Implementing a QMS in the Laboratory – NELAC Accreditation

Paul Mills

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, with Continuing Education Units