Transcript Internal Quality Audit

Internal Quality Audit
Course Purpose and Objectives
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Gain an understanding of the principles
of quality management
Increase knowledge of audit theory and
techniques
Develop and use audit checklists
Schedule and perform audits
Report audit results
Audit follow-up and closeout
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Purpose of Audit
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Improve processes
Improve internal and external customer
satisfaction
Improve profits
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Quality
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Deming - "Quality control does not
mean perfection. It means the efficient
production of quality that the market
expects.”
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Quality
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Juran - "fitness for use”
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Quality
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Crosby - "Conformance to
requirements”
Quality is free
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Quality
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Feigenbaum - "the total composite
product and service characteristics of
marketing, engineering, manufacturing,
and maintenance through which the
product and service in use will meet the
expectations of the customer”
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Quality
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ASQC - "the totality of features and
characteristics of a product that bear on
its ability to satisfy a given need”
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Achieving Quality
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Leadership in quality starts with quality
leadership
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Maintaining leadership in quality
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Issue a quality policy
Establish documented procedures
Develop performance standards
(benchmark)
Establish a program of audit
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Quality Management Standards
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Through the end of WW II, only
requirement was by the government to
ensure independent inspection
• MIL-Q-9858A
• NQA-1
• ISO-9000
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ISO 9000
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Patterned after US standards
Issued in 1987, updated in 1994, and in
2000
Generic for all types of manufacturing
and service industries
Registration makes ISO 9000 different
from other standards
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Accreditation
RAB
Assessors
Registrars
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Quality Management Principles
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A quality management principle is a
fundamental rule or belief for leading and
operating an organization. The eight
quality management principles addressed
in the new standard are primarily aimed at
continually improving performance over
the long term by focusing on internal and
external customers.
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1 Customer-Focused Organization
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Strives to understand current and future
customer needs, meet customer
requirements, and exceed customer
expectations.
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2 Leadership
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Leaders establish unity of purpose and
direction within the organization to
create and maintain an internal
environment in which people can
become fully involved in achieving the
organization's objectives.
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3 Involvement of People
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People are the most important asset of
an organization. Their full involvement
enables their abilities to be utilized for
mutual benefit.
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4 Process Approach
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Activities are managed as processes
resulting in a more efficient use of
resources.
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5 System Approach to Management
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Identifying, understanding and
managing interrelated processes as a
system to achieve given objectives.
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6 Continual Improvement
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Continual improvement is a permanent
objective of the organization.
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7 Factual Approach to Decision Making
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Management by fact. Decisions are
based on an analysis of data and
information.
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8 Mutually Beneficial Supplier
Relationships
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An organization and its suppliers are
interdependent, and a mutually
beneficial relationship enhances the
ability of both to create value.
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ISO 9000:2000
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Approved December 13, 2000
Current registrations valid to 1994
revision
Registrations still given to 1994 revision
1994 version registrations expire in 3
years
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ISO 9000:2000
Continual Improvement of the
quality management system
Management
Responsibility
Customer
Requirements
Measurement,
Analysis, and
Improvement
Resource
Management
Product
Realization
Customer
Satisfaction
Product
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9K2K
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6 required procedures
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document control
records
audit
control of nonconformances
corrective action
preventive action
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1 Scope
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No longer a 9002 or 9003
Registration to 9001 with exclusions
Exclusions limited to requirements in
section 7.0 of the standard
Exclusions must be justified in the
quality manual
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2 Reference
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ISO 9000:2000, “Quality Management
Systems - Fundamentals and
vocabulary”, a part of 9001 by reference
Requirements in 9001 further defined by
definitions in 9000
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3 Terms and definitions
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Supplier
Organization
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4 Quality Management System
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4.1 General
4.2 Documentation
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4.1 General Requirements
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Identify processes needed and
determine sequence and interaction
Identify the resources and information
necessary to:
monitor, measure, analyze processes
implement actions needed to achieve
planned results with continual
improvement.
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4.2 Documentation Requirements
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4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Records
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4.2.1 General
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Documentation must include:
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Quality policy
Stated quality objectives
Quality manual
Procedures as required
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4.2.2 Quality manual
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Controlled document that describes the
sequence and interaction of the
processes in the quality system
Include or reference lower level
documented procedures
Include the scope of the quality
management system including
exclusions
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4.2.3 Control of documents
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Documented procedure
Development, review, approval of
documented procedures
Distribution to point of use
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4.2.3 Control of documents
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Documents of external origin
Review and update
Current revision status identified
Unintended use of obsolete documents
prevented.
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4.2.4 Control of quality records
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Documented procedure
Legible, identifiable, and retrievable
Evidence of conformance and effective
operation of the quality system
Identification, storage, retrieval,
protection, retention times, and
disposition.
