Implementing a Quality Management System Presented by USDA

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Implementing a Quality Management
System Presented by USDA GRAIN INSPECTION,
PACKERS AND STOCKYARDS ADMINISTRATION
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What is a QMS?

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

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QMS Definitions

• A Quality Management System is
• System for managing the quality of an
  organization
• Includes everything in the organization that
  relates to quality
• Products and services
• Processes
• Operations
• Customer Satisfaction

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QMS Description

• As required by ISO 9000
• The Quality System is well documented,
  implemented, understood, maintained and
  continually improved
• Emphasis is placed on problem prevention rather
  than inspection
• Quality planning is required
• The PROCESS APPROACH to management is encouraged

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QMS Description

• Quality Standard or Regulation
• ISO 90012000
• Process Verified
• ISO Guide 65
• Quality System Assessment Program
• National Organic Program

• Product or Service
• Consistent quality feed
• Identity Preserved livestock or grain
• Consulting Service
• Organic Certification and Organic Production
• Beef Export Verification (BEV)

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What makes it so special?

• Process Approach to management
• Integration of processes into a System/
  Interrelation of all activities
• Continual Improvement at all levels
• Communication among all employees and management
  that leads to full utilization of everyones
  talents

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DEFINITION

• A desired result is achieved more efficiently
  when activities and related resources are managed
  as a process.
• PROCESS collection of interrelated activities
  that transform inputs into outputs

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DEFINITION

• Identifying, understanding, and managing
  interrelated processes as a system contributes to
  the organizations effectiveness and efficiency
  in achieving its objective.
• SYSTEM a collection of interrelated processes
  with a common set of objectives and outputs.

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Yes, more DEFINITIONS

• PROCESS CHAMPION member of top management who
  has interest in promoting the control and
  improvement of a specific process.
• PROCESS OWNER the head of one of the key
  functions involved in the actual operation of the
  process and is responsible for ensuring that the
  process is understood, documented, implemented,
  controlled, and improved.

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Last of the DEFINITIONS

• VERIFICATION the confirmation that specified
  requirements have been met
• VALIDATION confirmation through the provision
  of objective evidence that the requirements for a
  specific intended use or application have been
  fulfilled

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Process making coffee
INPUTS
Sub-process
MEASURE
MANUFACTURE
VERIFY
OUTPUT
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Process making coffee
VALIDATION
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SYSTEM- MAKING BREAKFAST
COFFEE
BACON EGGS
ORANGE JUICE
TOAST
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SYSTEM making BREAKFAST
VALIDATION
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VERTCAL MANAGEMENTvs.QUALITY MANAGEMENT SYSTEM
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Vertical Management
Inputs
Administration/Management
Marketing
Research and Development
Purchasing
Production
Outputs
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Vertical Management Style

• Focus on end product
• Customer satisfaction only relevant to complaints
• Communication on a need to know basis
• Improvement on an as needed basis
• Responsibility not established until something
  goes wrong!

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ISO 9000 QM System
Continuous Improvement of the QMS
Management Responsibility
Customers
Customers
Measurement, Analysis and Improvement
Resource Management
Satisfaction
Product Realization
Requirements
Product
Input
Output
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Quality Management Style

• Focus on the entire system
• Customer is main concern
• Communication at all levels
• Continuous Improvement
• Responsibility assigned

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Why Implement a QMS?(ISO 9000)

• Ensure Customer Satisfaction
• Improve Quality System
• Enhance Control of Resources
• Improve Suppliers Performance

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ISO 9000 REQUIREMENTS
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ISO 9000 Requirements

• SCOPE covers why the standard is used
• APPLICATION states that the standard is generic
  and there can be exclusions from section 7
• 3. TERMS AND DEFINITIONS reference ISO 9000 and
  9001 vocabulary

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ISO 9000 Elements

• General Requirements (Documentation requirements
  covered in earlier training)
• 5. Management Responsibility
• 6. Resource Management
• 7. Product Realization
• 8. Measurement, Analysis and Improvement

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Just a Refresher

• Documentation The information used to provide a
  description of your operation and to record its
  activities
• Quality Manual, Work Instructions, Sales
  Invoices
• Documents work papers used for activities.
  They will change over time (living)
• Procedures, Forms, Policies
• Records historical material that will not
  change, but will be retained for reference (dead)
• Meeting minutes, Completed forms, Reports

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ISO 9000 Element 4

• General ( Documentation)
• Covered in Creating and Documenting a Quality
  Management System
• Managers and supervisors most likely would write
  or participate in writing documents
• procedures
• forms
• work instructions
• Managers and supervisors provide oversight of
  record creation, preservation, and retention

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ISO 9000 Element 5 Management Responsibility

• Management Commitment
• Customer Focus
• Planning (Objectives QMS)
• Responsibility, Authority and Communication
  (Management Representative)
• Management Review

