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									News
 You   NELAC Update
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
 DW Microbiology PT clarification for
  total/fecal coliforms
                                 FSEA Spring Meeting ’05
                                                           2
  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

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  Introduction (’03)

 Clarification (“data of known and
  documented quality”)
 Removed reference to PBMS
 All references to “calibration laboratories”
  removed from Chapter 5



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    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)
                                         FSEA Spring Meeting ’05
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   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

                                  FSEA Spring Meeting ’05
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  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
                                  FSEA Spring Meeting ’05
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 Control of Nonconforming
 Work (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
                                       FSEA Spring Meeting ’05
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  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

                                    FSEA Spring Meeting ’05
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Corrective Action
(5.4.10 cont’d)

Document & implement any changes
 resulting from corrective actions
 investigations
Monitor results for effectiveness




                                FSEA Spring Meeting ’05
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  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
                                 FSEA Spring Meeting ’05
                                                       11
  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

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  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

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Technical Records (5.4.12.3)

Document reason for error correction
if other than for a transcription error
(‟03)




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  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

                                    FSEA Spring Meeting ’05
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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
                                      FSEA Spring Meeting ’05
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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)




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Personnel

5.5.2.7 – Annual data integrity training
Organizational mission as related to
 honesty and full disclosure
Procedures
Documentation
Consequences
Management support
                                FSEA Spring Meeting ’05
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  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)


                                 FSEA Spring Meeting ’05
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  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


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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

                                FSEA Spring Meeting ’05
                                                      21
    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
                                    FSEA Spring Meeting ’05
                                                          22
  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


                                  FSEA Spring Meeting ’05
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   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


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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

                                FSEA Spring Meeting ’05
                                                      25
  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

                                     FSEA Spring Meeting ’05
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  Measurement Uncertainty
  Estimates (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

                                        FSEA Spring Meeting ’05
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      Technical Requirements
      Equipment (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

                                                  FSEA Spring Meeting ’05
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   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
                                       FSEA Spring Meeting ’05
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      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)



                                          FSEA Spring Meeting ’05
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 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


                                FSEA Spring Meeting ’05
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  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

                                      FSEA Spring Meeting ’05
                                                            32
  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)
                                 FSEA Spring Meeting ’05
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  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
                                  FSEA Spring Meeting ’05
                                                        34
 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


                                      FSEA Spring Meeting ’05
                                                            35
  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
                                   FSEA Spring Meeting ’05
                                                         36
  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)


                                   FSEA Spring Meeting ’05
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    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



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   Appendix C.3 Initial
   Test 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

                                           FSEA Spring Meeting ’05
                                                                 39
  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



                                  FSEA Spring Meeting ’05
                                                        40
  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

                                      FSEA Spring Meeting ’05
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   Tests For Which LOD is
   Not Required
 pH                            Parameters calculated
 BOD/cBOD                         from the results of
 Titrimetric determinations
                                   different tests such as
                                   corrosivity, organic
 Specific conductance
                                   nitrogen and unionized
 Turbidity                        ammonia
 Residues (TSS, TDS,             Organoleptic tests (odor,
  etc.)                            taste)
 Dissolved Oxygen                Color
 Salinity                        Temperature
 Ignitibility                    Chlorophyll

                                                  FSEA Spring Meeting ’05
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  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
                                 FSEA Spring Meeting ’05
                                                       43
   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
                                     FSEA Spring Meeting ’05
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      Improvements and Reminders
      Technical 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

                                              FSEA Spring Meeting ’05
                                                                    45
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
                                   FSEA Spring Meeting ’05
                                                         46
  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
                                       FSEA Spring Meeting ’05
                                                             47
  Improvements and Reminders
  Proficiency 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)
                                               FSEA Spring Meeting ’05
                                                                     48
  Improvements and Reminders
  Proficiency Testing Types

 “Regular” studies required for routine
  bi-annual testing
 “Supplemental” studies allowed only
  for remedial action or expansion of
  scope



                                 FSEA Spring Meeting ’05
                                                       49
  Improvements and Reminders
  Proficiency 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)


                                  FSEA Spring Meeting ’05
                                                        50
  Improvements and Reminders
  Proficiency Testing Reporting

 Report the correct method identifier
 Prior to study closing, designate
  DOH to receive the final report
 Unless the fault of the provider,
  reports cannot be changed after the
  results are released


                                  FSEA Spring Meeting ’05
                                                        51
Web Stuff

           Application, Rules, Checklists
   http://www.dep.state.fl.us/labs/qa/dohforms.htm

       Information on Certified Laboratories
http://www.dep.state.fl.us/labs/cgi-bin/aams/index.asp

          NELAC Standards, PT Tables
http://www.epa.gov/nerlesd1/land-sci/nelac/index.html

            steve_arms@doh.state.fl.us
                   904-791-1502
                                               FSEA Spring Meeting ’05
                                                                     52

								
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