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5 Management Responsibility
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5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
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5.1 Management Commitment
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Demonstrated senior management
commitment
Development, implementation, and
continual improvement of the quality
system
Creating awareness of importance of
fulfilling customer requirements
Establishing objectives consistent with
quality policy
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5.1 Management Commitment
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Addressing statutory and regulatory
requirements of the product or service
Provide necessary resources
Conduct management review
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5.2 Customer Focus
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Determine and meet customer needs
and expectations
Emphasis on “Customer Focus”
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5.3 Quality Policy
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Relevant, appropriate
Communicated and understood
Define approach to fulfillment of
customer requirements
Achievable and measurable
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5.4 Planning
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5.4.1 Quality Objectives
5.4.2 Quality Management System
Planning
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5.4.1 Quality Objectives
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Specific, measurable objectives for
quality
Consistent with the quality policy
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5.4.2 Quality Management System
Planning
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Activities to achieve objectives carried
out in a planned manner
Changes to the quality system must be
planned and implemented so as to
maintain the integrity of the quality
system
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5.5 Responsibility, Authority, and
Communication
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5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communication
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5.5.1 Responsibility and Authority
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Responsibility and authority of key
groups and/or individuals and their
interrelations must be defined and
communicated within the organization
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5.5.2 Management Representative
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“Quality Champion” of the organization
Ensuring quality management
processes are established, maintained,
and operating
Reporting performance of the system to
the top management
Promoting awareness of customer
requirements
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5.5.3 Internal Communication
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Information on the effectiveness of the
quality management system process
Customer requirements
General business issues
Operation of the quality system
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5.6 Management Review
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5.6.1 General
5.6.2 Review Input
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5.6.1 General
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Review operation of the quality system
at planned intervals
System continues to be suitable,
adequate, and effective
Changes to the quality system, the
quality policy, and/or the quality
objectives
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5.6.2 Review Input
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Inspection results
Customer surveys
Internal audit
Corrective and preventive action
Effects of changes in the system
Follow-up on actions from past reviews
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5.6.3 Review Output
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Improvement of the quality
management system
Ensure product/service to provide
customer satisfaction
Resource needs
Results recorded as a quality record,
tracked, and closed out at a later
meeting
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6 Resource Management
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6.1 Provision of Resources
6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment
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6.1 Provision of Resources
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Management is responsible to provide
adequate resources to determine and
implement the processes necessary to
provide customer satisfaction and to
continuously improve the processes
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6.2 Human Resources
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6.2.1 General
6.2.2 Competence, awareness, and
training
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6.2.1 General
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Adequately trained/experienced staff
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6.2.2
Competence, Awareness, and Training
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Identify the competencies needed
Ensure personnel are qualified
Evaluate effectiveness of training
Employee awareness their actions to
meet company objectives
Records
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6.3 Infrastructure
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Buildings, work space, tools &
equipment, supporting services
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6.4 Work Environment
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“Human & physical” factors which affect
the suitability of your product/service
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7 Product Realization
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7.1 Planning of Product Realization
7.2 Customer-related Processes
7.3 Design and Development
7.4 Purchasing
7.5 Production & Service Provision
7.6 Control of Measuring and Monitoring
Devices
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7.1 Planning of Product Realization
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Planned processes and sub-processes
necessary to provide products/services
Processes, procedures, and other
resources
Verification, validation, monitoring,
inspection, and test
Records of activities maintained
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7.2 Customer-related Processes
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7.2.1 Determination of Requirements
related to the product
7.2.2 Review of Requirements Related
to the Product
7.2.3 Customer Communication
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7.2.1 Determination of Requirements
Related to the Product
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Customer requirements, stated and
necessary
Obligations such as legal requirements,
warranties, and support, etc
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7.2.2 Review of Requirements
Related to the Product
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Customer requirements defined
Organization has resources to meet
requirements
Differences resolved prior to
commitment
Records of review
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7.2.3 Customer Communication
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Identify how the customer contacts the
organization
Product information
Feedback including complaints,
inquiries and orders, including
amendments.
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7.3 Design and Development
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7.3.1 Design and Development Planning
7.3.2 Design and Development Inputs
7.3.3 Design and Development Outputs
7.3.4 Design and Development Review
7.3.5 Design and Development Verification
7.3.6 Design and Development Validation
7.3.7 Control of Design and Development
Changes
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7.3.1 Design and Development
Planning
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All stages planned and defined
Review
Verification
Validation
Communication
Responsibility and authority for design and
development defined
Plan updated as required
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7.3.2 Design and Development Inputs
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Design inputs needed to design or
develop the product or service
Functional and performance
requirements defined by the customer
Lessons learned from previous designs
Capability studies
Customer complaints
Marketing studies
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7.3.3 Design and Development Outputs
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In a form that can be checked to ensure they
meet design requirements
Approved prior to release
Adequate for use by purchasing, production,
and other elements of the organization
Acceptance criteria defined
Characteristics of the product that affect safe
and proper operation identified
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7.3.4 Design and Development Review
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Progress reviewed at appropriate
stages
Include theoretical calculation checks,
beta testing, etc.
Records of reviews
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7.3.5
Design and Development Verification
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Output of the design verified
Records of the verification are
maintained.
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7.3.6
Design and Development Validation
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Product or service works correctly in practice
and meets the stated or implied needs of the
customer
Usually accomplished before product release
May include reviews of customer feedback
after release
Validation documented and records
maintained
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7.3.7 Control of Design and
Development Changes
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Changes documented, reviewed,
verified, validated, and approved prior to
implementation
Effect of changes on activities
completed and product delivered
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7.4 Purchasing
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7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
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7.4.1 Purchasing Process
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Ensure purchased product conforms to
purchase requirements
Supplier selection and evaluation
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7.4.2 Purchasing Information
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Products or services being purchased
must be clearly defined
Reviewed for adequacy
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7.4.3
Verification of Purchased Product
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Receiving inspection
In-process inspection
Supplier’s location
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7.5 Production & Service Provision
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7.5.1 Operations Control
7.5.2 Validation of Processes for
Production and Service Provision
7.5.3 Identification and Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
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7.5.1 Operations Control
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Activities must be carried out under controlled
conditions
Characteristics of the product are clearly
defined
Equipment and associated maintenance is
suitable
Process and product parameters are
measured or monitored
Activities for release, delivery and postdelivery are defined
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7.5.2 Validation of Processes for
Production and Service Provision
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When output cannot be verified by
monitoring or inspection or where
defects may only become apparent after
the product is in use, process must be
validated
Records of the results of validation
and/or re-validation must be
documented and maintained.
