NELAP ACCREDITATION BODY. REPORT of ON-SITE EVALUATION. According to the 2009 TNI Standard

Transcription

1 NELAP ACCREDITATION BODY REPORT of ON-SITE EVALUATION According to the 2009 TNI Standard California State Environmental Laboratory Accreditation Program Richmond, CA March

2 TABLE OF CONTENTS Team Composition...3 Members of California ELAP...3 Dates of On-Site Evaluation...4 Background...5 Findings...6 Summary...11 Attachment 1: Observation of On-site Laboratory Assessment...12 Attachment 2: Fields of Accreditation

3 A. Evaluation Team (ET) Composition, Kristin Brown. Lead Evaluator Utah Department of Health Bureau of Laboratory Improvement 4431 South 2700 West Taylorsville, UT (801) Jack Berges, Evaluator US EPA Region 9 Laboratory 1337 S. 46th St. Bldg 201 Richmond, CA (510) The NELAP Quality Assurance Officer (QAO), Paul Ellingson, AQS, Inc., Salt Lake City, Utah, employed by the NELAP Board of The NELAC Institute (TNI) accompanied the ET, but did not directly participate in the Evaluation Team s on-site program evaluation. The QAO was present to help assure uniformity of the AB evaluation procedures consistent with the NELAC standards. B. CA ELAP Personnel (Northern California): David Mazzera, Assistant Division Chief Fred Choske, Supervising Chemist Aida Dente, Supervising Chemist Jane Jensen, Staff Chemist Steven Bogs, Staff Environmental Scientist Frank Riley, Staff Environmental Scientist Joseph Ondo, Staff Chemist Wayne Tseng, Chemist Ronald Mills, Staff Chemist Nelia Beaman, Staff Chemist Linda Louie, Staff Chemist Mandy Mok, Chemist 3

4 Dharmendra Rishi, Chemist Karen Lee, Chemist C. Dates of On-Site Evaluation: The on-site program review of the CA ELAP was performed on May 2-3, The observation of the CA assessors performing a NELAP laboratory assessment was performed on May 1, 2012 of Kiff Analytical, nd Street, Davis, CA Background: The California State Environmental Laboratory Accreditation Program (CA ELAP) currently issues primary accreditation to 35 laboratories. In 2012 CA ELAP s NELAP recognition was renewed following satisfactory completion of a comprehensive evaluation of the CA ELAP s program. The following NELAC Standards applied to the 2012 evaluation: June 2003 (Constitution and Bylaws; Program, Policy, and Structure; Proficiency Testing; Accrediting Authority) and May 2001 (On-site Assessment; Accreditation Process; Quality System). The June 2003 version of the NELAC Standards extended the interval between evaluations to three years. Additionally, NELAP gave accreditation bodies due for renewal a one-year extension, due to the shift of the NELAP program from EPA to the NELAC Institute (TNI). Renewals which include on-site evaluations and laboratory assessment observations are required every three years. This evaluation is conducted under the 2009 TNI Environmental Laboratory Sector Standard, adopted by the NELAP Accreditation Council (AC) to become effective July 1, While not all ABs have been able to adopt the Volume 1 laboratory standards, all ABs are expected to modify their operations (where not codified in regulatory or legislative language) to comply with Volume 2, effective that date. In October 2011, CA ELAP submitted its renewal application along with required documentation, including its regulations, rules and standard operating procedures, and the NELAP checklists. This documentation was reviewed for completeness October 31, 2011 and the application was accepted on November 28, The completed application technical review report was sent to CA ELAP on April 27, Due to the short turn around time between the technical review and the program onsite evaluation the CA ELAP was informed that issues found during the technical review would be reviewed during the program onsite evaluation. The CA ELAP has requested that the following areas of accreditation be maintained: Drinking water, Non-Potable Water, Solid and Chemical Materials, 4

