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NELAC Update

NELAC Update. News You Can Use. Stephen Arms Bureau of Laboratories Environmental Laboratory Certification Program. 64E-1, FAC Amendments January 24, 2005. 2002 NELAC standards in effect now 2003 NELAC standards take effect July 1 Application is completed by on-site assessment

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NELAC Update

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  1. NELAC Update News You Can Use Stephen Arms Bureau of Laboratories Environmental Laboratory Certification Program

  2. 64E-1, FAC AmendmentsJanuary 24, 2005 • 2002 NELAC standards in effect now • 2003 NELAC standards take effect July 1 • Application is completed by on-site assessment • DW Microbiology PT clarification for total/fecal coliforms

  3. NELAC Chapter 5 • 5.0 - Quality Systems - Introduction • 5.1 - Scope • 5.2 - References • 5.3 - Terms & Definitions • 5.4 - Management Requirements • 5.5 - Technical Requirements

  4. Introduction (’03) • Clarification (“data of known and documented quality”) • Removed reference to PBMS • All references to “calibration laboratories” removed from Chapter 5

  5. Management Requirements • 5.4.5 - Subcontracting • Laboratory is responsible for the subcontractor’s work, except where the client or regulatory agency specifies the subcontractor • Laboratory maintains a register of subcontractors and documents compliance with subcontracting requirements • 5.4.5.2 - Gain client’s approval when “possible” not when “appropriate” (’03)

  6. Management Requirements • 5.4.6 - Purchasing Services & Supplies • New language to require policy & procedures (vs. ensuring only) for purchasing services & supplies • Procedures for purchasing, receiving, & storing reagents and consumable materials • Documented evaluation of suppliers

  7. Management Requirements • 5.4.9 - Control of Nonconforming Work (New in '02) • Implement policy & procedures when work does not conform to lab’s own procedures or to client’s requirements • Designate responsibilities & authorities for managing nonconforming work • Take actions immediately when nonconforming work is identified

  8. Control of NonconformingWork (5.4.9 cont’d) • Evaluate significance of nonconforming work • Decide if any nonconforming work is still acceptable • Notify client, rather than recall work when nonconforming work impacts data quality (’03) • Define responsibility for authorizing resumption of work

  9. Management Requirements • 5.4.10 - Corrective Actions (New in '02) • Designate authority to implement corrective actions when non-conforming work or departures from quality system or technical operations are identified • Determine the root cause(s) • Identify potential corrective actions, eliminate the problem & prevent recurrence

  10. Corrective Action(5.4.10 cont’d) • Document & implement any changes resulting from corrective actions investigations • Monitor results for effectiveness

  11. Management Requirements • 5.4.11 - Preventive Action (New in '02) • Identify needed improvements & potential problems • Develop, implement, & monitor preventive action plans • Procedures include initiating such actions & applying controls to ensure effectiveness

  12. Management Requirements • 5.4.12.2 - Technical Records - Retain records (for a defined period) of: • original observations • derived data • sufficient info to establish an audit trail • calibration records • staff records • copy of each test report

  13. Technical Records(5.4.12.2 cont’d) • Sufficient to identify factors affecting uncertainty • Sufficient to facilitate test repetition under original conditions • Must identify personnel responsible for sampling, test performance, & checking of results

  14. Technical Records (5.4.12.3) Document reason for error correction if other than for a transcription error (’03)

  15. Management Requirements • 5.4.13 - Internal Audits (New language in '02) • 5.4.13.2 - Specify in QM the time frame for notifying client if validity of results is in doubt (e.g., by internal audit findings) (’03) • 5.4.13.4 - Audit follow-up must record effectiveness of corrective actions

  16. Technical Requirements 5.5.2 - Personnel (New language in '02) • Goals for education, training, & skills • Policy & procedures for identifying training needs & providing training • Training program relevant to present & anticipated tasks • Employed or contracted • Ensure supervision, competence, & QS-compliant work

  17. Personnel 5.5.2.6(c)(3)(iii) - Laboratory must pre-determine on-going DOC acceptance limits when using the “4 consecutive LCS” option (’03)

  18. Personnel 5.5.2.7 – Annual data integrity training • Organizational mission as related to honesty and full disclosure • Procedures • Documentation • Consequences • Management support

  19. Technical Requirements • 5.5.4 - Environmental Test Methods & Method Validation • 5.5.4.1.1 - Manufacturer manuals or published methods allowed as SOPs if no changes needed and sufficiently detailed to be used as written (‘03)

