Table of Contents
The Quality Audit
Did I Catch You Unaware?
Auditing
An Open Source Document
Partial List Of Files In This Guide
Guide Objectives
Related 'Stuff' We'll Be Covering
Caution
Caution II
Auditing - The Program
The Goal Of An Audit
Basic Types of Audits
Audit Sub-Types
Audit Types
A Typical Audit System
Definitions: "Who"
Definitions: "What"
Phases of Auditing
The 'Standard' Four Phases
The Part People See
Quality Audit
Objective Evidence
Objective Evidence II
Reasons For Audits
More Reasons For Audits
The Audit Must Be
Validation
Auditors Are Not....
Why A Formal Audit Program?
Internal Audits
The Internal Audit
IIA's Definition Of Internal Audit
Internal Audit System Base Requirements
Internal Audit System Base Requirements
Role of the Internal Auditor
Internal Quality Auditing
PPT Slide
Compliance Audits
Compliance Audits
Compliance Audit
Compliance Audit
Systems Audits
Systems Audit
Systems Audit
Example Training System - A Support System
Process Audits
Process Audit
A Typical Series Of Manufacturing Processes
Process White Space Issues
Manufacturing Processes
Product Audits
Product Audit
Product Audit - A Brief Review
What Will YOU Will Be Auditing?
Basic Audit Focus?
Internal Audits - Focus
Reasons To NOT Address Compliance In Internal Audits
Reasons To NOT Address Compliance In Internal Audits
Reasons To NOT Address Compliance In Internal Audits
Reasons To NOT Address Compliance In Internal Audits
The Famed Document Pyramid
4.2.3 Control of Documents (4.5)
Another Document Control System
Audit Types - A Brief Review
A Quality Management System?
A Quality Management System?
ISO/QS-9000 (now IATF 16949) Quality Management System
Procedures & Systems
Many Requirements
The ISO Standards
The QS 9000 Document Origins
Documentation Hierarchy
PPT Slide
Typical Operations Flowchart
The Bottom Line
The Details
Complex Trade Relationships
An Organization As A Collection of Systems
What is a System?
System vs. Process
Systems Responsibilities
Systems Responsibilities II
The Organization as a System, Subsystems, and Processes
Systems and Subsystems
Extending Outside the Organization
An Extended System
Measures In The Extended System
CAUTION!
What is a Process?
Examples of Processes
Quality Through Process Improvement
Significant and Critical Processes
Responsibilities
Client's Responsibility
Auditor's Responsibility
Auditee's Responsibility
Auditor Qualifications
Education, Training & Experience
Auditor Personal Qualities
Personal Attributes
Applying Auditor Attributes
Audit Preparation
Planning The Audit
Audit Scope
The Audit Plan
Audit Failure Modes
A Second Auditor
Audit Team Assignments
Audit Frequency
QS-9000 (now IATF 16949) Requirements
ISO 9001:2000 Requirements
ISO 9001:2000 Requirements Summary
Internal Audit Schedule Example
Example Responsibilities Matrix
A Sample Compliance Audit Schedule
Check Lists
Check Lists
Check List Benefits
Check List Preparation
Check List Example
Check List Thoughts
Sample Size
Sample Size
Sample Size II
Audit Strategy
Audit Strategies
Internal Audit Strategies
Available Information
Review of Working Documents
Representative Samples
Pre-Audit Confirmation
Executing the Audit
Changes Happen
Opening Meeting
A Registrar's Opening Meeting 'Outline' I
A Registrar's Opening Meeting 'Outline' II
A Registrar's Opening Meeting 'Outline' III
A Registrar's Opening Meeting 'Outline' IV
A Typical Registrar's Finding Record
A Registrar's Opening Meeting 'Outline' V
A Registrar's Opening Meeting 'Outline' VI
Other Interpretations
Other Interpretations
Other Interpretations
Other Interpretations
Conducting The Audit
Registrar Audits
Registrar Audits II
Registrar Audits III
Audit Hints
Questions To Ask?
Taking Notes As Reference
Take Copious Notes!!!!
Taking Notes As Evidence
Avoiding Trouble
Good Auditing Practices
Keep People Informed
Bad Auditing Behavior
Expect These Reactions / Emotions
Interview the Right People
You're In The Audit Now!
