Implementing a

Quality Management System

Presented by

USDA GRAIN INSPECTION, PACKERS AND STOCKYARDS

ADMINISTRATION

What is a QMS?What is a QMS?

The short answer:The short answer: Say what you do (documentation)Say what you do (documentation) Do what you say (implementation)Do what you say (implementation) Prove what you do (records)Prove what you do (records) Review and improve (continuous Review and improve (continuous

improvement)improvement)

QMS DefinitionsQMS Definitions

A Quality Management System is:A Quality Management System is: System for managing the quality of System for managing the quality of

an organizationan organization Includes everything in the Includes everything in the

organization that relates to quality:organization that relates to quality: Products and servicesProducts and services ProcessesProcesses OperationsOperations Customer SatisfactionCustomer Satisfaction

QMS DescriptionQMS Description

As required by ISO 9000:As required by ISO 9000: The Quality System is well The Quality System is well

documented, implemented, documented, implemented, understood, maintained and understood, maintained and continually improvedcontinually improved

Emphasis is placed on problem Emphasis is placed on problem prevention rather than inspectionprevention rather than inspection

Quality planning is requiredQuality planning is required The PROCESS APPROACH to The PROCESS APPROACH to

management is encouragedmanagement is encouraged

QMS DescriptionQMS Description

Quality Standard Quality Standard or Regulationor Regulation

ISO 9001:2000ISO 9001:2000

Process VerifiedProcess Verified

ISO Guide 65ISO Guide 65

Quality System Quality System Assessment Assessment ProgramProgram

National Organic National Organic ProgramProgram

Product or ServiceProduct or ServiceConsistent quality Consistent quality

feedfeed

Identity Preserved Identity Preserved livestock or grainlivestock or grain

Consulting ServiceConsulting Service

Organic Certification Organic Certification and Organic and Organic ProductionProduction

Beef Export Beef Export Verification (BEV)Verification (BEV)

What makes it so What makes it so special?special?

ProcessProcess ApproachApproach to management to management Integration of processes into a Integration of processes into a

System/System/ Interrelation of all activities Interrelation of all activities Continual ImprovementContinual Improvement at all levels at all levels CommunicationCommunication among all employees among all employees

and management that leads to full and management that leads to full utilization of everyone’s talentsutilization of everyone’s talents

DEFINITIONDEFINITION

““A desired result is achieved more A desired result is achieved more efficiently when activities and efficiently when activities and related resources are managed as a related resources are managed as a process.”process.”

PROCESSPROCESS – collection of – collection of interrelated activities that transform interrelated activities that transform inputs into outputsinputs into outputs

DEFINITIONDEFINITION

““Identifying, understanding, and Identifying, understanding, and managing interrelated processes as a managing interrelated processes as a system contributes to the system contributes to the organization’s effectiveness and organization’s effectiveness and efficiency in achieving its objective.”efficiency in achieving its objective.”

SYSTEMSYSTEM – a collection of interrelated – a collection of interrelated processes with a common set of processes with a common set of objectives and outputs.objectives and outputs.

Yes, more DEFINITIONSYes, more DEFINITIONS PROCESS CHAMPIONPROCESS CHAMPION – member of top – member of top

management who has interest in management who has interest in promoting the control and improvement promoting the control and improvement of a specific process.of a specific process.

PROCESS OWNERPROCESS OWNER – the head of one of – the head of one of the key functions involved in the actual the key functions involved in the actual operation of the process and is operation of the process and is responsible for ensuring that the process responsible for ensuring that the process is understood, documented, is understood, documented, implemented, controlled, and improved.implemented, controlled, and improved.

Last of the DEFINITIONSLast of the DEFINITIONS

VERIFICATION – VERIFICATION – the confirmation the confirmation that specified requirements have that specified requirements have been metbeen met

VALIDATION –VALIDATION – confirmation confirmation through the provision of objective through the provision of objective evidence that the requirements for a evidence that the requirements for a specific intended use or application specific intended use or application have been fulfilledhave been fulfilled

Process – making coffee

INPUTS

MANUFACTURE

OUTPUT

VERIFY

MEASURE

Sub-process

Process – making coffee

VALIDATION

SYSTEM- MAKING BREAKFAST

COFFEE

BACON & EGGS

ORANGE JUICE

TOAST

SYSTEM – making BREAKFAST

VALIDATION

VERTCAL VERTCAL MANAGEMENTMANAGEMENT

vs.vs.QUALITY QUALITY

MANAGEMENT MANAGEMENT SYSTEMSYSTEM

Vertical ManagementVertical Management

Inputs

Administration/ManagementMarketing

Purchasing

Production

Outputs

Research and Development

Vertical Management Vertical Management StyleStyle

Focus on end productFocus on end product Customer satisfaction only Customer satisfaction only

relevant to complaintsrelevant to complaints Communication on a “need to Communication on a “need to

know” basisknow” basis Improvement on an “as needed” Improvement on an “as needed”

basisbasis Responsibility not established Responsibility not established

until something goes wrong!until something goes wrong!