  20. Test Methods &Method Validation • 5.5.4.2 - Selection of Methods • Preferentially use methods published in international, regional, or national standards • Use latest valid edition unless inappropriate or impossible • Supplement with additional details, when necessary, to ensure consistent application • Use any method specified by the client; inform client if this method is inappropriate or out-of-date

  21. Method Selection(5.5.4.2 cont’d) • Appropriate validated laboratory-developed methods may be used • Inform client of method chosen • Confirm ability to run the test method properly before analyzing samples • Repeat the confirmation if the test method changes

  22. Test Methods &Method Validation • 5.5.4.3 - Laboratory-developed Methods (New in '02) • Must plan the use of lab-developed methods • Assign to qualified, adequately equipped personnel • Update plans as method development proceeds • Ensure effective communication

  23. Test Methods &Method Validation • 5.5.4.4 - Non-Standard Methods (New in '02) • Usability subject to client’s agreement • Must include clear specification of client requirements & test purpose • Method must be validated before use

  24. Test Methods &Method Validation • 5.5.4.5 - Validation of Methods (New in '02) • Must validate the following cases to confirm fitness for the intended use: • Non-Standard Methods • Laboratory-developed methods • Standard Methods used outside intended scope • Amplifications & modifications to standard methods • Validation must be as extensive as necessary to meet the needs of the given application

  25. Validation of Methods(5.5.4.5 cont’d) • Record validation procedures used, results obtained, & statement as to whether the test method is fit for the intended use (Appendix C.3 requirements at a minimum (’03)) • Range & accuracy of values must be relevant to the client’s needs

  26. Test Methods &Method Validation • 5.5.4.6 - Estimation of Uncertainty of Measurement (New in '02) • Laboratory must apply procedures for estimating uncertainty of measurement • If actual calculations of uncertainty cannot be done, attempt to identify all components of uncertainty & make a reasonable estimate based on performance, scope, experience, & validation data

  27. Measurement UncertaintyEstimates (5.5.4.6 cont’d) • All uncertainty components must be taken into account using appropriate methods of analysis • NOTE: If well-recognized test method specifies limits to values of major sources of measurement uncertainty and if the form of presentation of calculated results is specified, THEN THE LABORATORY COMPLIES WITH THIS SECTION BY FOLLOWING THE TEST METHOD & REPORTING INSTRUCTIONS

  28. Technical RequirementsEquipment (5.5.5) • 5.5.5.2.2.1 - Initial calibration (New language in '02) • Flagged data allowed if i-cal fails acceptance criteria • Single-point i-cal allowed in special cases • 5.5.5.2.2.1 - Initial calibration (’03) • Flag data above highest i-cal standard as less certain • Flags not required for data within established linear range even if result falls above single-point standard concentration • Standard at or below regulatory limit no longer required

  29. Equipment (5.5.5 cont’d) • 5.5.5.4 - Uniquely identify each item of equipment & software used for testing & significant to the result • 5.5.5.5 - Logs include checks for compliance with specifications, location (’03), but not necessarily future maintenance (’03) • 5.5.5.6 - Procedures for safe handling, transport, storage, use, & planned maintenance of equipment

  30. Equipment (5.5.5 cont’d) • 5.5.5.10 (’03) • Conditions under which CCV must be performed given • CCV concentration need not be varied • Flag data associated with unacceptable CCV (conditions given are now for data usability)

  31. Equipment (5.5.5 cont’d) • 5.5.5.11 - Procedures to ensure correctly updated copies of calibration correction factors in software • 5.5.5.12 - Equipment, computers, & software safeguarded from adjustments that would invalidate test results

  32. Measurement Traceability • 5.5.6.3 - Reference Standards & Reference Materials (New language in '02) • Defined procedures & schedules for checks needed to maintain confidence in working standards & reference materials • Procedures for safe handling, transport, storage, & use of reference standards & materials to avoid deterioration, protect integrity, & prevent contamination

  33. Measurement Traceability • 5.5.6.3 - Standards and reference materials must be traceable “where commercially available” not “where possible” (’03) • 5.5.6.4 - Requirements for quality and documentation of reagents separated from that of standards and reference materials (’03)

  34. Technical Requirements • 5.5.8 - Handling of Samples (New language in '02) • Procedures for transport, storage, receipt, handling, protection, retention, & disposal of samples • Procedures have all provisions necessary to protect sample integrity & protect interests of the laboratory & client