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ISO 9000 Element 5

• Management Responsibility
• Top Management is responsible for Meeting
  Customer Requirements, Policy, Objectives,
  Planning, Management Review, and Management
  Representative
• Mid-level Managers and Supervisors are
  responsible for supporting Top Managements
  Objectives, Fostering Communication at ALL
  Levels, and Building Enthusiasm for the QMS
  Throughout the Company

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ISO 9000 Element 6 Resource Management

• (Human, Infrastructure and Environment)
• Provision of Resources
• Human Resources
• General
• Competence, Awareness, and Training
• Infrastructure
• Work Environment

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ISO 9000 Element 6 Resource Management

• (Human, Infrastructure and Environment)
• Mid-level Managers and Supervisors must
• Ensure that all employees are competent to do
  their jobs strive for performance improvement
• Be observant of buildings, machinery and
  property make recommendations as appropriate
• Follow all safety rules and make certain
  employees follow your example make working
  conditions as comfortable as possible including
  both physical and emotional comfort

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ISO 9000 Element 7Product Realization

• 7.1 Planning
• 7.2 Customer-Related Processes
• 7.3 Design and Development
• 7.4 Purchasing
• 7.5 Production and Service Provision
• 7.6 Control of Monitoring and Measuring Devices

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ISO 9000 Element 7.1Product RealizationPlanning
of Product Realization

• Plan and Develop Process
• Planning Consistent with other processes must
  determine
• Quality Objectives and Requirements
• New processes, documents and resources
• Verification, validation, monitoring, inspection
  and testing
• Records
• Suitability

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ISO 9000 Element 7.2Product Realization
Customer-Related Processes

• Determination of requirements related to the
  product
• Review requirements related to the product
• Customer communication

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ISO 9000 Element 7.3Product RealizationDesign
and Development

• Planning
• Inputs
• Outputs
• Review
• Verification
• Validation
• Control of changes

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ISO 9000 Element 7.4Product RealizationPurchasin
g

• Purchasing Process
• Purchasing Information
• Verification of Purchased Product

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ISO 9000 Element 7.5Product RealizationProductio
n and Service Provision

• Control of Production and Service Provision
• Validation of Processes
• Identification and Traceability
• Customer Property
• Preservation of Product

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ISO 9000 Element 7.6Product RealizationControl
of Monitoring and Measuring Devices

• Determine the monitoring and measurement needed
  and the devices to be used
• Establish processes to ensure that monitoring and
  measurement can be carried out
• Ensure that equipment is calibrated correctly,
  identified, safeguarded, protected and keep
  records
• Asses validity of previous measuring results when
  equipment is faulty/take appropriate
  action/record
• Confirm intended use of computer software

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ISO 9000 Element 8
Measurement, Analysis and Improvement

• General
• Monitoring and Measurement
• Control of Nonconforming Product
• Analysis of Data
• Improvement

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ISO 9000 Element 8.1 8.2
Measurement, Analysis and Improvement

• 8.1 General
• 8.2 Measurement
• Customer Satisfaction
• Internal Audit
• Monitoring and Measurement of Process
• Monitoring and Measurement of Product

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ISO 9000 Element 8.3 8.4
Measurement, Analysis and Improvement

• 8.3 Control of Nonconforming Product
• 8.4 Analysis of Data

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ISO 9000 Element 8.5
Measurement, Analysis and Improvement

• Improvement
• Continual Improvement
• Corrective Action
• Preventive Action

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ISO 9000 QM System
Continuous Improvement of the QMS
Management Responsibility
Customers
Customers
Measurement, Analysis and Improvement
Resource Management
Satisfaction
Product Realization
Requirements
Product
Input
Output
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QUALITY MANAGEMENT PRINCIPLES
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What are ISO 9000 Principles?

• Fundamental beliefs that form the foundation of
  the ISO requirements
• Lead to quality excellence by following them
• Are based on practical application
• Can be applied at any level of the quality
  pyramid
• Quality Control (QC)
• Quality Management (QM)
• Total Quality Management (TQM)

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ISO 9000 Principles

• Customer Focus
• Leadership
• Involvement of People
• Process Approach
• Systems Approach to Management

• Continual Improvement
• Factual Approach to Decision Making
• Mutually beneficial supplier relationship

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ISO 9000 Principles

• 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

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ISO 9000 Principles

• 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

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ISO 9000 Principles

• 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

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ISO 9000 Principles

• 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

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ISO 9000 Principles
5. 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
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ISO 9000 Principles

• 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/preventiv
  e loop
• TQM focus on efficiently meeting customer needs
  through the QMS leaders involved in improvement
  process

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ISO 9000 Principles

• 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

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ISO 9000 Principles

• 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

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THANK YOU for Your Participation
Beth Hayden, Process Verified Program
Manager Grain Inspection, Packers and Stockyards
Administration Beth.E.Hayden_at_usda.gov 202
205-4007