IIT & CII - FACE Certified Food Professional Course

WebinarISO 9001 : 2008 & ISO 22000

Quality & Food Safety Management Quality & Food Safety Management Systems (QMS & FSMS)

Tutor : Dr. Indrani Ghose (Principal Counsellor, CII – FACE)Date: Oct 2013Date: Oct 2013

Key Features of ISO 9001Key Features of ISO 9001

A Q lit M t S t Std (QMS)• A Quality Management System Std (QMS)

• Based on 8 Fundamental Principles & PDCABased on 8 Fundamental Principles & PDCA

• Drives process oriented management

• Proactively captures customer / consumer / end user needs and perceptionperception

• Communication & Continual Improvement

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Key features of ISO 22000 Standard y

– A Food Safety Management System Std (FSMS)

– Based on Codex HACCP Risk Analysis

– To harmonize the requirements for Food Safety Management for

business within the food Chain on a Global Level

– To meet any applicable food safety related statutory and

regulatory requirements

– To seek a more focused, coherent and integrated FSMS than is

required by lawq y

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What is ISO 22000 standard all aboutWhat is ISO 22000 standard all about

• Integrates the principles of HACCP system, application steps (of Codex) & Pre-requisite programs

• Has taken due consideration of the provisions of ISO 9001:2000

• It requires an organization to incorporate any applicable food safety related statutory & regulatory requirements into its Food Safety Management Systems

• Has been developed as an auditable standard

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ISO 9000 FamilyISO 9000: 2005 – Quality management systems – fundamentals and

vocabulary

ISO 9000 Family

vocabulary

ISO 9001: 2008 – Quality management systems – requirements

ISO 9004: 2009 – Managing for the sustained success of an organization — A quality management approach

ISO 9004 2009 id id t i ti t t th hi t f t i dISO 9004:2009 provides guidance to organizations to support the achievement of sustained success by a quality management approach. It is applicable to any organization, regardless of size, type and activity.ISO 9004:2009 is not intended for certification, regulatory or contractual use.

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ISO 22000 Family of Standards

• ISO 22000 - Food safety management systems -

• ISO TS 22003 - Food safety management systems forg y

Requirements for any organization in the food chain.

• ISO 22001 - Guidelines on the

management systems for bodies providing audit and certification of food safety management systems.

application of ISO 9001:2000 for the food and drink industry (replaces: ISO 15161:2001).

g y• ISO TS 22004 - Food safety

management systems -Guidance on the application of

• ISO/TS 22002- Prerequisite programmes on food safety—Part 1: Food manufacturing

ppISO 22000:2005.

• ISO 22005 - Traceability in the feed and food chain - General

• Part 2: Catering principles and basic requirements for system design and implementation.

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ISO 9001 & ISO 22000B d C liti d S ifi ClBroad Commonalities and Specific Clauses

Commonalities• The Management System Structure

Specific Clauses of ISO 22000• External Communication 5 6 1The Management System Structure

Clauses are common to both i.eClauses 4,5,6 mostly (Document & Record Control, Management R ibilit I t l

• External Communication 5.6.1• Emergency Preparedness 5.7• Clauses on PRP (Clause 7.2)• Clauses on 5 Preliminary StepsResponsibility, Internal

Communication, Resources, Correction, Corrective Action, Internal Audit, Monitoring and

• Clauses on 5 Preliminary Steps and 7 Principles of Codex HACCP (Clause 7.3-7.8)

• Withdrawal , Validation (Clause, gMeasurement ,Continual Improvement (8.5.1)

• Auditable standards

Withdrawal , Validation (Clause 7.10.4, 8.2)

• Updating FSMS (8.5.2)

Specific Clauses of ISO 9001• Customer Measurement 8.2.1•Product realisation 7 1-7 5 5•Product realisation 7.1-7.5.5 •Preventive Action 8.5.3

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Implication of the some vocabulary used in the standards

• Product: Incoming, In Process, End Product

• Shall: Mandatory Requirement

• As applicable/ Where relevant: Optional with justification

N t G id li (N t d t )• Note: Guideline (Not mandatory)

• Important Terms & Definitions: Quality, Grade, Quality Policy, Quality Objectives, Top Management, Conformity, Non Conformity, Defect, Efficiency, Effectiveness, Correction, Corrective Action, Preventive Action & others : Ref ISO 9000: 2005

