Module 1 Flashcards
The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended.
Verification
A physical examination in real time with minimal document review. It identifies what is seen, but doesn’t determine the cause or offer a solution. It is limited in scope and seeks out non-conformances.
Inspection
A systematic and independent examination to determine whether activities and related results comply with the documented procedures and whether these procedures are implemented effectively and are suitable.
Audit
Examples of Verification
HACCP plan and food safety management system
Examples of Inspection
Good Manufacturing Practices (GMP) inspection
An audit of your facility by a customer-approved auditor to satisfy a customer requirement using a customer approved checklist.
Second Party Audit
An audit of your facility by an accredited certification body
Third Party Audit
An audit of your own system or processes using an individual independent of the function being audited.
First Party Audit
What is defined as a series of sequential steps resulting in a desired outcome?
Process
Which type of audit focuses on examining processes and testing them for suitability and effectiveness against the audit standard?
Process Audit
What are some of the benefits of internal auditing?
Determines compliance
Supports continuous improvement
Assesses system effectiveness
Prepares the company for an outside audit
Which parts of the PDCA cycle of continuous improvement refers to the audit?
Check/Act
Which of the following tasks are part of an audit?
Reviewing policies, procedures, work instructions, and records
Observing and asking questions to individuals who perform the work
What are the best ways to describe an audit?
A systematic examination to determine whether activities and related results comply with the documented procedures
A systematic examination to determine whether procedures are implemented effectively and are suitable.
Organizations use first party audits to audit themselves. They confirm or improve the effectiveness of management systems.
True