5 Please refer to Attachment 1 for a complete listing of all fields of accreditation for which recognition is being sought. Evaluation Process: This evaluation was conducted according to the following standards and procedures: 2009 NELAP Standard, available at administered by the National Environmental Laboratory Accreditation Program (NELAP) Accreditation Council (AC) operating within The NELAC Institute ( Standard Operating Procedure For the Evaluation of Accreditation Bodies, Revision 3. Checklist to Determine Accrediting Body Compliance, for the 2009 TNI Standards. The evaluation team reviewed the following materials: renewal application; NELAP completeness checklist; NELAP Technical Review Checklist; statutes authorizing CA ELAP; standard operating procedures comprising the CA ELAP quality system; various CA ELAP applications and checklists; laboratory assessment schedules and program reviews; and the complete program files, covering the period since the last NELAP renewal, for Babcock and Sons, Accutest Laboratories Northern California, Columbia Analytical Services Simi Valley, University of Iowa-Hygenic Lab, Accutest Laboratories SE, Pace Analytical PA, and Midwest Laboratories. During the on-site evaluation, the team: interviewed both CA ELAP assessors and the program s supervisor, Fred Choske. received a detailed description of the steps a laboratory must take to become accredited, including the materials each prospective applicant receives; reviewed the program s system for tracking proficiency testing (PT) data and adjusting its laboratories accreditation; and discussed its findings from the technical review and on-site evaluation with the CA ELAP assessors and their supervisor. The team also observed a CA ELAP laboratory assessment; the report of this observation is attached. 5

6 Findings: Each finding includes a citation of the relevant section of the 2009 NELAP Standard and/or the CA ELAP Quality Manual. In addition we have provided a recommended corrective action which CA ELAP may consider during the development of its corrective action response. 1. Finding: During the onsite evaluation the accreditation body did not have a member of management with the responsibility and authority including reporting to top management on the performance of the management system and any need for improvement. Citation(s): V2, M1, 5.2.3(b): The accreditation body's top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes reporting to top management on the performance of the management system and any need for improvement. Discussion/Rationale: The California State Environmental Laboratory Accreditation Branch s Chief George Kulasingam had recently retired at the time of the onsite assessment. Roles and responsibilities within the branch were not clearly defined at the time of the assessment. Recommended Corrective Action: The accreditation body needs to assign a Branch Chief or equivalent to the program. The roles and responsibilities of management need to be clearly defined. 2. Finding: The laboratory needs to develop a corrective action procedure that eliminates the causes of nonconformities in order to prevent recurrence. Citation(s): V2, M1, 5.5: The accreditation body shall also, where necessary, take actions to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the impact of the problems encountered. Discussion/Rationale: During the onsite evaluation the QAO was interviewed and stated that there have been several problems noted during internal audits that have been reoccurring problems for several years. Recommended Corrective Action: The accreditation body needs to take appropriate action to ensure that problems are eliminated and do not reoccur. 3a. Finding: Several of the CA ELAP documents reviewed during the evaluation had been updated recently. At the time of the evaluation the staff of the CA ELAP were not aware of these changes. Citation(s): V2, M1, 5.2.2: The accreditation body shall ensure that the manual and relevant associated documents are accessible to its personnel and shall ensure effective implementation of the system s procedure. 3b. Finding: The program Quality Manual had been updated on November 1, At the time of the evaluation the only staff member who had read the update was the QAO. 6