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7.5.3 Identification and Traceability
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Materials and goods identified to
prevent accidental mix-ups and to
permit tracing
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7.5.4 Customer Property
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Activities for the receipt, control, and
maintenance of the items belonging to
the customer must be defined
Records are maintained of items lost,
damaged, or found to be unsuitable
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7.5.5 Preservation of Product
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Materials, subassemblies and finished
goods, etc. must be stored, handled,
and packaged so as to prevent damage
or deterioration
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7.6 Control of Measuring and
Monitoring Devices
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Identify what is to be measured or
monitored
Identify suitable equipment or software
to be used
Monitoring and measuring devices
regularly adjusted and/or checked
Records of the calibration are
maintained
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7.6 Control of Measuring and
Monitoring Devices
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For equipment out of calibration
• actions to prevent future out of calibration
conditions
• effect on measurements taken
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Equipment protected from unauthorized
adjustments.
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8 Measurement, Analysis &
Improvement
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8.1 General Requirements
8.2 Monitoring and Measurement
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8.1 General Requirements
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Processes necessary to measure,
monitor, analyze, and assure the
conformance of product, process, or the
quality management system
The need for any statistical techniques
identified
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8.2 Monitoring and Measurement
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8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring and Measurement of
Processes
8.2.4 Monitoring and Measurement of
Product
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8.2.1 Customer Satisfaction
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Collect, analyze, and use information on
customer satisfaction and/or
dissatisfaction
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8.2.2 Internal Audit
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Documented procedure
Planned, systematic audit program to
evaluate the compliance of the quality
management system with requirements
and the effectiveness of its
implementation
Qualified, impartial, and objective
auditors with no responsibilities in the
areas audited
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8.2.2 Internal Audit
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Elements of the quality system, processes,
and areas that have had problems in the past
or are critical to the proper operation of the
quality system are audited more frequently
Responsibilities for planning, conducting,
reporting the results of audit, and timely
corrective action must be defined and
documented
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8.2.2 Internal Audit
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Follow-up activities verify the
effectiveness of corrective action
Records of the results of the verification
and other internal audits
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8.2.3 Monitoring and Measurement
of Processes
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Methods to monitor and/or measure quality
management system processes shall be
defined and implemented to evaluate the
ability of the processes to produce acceptable
goods or services
If periodic review of failure rates, customer
returns, etc, show that planned results are not
being achieved, corrective action shall be
taken as necessary
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8.2.4 Monitoring and Measurement
of Product
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The characteristics of the product are
monitored and measured at “appropriate
stages” to ensure conformity of the product
with requirements
Product cannot be released for delivery until
completion of required verification
Records showing the conformity of the
product and the person responsible for
product release must be maintained
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8.3 Control of Nonconforming Product
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Documented procedure
Nonconforming product is identified and
controlled to prevent its inadvertent use
or shipment Nonconforming product is
dispositioned
If product is reworked or repaired, it
must be re-evaluated
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8.4 Analysis of Data
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Data relative to product and process
conformance, customer satisfaction,
supplier performance, internal audit,
corrective and preventive action, etc. is
collected and analyzed to evaluate the
effectiveness of the quality
management system and to identify
opportunities for continual improvement.
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8.5 Improvement
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8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
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8.5.1 Continual Improvement
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Through the use of the quality policy,
quality objectives, audit results, data
analysis, corrective action, preventive
action, and management review,
management must strive to continually
improve the effectiveness of the quality
management system.
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8.5.2 Corrective Action
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Documented procedure
Identify the need for corrective action to
prevent recurrence
Evaluate the root cause of the
occurrence
Determine and implement appropriate
corrective action
Follow up to evaluate the effectiveness
of the actions taken
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8.5.3 Preventive Action
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Documented procedure
Action taken to prevent the initial
occurrence of nonconformity of product
or process
Identify the sources of information to
identify the need for preventive action
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8.5.3 Preventive Action
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Evaluate potential causes of the
nonconformity
Determine and implement appropriate
preventive action
Follow up to evaluate the effectiveness
of the actions taken
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Quality Assurance Functions
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Quality engineering
Quality audit
Procurement quality
Metrology
Administration
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Audit
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Webster's defines audit as "An official
examination and verification of accounts
and records, especially financial
records." "A judicial hearing.”
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Audit
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The Thesaurus lists the following
synonyms for audit.
