managed through PRPs) orSpecific Control Measures (related toCCPs), regarding to:

a) Effect on identified food safety hazardsrelative to the intensity applied

b) Feasibility for monitoring

c) Place within the system relative toother control measures

d) Likelihood of failure in the functioning

e) Severity of the consequence

f) Specifically to eliminate/reduce thelevel of the hazard(s)

g) Synergistic effects

Methodology of categorizationdocumented and results recorded

8.2. Validation of control measure

combinationsPrior to implementation and after anychange of General/Specific ControlMeasures, ensure that:

a) Associate hazards are effectivelycontrolled

b) End Products meet the definedacceptable levels

If a) / b) are failed modification & re-assessment of:

Control measures

Raw materials

Technologies

Product characteristics

Distribution

Intend of use


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7.6. ESTABLISHING HACCP Plan

7.6.2. Identification of CCPs

Hazard to be controlled by specificcontrol measures CCP (7.4.4.)

7.6.3. Determination of critical limits

For the monitoring of each CCP

Requirements of legislation regulations internal risk analysis clients are met

In terms of measurable parameterssupported by instructions,

specifications, education/training.

Selection documented

7.6.4. Monitoring of the CCPs

A monitoring system for effective andefficient control of CCPs(measurements relative to the criticallimits) established and maintained

Procedures + instructions + recordsincluding:

a) Measurements that provide resultswithin an adequate time frame

b) Monitoring devices identified

c) Calibration methods (8.3.)

d) Frequency

e) Responsibility & Authority

f) Records / methods

8.3. Control ofmonitoring and measuring

To ensure valid results (if necessary),measuring equipment have to becontrolled:

a) Calibrated / verified againstmeasurement standards; where nosuch standards exist, the basis used

shall be recorded

b) Adjusted or re-adjusted as necessary

c) The calibration status identified

d) Safeguarded

e) Protected from damage

Records of calibrations

If no conformance assess thevalidity of previous results + treatmentof the equipment / product. Records

Suitability of software confirmed: priorto initial use + reconfirm


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7.6.5. Actions when monitoring resultsexceed critical limits

7.10. CONTROL OF NONCONFORMITY

7.10.1. Corrections

A procedure to:

a) Identify & assess of affected endproducts

b) Review the corrections carried out

Approved by the responsible person

Records with information on the natureof the nonconformity, cause,consequence and traceability

7.10.2. Corrective actions (CAs)

Data derived from the monitoring ofPRPs + CCPs evaluated by designatedperson to initiate corrective actions

Initiated when critical limits areexceeded or lack of conformity withPRPs. Records

A procedure to:

a) Review NCs (complaints included)

b) Review trends

c) Determine cause of NCs

d) Evaluate the need for CAs

e) Determine and implementing CAs

f) Records of CAs

g) Reviewing CAs

7.10.3. Handling of potentially unsafe products

7.10.3.1 NCs product don t enter the food chainunless it is possible to assure that thehazards have been reduced toacceptable levels, and the product issafe

All lots of products affected by NC

identified and controlled until they havebeen evaluated

A procedure with responses +authorization + actions and controls

7.10.3.2 Evaluation for release

Product is released as safe when:

a) Others evidence indicates that thecontrol measures have been effective

b) Combined effect of the controlmeasures has been effective

c) Analysis (or other verification activities)indicate that the product is safe


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7.10.3.3. Disposition of nonconforming products

Products not acceptable for releasehave to be:

a) Reprocessed to ensure that thehazards are controlled

b) Destroyed

7.9. TRACEABILITY SYSTEM

Identification of product lots and theirrelation to batches of:

raw materials (from theimmediate suppliers)

processing

distribution records (to theimmediate distributors)

Records maintained for a definedperiod

Meet customers and regulatoryrequirements. Based on the shelf life

7.10.4. WITHDRAWALS

To facilitate a recall:

a) Authority & Responsibility appointed bytop management

b) Procedure for:

Notification

Handling of recalled productsas well as involved productsstill in stock

Defining the sequence ofactions

Recalled products held undersupervision until their treatment

Records with the cause, extent andresult of a recall. Reported to the topmanagement as input to managementreview (see 5.8.2).

Effectiveness of the programme recallverified. Records

5.7. Emergency preparedness andresponse

Procedures to manage potentialemergency situations established byTop management


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7.8. Verification planning

Establish, document & implementprocedures for verification of theHACCP system: purpose methods frequencies responsibilities records

Shall to confirm that:

a) The PRPs are implemented

b) The hazard analysis is continuallyupdated

c) The operational PRPs and theelements within the HACCP plan are

implemented and effectived) Hazard levels are within identified

acceptable levels

Records communicated to the FST

NCs results in test samples of endproducts affected lots handled aspotentially unsafe

8.4.2. Evaluation of individualverification results

Are evaluated systematically by theFST

NCs with the planned arrangements

actions to achieve conformity. Review:

a) Procedures and communicationchannels (5.6. / 7.7.)

b) Conclusions of the hazard analysis /operational PRPs / HACCP plan

c) PRPs

d) Human resources / Training

8.4.3. Analysis of results of verificationactivities

Are analysed by the FST, including theresults of internal & external audits, inorder to:

a) Confirm that FSMS meets the plannedarrangements

b) Identify the need for updating /improving the FSMS

c) Identify trends

d) Establish information for planninginternal audits

e) Confirm effectiveness of correct ions &CAs

Records reported Top Management.Input to the management review and

for updating the FSMS


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checklist audit iso 22000

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