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QualityQualityDegree to which a set of inherent characteristics

fulfills requirementsfulfills requirements

GradeCategory or rank given to different quality requirements for

products, processes or systems having the same functional use

Customer satisfactionCustomer’s perception of the degree to which the customer’s

requirements have been fulfilled

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Quality Policy

Overall intentions and direction of an organization related to quality, as formally expressed by top management

Quality ObjectivesQuality Objectives

Something sought or aimed for, related to quality

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Top management

Person or group of people who directs and controls an organization, at the

highest level

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Conformity

The fulfillment of a requirementThe fulfillment of a requirement

Non – conformity

The non – fulfillment of a requirement

DefectDefect

The non – fulfillment of a requirement, related to an intended or specified usespecified use

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Effectiveness

Extent to which planned activities are realized and planned results achieved

Efficiency

Relationship between the result achieved and resources used

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Quality Management Principles&

PDCA

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Principle 1

Quality Management Principlesp

Customer - Focused Organization

Principle 2

Principle 5Systems approach to management

Principle 6Principle 2Leadership

Principle 6Continual Improvement

Principle 3Involvement of people

Principle 7

Factual approach to decision making

Principle 4Process approach

Principle 8Process approach

Mutually beneficial supplier relationships

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Principle 1Customer - Focused

Organization

Principle 2Leadership

Organization

“Organizations depend on their “Leaders establish unity of

purpose and direction of the customers and therefore should

understand current and future organization. They should create

and maintain the internal customer needs, meet customer

requirements and strive to environment in which people can

become full involved in achievingexceed customer expectations”

become full involved in achieving

the organization’s objectives”

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Principle 3Involvement of people

Principle 4Process approach

“People at all levels are the

essence of an organization and“A desired result is achieved

essence of an organization and

their full involvement enables

th i biliti t b d f th

more efficiently when related

resources and activities are their abilities to be used for the

organization’s benefit”managed as a process. ”

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Principle 5Systems approach to

managementPrinciple 6

management

“Identifying, understanding and

Continual Improvement

“Continual improvement shouldmanaging a system of

interrelated processes for a given

Continual improvement should

be a permanent objective of the

organization”te e ated p ocesses o a g e

objective improves the

organization’s effectiveness and

organization”

organization s effectiveness and

efficiency”

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Principle 7Principle 8

Mutually beneficial supplier Factual approach to

decision making

utua y be e c a supp erelationships

“A i ti d it

“Effective decisions are based on

the analysis of data and

“An organization and its

suppliers are interdependent, and

the analysis of data and

information”

a mutually beneficial relationship

enhances the ability of both to

create value.”

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P-D-C-A ApproachP-D-C-A Approach

ACT PLAN

CHECK DO

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P-D-C-A ApproachP D C A Approach

• Concept introduced by Dr. Shewhart in early 40’s

• Popularized by Dr. Deming in the 1950’s

• Became known as Deming cycle

PDCA stands for plan do check and act• PDCA stands for plan, do, check and act

• PDCA cycle can be applied at all levels within the i tiorganization

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ISO 9001 : 2008ISO 9001 : 2008

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ISO 9001: 2000 QMS Requirements

1.Scope and general

ISO 9001: 2000 QMS Requirements

p g

2.Normative references

3.Terms & definitions3.Terms & definitions

4.Quality management system

5 Management responsibility5.Management responsibility

6.Resource management

7 Product realization7.Product realization

8.Measurement, analysis and improvement

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Application

• All requirements of this International Standard are generic d i t d d t b li bl t ll

pp cat o

and are intended to be applicable to all organizations, regardless of type, size and product provided.p

• Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product this can be considered for exclusionits product, this can be considered for exclusion.

• Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these pexclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility to provide product that meets customer andresponsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

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Justification of exclusionsJustification of exclusions

• When an organization limits the application of the requirements of the ISO 9001: 2000, this must be detailed and justified in the organization’s quality manual.