Recording Nonconformances
Nonconformance Exists Because
'Standard' Nonconformance Categories
Establish The Facts
Facts About Facts
Things to Consider -- Is It Serious?
Assessing Nonconformances
Simple Nonconformance Report Form
Sample Audit Summary Sheet
The Closing Meeting
Nonconformance Reports
Writing Nonconformance Reports
Summary Content
Audit Reports
The Audit Report
Audit Report Example
Corrective Action
Corrective & Preventive Actions
Audit Follow-Up
Re-Audit Focus
Audit Records
Being Audited - Life on The Other Side Of The Fence
Being Audited
What is Controlled Documentation?
What is an Auditor?
What Will The Auditors Do?
Who Will Be Audited?
The Audit Team
Types of Audits
The Reason For Audits
What Will Happen If...
Things Everyone Must Know
Things to Do
Things NOT to Do
General Things To Know and Do
Some Typical Questions to Expect
Managers Should Think About...
Some Last Things to Think About
Good Luck!
|
Author: Marc Smith
Home Page: Elsmar.com
Editable Powerpoint file available. Free!.
|
Acceptable Quality Level (AQL) |
The maximum percentage of non-conforming units in a lot or batch that,
for the purpose of acceptance sampling, can be considered satisfactory
as a process average. |
Acceptance Number |
The maximum number of defective units or defects in a sample that will
permit acceptance of the inspected lot. |
Apprasial |
A form of the quality system audit, normally conducted to examine the
total quality program effectiveness and implementation. An apprasial
is usually conducted by a third party and reported to the highest level
of management. |
Assessment |
An estimate or determination of the significance, importance or value
of something. |
Attribute |
A characteristic or property that is appraised in terms of whether
it does or does not exist with respect to a given requirement. |
Attribute Inspection |
Inspection whereby either the product or product characteristics are
classified as defective or non-defective, or the number of defects in
a unit of product counted. |
Audit |
A planned, independent and documented assessment to determine whether
agreed-upon requirements are met. |
Audit Program |
The organizational structure, commitment and documented methods used
to plan and perform audits. |
Audit Standard |
The organizational structure, commitment and documented methods used
to plan and perform audits. |
Audit Team |
The group of individuals conducting an audit under the direction of
a team leader. |
Auditee |
An organization or person to be audited. |
Auditing Organization |
A unit or function that carries out audits through its employees. This
organization may be a department of the auditee (when the auditee is
a company), a client or an independent third party. |
Auditor |
The individual who carries out the audit. |
Average Outgoing Quality (AOQ) |
The expected quality of outgoing product following the use of an acceptance
sampling plan for a given value of incoming product. |
Average Outgoing Quality Limit (AOQL) |
For a given acceptance sampling plan, the maximum AOQ for all possible
levels of incoming quality. |
Batch |
A definite quantity of product or material produced under conditions
that are considered uniform. |
Calibration |
A comparison of an instrument or measuring device to a 'standard' of
known accuracy traceable to a national or international standard in order
to detect, report or eliminate by adjustment any discrepancy in accuracy
of the measuring device. |
Certification |
The procedure and action, by a duly authorized body, of determining,
verifying and attesting in writing to the qualifications of personnel,
processes, procedures or items in accordance with applicable requirements. |
Characteristic |
A property that helps to identify or to differentiate between entities
and that can be described or measured to determine conformance to requirements. |
Client |
The person or organization requesting the audit. Depending upon the
circumstances, the client may be the auditing organization, the aduitee
or a third party. |
Compliance |
An affirmative indication of judgement that the supplier of a product
or service has met the requirements of the relevant specification(s),
contract and/or regulation. Also, the state of meeting that (those) requirement(s). |
Confirmation |
The agreement of data or information obtained from two or more different
sources. |
Conformance |
An affirmative indication or judgement that a product or service meets
the requirements of relevant specifications, contract or regulation.