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Review
appraisal
surveillance
assessment
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Audit
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ASQ - Quality Audit
• "A systematic examination of the acts and
decisions by people with respect to quality,
in order to independently verify; or evaluate
and report compliance to the operational
requirements of the quality program or the
specification or contract require
Audit
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ASQ - Quality System Audit
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A planned and documented activity
performed to determine by investigation,
examination or evaluation of objective
evidence the adequacy of and
compliance with established
procedures, instructions, drawings, and
other applicable documents, and the
effectiveness
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The Quality Management Process
Planning
Improving
Performing
Measuring
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Audit
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Purpose of Audit
• Assess individual performance based on
fact (training needs assessment)
• Verify corrective action
• Evaluate need for improvement
• Improve communications
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Audit
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Evaluate auditee's own internal
management system (first party)
Evaluate a potential
supplier/subcontractor (second party)
Audit by a regulatory agency or a
registration body (third party)
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Audit
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Key Elements
• Organizational structure must provide a
high level of independence for the audit
function
• All activities affecting quality must be
audited
• Audit is not a surveillance or inspection
activity conducted to verify the acceptability
of product
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Audit and Decision Making
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Audits are fact finding exercises which
examine objective evidence in an
unbiased manner
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Audit
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Fact Finding Not Fault Finding
• Fact finding denotes the correct attitude,
fault finding does not.
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A management audit is a fact finding
exercise.
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Audit Types
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System audit
Product audit
Process audit
Follow-up audit
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Audit
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Systems Audit
• Overall quality program or system review.
Also known as procedure or management
audit. May be internal, external, or
extrinsic; first, second, or third party
• Detailed evaluation of an existing system
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Systems Audit
Documented
Effective
Implemented
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Audit
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System and Procedure Effectiveness
• Conformance to requirements and
compliance to procedures is not enough,
the system must also be effective
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Audit
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System and Procedure Effectiveness
• Scrap and rework due to handling damage
indicates material handling procedures not
effective
• Instruments being used beyond calibration
due date may indicate recall procedure not
effective
Internal Quality Audit - 117
Quality Education Services, Inc.
Audit
•
System and Procedure Effectiveness
• Supplier rejection rates
• Percentage of obsolete drawings in use
• Recurring problems after corrective action
completed
• Customer complaints
Internal Quality Audit - 118
Quality Education Services, Inc.
Product Audit
•
A detailed examination of some finished
product prior to acceptance by the
purchaser but after acceptance by
manufacturing and/or inspection.
Internal Quality Audit - 119
Quality Education Services, Inc.
Process Audit
•
Examination of an activity to verify that
the inputs, processing, and outputs are
being performed in accordance with
established requirements.
Internal Quality Audit - 120
Quality Education Services, Inc.
Process Audit
•
Services
• Activities designed to meet needs of
customers
• Activities observed by customer
• Activities not directly observed by customer
• Control of process vs. individual
• Special emphasis placed on interface with
customer
Internal Quality Audit - 121
Quality Education Services, Inc.
Follow-up Audit
•
Follow-up audits are conducted to verify
that corrective action commitments
were met and the action eliminated the
cause of the deficiency.
Internal Quality Audit - 122
Quality Education Services, Inc.
Audit
•
•
Quantitative Audit gives a grade or score
for the degree of conformance to specific
requirements ÿ may be difficult to establish
what is an acceptable score
Qualitative Audit gives a pass or fail type
of evaluation ÿ requires judgement call by
auditor as to whether the element is
effectively implemented or it is not
Internal Quality Audit - 123
Quality Education Services, Inc.
Audit Program Responsibility
•
The responsibility for audit at various
levels must be defined and those
responsible delegated sufficient
authority
Internal Quality Audit - 124
Quality Education Services, Inc.
Audit Organizational Structure
•
•
•
Management system must provide a
high level of independence
Auditing organization should report at
the same level, or one level higher, than
the auditee
Auditing organization must interface
with and conduct audits of all functions
engaged in activities affecting quality
Internal Quality Audit - 125
Quality Education Services, Inc.
Audit Organizational Structure
•
•
•
There are no basic outlines for an
effective organization, tailor the program
to your management system
The local audit function is usually a part
of the quality assurance organization
The independence of the audit function
is evidenced in the quality and
effectiveness of the audits, not the org
chart
Internal Quality Audit - 126
Quality Education Services, Inc.
Planning and Scheduling
•
Planning and scheduling are affected by
• Type of audit
• Availability and experience of audit
personnel
• Availability of objective evidence
• Preparation of checklists and forms
• Audit frequency established by standards
or by need
Internal Quality Audit - 127
Quality Education Services, Inc.
Master Audit Plan
•
•
•
•
•
•
•
•
•
Auditee
Location to be audited
Documentation or implementation audit
Scope of audit
Tentative date of audit
Reference documents
Previous audits
Auditor skills required
Number of auditors estimated
Internal Quality Audit - 128
Quality Education Services, Inc.
Scheduling Audits
•
•
Contact the auditee and schedule a
mutually agreeable time to perform the
audit
Formal written notification should be
forwarded to the auditee at an
established interval before the audit
Internal Quality Audit - 129
Quality Education Services, Inc.
Audit
•
Who Schedules or Initiates Audits
• Management
• Quality Assurance
• Purchasing (procurement)
Internal Quality Audit - 130
Quality Education Services, Inc.
Audit
•
When Are Audits Scheduled
• External and internal audits - scheduled in
advance so that all areas are covered
annually, frequency adjusted as needed
• Surprise audit - ?
Internal Quality Audit - 131
Quality Education Services, Inc.
Personnel Requirements
•
•
•
Team size - minimum is one, but two or
more can be more effective
Team composition
Length of audit
Internal Quality Audit - 132
Quality Education Services, Inc.
Checklists
•
Checklists or procedures provide
• Continuity from audit to audit
• Ensure complete coverage
• Documented evidence of the thoroughness
of the audit
• Keep the audit on target
Internal Quality Audit - 133
Quality Education Services, Inc.