• This must also be clear in any other publicly available document, such as certification/registration documentdocument, such as certification/registration document or marketing material

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Most likely exclusions

• Within clause 7 (product realization), the following are

Most likely exclusions

(p ), gthe most likely requirements, though not the only ones, that could be considered as not being applicable in certain circumstancesin certain circumstances

7.3 Design & development

7.5.3 Identification & traceability (traceability may not be applicable)

7.5.4 Customer property

7.6 Control of monitoring & measuring devices.

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4.0 Quality Management System

4.1 General requirementsThe organization shall establish, document, implement and maintain a

lit /f d f t t t d ti ll i itquality/food safety management system and continually improve its effectiveness in accordance with the requirements of this International Standard.The organization shallThe organization shalla) determine the processes needed for the quality management system

and their application throughout the organization (see 1.2),b) determine the sequence and interaction of these processesb) determine the sequence and interaction of these processes,c) determine criteria and methods needed to ensure that both the

operation and control of these processes are effective,d) ensure the availability of resources and information necessary to d) e su e e a a ab y o esou ces a d o a o ecessa y o

support the operation and monitoring of these processes,e) monitor, measure where applicable, and analyse these processes,

and Contdf) implement actions necessary to achieve planned results and

continual improvement of these processes.

Contd..

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4.1 General requirementsCommon Clause

Contd..Common Clause

These processes shall be managed by the organization in accordance with the requirements of this International Standard.requirements of this International Standard.

Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes The type and extent of control to be applied to these outsourcedprocesses. The type and extent of control to be applied to these outsourced processes shall be defined within the quality/food safety management system.

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4.2 Documentation requirements

4.2.1 General

The quality management system documentation shall include

a) documented statements of a quality policy and quality objectives,

b) a quality manual,

c) documented procedures and records required by this International Standard andStandard, and

d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.

Contd..

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4.2.2 Quality Manual4.2.2 Quality Manual

The organization shall establish and maintain a quality manual g q ythat includes

a) the scope of the quality management system, including details of and justification for any exclusions(see 1.2),

b) the documented procedures established for the qualityb) the documented procedures established for the quality management system, or reference to them, and

c) a description of the interaction between the processes of thec) a description of the interaction between the processes of the quality management system.

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4.2.3 Control of documentsC CCommon Clause

Documents required by the quality management system shall be controlled Records are a special type of document and shall becontrolled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.

A documented procedure shall be established to define the pcontrols needed

C tdContd..

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4.2.4 Control of recordsC CCommon Clause

Records established to provide evidence of conformity to p yrequirements and of the effective operation of the quality management system shall be controlled.

The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection retrieval retention and disposition of recordsprotection, retrieval, retention and disposition of records.

Records shall remain legible, readily identifiable and retrievable.

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5.0 Management responsibilityC CCommon Clause

5.1 Management commitmentgTop management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness bysystem and continually improving its effectiveness by

a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirementsrequirements,

b) establishing the quality / food safety policyc) ensuring that quality / food safety objectives are ) g y y j

established,d) conducting management reviews, ande) ensuring the availability of resourcese) ensuring the availability of resources.

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5.2 Customer focus

Top management shall ensure that customer requirements are d t i d d t ith th i f h i tdetermined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).

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5.3 Quality/Food Safety policyC CCommon Clause

Top management shall ensure that the quality policyp g q y p ya) is appropriate to the purpose of the organization,b) includes a commitment to comply with requirements and

continually improve the effectiveness of the quality management system,

c) provides a framework for establishing and reviewing qualityc) provides a framework for establishing and reviewing quality objectives,

d) is communicated and understood within thed) is communicated and understood within the organization, and

e) is reviewed for continuing suitability.

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5.4 Planning / 5.3 FSMS PlanningC CCommon Clause

5.4.1 Quality objectives5.4.1 Quality objectives

Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7 1 a)] arethose needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and g q y jconsistent with the quality policy.

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5.5 Responsibility, authority and communicationcommunicationCommon Clause

5.5.1 Responsibility and authorityTop management shall ensure that responsibilities and authorities are defined and communicated within the organization.

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5.5.2 Management representative5.5.2 Management representative Top management shall appoint a member of the organization's management who irrespective of other responsibilities shall have responsibility andwho, irrespective of other responsibilities, shall have responsibility and authority that includes

a) ensuring that processes needed for the quality management system are established implemented andestablished, implemented andmaintained,

b) reporting to top management on the performance of the quality t t d d fmanagement system and any need for

improvement, and

c) ensuring the promotion of awareness of customer requirements throughout the organization.

NOTE: The responsibility of a management representative can include liaison with external parties on matters relating to the quality p g q ymanagement system.

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5.5.3 Internal communicationC CCommon Clause

Top management shall ensure that appropriate communication processes are established within thecommunication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.the effectiveness of the quality management system.

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5.6 Management reviewC CCommon Clause

Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, includingneed for changes to the quality management system, including the quality policy and quality objectives.

Records from management reviews shall be maintained (see 4.2.4).