Also the state of meeting requirements. |
Contractor |
Any organization or person under contract to furnish items and/or services:
a vendor, supplier, sub-contractor, fabricator, and sub-tier levels of
these where appropriate. |
Convention |
A customary practice, rule or method. |
Corrective Action |
Action taken to eliminate the Root Cause(s) and symptom(s) of an existing
undesirable deviation or non-conformity to prevent recurrence. |
Corrective Action Request |
A formal document noting audit or other nonconformance finding(s) and
requesting a resolution. |
Defect |
A departure of a quality characteristic from its intended level that
occurs with a severity sufficient to cause a product or service not to
satisfy intended normal requirements. |
Defective |
A unit of product or service containing at least one defect, or having
several defects, that alone, or in combination, cause the unit not to
satisfy intended requirements. |
Deviation |
A non-conformance or departure of one or more characteristic(s) from
specified product, process or systems requirements. |
Evaluation |
The act of examining a process or item to some standard and forming
certain conclusions as a result. |
Examination |
A measurement of goods or services to determine conformance to some
specified requirement. |
Exit Meeting |
The meeting at the end of an audit between the auditors and the representative
auditees at which time a rough draft of audit findings and observations
are discussed and presented. |
Finding |
A conclusion of importance based upon observation(s). |
Follow-up Audit |
An audit which verifies that some corrective action has been accomplished
as scheduled and determines that the action(s) are effective in preventing
or minimizing recurrence. |
Guidelines |
Documented instructions that are considered good practice but that
are not mandatory. |
Independence |
Freedom from bias and external influence. |
Inspection |
Activities (e.g.: measuring, examining, testing) that gague one or
more characteristics of a product or service and the comparison of these
with specified requirements to determine conformity. |
Inspection Level |
A feature of a sampling scheme relating to the size of the sample to
that of the lot. Selection of an inspection level may be bsed upon simplicity,
unit inspection cost, inspection destructiveness or lot consistency. |
Inspection Lot |
A specific qualtity of similar units offered for inspection and subject
to an acceptance decision. |
Inspection Record |
Recorded data concerning inspection results. |
Inspection, Normal |
See Inspection, Normal |
Inspection, Reduced |
A feature of a sampling scheme permitting smaller sample sizes than
are used in 'normal' inspection. Reduced inspection is used when experience
(history) with the level of submitted quality is 'sufficiently good'. |
Inspection, Tightened |
A feature of a sampling scheme using stricter acceptance criteria than
those used in 'normal' inspection. Tightened inspection is used as a
protective measure to increase the probability of rejecting lots when
experience (history) shows the level of submitted quality has deterioriated. |
Lead Auditor |
The individual who supervises auditors during an audit and serves as
team leader. |
Lot |
A defined quantity of a product or material accumulated under conditions
that are considered uniform for sampling purposes. |
Lot Size (N) |
The number of units in a lot. |
Measuring and Test Equipment |
Any device used to measure, gage, test, inspect, diagnose or ottherwise
examine materials, supplies and equipment to determine compliance with
technical requirements. |
Nonconforming Unit |
A unit of product or service containing at least one defect (at least
1 nonconformity). Also see Defective. Also see Unit. |
Nonconformity |
A departure of a quality characteristic from its intended level or
state that has a severity sufficient to cause an associated product or
service not to meet a specification requirement. |
Normal Inspection |
Inspection under a sampling plan which is used when there is no evidence
that the quality of the product being submitted is better or poorer than
the specified quality level. |
Objective Evidence |
Verifiable (reproducable) qualitative or quantitative observations,
information, records or statements of fact pertaining to the quality
of an item or service or to the existence and implementation of a quality
system element. |
Observation |
An item of objective evidence found during an audit. Observations are
not non-conformances. |
Pre-Audit Meeting |
The introductory meeting between auditors and the representative auditees
at which time the overview of the planned audit is presented. |
Pre-Award Survey |
An activity conducted prior to a contract award and used to evaluate
the overall capability of a prospective supplier or contractor. May include
one or more of many elements, including quality aspects, facilities,
equipment, etc. |
Precision |
The closeness of agreement between randomly selected individual measurements
or test results. |
Procedure |
A document that specifies the method to perform an activity. |
Process |
The particular method of producing a product or service, generally
involving a number of steps or operations. |
Process Average |
The average percent of defective or average number of defects per hundred
units of product submitted by the supplier for original inspection. |
Process Quality Audit |
An analysis of elements of a process and apprasial of completeness,
correctness of conditions, and probable effeciveness. |
Product |
A unit manufactured for a customer or a service delivered to a customer. |
