The document discusses different types of audits including quality audits, operations audits, and various classifications of audits. A quality or operations audit compares actual processes and operations to documented standards and specifications. The quality manual defines what is supposed to be for a quality system audit, while the operations manual defines standards for an operations audit. Common types of audits mentioned include policy, practice, and product audits. The document also outlines the primary references and typical steps for performing a quality or operations audit.
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Operations auditing
1. Quality and Operations
Auditing
A quality or operations audit compares what is to what is
supposed to be. Therefore a quality audit cannot be performed
unless what is supposed to be is properly documented. It is
Impossible to determine the degree of compliance with an
undefined state. For a quality system audit, the quality
manual is the definition of what is supposed to be. For an
operations audit, the operations manual is the definition of
what is supposed to be.
2. Audit Types
Tunner’s Generic Types
Policy Audit
compares written policies and procedures
with standards and specifications
Practice Audit
compares actual practices with established
procedures.
Product Audit
compares performance of a product or
service with its specifications.
SOP
SOP Policy
TAKS
3. Audit Types
Arter’s Classification
First-Party Audit
Second-Party Audit
Third-Party Audit
Quality auditor in your organization
audits your quality system.
Quality auditor from your source of
funds audits your quality system.
MBNQA audit team audits your
organization’s quality system.
4. Quality System Audit
Primary references for quality system auditing are:
ANSI/ASQC Q1-1986, American National Standard
Generic Guidelines for Auditing Quality Systems.
ANSI/ASQC Q10011-1-1994, American National
Standard Guidelines for Auditing Quality Systems.
5. Steps in Performing a
Quality or Operations
Audit
Initiation
Planning
Implementation
Reporting
Source: ANSI/ASQC Q1-1986
6. Steps in Performing a
Quality or Operations
Audit
Initiation
Planning
Implementation
Reporting
Source: ANSI/ASQC Q1-1986