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Implementing a Quality Management System Presented by USDA GRAIN INSPECTION, PACKERS AND STOCKYARDS ADMINISTRATION. 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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slide1

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:

  • Say what you do (documentation)
  • Do what you say (implementation)
  • Prove what you do (records)
  • Review and improve (continuous improvement)
qms definitions
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
qms description
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
qms description5
Quality Standard or Regulation

ISO 9001:2000

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)

QMS Description
what makes it so special
What makes it so special?
  • ProcessApproach 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 everyone’s talents
definition
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
definition8
DEFINITION

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

  • SYSTEM – a collection of interrelated processes with a common set of objectives and outputs.
yes more definitions
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.
last of the definitions
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
slide11

Process – making coffee

INPUTS

Sub-process

MEASURE

MANUFACTURE

VERIFY

OUTPUT

slide13

SYSTEM- MAKING BREAKFAST

COFFEE

BACON & EGGS

ORANGE JUICE

TOAST

vertical management
Vertical Management

Inputs

Administration/Management

Marketing

Research and Development

Purchasing

Production

Outputs

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!

Vertical Management Style
iso 9000 qm system
ISO 9000 QM System

Continuous Improvement of the QMS

Management Responsibility

Customers

Customers

Measurement, Analysis and Improvement

Resource Management

Satisfaction

Requirements

Product Realization

Product

Input

Output

quality management style
Focus on the entire system

Customer is main concern

Communication at all levels

Continuous Improvement

Responsibility assigned

Quality Management Style
why implement a qms iso 9000
Why Implement a QMS?(ISO 9000)
  • Ensure Customer Satisfaction
  • Improve Quality System
  • Enhance Control of Resources
  • Improve Suppliers Performance
iso 9000 requirements
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

iso 9000 elements
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

just a refresher
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

iso 9000 element 4
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
iso 9000 element 5 management responsibility
ISO 9000 Element 5 Management Responsibility
  • Management Commitment
  • Customer Focus
  • Planning (Objectives & QMS)
  • Responsibility, Authority and Communication (Management Representative)
  • Management Review
iso 9000 element 5
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 Management’s Objectives, Fostering Communication at ALL Levels, and Building Enthusiasm for the QMS Throughout the Company
iso 9000 element 6 resource management
ISO 9000 Element 6 Resource Management

(Human, Infrastructure and Environment)

  • Provision of Resources
  • Human Resources
    • General
    • Competence, Awareness, and Training
  • Infrastructure
  • Work Environment
iso 9000 element 6 resource management29
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
iso 9000 element 7 product realization
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
iso 9000 element 7 1 product realization planning of product realization
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
iso 9000 element 7 2 product realization customer related processes
ISO 9000 Element 7.2Product RealizationCustomer-Related Processes
  • Determination of requirements related to the product
  • Review requirements related to the product
  • Customer communication
iso 9000 element 7 3 product realization design and development
ISO 9000 Element 7.3Product RealizationDesign and Development
  • Planning
  • Inputs
  • Outputs
  • Review
  • Verification
  • Validation
  • Control of changes
iso 9000 element 7 4 product realization purchasing
ISO 9000 Element 7.4Product RealizationPurchasing
  • Purchasing Process
  • Purchasing Information
  • Verification of Purchased Product
iso 9000 element 7 5 product realization production and service provision
ISO 9000 Element 7.5Product RealizationProduction and Service Provision
  • Control of Production and Service Provision
  • Validation of Processes
  • Identification and Traceability
  • Customer Property
  • Preservation of Product
iso 9000 element 7 6 product realization control of monitoring and measuring devices
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
iso 9000 element 8
ISO 9000 Element 8

Measurement, Analysis and Improvement

  • General
  • Monitoring and Measurement
  • Control of Nonconforming Product
  • Analysis of Data
  • Improvement
iso 9000 element 8 1 8 2
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
iso 9000 element 8 3 8 4
ISO 9000 Element 8.3 & 8.4

Measurement, Analysis and Improvement

  • 8.3 Control of Nonconforming Product
  • 8.4 Analysis of Data
iso 9000 element 8 5
ISO 9000 Element 8.5

Measurement, Analysis and Improvement

  • Improvement
    • Continual Improvement
    • Corrective Action
    • Preventive Action
iso 9000 qm system41
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

what are iso 9000 principles
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)
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

ISO 9000 Principles
iso 9000 principles45
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
iso 9000 principles46
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
iso 9000 principles47
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
iso 9000 principles48
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
iso 9000 principles49
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

iso 9000 principles50
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/preventive loop
  • TQM – focus on efficiently meeting customer needs through the QMS; leaders involved in improvement process
iso 9000 principles51
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
iso 9000 principles52
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
thank you for your participation
THANK YOU for Your Participation

Beth Hayden,

Process Verified Program Manager

Grain Inspection, Packers and Stockyards Administration

Beth.E.Hayden@usda.gov

202 205-4007