Product Quality Audit |
A quantitative assessment of conformance to required product characteristics. |
Qual;ity System |
The organizational structure, responsibilities, procedures, processes
and resources for implementing quality management. |
Qualification |
The status given to an entity or person when the fulfillment of specified
requirements has been demonstrated. The process of obtaining that status. |
Quality Assurance |
All those planned and systematic actions necessary to provide adequate
confidence that a product or service will satisfy given quality requirements. |
Quality Audit |
A systematic and independent examination and evaluation to determine
whether quality activities and results comply with planned arrangements,
and whether these arrangements are implemented effectively and are suitable
to achieve objectives. |
Quality Control |
The operational techniques and activities that are used to fulfill
requirements for 'quality'. |
Quality Management |
The totality of functions involved in the determination and achievement
of quality. |
Quality Manual |
A document (typically) stating the quality policy (and other policies),
quality system and quality practices of an organization. Sometimes called
a Systems Manual or Quality Systems Manual. |
Quality Plan |
One or more documents setting out the specific quality practices, resources
and activities relevant to a particular product, process, service, contract
or project. |
Quality Policy |
The overall intentions and direction of an organization regarding quality
as formally expressed by top management. |
Quality Surveillance |
The continuing monitoring and verification of the status of procedures,
methods, conditions, products, processes and services and the analysis
of records in relation to stated references to ensure that requirements
for quality are being met. |
Quality System Audit |
A documented activity performed to verify, by examination and evaluation
of objective evidence, that applicable elements of the quality system
are suitable and have been developed, documented and effectively implemented
in accordance with specified requirements. |
Quality System Review |
A formal evaluation bt management of the status and adequacy of the
quality system in relation to quality policy and/or new objectives resulting
from changing circumstances. |
Random Sampling |
The selection of units for a sample size (n) in such a manner that
all combinations of (n) units under consideration have an equil chance
of being selected. |
Rejection Number |
The minimum number of variants or varient units in the sample that
will cause the lot or batch to be designated as not acceptable. |
Reliability |
The probability that an item will perform its intended function(s)
for a specified interval under stated conditions. |
Root Cause |
A fundamental deficiency that results in a non-conformance and must
be corrected to prevent recurrence of the same or similar non-conformances. |
Sample |
A small group of units or observations taken from a lot or batch of
units or observations that serves to provide an information basis (typically
statistically) for making a decision (by a statistically based prediction)
concerning the lot or batch. |
Sample Size (n) |
The number of units or observations in a sample. |
Sampling Plan |
A statement of the sample size or sizes to be used and the associated
aceptance and rejection criteria. |
Specification |
The document that prescribes the requirements with which the product
or service must conform. |
Specification Limits |
Limits that define the conformance boundaries for an individual manufacturing
unit, design or other requirement criteria or service operation. |
Standard |
The documented result of a particular standardization effort by a recognized
authority. |
Standardization |
The act of documenting, formalizing and implementing efforts which
result in an improvement (by way of conformity [standardization]) to
similar or applicable methodologies, properties, processes or systems. |
Survey |
An examination for some specific purpose. To inspect or consider carefully.
To review in detail. Some authorities use the words audit and survey
interchangably. Audit implies the existence of agreed upon criteria against
which plans and execution can be checked. Survey implies the inclusion
of matters not covered by agreed upon criteria. |
Testing |
A means of determining an item's capability to meet specified requirements
by subjecting the item to a set of physical, chemical, environmental
or operating actions and conditions. |
Testing |
A means of determining the capability of an item to meet specified
requirements by subjecting the item to a set of physical, chemical, environmental
or operating actions and conditions. |
Traceability |
The ability to trace the history, application or location of an item
or activity and like items or activities by means of reorded identification. |
Unit |
Item. May be a physical item or a service. |
Unit |
A quantity of product, material or service forming a cohesive entity
on which a measurement or observation may be made. |
Universe |
A group of populations, often reflecting different characteristics
of the items or material under consideration. |
Variable Inspection |
Inspection wherein certain quality characteristics of samples are evaluated
with respect to a measurement. |
Variant |
An item or event that is classified differently from others of its
type. |
Verification |
The act of reviewing, inspecting, testing, checking, auditing or otherwise
establishing and documenting whether items, processes, services and/or
documents conform to specified requirements. |