FIS 480 EXAM 2 QUESTIONS AND ANSWERS A+ GRADED
What is the main purpouse of an audit?
Verify compliance
True/False:An Audit is a fact finding mission
True
An Audit is a search for ________
Opportunities for Improvement
*not an excercise for blame
Who performs an internal audit?
The laboratry itself
Who performs Assesments or external audits?
ASCLAD-LAB/ANAB or FQS-ISO
Purposes of Audit
*make sure management system is impemented
*Investigate causes of quality problems
*Identify oppertunites for improvement
Basic Audit Process
*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)
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
*Self answering
*"You do this, dont you?"
*No trick, ambiguous or compound questions
Keys to communication during an audit
Keep it simple: clear, breif, direct, focused
*3 ways of receiving information: seeing, hearing, experiencing
*Spend most of your time listening
Pre-audit Prep
*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?
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?
SOP should be a the bench or beside the instument
, What is Validation?
make sure certain method/equipment actiually does what it should
True/False: Every method needs to be validated before use in the lab
True
What is uncertainty of measurment?
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 measurments does MU (measurement uncertainty) apply to?
Quantitative Measurments
5.4.7.1- Checking Data
A second person must check calculations and data transfers and initial/Date the transfer
4.3.1- Controlling lab enviromental conditions
Lab must control:
* Tempature
*Humidity
*Vibration
*Noise
*Dust
*Power Supplies
*High purity water
What are the aspects of controlling access to the lab?
*List who has access to what areas
*Records of Key/Keycards
*Visitors
*After hours security
*Emergency calls
*Evidence storage areas
5.3.5- Housekeeping
SOPs for cleaning. Such as: frequency, who cleans, health/safety concerns
Authorization of equipment/ work?
work authorization- Must be stated that lab emplyee perform certain tasks/ use
equipment
labeling of equipment that is good or out of service
Eqipemnt should be labeled with "GOOD TO GO" or "OUT OF SERVICE" on the actual
peice of equipment
What is traceability?
Properties of the result of a measurment or the value of a standard whereby it can be
related to stated references, usually national or international standards, through an
unbroken chain of comparisons all having states uncertainties
*traceability is t he ability to verify the history, location, or application of an item by
means of documented recorded identification
Difference between reference standard and reference material
*reference standards- used to check calibration (Weights/ rulers)
*Reference material- Knows for tests (ie- blood, paint, glass ect)
Sampling vs sample selection
What is the main purpouse of an audit?
Verify compliance
True/False:An Audit is a fact finding mission
True
An Audit is a search for ________
Opportunities for Improvement
*not an excercise for blame
Who performs an internal audit?
The laboratry itself
Who performs Assesments or external audits?
ASCLAD-LAB/ANAB or FQS-ISO
Purposes of Audit
*make sure management system is impemented
*Investigate causes of quality problems
*Identify oppertunites for improvement
Basic Audit Process
*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)
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
*Self answering
*"You do this, dont you?"
*No trick, ambiguous or compound questions
Keys to communication during an audit
Keep it simple: clear, breif, direct, focused
*3 ways of receiving information: seeing, hearing, experiencing
*Spend most of your time listening
Pre-audit Prep
*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?
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?
SOP should be a the bench or beside the instument
, What is Validation?
make sure certain method/equipment actiually does what it should
True/False: Every method needs to be validated before use in the lab
True
What is uncertainty of measurment?
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 measurments does MU (measurement uncertainty) apply to?
Quantitative Measurments
5.4.7.1- Checking Data
A second person must check calculations and data transfers and initial/Date the transfer
4.3.1- Controlling lab enviromental conditions
Lab must control:
* Tempature
*Humidity
*Vibration
*Noise
*Dust
*Power Supplies
*High purity water
What are the aspects of controlling access to the lab?
*List who has access to what areas
*Records of Key/Keycards
*Visitors
*After hours security
*Emergency calls
*Evidence storage areas
5.3.5- Housekeeping
SOPs for cleaning. Such as: frequency, who cleans, health/safety concerns
Authorization of equipment/ work?
work authorization- Must be stated that lab emplyee perform certain tasks/ use
equipment
labeling of equipment that is good or out of service
Eqipemnt should be labeled with "GOOD TO GO" or "OUT OF SERVICE" on the actual
peice of equipment
What is traceability?
Properties of the result of a measurment or the value of a standard whereby it can be
related to stated references, usually national or international standards, through an
unbroken chain of comparisons all having states uncertainties
*traceability is t he ability to verify the history, location, or application of an item by
means of documented recorded identification
Difference between reference standard and reference material
*reference standards- used to check calibration (Weights/ rulers)
*Reference material- Knows for tests (ie- blood, paint, glass ect)
Sampling vs sample selection