ISO 9000 QM SystemISO 9000 QM System

Customers

Customers

Resource Management

Measurement, Analysis and Improvement

Management Responsibility

Product Realization

Continuous Improvement of the QMS

Requirements Input Outp

ut

Satisfaction

Product

Quality Management Quality Management StyleStyle

Focus on the entire systemFocus on the entire system Customer is main concernCustomer is main concern Communication at all levelsCommunication at all levels Continuous ImprovementContinuous Improvement Responsibility assignedResponsibility assigned

Why Implement a QMS?Why Implement a QMS?(ISO 9000)(ISO 9000)

Ensure Customer Ensure Customer SatisfactionSatisfaction

Improve Quality SystemImprove Quality System Enhance Control of Enhance Control of

ResourcesResources Improve Suppliers Improve Suppliers

PerformancePerformance

ISO 9000 REQUIREMENTS

ISO 9000 RequirementsISO 9000 Requirements

1.1. SCOPE SCOPE covers why the standard is covers why the standard is used used

2.2. APPLICATION APPLICATION states that the states that the standard is generic and there can standard is generic and there can be exclusions from section 7be exclusions from section 7

3. TERMS AND DEFINITIONS 3. TERMS AND DEFINITIONS reference ISO 9000 and 9001 reference ISO 9000 and 9001 vocabularyvocabulary

ISO 9000 ElementsISO 9000 Elements

4.4. General Requirements General Requirements (Documentation requirements (Documentation requirements covered in earlier trainingcovered in earlier training))

5. Management Responsibility5. Management Responsibility

6. Resource Management6. Resource Management

7. Product Realization7. Product Realization

8. Measurement, Analysis and 8. Measurement, Analysis and ImprovementImprovement

Just a RefresherJust a Refresher DocumentationDocumentation – The information used to – The information used to

provide a description of your operation and provide a description of your operation and to record its activitiesto record its activitiesQuality Manual, Work Instructions, Sales InvoicesQuality Manual, Work Instructions, Sales Invoices

DocumentsDocuments – work papers used for – work papers used for activities. They will change over time activities. They will change over time (living)(living)Procedures, Forms, PoliciesProcedures, Forms, Policies

RecordsRecords – historical material that will not – historical material that will not change, but will be retained for reference change, but will be retained for reference (dead)(dead)Meeting minutes, Completed forms, ReportsMeeting minutes, Completed forms, Reports

ISO 9000 Element 4ISO 9000 Element 4

General ( Documentation)General ( Documentation) Covered in “Creating and Documenting Covered in “Creating and Documenting

a Quality Management System”a Quality Management System” Managers and supervisors most likely Managers and supervisors most likely

would write or participate in writing would write or participate in writing documents:documents: procedures procedures forms forms work instructionswork instructions

Managers and supervisors provide Managers and supervisors provide oversight of record creation, oversight of record creation, preservation, and retentionpreservation, and retention

ISO 9000 Element 5ISO 9000 Element 5Management ResponsibilityManagement Responsibility

Management CommitmentManagement Commitment Customer FocusCustomer Focus Planning (Objectives & QMS)Planning (Objectives & QMS) Responsibility, Authority and Responsibility, Authority and

Communication (Management Communication (Management Representative)Representative)

Management ReviewManagement Review

ISO 9000 Element 5ISO 9000 Element 5Management ResponsibilityManagement Responsibility

Top Management is responsible for Top Management is responsible for Meeting Customer Requirements, Policy, Meeting Customer Requirements, Policy, Objectives, Planning, Management Objectives, Planning, Management Review, and Management Review, and Management RepresentativeRepresentative

Mid-level Managers and Supervisors are Mid-level Managers and Supervisors are responsible for supporting Top responsible for supporting Top Management’s Objectives, Fostering Management’s Objectives, Fostering Communication at Communication at ALLALL Levels, and Levels, and Building Enthusiasm for the QMS Building Enthusiasm for the QMS Throughout the Company Throughout the Company

ISO 9000 Element 6ISO 9000 Element 6 Resource Management Resource Management

(Human, Infrastructure and Environment)(Human, Infrastructure and Environment) Provision of ResourcesProvision of Resources Human ResourcesHuman Resources

