FIS 480 – Exam 2 Study Guide and Practice Questions
What is the main purpose of an audit? - ANS✔✔ Verify compliance
True/False: An Audit is a fact-finding mission - ANS✔✔ True
An Audit is a search for ________ - ANS✔✔ Opportunities for Improvement
*not an exercise for blame
Who performs an internal audit? - ANS✔✔ The laboratory itself
Who performs Assessments or external audits? - ANS✔✔ ASCLAD-LAB/ANAB or FQS-ISO
Purposes of Audit - ANS✔✔ *make sure management system is implemented
*Investigate causes of quality problems
*Identify opportunities for improvement
Basic Audit Process - ANS✔✔ *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) - ANS✔✔ 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 - ANS✔✔ *Self answering
*"You do this, dont you?"
*No trick, ambiguous or compound questions
Keys to communication during an audit - ANS✔✔ Keep it simple: clear, breif, direct, focused
*3 ways of receiving information: seeing, hearing, experiencing
*Spend most of your time listening
Pre-audit Prep - ANS✔✔ *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? - ANS✔✔ 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? - ANS✔✔ SOP should be a the
bench or beside the instument
What is Validation? - ANS✔✔ make sure certain method/equipment actiually does what it
should
True/False: Every method needs to be validated before use in the lab - ANS✔✔ True
What is uncertainty of measurment? - ANS✔✔ A parameter associated with the result of a
measurement, that characterizes the dispirsion of the values that could reasonably be
attributed to the measurand
What is the main purpose of an audit? - ANS✔✔ Verify compliance
True/False: An Audit is a fact-finding mission - ANS✔✔ True
An Audit is a search for ________ - ANS✔✔ Opportunities for Improvement
*not an exercise for blame
Who performs an internal audit? - ANS✔✔ The laboratory itself
Who performs Assessments or external audits? - ANS✔✔ ASCLAD-LAB/ANAB or FQS-ISO
Purposes of Audit - ANS✔✔ *make sure management system is implemented
*Investigate causes of quality problems
*Identify opportunities for improvement
Basic Audit Process - ANS✔✔ *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) - ANS✔✔ 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 - ANS✔✔ *Self answering
*"You do this, dont you?"
*No trick, ambiguous or compound questions
Keys to communication during an audit - ANS✔✔ Keep it simple: clear, breif, direct, focused
*3 ways of receiving information: seeing, hearing, experiencing
*Spend most of your time listening
Pre-audit Prep - ANS✔✔ *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? - ANS✔✔ 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? - ANS✔✔ SOP should be a the
bench or beside the instument
What is Validation? - ANS✔✔ make sure certain method/equipment actiually does what it
should
True/False: Every method needs to be validated before use in the lab - ANS✔✔ True
What is uncertainty of measurment? - ANS✔✔ A parameter associated with the result of a
measurement, that characterizes the dispirsion of the values that could reasonably be
attributed to the measurand