Personnel Administration
•
•
•
•
Well qualified staff of auditors is a
prerequisite to an effective audit program
Qualification requirements must be stated
in procedures
Team leader should be most qualified
Auditor doesn't have to be fully qualified if
working under a qualified lead auditor
Internal Quality Audit - 134
Quality Education Services, Inc.
Auditor Traits
•
•
•
•
•
•
•
•
•
Personal integrity
Responsible
Consistent
Cooperative
Constructive
Adaptability
Curiosity
Persistence
Common sense
Internal Quality Audit - 135
Quality Education Services, Inc.
The Auditor
Good traits
Good judgement
Open minded
Resilient
Diplomatic
Self disciplined
Honest
Unbiased
Listens
Patient
Articulate
Professional
Interested
Analytical
Self confident
Human
Bad traits
Injudicious
Closed mind
Gives in
Argumentative
Undisciplined
Dishonest
Opinionated
Won't listen
Impatient
Inarticulate
Unprofessional
Apathetic
Gullible
Need to be liked
Unreasonable
Internal Quality Audit - 136
Quality Education Services, Inc.
Training
•
•
•
Education.
Formal audit training.
On the job training.
Internal Quality Audit - 137
Quality Education Services, Inc.
Auditor Knowledge
•
•
•
•
•
•
Contractual and legislative
requirements.
Codes , standards, and regulations.
Quality management practices.
Work processes in use.
How to organize.
Audit techniques
Internal Quality Audit - 138
Quality Education Services, Inc.
Maintenance of Audit Records
•
•
Formal audit records consist of letters of
notification, blank checklists, final audit
reports, and audit closeout letters
Audit schedules, audit plans, audit reports,
completed checklists, qualification records,
and follow-up records are working papers
and/or personnel records
Internal Quality Audit - 139
Quality Education Services, Inc.
Audit Personnel Records
•
•
Should be maintained current and
retained for as long as the records of
the audits they performed are retained
Personnel records include
•
•
•
•
Qualification forms
Training records
Examinations
Records of audits conducted
Internal Quality Audit - 140
Quality Education Services, Inc.
Audit
•
•
•
•
•
Initiation
Preparation
Performance
Reporting
Follow-up and closeout
Internal Quality Audit - 141
Quality Education Services, Inc.
Audit Team Selection
•
•
Auditing organization selects the
auditors and the lead auditor
In the case of a conflict with the audit
assignment, notification to the client
must be given by the party in conflict
Internal Quality Audit - 142
Quality Education Services, Inc.
Audit team Preparation
•
•
Lead auditor and audit team reviews the
audit plan to understand the scope and
requirements
The lead auditor establishes the ground
rules for the audit: area, security,
access, safety, etc.
Internal Quality Audit - 143
Quality Education Services, Inc.
Documentation Hierarchy
•
•
•
•
•
•
Government regulations
Industry standards
Contract specifications
Company manuals/procedures
Department procedures
Process instructions
Internal Quality Audit - 144
Quality Education Services, Inc.
Documentation for Review
•
•
•
•
•
•
Results of previous audit
Corrective action results
Receiving records
Customer complaints
Special processes
System or equipment criteria
Internal Quality Audit - 145
Quality Education Services, Inc.
Developing the Audit Checklist
•
The checklist should identify:
•
•
•
•
•
•
•
Requirements
Auditor
Auditee
Date
Individuals contacted
Items examined
Audit results
Internal Quality Audit - 146
Quality Education Services, Inc.
CHECKLISTS
•
Criteria checklist - structured in
accordance with the code, standard, or
regulation. Questions are usually the
words of the code rearranged into a
question
Internal Quality Audit - 147
Quality Education Services, Inc.
CHECKLISTS
•
Departmental (process) checklist structured to match the operation of a
specific department. Reflects the
inputs, outputs, and processes of that
department only
Internal Quality Audit - 148
Quality Education Services, Inc.
Criteria Checklist
Requirement
Yes
No
Comments
5.3.1 Are the elements of the
quality system documented in
the form of written policies and
procedures.
5.3.2.3 Have methods been
established for making changes,
modifications, revisions, or
additions to the quality manual?
Internal Quality Audit - 149
Quality Education Services, Inc.
Departmental (Process) Checklists
Yes
No
Comments
Are materials delivered on time?
Are materials identified
properly?
Is the correct quantity received?
Are the correct tools present?
Are instruments the correct
range?
Are instruments calibrated?
Internal Quality Audit - 150
Quality Education Services, Inc.
Alternate Checklists
•
•
•
•
Flow charts for a process
Highlighted sections of a procedure
Selected portions of an instruction or
drawing
Instructions/procedures for specific
audits conducted on a regular basis
Internal Quality Audit - 151
Quality Education Services, Inc.
Trace Audits
•
•
Tracing (tracking) follow the progress of
product or paperwork as it passes
through the process
Starts at the beginning or the end and
traces forward or backward
Internal Quality Audit - 152
Quality Education Services, Inc.
Pre-audit Conference
•
•
The primary objective of the pre-audit
conference is to establish rapport and
set the ground rules for conducting the
audit
The formality is flexible and depends on
the audit scope, size of the audit team,
and if the audit is internal or external
Internal Quality Audit - 153
Quality Education Services, Inc.
