Human Error; Human Error Prevention; Human Error Reduction; Error; Human Performance; Human Performance Improvement; Root Cause Analysis; Corrective Action; Process Improvement

LABORATORY QMS – NELAC ACCREDITATION – 3 DAYS

Audience

Laboratory managers, supervisors and analysts.  Laboratory auditors.  Users of laboratory services.

Learning Outcomes

Upon completion of this seminar, one will be able to:

  • Understand and apply laboratory quality terminology;
  • Understand the requirements of laboratory quality standards and their underlying principles;
  • Design and implement a laboratory quality management system;
  • Given knowledge of auditing, assess the effectiveness of a laboratory quality management system;

Apply for or maintain NELAC accreditation.

Outline

Summary of the NELAC Standards

–– PBMS
–– ISO 17025, ISO 9001, ISO 9002
–– Proficiency testing program
–– On-site assessment
–– Accreditation process
–– Laboratory quality system

Scope of Accreditation

–– Field
–– Matrix
–– Technology / Method
–– Analyte / Analyte Group
–– Supplemental

General Laboratory Requirements

–– Organization and management
–– Quality system
–––– Establishment
–––– Essential quality controls
–––– Data verification
–––– Audits
–– Personnel
–– Physical facilities
–––– Accommodation
–––– Environment
–– Equipment and reference materials
–– Measurement traceability and calibration
–– Test methods and standard operating procedures
–– Sample handling, sample acceptance policy and sample receipt
–– Records
–– Laboratory report format and contents
–– Subcontracting analytical samples
–– Outside support services and supplies
–– Complaints

Chemistry Requirements

–– Quality systems: positive and negative controls
–– Analytical variability / Reproducibility
–– Method evaluation
–– Detection limits
–– Data reduction
–– Quality of standards and reagents
–– Selectivity
–– Constant and consistent test conditions

Documentation for Accreditation

–– The laboratory’s accreditation application
–– Previous assessment reports
–– Proficiency test sample results
–– Official laboratory communications with the accrediting authority and associated records
–– Laboratory organization charts
–– Signature log
–– Personnel qualifications, experience and training
–– Laboratory quality manual
–– Sops, including those for the test methods for which accreditation is sought
–– Instrumentation and equipment
–– Standard and reagent origin, receipt, preparation, and use
–– Initial method validation studies
–– Demonstrations of capability for each analyst
–– Test method measure of precision, central tendency and accuracy
–– Sample receipt and handling
–– Internal audits
–– Software documentation and verification, software and hardware audits, records of changes to automated data entries
–– Annual management review
–– Document control records
–– Corrective action reports
–– Complaints
–– Subcontractor registry
–– Measurement uncertainty calculations
–– A sample client report

Ethics in the Laboratory

–– Ethical conduct in business
–––– Standards of behavior
–––– Professional codes
–– Understanding goals — how and why the analyst contributes to goals
–– Independent judgment
–– Lab fraud
–––– Definitions
–––– Consequences
–––– Examples
–– Data integrity
–––– Data integrity plan
–––– Management responsibilities
–––– Training
–––– Control and documentation
–– Information processing and reviews
–––– Flowcharts
–––– Responsibilities
–– Physical and electronic data security
–––– Data access
–––– Data use
–––– Data storage
–– Confidential business information — client protections
–––– Plagiarism
–––– Definitions
–––– Examples
–– Licensing and copyright protection
–––– Definitions
–––– Examples
–– Ombudsman ­
–––– Access
–––– Confidentiality
–– Corrective action

Handouts

–– Copy of the visual aids
–– Typical laboratory QMS procedures
–– Supplemental reading materials
–– Certificate of Completion showing 22 ½ education hours, with 2.25 Continuing Education Units that may be used toward university course credits or professional re-certifications, signed by your instructor

 

Human Error; Human Error Prevention; Human Error Reduction; Error; Human Performance; Human Performance Improvement; Root Cause Analysis; Corrective Action; Process Improvement