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6.0 Resource managementC CCommon Clause

6.1 Provision of resourcesThe organization shall determine and provide the resources needed6.2.1 Human Resources

Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience.

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6.2.2 Competence, training and awarenessC CCommon Clause

The organization shallga) determine the necessary competence for personnel

performing work affecting conformity to product requirements,requirements,

b) where applicable, provide training or take other actions to achieve the necessary competence,

) l t th ff ti f th ti t kc) evaluate the effectiveness of the actions taken,d) ensure that its personnel are aware of the relevance and

importance of their activities and how they contribute to the yachievement of the quality objectives, and

e) maintain appropriate records of education, training, skills and experience (see 4.2.4).experience (see 4.2.4).

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6.3 InfrastructureC CCommon Clause

The organization shall determine, provide and maintain the g , pinfrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable,

) b ildi k d i t d tilitia) buildings, workspace and associated utilities,b) process equipment (both hardware and software), andc) supporting services (such as transport communication orc) supporting services (such as transport, communication or

information systems).

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6.4 Work environmentC CCommon Clause

The organization shall determine and manage the workThe organization shall determine and manage the work environment needed to achieve conformity to product requirements.

NOTE: The term "work environment" relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather).

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7.0 Product realization7.0 Product realization7.1 Planning of product realizationThe organization shall plan and develop the processes needed for productThe organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4 1)4.1).In planning product realization, the organization shall determine the following, as appropriate:a) quality objectives and requirements for the product;a) quality objectives and requirements for the product;b) the need to establish processes and documents, and to provide

resources specific to the product;) i d ifi ti lid ti it i t i ti dc) required verification, validation, monitoring, measurement, inspection and

test activities specific to the product and the criteria for product acceptance;

ContdContd..

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7.2 Customer-related processes7.2 Customer related processes

7.2.1 Determination of requirements related to the productThe organization shall determine

a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,y p y ,

b) requirements not stated by the customer but necessary for specified or intended use, where known,

c) statutory and regulatory requirements applicable to the product andc) statutory and regulatory requirements applicable to the product, andd) any additional requirements considered necessary by the

organization.NOTE:Post delivery activities include for example actions underNOTE:Post-delivery activities include, for example, actions under

warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposalrecycling or final disposal.

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7.2.3 Customer communication7.2.3 Customer communication

The organization shall determine and implement effective g parrangements for communicating with customers in relation toa) product information,b) enquiries, contracts or order handling, including

amendments, andc) customer feedback including customer complaintsc) customer feedback, including customer complaints.

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7.3 Design and development7.3 Design and development

7.3.1 Design and development planningg p p g7.3.2 Design and development inputs7.3.3 Design and development outputs7.3.4 Design and development review7.3.5 Design and development verification7.3.6 Design and development validation7.3.7 Control of design and development changes

ContdContd..

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7.4 Purchasing7.4 Purchasing7.4.1 Purchasing processThe organization shall ensure that purchased product conformsThe organization shall ensure that purchased product conforms to specified purchase requirements.The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).7 4 3 V ifi ti f h d d t7.4.3 Verification of purchased product7.4.2 Purchasing information

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7.5 Production and service provision & 7.67.5 Production and service provision & 7.67.5.1 Control of production and service provision

7.5.2 Validation of processes for production and service provision

7.5.3 Identification and traceability

7 5 4 C t t7.5.4 Customer property

7.5.5 Preservation of product

7 6 Control of monitoring and measuring equipment (Common7.6 Control of monitoring and measuring equipment (Common Clause)

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8.0 Measurement, analysis & improvement

8.1 GeneralThe organization shall plan and implement the monitoring, measurement, analysis and improvement processes

d dneededa) to demonstrate conformity to product requirements,b) to ensure conformity of the quality managementb) to ensure conformity of the quality management

system, andc) to continually improve the effectiveness of the quality

management system.This shall include determination of applicable methods, including statistical techniques and the extent of their usestatistical techniques, and the extent of their use.

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8.2 Monitoring and measurement8.2 Monitoring and measurement8.2.1 Customer satisfactionAs one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organizationrelating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined.

.

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8.2.2 Internal auditC CCommon Clause

The organization shall conduct internal audits at planned intervals to determine whether the quality management system

a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management systemthis International Standard and to the quality management system requirements established by the organization, and

b) is effectively implemented and maintained.

