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)

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
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 Description
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)

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

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

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.

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

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

Process making coffee

INPUTS
Sub-process

MEASURE
MANUFACTURE

VERIFY

OUTPUT

Process making coffee

VALIDATION

SYSTEM-

MAKING BREAKFAST

COFFEE

BACON & EGGS

ORANGE JUICE
TOAST

SYSTEM making BREAKFAST

VALIDATION

VERTCAL
MANAGEMENT
vs.
QUALITY
MANAGEMENT
SYSTEM

Vertical Management
Inputs
Administration/Manag
ement
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!

ISO 9000 QM System

Continuous Improvement of
the QMS
Managem
ent
Responsibi
lity

Custom
ers
Resource
Managem
ent

Requireme
nts
Input

Custom
ers

Measuremen
t, Analysis
and
Improvement
Product
Realizatio
n

Produ
ct
Outp
ut

Satisfacti
on

Quality Management
Style

Focus on the entire system

Customer is main concern
Communication at all levels
Continuous Improvement
Responsibility assigned

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

1.

SCOPE covers why the standard is

used

2.

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

General Requirements
(Documentation requirements
covered in earlier training)
5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis and
Improvement
4.

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

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

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

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

ISO 9000 Element 6

Resource Management

(Human, Infrastructure and Environment)

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

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

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

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
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

Planning
Inputs
Outputs
Review
Verification
Validation
Control of changes

ISO 9000 Element 7.4

Product Realization
Purchasing

Purchasing Process
Purchasing Information
Verification of Purchased
Product

ISO 9000 Element 7.5

Product Realization
Production and Service
Provision and
Control of Production

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

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

Measurement, Analysis and
Improvement

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

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

Measurement, Analysis and

Improvement

8.3 Control of Nonconforming

Product
8.4 Analysis of Data

ISO 9000 Element 8.5

Measurement, Analysis and
Improvement

Improvement
Continual Improvement
Corrective Action
Preventive Action

ISO 9000 QM System

Continuous Improvement of
the QMS
Managem
ent
Responsibi
lity

Custom
ers
Resource
Managem
ent

Requireme
Input
nts

Custom
ers

Measuremen
t, Analysis
and
Improvement
Product
Realizatio
n

Produ
ct
Outp
ut

Satisfacti
on

QUALITY
MANAGEMENT
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

1. 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

ISO 9000 Principles

2. 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

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

ISO 9000 Principles

4. 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.

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

ISO 9000 Principles

6. 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

ISO 9000 Principles

7. 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

ISO 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

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