Pre-audit Conference
•
•
Should be attended by the audit team
and appropriate members of the
auditee's staff with at least one member
of management
Attempts by the auditee to divert the
auditor should be handled by the audit
team leader in a diplomatic manner
Internal Quality Audit - 154
Quality Education Services, Inc.
Pre-audit Conference
•
•
•
•
•
•
•
Review scope/purpose of audit
Identify escorts
Identify personnel to be interviewed
Confirm schedule
Confirm background information
Review prior deficiencies
Answer any questions
Internal Quality Audit - 155
Quality Education Services, Inc.
Pre-audit Conference
•
•
•
•
•
Develop a daily schedule
Schedule each portion of the audit
Time for post audit conference
Auditee personnel expected at the post
audit conference
Assure the auditee that the auditors will
minimally disrupt operations
Internal Quality Audit - 156
Quality Education Services, Inc.
Pre-audit Conference
•
Interface personnel in each area should
be identified to save time and identify
any problems with availability of an
individual
Internal Quality Audit - 157
Quality Education Services, Inc.
Audit Performance
•
•
•
•
•
•
Interview personnel
Observe operations
Select samples
Review documents
Document observations
Document findings
Internal Quality Audit - 158
Quality Education Services, Inc.
No surprises
•
•
•
•
Conduct daily briefing with the audit
team
Conduct daily briefing with the auditee
Keep auditee escort informed of
observations as they occur
Specific items (drawing numbers, etc.)
should be entered on the checklist
Internal Quality Audit - 159
Quality Education Services, Inc.
Objective Evidence
•
•
•
Documented statement of fact
pertaining to the conformance of a
product or activity
Based on observation, measurement, or
tests which can be verified
Documents reviewed, hardware
examined, operations observed, and
interviews
Internal Quality Audit - 160
Quality Education Services, Inc.
Audit Sampling
•
•
•
Any size sample is adequate for audit
purposes since it is not for the purpose
of product acceptance or process
control
A documented sampling plan may be
used if required by Management or if
the auditor prefers
If a sampling plan is used it should be
made part of the audit plan
Internal Quality Audit - 161
Quality Education Services, Inc.
Finding
•
Objective evidence that a control
feature of an approved quality program
was not implemented in accordance
with documented requirements.
Internal Quality Audit - 162
Quality Education Services, Inc.
Observations
•
Procedures should address methods for
identifying observations and may
include:
•
•
•
•
Presentation at post audit conference
Inclusion in the audit report
Subject of future audit
Informal discussion with auditee
Internal Quality Audit - 163
Quality Education Services, Inc.
ISO Reporting of Observations
•
•
•
•
ISO 10011-1 requires reporting of all
observations
Auditor must identify which observations are
to be reported as "nonconformities”
Finding same as "nonconformity" and may be
designated as major or category 1
observation
Observation may be designated as minor or
category 2 observation
Internal Quality Audit - 164
Quality Education Services, Inc.
Audit Team Critique
•
•
•
•
An audit team critique should be held
prior to the post audit conference
Discuss observations and findings
Ensure findings are definitive and
substantiated
Group findings and observations where
possible so that significant problems
stand out
Internal Quality Audit - 165
Quality Education Services, Inc.
Post Audit Conference
•
•
•
•
•
•
Conducted immediately following the
conclusion of the audit
Summary of audit
Present findings/observations
Clarify facts
Present preliminary report
Establish response date
Internal Quality Audit - 166
Quality Education Services, Inc.
Post Audit Conference
•
•
Ensure the auditee understands all
findings and observations
Attendees include:
• Audit team
• Representative of senior management
• Other auditee personnel deemed
appropriate by auditee management
Internal Quality Audit - 167
Quality Education Services, Inc.
Post Audit Conference
•
Audit team leader moderates the
conference with findings presented by
one of the following
• Each auditor presents their own findings
• Team leader presents all findings with input
as needed
• Auditor may make recommendations for
improvement if requested
Internal Quality Audit - 168
Quality Education Services, Inc.
Final Audit Report
•
•
•
No Surprises
The final audit report should be basically the
same as the preliminary report issued at the
post audit meeting. Any findings issued as
part of the report should be the same as the
findings reported at post audit conference
Issued as soon as possible after the audit per
procedure
Internal Quality Audit - 169
Quality Education Services, Inc.
Final Audit Report
•
•
Report Distribution
Forwarded to client for further
distribution
Internal Quality Audit - 170
Quality Education Services, Inc.
Final Audit Report
•
For internal audit
• Management responsible for audited area
• Management responsible for auditing
function
•
For supplier audit
• Management representative for supplier
activities audited
•
Record files
Internal Quality Audit - 171
Quality Education Services, Inc.
Final Audit Report
•
Report Content
• Audit identification/date
• Purpose/scope of audit
• Auditor(s)
• Organization/activity audited
• Personnel contacted
• Findings/observations/concerns
• Summary (include effectiveness)
• Response required
• Report distribution
Internal Quality Audit - 172
Quality Education Services, Inc.
Final Audit Report
•
The lead auditor should review and
approve the report prior to submittal to
client
Internal Quality Audit - 173
Quality Education Services, Inc.
Audit Closeout
•
An audit assignment is considered
complete when the report has been
submitted to the client except when the
audit assignment includes verification of
corrective action
Internal Quality Audit - 174
Quality Education Services, Inc.