An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits The audit criteria scope frequency and methodsresults of previous audits. The audit criteria, scope, frequency and methods shall be defined. The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own workown work. Contd..

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8.2.3 Monitoring and measurement of processesg p

8.2.4 Monitoring and measurement of product

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8.3 Control of nonconforming productC CCommon Clause

The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming p g gproduct.

Where applicable, the organization shall deal with nonconforming product by one or more of the following ways:one or more of the following ways:

a) by taking action to eliminate the detected nonconformity;

b) by authorizing its use release or acceptance under concession by ab) by authorizing its use, release or acceptance under concession by a relevant authority and, whereapplicable, by the customer;

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8.4 Analysis of data8 a ys s o dataThe organization shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management y q y gsystem and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.

The analysis of data shall provide information relating to

a) customer satisfaction (see 8 2 1)a) customer satisfaction (see 8.2.1),

b) conformity to product requirements (see 8.2.4),

c) characteristics and trends of processes and products, including ) p p , gopportunities for preventive action(see 8.2.3 and 8.2.4), and

d) suppliers (see 7.4).d) suppliers (see 7.4).

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8.5 ImprovementC CCommon Clause

8.5.1 Continual ImprovementpThe organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

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8.5.2 Corrective actionC CCommon Clause

The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered.A documented procedure shall be established to define requirements forA documented procedure shall be established to define requirements fora) reviewing nonconformities (including customer complaints),b) determining the causes of nonconformities,c) evaluating the need for action to ensure that nonconformities do not

recur,d) determining and implementing action needed,) g p g ,e) records of the results of action taken (see 4.2.4), andf) reviewing the effectiveness of the corrective action taken.

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8.5.3 Preventive action

The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.

A documented procedure shall be established to define requirements forA documented procedure shall be established to define requirements for

a) determining potential nonconformities and their causes,

b) evaluating the need for action to prevent occurrence of nonconformities,) g p

c) determining and implementing action needed,

d) records of results of action taken (see 4.2.4), and

e) reviewing the effectiveness of the preventive action taken.

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Documented procedures specified p pin the standard

Clause Procedure for

4.2.3 Control of documents

4.2.4 Control of records

8.2.2 Internal audits

8.3 Control of non conforming product

8.5.2 Corrective action

8.5.3 Preventive action

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ISO 22000fImportant Terms and Definitions

• Critical LimitsCritical Limits• Monitoring• Critical Control PointsCritical Control Points• Validation• Verification• Verification• Control Measures• Others (Ref ISO 22000 ISO 19011)• Others (Ref ISO 22000, ISO 19011)

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5 2 Food safety policy5.2 Food safety policy

– to cover the organizations role in the food chain

– customer & regulatory– customer & regulatory requirements of safe food

– communicate, implement, maintain reviewmaintain review

– to address communication

– to be supported withto be supported with measurable objectives (goals for different functions, nature of hazards)

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5.5 Food safety team leader– manages the team & organizes its workmanages the team & organizes its work

– ensures establishment, implementation, maintenance & updation of FSMS

– reports to top management on effectiveness & suitability of FSMS

i t & d FSMS– communicates up & down on FSMS

– arranges training & education to the food safety teamy

– liaising with external agencies

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5 6 1External communication5.6.1External communication– establish mechanism to communicate

with the following on food safety issueswith the following on food safety issues

• suppliers

• contractors

• customers or consumers

• statutory / regulatory authorities

• transporters & others p

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5 7 Emergency preparedness and5.7 Emergency preparedness and response

– establish, implement & i t i d tmaintain procedure to

manage potential emergency situations & g yaccidents related to food safety

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7. Planning & realisation of safe products

7.1 General– plan & develop the process – Implement, operate & ensure effectiveness of

planed & updated activities including PRPs, operational PRPs & HACCP plan

• 7.2.1/ 7.2.2/7.2.3 Pre-requisite programs– purpose is to :

• control the possibility of introduction of food p ysafety hazards through work environment

• control the contamination with hazards including cross contamination between gproducts

• control hazard level in product & processing environment

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– Measures for the prevention of cross contamination

– Cleaning & sanitizing

– Pest control

– Personnel hygiene

– Other aspects as appropriateOther aspects as appropriate

– Verification of PRPs shall be planned and PRPs shall be modified as necessary

Records of verifications & modifications shall be– Records of verifications & modifications shall be maintained

– Documents should specify how activities included in the PRPs are managedthe PRPs are managed

