FIS 480 Exam 2 questions with 100%
complete solutions passed
What is the main purpose of an audit? - correct answer ✔✔Verify compliance
True/False: An Audit is a fact finding mission - correct answer ✔✔True
An Audit is a search for ________ - correct answer ✔✔Opportunities for Improvement
*not an excercise for blame
Who performs an internal audit? - correct answer ✔✔The laboratry itself
Who performs Assesments or external audits? - correct answer ✔✔ASCLAD-LAB/ANAB or FQS-
ISO
Purposes of Audit - correct answer ✔✔*make sure management system is impemented
*Investigate causes of quality problems
*Identify oppertunites for improvement
Basic Audit Process - correct answer ✔✔*Plan: Schedule audit, audit checklist, auditors
*Do: Audit as scheduled, ask questions, examine records
*Check: Check degree of conformity
*Act: make CARs
, when dont you have a nonconformity (#1 rule of auditing) - correct answer ✔✔If you cannot
express the nonconformance in the words of the standard or the company's own policies and
procedures then you DO NOT have a confonformity
Questions to avoid when doing an Audit - correct answer ✔✔*Self answering
*"You do this, dont you?"
*No trick, ambiguous or compound questions
Keys to communication during an audit - correct answer ✔✔Keep it simple: clear, breif, direct,
focused
*3 ways of receiving information: seeing, hearing, experiencing
*Spend most of your time listening
Pre-audit Prep - correct answer ✔✔*Review Management system documentation
*Review standards used for audit
*Prepare Gap Analysis
*Prepare any questions or checklists
*Familiarize yourself with lab procedures and processes
What is an appropriate method? - correct answer ✔✔A method that would be judged suitable
by the scientific community or by qualified scientific peers
what does it mean that test methods should be readily avaliable? - correct answer ✔✔SOP
should be a the bench or beside the instument
What is Validation? - correct answer ✔✔make sure certain method/equipment actiually does
what it should
complete solutions passed
What is the main purpose of an audit? - correct answer ✔✔Verify compliance
True/False: An Audit is a fact finding mission - correct answer ✔✔True
An Audit is a search for ________ - correct answer ✔✔Opportunities for Improvement
*not an excercise for blame
Who performs an internal audit? - correct answer ✔✔The laboratry itself
Who performs Assesments or external audits? - correct answer ✔✔ASCLAD-LAB/ANAB or FQS-
ISO
Purposes of Audit - correct answer ✔✔*make sure management system is impemented
*Investigate causes of quality problems
*Identify oppertunites for improvement
Basic Audit Process - correct answer ✔✔*Plan: Schedule audit, audit checklist, auditors
*Do: Audit as scheduled, ask questions, examine records
*Check: Check degree of conformity
*Act: make CARs
, when dont you have a nonconformity (#1 rule of auditing) - correct answer ✔✔If you cannot
express the nonconformance in the words of the standard or the company's own policies and
procedures then you DO NOT have a confonformity
Questions to avoid when doing an Audit - correct answer ✔✔*Self answering
*"You do this, dont you?"
*No trick, ambiguous or compound questions
Keys to communication during an audit - correct answer ✔✔Keep it simple: clear, breif, direct,
focused
*3 ways of receiving information: seeing, hearing, experiencing
*Spend most of your time listening
Pre-audit Prep - correct answer ✔✔*Review Management system documentation
*Review standards used for audit
*Prepare Gap Analysis
*Prepare any questions or checklists
*Familiarize yourself with lab procedures and processes
What is an appropriate method? - correct answer ✔✔A method that would be judged suitable
by the scientific community or by qualified scientific peers
what does it mean that test methods should be readily avaliable? - correct answer ✔✔SOP
should be a the bench or beside the instument
What is Validation? - correct answer ✔✔make sure certain method/equipment actiually does
what it should
