QUALITY MANAGEMENT SYSTEM IN LABORATORIES

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• QUALITY MANAGEMENT SYSTEM IN LABORATORIES

SIRIM QAS INTERNATIONAL SDN. BHD.
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Uncertainties in measurement
Operating Procedures
Sub contracting
Current standards validated method
Corrective preventive action
Management Commitment -Policy
Sampling
Complaints feedback
Documentation record control
LABORATORY
Internal Audits Management Review
Quality Control of testing
Handling samples
Equipment
Competent personnel
Testing conditions eg Temp, RH
Good laboratory practises
Purchasing
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DOCUMENTATION
IMPLEMENTATION
VERIFICATION OF IMPLEMENTATION
CORRECTIVE AND PREVENTIVE ACTION
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• Organizational structure, procedures , processes
  and resources to implement quality management.
• Once implemented, can assure the validity test
  and/ or calibration results.

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STRUCTURE

• Responsibility and authority - defined, specific
• Organizational structure - established, lines of
  authority
• Resources and personnel - sufficient, competent
• Operational procedures - clear, understood at
  all levels
• Maintenance and verification of quality system
  - audits, management reviews, process control

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DOCUMENTATION
Quality Manual
Quality System Procedures
Testing methods and Work Instructions
Records and forms
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• DOCUMENTATION - QUALITY MANUAL
• Contains policies and procedures
• quality policy and objectives
• policy on purchasing
• policy on subcontracting of tests
• policy on training of personnel competency
• ensuring conducive testing infrastructure

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• DOCUMENTATION OPERATIONAL PROCEDURES
• How to translate the policies into daily
• operational testing activities?
• procedure on selection of supplier,
  evaluation
• of purchase
• procedure on reviewing testing requests
• contract review
• procedure on training and assessing testing
• competencies of staff
• procedure for handling test items etc

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DOCUMENTATION - Methods of tests
International
Can be adopted
Regional
Can be adopted
Latest Method
Method
National
Can be adopted
Manufacturer of equipment
Can be adopted
Association
Can be adopted
Laboratory developed method
Must be validated and verified
Adopted
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• DOCUMENTATION WORK INSTRUCTIONS
• contains detailed instructions on how to
• conduct tests step by step
• EXAMPLES OF INSTRUCTIONS
• preparation or conditioning of samples how to
  do it
• mixing or homogenization of samples before
  testing etc

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• DOCUMENTATION- Forms and records
• record test data
• test data have to be recorded straight away. No
  delay as
• test data are valid during the time of
  testing only.
• correct transfer of test data from
  records/forms to test report.
• If incorrect transfer, can give wrong results
  to customer
• who in turn, may use the test report for
  advertising purposes
• which consequently lead to spread of incorrect
  information
• in test report

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RESOURCES

• Competent personnel - well trained
• Good working condition
• Good design of laboratory
• Sufficient, equipment well maintained and
  calibrated
• Reliable supply of testing equipment and
  components
• Updated test methods
• Sufficient financial resources

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RESOURCES - Personnel
Evaluation and review of tests results
New Personnel
Trained under supervision to conduct test and/or
calibration
Approved as qualified and competent to perform
test and/or calibration
Maintain competent (on going basis)
Interstaff comparison
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• IMPLEMENTATION OF QUALITY SYSTEM
• how to demonstrate
• records and forms
• document and record control

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• For evidence of implementation ,
• records form bulk of evidences
• practices of staff in accordance to written
  operating
• procedures
• Documentation and record control involve
• record masterlist with current number, issue/rev
  no, and
• retention times
• document change request form
• document tranmittal form

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• Verification of implementation
• Through
• internal audits
• customer feedback
• external audits
• quality assurance activities
• management review

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• INTERNAL AUDITS
• scheduled activity
• team of qualified personnel
• Self check, interdepartment activity
• auditing against standard
• objective findings , non conformities and
  observations
• findings presented in management review
  meeting

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• VERIFICATION OF IMPLEMENTATION
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  MANAGEMENT REVIEW
• schedule ie 1x or 2x per year
• agenda fixed
• objective to review quality management
  system in laboratory is
• effective and efficient
• chaired by top management who is able to
  make decisions on
• quality management system

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VERIFICATION OF IMPLEMENTATION- Management
Review
Laboratory Services (LS)
Customer Expectations (CE)
LS
CE
GAP
Equal
GAP
Not equal
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• CORRECTIVE AND PREVENTIVE ACTION
• sources are non conformities arising from
• complaints, feedback, audit findings (both
• internal and external),
• involve investigation to be conducted,
• make immediate correction, identify root
• cause and take corrective action
• take preventive action if possible

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Complaints and Feedback
Complaints Feedback from customers
Investigate root cause
Correct mistake immediately or as soon as
possible to customer
Take corrective (preventive) action
Preventive Action
Monitor and review actions taken
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PROCESSES

• Product services specification
• Research and Development of products/services
• Services measurement and review
• Purchasing raw materials
• Sub contractors
• Control of testing processes
• Equipment maintenance, calibration
• Suitable working environment
• Complaints
• Management review and internal audit
• After sales testing

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PROCESSES - Test measurement
SI units (base-m, kg, s, A,K,mole,cd)
Test measurement from equipment
Traceability of measurement
OR
Certified Reference Material (CRM), agreed
methods or consenses methods
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PROCESSES - Quality control of laboratories
(validity of test results)
Laboratory Maintain Competent Status
Interlaboratory comparison Retesting of
retained samples Use of CRM Replicate test by
different method
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PROCESSES - Interlaboratory Comparison
Standard Test Item
Standard Method
Laboratory A
Laboratory D
Laboratory B
Laboratory C
Results A
Results B
Results D
Results C
Results A
Equivalent
Results B
Results D
Results C
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Purchasing
Purchasing specifications
Evaluation of supply with purchasing
specifications
Supplier
Not comply
Comply
Reject
Accept and use in laboratory
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ORGANIZATION
CUSTOMER
GOOD QUALITY MANAGEMENT SYSTEM - CONTROLLED
PROCESS IN LABORATORY
CONSISTENT GOOD QUALITY TESTING / SERVICES

( Happy and Repeat Customer )
( Cost effective efficient system )
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• Effective quality system
• 2 inter related aspects

• Customers needs and expectations
• Satisfaction
• Confidence
• Safety
• Consistent
• Reduced cost

• Laboratory needs and interests
• Business consideration
• Desired quality optimum cost
• Efficient utilization of available resources

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CONCLUSION
LABORATORY
CUSTOMER
ORGANIZATION
Effective quality management system
Satisfaction and coming back for more
Increase in sales and enhanced image
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THANK YOU