Notes
Slide Show
Outline
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ILAP 2005

Laboratory Accreditation

Present & Future Scopes
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Laboratory Accreditation

  • Is a many splendored thing.


  • Is a multi-tentacled beast that devours all  laboratories in its path much like the planet-eater from the original Star Trek television series.
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ILAP 2005
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ILAP 2005
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ILAP 2005
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ILAP 2005
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Laboratory Accreditation
  • How Can We All Just Get Along?


  • Accrediting Bodies Must Meet Certain Expectations.
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Accrediting Bodies
  • Approved By Regional Cooperative Groups
    • Made up of Accrediting Bodies


  • Bound By ISO/IEC 17011
    • Replaces ISO Guide 58


  • Additional Requirements Established By The Regional Cooperatives
    • Accrediting Body Recognition Procedures
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Accrediting Bodies
  • How Does This Affect The Laboratories?


    • Must comply with all standard requirements (e.g. ISO 17025, SAE AS7101)


    • Must comply with all policies established by the Accrediting Body related to:
      • ISO 17011
      • Regional Cooperative Recognition Procedures
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Key Points For Accrediting Bodies
  • Consistency


  • Technical Competence


  • Response To Customer Needs
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Consistency
  • Auditors / Assessors
    • Knowledge of Specification Requirements
    • Knowledge of Accrediting Body Policies
    • Application of Requirements


  • Staff
    • Application of Requirements
    • Administration of the Accreditation Program
    • Response to Customer Inquiries
    • Review of Audit Reports


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Technical Competence
  • Auditors / Assessors & Staff


    • Education
      • Formal
      • On The Job

    • Experience
      • Testing
      • Supervision of Laboratory
      • Auditing

    • Application of Technical Knowledge






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Response To Customer Needs
  • Accrediting Bodies


  • Email & Telephone Calls
    • Respond to email and return calls within 24 hours

  • Feedback
    • Provide formal feedback opportunities

  • Complaints
    • Formal documentation and resolution process
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Response To Customer Needs
  • Accrediting Bodies


    • Make All Procedures & Policies Available To The Laboratory Prior To Scheduling An Audit.

    • Provide Electronic Tutorials To Laboratories Prior To Audits (e.g. Root Cause Corrective Action).


    • Encourage Laboratories To Perform Detailed Pre-Audits In Advance Of The Formal Audit.
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Response To Customer Needs
  • Accrediting Bodies


  • Formal Process To Drive Continuing Improvements


    • Must Be A Part Of The Business Plan


    • Must Be A Part of Performance Evaluations


    • Must Be Quantified And Monitored


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Monitoring
  • Accrediting Bodies


  • Create and Define Metrics For Each Aspect Of The Process.


  • Publish The Data On A Regular Basis.


    • Reports To Management And All Affected Personnel.
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Examples Of Metrics
  • Total Number Of Nonconformances By Checklist
    • Initial Audits
    • Reaccreditation Audits


  • Top Ten Nonconformances By Checklist


  • Audit Cycle Times
    • Laboratory Response Time
    • Staff / Reviewer Response Time
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Metrics
  • PUBLISH & UTILIZE THE DATA!
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The Future
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The Direction Of The Future Is Clear
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The Future

  • Electronic Audit Reports


    • Paperless


    • Complete And Ongoing Database
      • Each Laboratory
      • All Laboratories
      • Test Methods
      • Location
      • Captive / Independent


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Electronic Audits
  • Definition of Audit Scope
  • Sign Agreements / Contracts
  • Scheduling (Auto-Scheduling)
  • Information Gathering Documents (e.g. checklists)
  • Submittal Of The Completed Audit, Including Nonconformances
    • NOTE:  Audit Nonconformances May Not Be Familiar To Attendees Of This Meeting

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Electronic Audits
  • Response to Nonconformances / Open Issues from The Audit.
  • Review Of The Complete Audit Information By A Designated Reviewer (e.g. Staff, Technical Expert)
  • Requests For Additional Information or Clarifications
  • Ballot / Disposition Of The Audit Report
  • Issuance Of Accreditation & Certification
  • On-Line List of Accredited Laboratories & Scopes
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Electronic Audits
  • Benefits
    • Reduction of Paperwork
    • Immediate Access to Audit Information
      • Checklists / Job Audits / Observation of Tests
      • Nonconformances
    • Reduction of Costs to the Accrediting Body
    • Reduction of Audit Fees to Laboratories
  • Concerns
    • Reduction of Paperwork
    • Security


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eAuditNet at PRI
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eAuditNet
  • PRI Electronic Auditing Process
  • Developed With Complete Staff Input
    • Staff Engineers
    • Support Staff
    • Schedulers
    • Management
    • Sales & Marketing
    • Other Personnel Associated With The Accreditation Process
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Summary
  • AB’s must become more responsive to their customers’ needs.


  • AB ‘s must work to identify areas of improvement and must then actively work to enable improvements.


  • AB’s must provide more resources for laboratories to use in preparing for audits and for responding to audit issues.