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 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