GeneralGeneral Competence, Awareness, and TrainingCompetence, Awareness, and Training

InfrastructureInfrastructure Work EnvironmentWork Environment

ISO 9000 Element 6ISO 9000 Element 6 Resource Management Resource Management(Human, Infrastructure and Environment)(Human, Infrastructure and Environment)

Mid-level Managers and Supervisors must:Mid-level Managers and Supervisors must: Ensure that all employees are competent to do Ensure that all employees are competent to do

their jobs; strive for performance their jobs; strive for performance improvementimprovement

Be observant of buildings, machinery and Be observant of buildings, machinery and property; make recommendations as property; make recommendations as appropriateappropriate

Follow all safety rules and make certain Follow all safety rules and make certain employees follow your example; make working employees follow your example; make working conditions as comfortable as possible – conditions as comfortable as possible – including both physical and emotional comfortincluding both physical and emotional comfort

ISO 9000 Element 7ISO 9000 Element 7Product Realization Product Realization

7.1 Planning7.1 Planning 7.2 Customer-Related Processes7.2 Customer-Related Processes 7.3 Design and Development7.3 Design and Development 7.4 Purchasing7.4 Purchasing 7.5 Production and Service 7.5 Production and Service

ProvisionProvision 7.6 Control of Monitoring and 7.6 Control of Monitoring and

Measuring DevicesMeasuring Devices

ISO 9000 Element 7.1ISO 9000 Element 7.1Product RealizationProduct RealizationPlanning of Product Planning of Product

RealizationRealization Plan and Develop ProcessPlan and Develop Process Planning Consistent with other Planning Consistent with other

processes must determine:processes must determine: Quality Objectives and RequirementsQuality Objectives and Requirements New processes, documents and New processes, documents and

resourcesresources Verification, validation, monitoring, Verification, validation, monitoring,

inspection and testinginspection and testing RecordsRecords SuitabilitySuitability

ISO 9000 Element 7.2ISO 9000 Element 7.2Product RealizationProduct Realization

Customer-Related ProcessesCustomer-Related Processes

Determination of requirements Determination of requirements related to the product related to the product

Review requirements related to Review requirements related to the productthe product

Customer communicationCustomer communication

ISO 9000 Element 7.3ISO 9000 Element 7.3Product RealizationProduct Realization

Design and DevelopmentDesign and Development PlanningPlanning InputsInputs OutputsOutputs ReviewReview VerificationVerification ValidationValidation Control of changesControl of changes

ISO 9000 Element 7.4ISO 9000 Element 7.4Product RealizationProduct Realization

PurchasingPurchasing

Purchasing ProcessPurchasing Process Purchasing InformationPurchasing Information Verification of Purchased Verification of Purchased

ProductProduct

ISO 9000 Element 7.5ISO 9000 Element 7.5Product RealizationProduct Realization

Production and Service Production and Service ProvisionProvision Control of Production and Control of Production and

Service ProvisionService Provision Validation of Processes Validation of Processes Identification and TraceabilityIdentification and Traceability Customer PropertyCustomer Property Preservation of ProductPreservation of Product

ISO 9000 Element 7.6ISO 9000 Element 7.6Product RealizationProduct Realization

Control of Monitoring and Control of Monitoring and Measuring DevicesMeasuring Devices

Determine the monitoring and measurement Determine the monitoring and measurement needed and the devices to be usedneeded and the devices to be used

Establish processes to ensure that monitoring Establish processes to ensure that monitoring and measurement can be carried outand measurement can be carried out

Ensure that equipment is calibrated correctly, Ensure that equipment is calibrated correctly, identified, safeguarded, protected and keep identified, safeguarded, protected and keep recordsrecords

Asses validity of previous measuring results Asses validity of previous measuring results when equipment is faulty/take appropriate when equipment is faulty/take appropriate action/recordaction/record

Confirm intended use of computer softwareConfirm intended use of computer software

ISO 9000 Element 8ISO 9000 Element 8

GeneralGeneral Monitoring and MeasurementMonitoring and Measurement Control of Nonconforming ProductControl of Nonconforming Product Analysis of DataAnalysis of Data ImprovementImprovement

Measurement, Analysis and Measurement, Analysis and ImprovementImprovement

ISO 9000 Element 8.1 & ISO 9000 Element 8.1 & 8.28.2

8.1 General8.1 General 8.2 Measurement8.2 Measurement

Customer SatisfactionCustomer Satisfaction Internal AuditInternal Audit Monitoring and Measurement of ProcessMonitoring and Measurement of Process Monitoring and Measurement of ProductMonitoring and Measurement of Product

