MANAGEMENT SYSTEM AUDITS The Assessment of Quality Management Systems

WHY AUDIT? To obtain factual input for management decisions To clarify notions of whether various parts of the company are working correctly or not To identify areas for opportunity To improve communications and motivation To assess status and capability of equipment To assist in training company staff

To obtain factual input for management decisions

To clarify notions of whether various parts of the company are working correctly or not

To identify areas for opportunity

To improve communications and motivation

To assess status and capability of equipment

To assist in training company staff

SIX CAUSES OF QUALITY PROBLEMS Lack of Organization Lack of Training Lack of Discipline Lack of Resources Lack of Time Lack of Support

Lack of Organization

Lack of Training

Lack of Discipline

Lack of Resources

Lack of Time

Lack of Support

AUDIT TYPES Internal – Company audits itself External – Outside source audits company System Audit – focus is on the overall QMS Process Audit – Focus is on the process but may include product audit activities as well Product Audit – Concentrates on one or more products or services

Internal – Company audits itself

External – Outside source audits company

System Audit – focus is on the overall QMS

Process Audit – Focus is on the process but may include product audit activities as well

Product Audit – Concentrates on one or more products or services

AUDIT DEPTH System Audit – to determine if QMS exists and if it is capable of meeting ISO-9001 Compliance Audit – to determine of the management system is being implemented

System Audit – to determine if QMS exists and if it is capable of meeting ISO-9001

Compliance Audit – to determine of the management system is being implemented

AUDIT SCOPE Full Audit – “cradle to grave” covers all activities and dept. within the audit type Partial Audit – covers only certain task or dept. within the audit type. Follow-up Audit – to assess the effectiveness of corrective actions taken as the result of a previous audit

Full Audit – “cradle to grave” covers all activities and dept. within the audit type

Partial Audit – covers only certain task or dept. within the audit type.

Follow-up Audit – to assess the effectiveness of corrective actions taken as the result of a previous audit

A CHAIN OF TASKS A quality management system can be viewed as a chain of tasks whose purpose is to ensure that products and services satisfy customer requirements.

A quality management system can be viewed as a chain of tasks whose purpose is to ensure that products and services satisfy customer requirements.

THE FOUR TASK ELEMENTS THE PERSON someone to perform or supervise the task THE ITEM(S) something on which to work THE EQUIPMENT the tools and facilities to perform the task INFORMATION Knowledge that is received, generated, or transmitted by the particular task

THE PERSON

someone to perform or supervise the task

THE ITEM(S)

something on which to work

THE EQUIPMENT

the tools and facilities to perform the task

INFORMATION

Knowledge that is received, generated, or transmitted by the particular task

THE FOUR TASK ELEMENTS

THE PERSON CORRECT COMPETENCE Demonstrated ability to perform the task correctly CORRECT TRAINING Skills and knowledge required for the task CORRECT IDENTIFICATION The task is traceable to the person who performed it CORRECT ATTRIBUTES E.G. good eyesight for inspectors, honesty for money handlers, health for hospital staff

CORRECT COMPETENCE

Demonstrated ability to perform the task correctly

CORRECT TRAINING

Skills and knowledge required for the task

CORRECT IDENTIFICATION

The task is traceable to the person who performed it

CORRECT ATTRIBUTES

E.G. good eyesight for inspectors, honesty for money handlers, health for hospital staff

THE ITEM(S) CORRECT TYPE Correct item is defined for, issued to, and released for that workplace CORRECT CONDITION Item possesses required characteristics CORRECT QUANTITY The correct quantity is issued to and used by the task and released to the next workplace CORRECT IDENTIFICATION The method for correct identification is defined and communicated to that workplace

CORRECT TYPE

Correct item is defined for, issued to, and released for that workplace

CORRECT CONDITION

Item possesses required characteristics

CORRECT QUANTITY

The correct quantity is issued to and used by the task and released to the next workplace

CORRECT IDENTIFICATION

The method for correct identification is defined and communicated to that workplace

THE EQUIPMENT CORRECT TYPE Correct type of equipment is defined, issued, and communicated to that workplace CORRECT CONDITION Correct maintenance, calibration, cleanliness, handling, safety CORRECT CAPABILITY The capability of equipment is defined and is consistent with the needs of the task

CORRECT TYPE

Correct type of equipment is defined, issued, and communicated to that workplace

CORRECT CONDITION

Correct maintenance, calibration, cleanliness, handling, safety

CORRECT CAPABILITY

The capability of equipment is defined and is consistent with the needs of the task

THE EQUIPMENT CORRECT LOCATION The relative position of different pieces of equipment to each other can affect quality CORRECT IDENTIFICATION The equipment is traceable to the the information and products that it has helped to make CORRECT ENVIRONMENT The environment in which the work is processes can affect the quality of the product

CORRECT LOCATION

The relative position of different pieces of equipment to each other can affect quality

CORRECT IDENTIFICATION

The equipment is traceable to the the information and products that it has helped to make

CORRECT ENVIRONMENT

The environment in which the work is processes can affect the quality of the product

THE INFORMATION CHECKED CORRECTLY Failure to take checking seriously is often the cause of repeated mistakes CORRECT CONTENT Content is clear, complete, unambiguous, and is based on what the end user really needs CORRECT EDITION Edition or revision of information must be clearly indicated, correct and valid

CHECKED CORRECTLY

Failure to take checking seriously is often the cause of repeated mistakes

CORRECT CONTENT

Content is clear, complete, unambiguous, and is based on what the end user really needs

CORRECT EDITION

Edition or revision of information must be clearly indicated, correct and valid

THE INFORMATION CORRECT CONDITION Documents need to be legible, and stored and handled in such a way as to keep them in usable condition CORRECT IDENTIFICATION Information must clearly state exactly what it is and to what it relates CORRECT DISTRIBUTION Distribution must be based on finding out who needs to know what, not on opinion

CORRECT CONDITION

Documents need to be legible, and stored and handled in such a way as to keep them in usable condition

CORRECT IDENTIFICATION

Information must clearly state exactly what it is and to what it relates

CORRECT DISTRIBUTION

Distribution must be based on finding out who needs to know what, not on opinion