Corrective Action
•
Audited activity management shall
investigate findings and indicate in
writing the corrective action
taken/planned to prevent recurrence
Internal Quality Audit - 175
Quality Education Services, Inc.
Audit Follow-up
•
The audit team leader or the
management of the auditing activity
should follow-up by:
• Obtain written response
• Evaluate for adequacy - in the auditor's
best judgement, the corrective action will
prevent the situation from recurring
• Conduct follow-up audit
Internal Quality Audit - 176
Quality Education Services, Inc.
Follow-up Audit
•
•
•
•
Follow-up audit must be documented.
Follow-up audit verifies satisfactory
completion of Corrective action
Follow-up audit verifies corrective action
was effective
Follow-up audit must use same
methodology as original audit
Internal Quality Audit - 177
Quality Education Services, Inc.
Official Audit Records
•
•
•
•
•
•
•
Audit notification letter
Audit plan
Blank checklists
Audit report and cover letter
Response from auditee
Closing letter
Lead auditor/auditor qualification records
Internal Quality Audit - 178
Quality Education Services, Inc.
Supporting Audit Records
•
•
•
•
•
•
Audit notes
Used checklists
Documents obtained from auditee
Additional correspondence
Audit schedules
Audit procedures
Internal Quality Audit - 179
Quality Education Services, Inc.
Product Audit In-line
•
•
•
Re-inspection or retest of item
previously accepted
Measures the ability of the system to
detect non-conformances
Requires auditors trained in inspection
and quality standards
Internal Quality Audit - 180
Quality Education Services, Inc.
Product Audit In-line
•
Verifies conformance to design
specifications only
Internal Quality Audit - 181
Quality Education Services, Inc.
Product Audit In-line
•
•
•
Sampling methods
Reporting methods
Disposition of nonconforming product
Internal Quality Audit - 182
Quality Education Services, Inc.
Product Audit In-line
•
Classification of defects uses same
system as inspection
Internal Quality Audit - 183
Quality Education Services, Inc.
Product Audit In-line
•
•
Auditee responsible for investigation
and action
Audit administration responsible for
follow up
Internal Quality Audit - 184
Quality Education Services, Inc.
Product Audit - End Item
•
•
Evaluation of a sample (usually small)
of product ready for shipping
Tests for design conformance and
customer expectations
Internal Quality Audit - 185
Quality Education Services, Inc.
Product Audit - End Item
•
Evaluation Criteria for Product Audit End Item
•
•
•
•
•
•
•
Customer's point of view
Marketing surveys
Information on competitor's products
Field service information
Customer complaints
Advertising literature
Purchase order/contract stipulations
Internal Quality Audit - 186
Quality Education Services, Inc.
Product Audit - End Item
•
•
•
•
Estimate outgoing quality
Measure quality program effectivity
Product re-qualification
Supplier product quality verification
Internal Quality Audit - 187
Quality Education Services, Inc.
Product Audit - End Item
•
•
Sample of three provides adequate
confidence
Samples must be selected in the same
configuration as they will be received by
the customer
Internal Quality Audit - 188
Quality Education Services, Inc.
Selection for Product Audit - End Item
•
•
•
•
•
•
•
Marketing information
New product
Customer complaints
Manufacturing reject rates
Changes in processes, vendors, design,
etc.
Previous audit results
Schedule
Internal Quality Audit - 189
Quality Education Services, Inc.
Product Audit - End Item
•
Classification of deficiencies and nonconformances based on seriousness
from customer's point of view
Internal Quality Audit - 190
Quality Education Services, Inc.
Process Audit
•
•
•
Applies to specially identified and
engineering specified processes
May be associated with characteristics
not economical to inspect
Observe or verify conditions are
maintained as specified
Audit
Internal Quality Audit - 191
Quality Education Services, Inc.
Purpose of Process Audit
•
•
•
Verify control systems adequate.
Vendor qualification
Process requalification
Internal Quality Audit - 192
Quality Education Services, Inc.
Process Audit
•
Special Requirements for Process Audit
• Personnel qualified in audit techniques and
special processes
• Detailed checklists
• Significant conditions should be reported
immediately to those responsible for the
process
Internal Quality Audit - 193
Quality Education Services, Inc.
Human Factors
•
Auditee
•
•
•
•
Fear of the unknown
Hostility
Fear of reprisal
Resistance to change
Internal Quality Audit - 194
Quality Education Services, Inc.
Human Factors
•
Auditor
•
•
•
•
•
•
Respect for other's values
Questioning vs. interrogation
Professionalism
Self control
Confidentiality
Empathy
Internal Quality Audit - 195
Quality Education Services, Inc.
The Interview
•
Location
• Full rapport can only come in the proper
environment or atmosphere
• A remote private location is best for
interviews
Internal Quality Audit - 196
Quality Education Services, Inc.
The Interview
•
Attitude
• The auditor should demonstrate through
his actions a thorough knowledge of the
audit subject
• Not an expert
Internal Quality Audit - 197
Quality Education Services, Inc.
The Interview
•
Empathy
• "The common identification and
understanding of the experience, feelings,
and thoughts and attitudes of the other
person”
• Empathy is acceptable, sympathy is not
Internal Quality Audit - 198
Quality Education Services, Inc.
Volunteered Information
•
•
•
•
The employee may believe the auditor can
accomplish what the employee cannot
Make written note, identify the individual, and
determine where more information can be obtained
The individual who volunteers information deserves
attention
Determine by questioning and investigation additional
objective evidence
Internal Quality Audit - 199
Quality Education Services, Inc.