Measurement, Analysis and Measurement, Analysis and ImprovementImprovement

ISO 9000 Element 8.3 & ISO 9000 Element 8.3 & 8.48.4

8.3 Control of Nonconforming 8.3 Control of Nonconforming ProductProduct

8.4 Analysis of Data8.4 Analysis of Data

Measurement, Analysis and Measurement, Analysis and ImprovementImprovement

ISO 9000 Element 8.5ISO 9000 Element 8.5

ImprovementImprovement Continual ImprovementContinual Improvement Corrective ActionCorrective Action Preventive ActionPreventive Action

Measurement, Analysis and Measurement, Analysis and ImprovementImprovement

ISO 9000 QM SystemISO 9000 QM System

Customers

Customers

Resource Management

Measurement, Analysis and Improvement

Management Responsibility

Product Realization

Continuous Improvement of the QMS

Requirements Input Outp

ut

Satisfaction

Product

QUALITY MANAGEMENT

PRINCIPLES

What are ISO 9000 What are ISO 9000 Principles?Principles?

Fundamental beliefs that form the Fundamental beliefs that form the foundation of the ISO requirementsfoundation of the ISO requirements

Lead to quality excellence by following themLead to quality excellence by following them Are based on practical applicationAre based on practical application Can be applied at any level of the quality Can be applied at any level of the quality

pyramidpyramid Quality Control (QC)Quality Control (QC) Quality Management (QM)Quality Management (QM) Total Quality Management (TQM)Total Quality Management (TQM)

ISO 9000 PrinciplesISO 9000 Principles

Customer FocusCustomer Focus LeadershipLeadership Involvement of Involvement of

People People Process ApproachProcess Approach Systems Systems

Approach to Approach to ManagementManagement

Continual Continual ImprovementImprovement

Factual Factual Approach to Approach to Decision MakingDecision Making

Mutually Mutually beneficial beneficial supplier supplier relationshiprelationship

ISO 9000 PrinciplesISO 9000 Principles1. Customer Focus

QC -- understand and meet basic requirements; little or no knowledge of customer perceptions

QM – better understanding of overall requirements; customer satisfaction tracked

TQM – customer information collected systematically throughout the company; knowledge of customer perception; ability to offer preferred products

ISO 9000 PrinciplesISO 9000 Principles2. Leadership

QC – management provides resources sufficient for quality control

QM – management establishes policy, objectives and environment to control processes that ensure quality

TQM – managers provide personal examples that create customer satisfaction; quality is a strategic issue

ISO 9000 Principles ISO 9000 Principles

3. Involvement of people

QC – people must create and operate basic process; does not draw on full talents

QM – processes defined and personnel qualified; employees contribute to improvement

TQM – employees fully engaged & entirely involved; high level of communication between leaders and employees

ISO 9000 PrinciplesISO 9000 Principles4. Process Approach

QC – inspection and testing are common; controlled processes provide feedback

QM – movement from control of only process outputs to control of the process itself ; additional processes such as management review, corrective actions, etc.

TQM – optimizes resources, continually improves, uses process measures

ISO 9000 PrinciplesISO 9000 Principles5. System Approach to

Management

QC – inspection and control systems work together but not integrated with the rest of the organization

QM – moved to integrate the process for creating the product with verification of the final product; focus on customer satisfaction

TQM – fully understands the interaction among the processes; continually improves

ISO 9000 PrinciplesISO 9000 Principles6. Continual Improvement

QC – focus on improvements to ensure that the customer does not receive defective products

QM – focus on improving the effectiveness and efficiency of the QMS; mature corrective/preventive loop

TQM – focus on efficiently meeting customer needs through the QMS; leaders involved in improvement process

ISO 9000 PrinciplesISO 9000 Principles7. Factual Approach to Decision

Making

QC – uses data to distinguish nonconformities; statistical data ensure requirements are met; little use of data to measure trends

QM – facts and data used to make decisions regarding the QMS; focus on improvement

TQM – analysis used to improve market position; information gathered from all members of the organization

ISO 9000 PrinciplesISO 9000 Principles

8. Mutually Beneficial Supplier Relationship

QC – some validation of the suppliers product

QM – processes to define and document, review and evaluate; well developed and defined validation process

TQM – focus changes with established strategic alliances or partnerships; mutual commitment to customer satisfaction; focus on continual improvement becomes common

THANK YOU THANK YOU for Your Participationfor Your Participation

Beth Hayden,

Process Verified Program Manager

Grain Inspection, Packers and Stockyards Administration

Beth.E.Hayden@usda.gov

202 205-4007