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7 3 Preliminary steps to enable hazards7.3 Preliminary steps to enable hazards analysis

Food safety team– multi-disciplinary knowledge & p y g

experience

– records of competence of the members to be maintained

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Raw materials, ingredients & product contact materials : 7.3.3.1

Characteristics of end products: 7.3.3.2

Intended use : 7 3 4 target consumers for each productIntended use : 7.3.4 target consumers for each product or process category

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7.3.5.1 Flow diagrams3 5 o d ag a s– to be prepared for products or process

categories covered by FSMS

– flow diagrams to cover

• sequence & interaction

• outsourced processes• outsourced processes

• entry of RMs & intermediate products & ingredients

• optional steps like rework, recycled products

• removal of end product, intermediate p ,product, by product & waste

• verify flow diagrams & maintain records

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7 3 5 2 D i ti f t &7.3.5.2 Description of process steps & control measures

– Describe existing control measures,process t d t l l l f ll l tparameters and tolerance levels of all relevant process

steps affecting food safety

I l d ifi t d l t i t– Include specific customer and regulatory requirements

– Update as necessary

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7.4 Hazard analysis

7.4.1 General

– food safety team conducts hazard analysis for eachhazard analysis for each product category and / or process category

h d h d b– hazards that need to be controlled

– degree of control

– combination of control measures

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7 4 4Selection & assessment of control7.4.4Selection & assessment of control measures

– select appropriate combination control measures for the identified hazards

– review the effectiveness of these control measures against identified hazard

– categorize whether these control measures would be managed through operational PRPs or HACCP planPRPs or HACCP plan

– use a logical approach for selection and categorization using:

• effect on identified hazards w.r.t. strictness

• feasibility of monitoring w.r.t immediate correction

• likelihood or severity of consequence

• categorization of control measures w.r.t. HACCP plan (7.6) or operational PRPs (7.5)

• maintain records and documents on methodologygy

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Stage 1 : Comprehensive Hazard Analysis Table of all process steps and ingredients, PM, RM and Water if required.

Stage 2: Hazard Analysis of Significant Hazards: An Example only ( There could

Sl. No

Process Steps/

RM/Ingr

Hazards

(B,P,C

Control

Meas

Scores

base

CCPs/OPR

P

g y g p y (be other methodologies too)

Questions from Clause 7 4 4gdients

(B,P,C,A) ure d on

weightages

Questions from Clause 7.4.4

Stage 2 Example

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7.5 Establishing the operational PRPsg p

Documentation to include :– hazards to be controlled by operational

PRPs

– control measures for specific hazards

– relevant monitoring procedures to d t t th t OPRP i ldemonstrate that OPRPs are in place

– corrections & corrective actions to be taken in case of deviation

– responsibility & authority of each OPRP

– records of monitoring

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7.6 Establishing the HACCP plan

CC ( )HACCP plan (documentation required)

– hazards identification

– critical control points (CCPs)– critical control points (CCPs)

– control measures

– critical limits (CLs)( )

– monitoring

– correction & corrective actions to be taken when d i ti f CLdeviation from CL occurs

– responsibilities & authorities of monitoring

– record results of monitoringrecord results of monitoring

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7.7 Updating of preliminary information & documents specifying the PRPs &

HACCP plan– On establishing HACCP plan & operational PRPs, update

the following information as necessary:

• product characteristics

• intended use

• flow diagrams

• process steps & control measures

• amend HACCP plan if necessary

• amend procedures, instructions specifying operational p , p y g pPRPs if necessary

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7.8 Verification planning– define purpose, methods, frequencies & responsibilities for verification

activities

– verification activities to confirm– verification activities to confirm

• PRPs are implemented

• continual updation of input to hazard analysis

• operational PRPs & HACCP plan are implemented & effective

• infrastructure & maintenance programs are implemented

• hazard levels are appropriate and within acceptable limitshazard levels are appropriate and within acceptable limits

• other procedures required by the organization are implemented & effective

• define record requirements• define record requirements

• communicate results of verification to food safety team

• analyze results of verification activity, identify potentially unsafe d t & h dl di lproduct & handle accordingly

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7.10.4 Withdrawals7.10.4 Withdrawals– documented procedure for notifying interested parties for complete & timely

withdrawal of unsafe end product:

– establish a recall procedure that covers

• designating personnel to initiate recall

designating personnel to execute recall• designating personnel to execute recall

• procedures for notification to interested parties

• procedures for handling recalled products & those in stock

• procedures for sequence of actions to be taken on recall

• secured or held under supervision until disposition plan is executed

• evaluate cause extent & result of withdrawal to be recorded & reported• evaluate cause, extent & result of withdrawal to be recorded & reported to top management as management review input

• verification & recording of withdrawal program effectiveness

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8 Validation verification &8. Validation, verification & improvement of FSMS

8.1 General

responsibility of food safety– responsibility of food safety team

determine applicable– determine applicable methods to plan & implement processes needed to validate control measures & verify & improve FSMSp

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8 5 2Updating the food safety8.5.2Updating the food safety management system

– top management ensures continual updationp g p

– food safety team evaluates FSMS at defined intervals

d t i it t i b d– determines necessity to review based on:

• external & internal communication

• information of suitability adequacyinformation of suitability, adequacy, effectiveness of FSMS

• output from analysis of verification activities

• output from management review

– record system updating activities & reported as management review input

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Quality / Food Safety management system documentationdocumentation

Quality Policy, Objectives, Business Plan

Quality ManualQua y a ua

PProcedures Processes

Work

Procedures

Work Instructions

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Procurement process• Actions on vendor related

quality problem• Improvement project with

d

• Procure material as per required specs and at required date

• Improve quality of incoming materialvendor

• Training needs of dept. Personnel & vendors

P

material• Improve turn over• Optimize inventory• Cost reduction• Timely payment of vendors

• Review of pending payments beyond agreed time

• Review incoming material go rate w.r.t. goal (item wise)

A D

C • Vendor selection and w.r.t. goal (item wise)• Chronic vendor problems• Cost reduction achievement

review• Status of inventory item wise &

reduction of prod. Lead Time.

evaluation• Cost reduction project

allotment• Procure products as per

drg and tech specs.P i di dit d

p(item wise)

• Review of matl. With Material Requirement Planning % (MRP) delivery adherance

• Review inspection cycle time

• Periodic process audit and periodic Rating

• Processing of bill/invoice• Inventory management• Disposal of receipt

j tiincoming (itemwise SRV) rejection

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St f C tifi tiSteps for Certification

84

Activity Responsibility Time(in week)

Formation of core group

Quality / Food Safety policy CEO(Formation & communication) Chief Executive Officer

Management rep (MR)/ FS Leader CEO

Establishment of objectives CEO(At l t l l & f ti ) D tt H d(At relevant levels & functions) Deptt. Head

Awareness programme for ISO MR/ FS Leader9001 /22000 for all

Gap anal sis MR /FS LeaderGap analysis MR /FS LeaderDeptt. Head

Preparation for matrix for MR/ FS LeaderDeciding Requirements OF Deptt. HeadProcedures / processes for co

Issue of documentation MR /FS LeaderFormat for procedures / Processes/ SOPs/ Maintenance /GMP/GHP Checklists

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Activity Responsibility Time(i k)(in week)

Documenting existing procedures / Deptt. HeadProcesses/SOPsComparing with ISO 9001/ISO 22K standard Deptt. HeadCo pa g SO 900 / SO s a da d ep ead

(CII If required)Issue/modifications of additional Deptt. Head Procedures MR / FS LeaderIssue/modifications of additionalIssue/modifications of additionalProcedures• Document control MR / FS Leader• Record control MR / FS Leader• Quality / FS audit MR / FS Leader• Quality / FS audit MR / FS Leader• Others (if any) MR / FS LeaderApex Manual MR / FS Leader

(CII If required)Compile manual & MR/ FS LeaderEstablishing linkage among ProceduresDocumentation review MR /FS Leader

Deptt. Head

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Activity Responsibility Timey p y(in week)

Request to assessment body CEOMR /FS Leader

Training programme for MR /FS LeaderTraining programme for MR /FS LeaderInternal audit (Retraining if required)Internal audits MR/ FS Leader

AUDITORSAUDITORS

Compliance audit MR/ FS Leader

Compliance audit by assessment MRCompliance audit by assessment MRBody (AB) AB

Certification :CEO : Chef executive officerCEO : Chef executive officerMR : Management representativeAB : Assessment body

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Self Test Questionnaires

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Questions..?Q

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Thank you for your kind attention

Contact details :Dr.  Indrani  GhosePrincipal Counselor , Food Safety and Quality, CII‐FACEMob: ‐ +91‐9831170076Email ID – indrani.ghose@cii.in

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