  35. Handling of Samples(5.5.8 cont’d) • Consult client for further instructions & record results of discussion whenever samples are not suitable to the requested test, do not conform to the description provided, or requested test is not specified in sufficient detail • Allowance for no chlorine checks of micro samples from chlorinated water systems

  36. Technical Requirements • 5.5.10 - Reporting the Results (New items in '02) • Allows for “simplified” report format • Where necessary for the interpretation of test results, include: • Opinions & interpretations where appropriate, including basis • Additional information required by clients or by test methods

  37. Reporting the Results(5.5.10 cont’d) • Ambiguities due to text such as “where relevant” clarified in test report requirements (’03) • 5.5.10.5 - Copy of subcontractor’s report must be made available to client on request (’03)

  38. Appendices • C.1 (’03) • DOC data need not be attached to form • Clarification that DOC is analyte-specific • Analyte concentrations linked to LOQ, not MDL

  39. Appendix C.3 InitialTest Method Evaluation (’03) • C.3.1 - Limit of Detection (LOD) applicable to all methods but toxicity and microbiology • Must be verified on every instrument (!) • C.3.2 - Limit of Quantitation (LOQ) applicable to all methods but toxicity and microbiology • C.3.3 - Evaluation of Precision & Bias required for standard and non-standard methods • C.3.4 - Evaluation of Selectivity

  40. Appendix D (’03) • D.1.1.1 - Documented corrective action required for contaminated blanks • D.1.1.2.1 • LCS is a “quality system” matrix • New section on LCS acceptance specs

  41. Appendix D (cont’d) • D.1.2.1 - LOD • Requirement to include all processing steps moved to C.3 • Not required if no results are reported outside calibration range (Required nonetheless by FDEP, with exceptions) • Verify LOD annually for each FOA by procedure in C.3 on every instrument to be used for analysis and reporting

  42. pH BOD/cBOD Titrimetric determinations Specific conductance Turbidity Residues (TSS, TDS, etc.) Dissolved Oxygen Salinity Ignitibility Parameters calculated from the results of different tests such as corrosivity, organic nitrogen and unionized ammonia Organoleptic tests (odor, taste) Color Temperature Chlorophyll Tests For Which LOD isNot Required

  43. Appendix D (cont’d) • D.1.2.2 • LOQ must be above LOD • Verify LOQ annually unless LOD is verified • D.1.5 - Retention time windows replaced with general selectivity evaluation

  44. Appendices • D.3 Microbiology Testing • D.3.1 Filtration sterility checks specified • D.3.6 Laboratory allowed to make media from basic ingredients if better than commercial • D.5.4 - Air LOD specs replaced with section D.1.2.1

  45. Improvements and RemindersTechnical Director (4.1.1.1) • Grandfathering ended after first round • New TD must meet educational and experience requirements • Exceptions of 4.1.1.2 still apply • Technical Directorship is portable for specific scope • Lab must notify the ELCP of change within 30 days • Lab submits documentation, which will be scrutinized • ELCP evaluates and replies

  46. Improvements and Reminders“On-going DOC (5.5.2.6(c))” Analyst training files must contain documentation of: • Technical training courses • Using latest version of quality documentation and test method • Continued proficiency Appendix C certificate unnecessary

  47. Improvements and Reminders“Latest Version of the Test Method (5.5.4.2.1)” • Latest valid edition of a “standard” (e.g., methods published in CFR) • If a choice of editions, use latest • Otherwise, define in document control system • If not defined by lab, must use latest available published version

  48. Improvements and RemindersProficiency Testing Frequency • 2 studies per fiscal year per FOPT(matrix-technology/method-analyte) • Matrix-analyte defined by NELAC PT tables(New tables for water effective June 1) • Multiple technologies allowed • Report each DW method once per year even if the same technology • AND < 7 months between studies(measured closing to closing) • > 15 days between studies(measured closing to shipping)

  49. Improvements and RemindersProficiency Testing Types • “Regular” studies required for routine bi-annual testing • “Supplemental” studies allowed only for remedial action or expansionof scope

  50. Improvements and RemindersProficiency Testing Performance • Passing 2 of the latest 3 attempts is acceptable • Non-participation within 7 months counts as a failure • Run PTs like samples (or, if preferred, run samples like PTs)

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