Auditee Tactics
•
Diversions
• Sometimes used to limit time for audit
• Politely emphasize time does not allow the
"diversion”
•
Deceptions
• Data, statistics, or other information used
to prove no problems exist
• Check other sources for verification
Internal Quality Audit - 200
Quality Education Services, Inc.
Audit Team Problems
•
Assignment of higher level management
personnel to the audit can cause problems
• Make clear the role of the manager on the audit
team
• Make clear the role of the audit team leader
• If problems develop counsel the manager, then if
necessary, refer the matter to higher management
Internal Quality Audit - 201
Quality Education Services, Inc.
Audit Team Problems
•
Assignment of technical specialists can
cause problems if the specialist would
rather solve problems than audit
• Make clear the role of the specialist on the
audit team
• Train the specialist in audit techniques
• Pair the specialist with a trained auditor
Internal Quality Audit - 202
Quality Education Services, Inc.
Audit Team Problems
•
If the audit objectives appear to become
unattainable for any reason, the lead
auditor may terminate the audit and
notify the client and the auditee of the
reasons
Internal Quality Audit - 203
Quality Education Services, Inc.
Auditor Morale
•
•
One technique to improve morale is to
let the auditor who identified the finding
to make the presentation of the finding
at the post audit meeting
Let the same auditor review the
corrective action for the finding during
the follow-up audit
Internal Quality Audit - 204
Quality Education Services, Inc.
Maintaining Objectivity
•
•
•
The auditor should endeavor to remain
free of bias toward the audit subject
Previous involvement or personal
beliefs may adversely affect
understanding of conditions
If the auditor cannot maintain objectivity,
he/she should refuse the assignment
Internal Quality Audit - 205
Quality Education Services, Inc.
Keeping Notes
•
•
•
Details become lost without notes
Symptomatic problems may be overlooked
without notes to review and consolidate
The use of a tape recorder may be helpful
• Should only be used with the consent of the
auditee
• Many people are reluctant to speak freely
Internal Quality Audit - 206
Quality Education Services, Inc.
Back Up Data
•
•
Sufficient data must be available to
substantiate audit findings
Names, places, documents, etc. that
would permit a reasonable person to
come to the same conclusion
Internal Quality Audit - 207
Quality Education Services, Inc.
Back Up Data
•
•
Permanent records signed by a
responsible individual
Reports, correspondence, worksheets,
notebooks, and notes may be used if
author is known
Internal Quality Audit - 208
Quality Education Services, Inc.
Back Up Data
•
•
Responses to questions are objective
evidence only if substantiated by other
evidence or an acknowledging signature
Copies of documents should be
collected unless prohibited by the
auditee
Internal Quality Audit - 209
Quality Education Services, Inc.
Discussions of Findings
•
•
•
•
Keep escort informed of observations
as they occur
Conduct daily briefing with auditee
Conduct daily briefing with audit team
Significant findings should be brought to
the immediate attention of the auditee's
management
Internal Quality Audit - 210
Quality Education Services, Inc.
Discussions of Findings
•
Premature disclosure
• Partial information may lead to a finding
that later information refutes
• Do not inform the auditee of a finding or a
lack of a finding until sure
Internal Quality Audit - 211
Quality Education Services, Inc.
Post Audit Conference
•
•
The team leader should express
appreciation for help and courtesy
Use functions that were evaluated or
the level of the person in that function,
instead of names
Internal Quality Audit - 212
Quality Education Services, Inc.
Post Audit Conference
•
•
Personal competence or capability
should not be part of the audit report
Names of persons contacted is part of
the audit report, but not in association
with specific findings/observations
Internal Quality Audit - 213
Quality Education Services, Inc.
Presentation of Findings
•
Every finding should include:
• A statement of the requirement
• A description of the deficiency
• Where the deficiency was observed
Internal Quality Audit - 214
Quality Education Services, Inc.
Post Audit Conference
•
The post audit conference is an
opportunity for the auditee to provide
additional evidence to clarify a finding or
to discuss the wording of a finding to
ensure the meaning is clear
Internal Quality Audit - 215
Quality Education Services, Inc.
Corrective Action
•
•
•
The auditee is usually responsible to propose
corrective action to correct findings
Corrective action may be proposed at the
post audit conference with the schedule for
completion and re-audit established
Any recommendations by the auditor are not
binding on the auditee, nor do they relieve the
auditee of responsibility
Internal Quality Audit - 216
Quality Education Services, Inc.
Corrective Action
•
Unless requested by management, the
auditor should refrain from suggestions
of corrective action especially
concerning the auditee's staffing
Internal Quality Audit - 217
Quality Education Services, Inc.
The Audit Report
•
•
The report must reflect the results and
impressions left with the auditee during
the post audit conference and should
contain no surprises
The report should not contain any
personal feelings
Internal Quality Audit - 218
Quality Education Services, Inc.
The Audit Report
•
•
The report should be in the third person
The report must reflect an honest and
objective appraisal of the audited
organization's conformance with
requirements
Internal Quality Audit - 219
Quality Education Services, Inc.
Audit Ethics
•
•
•
•
•
•
•
Impartial
Objective
Fair
Open
Integrity
Confidential when required
Avoid false, unsupported, or misleading
statements that tend to injure or discredit the
auditee's organization
Internal Quality Audit - 220
Quality Education Services, Inc.