7 Citation(s): V2, M3, 4.2.7: The accreditation body shall ensure that assessors and, where relevant, experts: (a) are familiar with accreditation procedures, accreditation criteria and other relevant requirements. Discussion/Rationale: During the interviews with the staff of the ELAP it was learned that the staff was unaware of recent updates to CA ELAP documents. Recommended Corrective Action: The Quality Manual and documents related must be accessible to personnel. The accreditation body shall take steps to ensure that the assessors are familiar with accreditation procedures, accreditation criteria and other relevant requirements. 4. Finding: The internal audit does not show that the program conforms to the requirements of the standard, and that the system is implemented and maintained. Citation(s): V2, M1, 5.7.1: The accreditation body shall establish procedures for internal audits to verify that they conform to the requirements of this Standard and that the management system is implemented and maintained. NOTE: As an indication, ISO provides guidelines for conducting internal audits. Discussion/Rationale: The internal audit available for review during the evaluation process did not show that the program conforms to the standard. Recommended Corrective Action: The CA ELAP internal audits must document that the program conforms to the requirements of the standard, and that the system is implemented and maintained 5. Finding: The program did not have a managerial review available for the team to review at the time of the evaluation. Citation(s): V2, M1, 5.8.1: The accreditation body's top management shall establish procedures to review its management system at planned intervals to ensure its continuing adequacy and effectiveness in satisfying the relevant requirements, including this Standard and the stated policies and objectives. These reviews should be conducted normally at least once a year. Recommended Corrective Action: The CA ELAP shall conduct a review normally once a year to establish procedures to review its management system at planned intervals to ensure its continuing adequacy and effectiveness in satisfying the relevant requirements, including this Standard and the stated policies and objectives. 5. Finding: The documentation of complaints received by the CA ELAP were incomplete. The documentation did not include the validity of the complaint and the actions taken. Citation(s): V2, M1, 5.9(a); V2, M1, 5.9(c): In established procedures for dealing with complaints, the accreditation body shall decide on the validity of the complaint. In established procedures for dealing with complaints, the accreditation body shall take appropriate actions and assess their effectiveness. 7

8 Discussion/Rationale: Documentation available on complaints received at CA ELAP was sparse with little information. Recommended Corrective Action: The CA ELAP needs to review their complaint program to make sure that all employees are aware of what documentation needs to be maintained when a complaint is received. 6a. Finding: During interviews with CA ELAP staff, one staff member of CA ELAP did not show a knowledge of the ability to conduct a successful assessment. Citation(s): V2, M1, 6.1.1: The accreditation body shall have a sufficient number of competent personnel (internal, external, temporary, or permanent, full time or part time) having the education, training, technical knowledge, skills and experience necessary for handling the type, range and volume of work performed. Discussion/Rationale: Several questions were asked to staff members on how to prepare for an assessment and evaluate a laboratory at an assessment. There was significant concern by the team during one interview on the staff member s lack of knowledge in these areas. 6b. Finding: The CA ELAP does not have records to show that its personnel are reviewed for competency and that additional training needs are identified. Citation(s): V2, M1, 6.3.1: In particular, the accreditation body shall review the performance and competence of its personnel in order to identify training needs and V2, M1, 6.3.2: The accreditation body shall conduct monitoring (e.g., by on-site observations, or by using other techniques such as review of assessment reports, feedback from CABs and peer monitoring of assessors) to evaluate an assessor s performance and to recommend appropriate follow-up actions to improve performance. Recommended Corrective Action: The CA ELAP must evaluate their training and evaluation process to identify when additional training may be needed. 7. Finding: There is no record of signature or equivalent by the staff to commit themselves to comply with the rules as defined by the accreditation body. Citation(s): V2, M1, 6.1.4: The accreditation body shall require all personnel to commit themselves formally by a signature or equivalent to comply with the rules defined by the accreditation body. Recommended Corrective Action: CA ELAP should develop a procedure to obtain and document the staff commitment to comply with their AB rules as defined. 8. Finding: The records for CA ELAP staff that he is approved to assess both microbiology and chemistry, however records show he has only successfully passed training in Organic Chemistry. 8

9 Citation(s): V2, M1, 6.2.4(b): The accreditation body shall ensure that assessors and, where relevant, experts have undergone a relevant accreditation assessor training. Recommended Corrective Action: Accurate records of training must be kept for all CA ELAP staff. These records must show successful training for all relevant accreditation fields. 9. Finding: The CA ELAP shall observe each assessor on-site regularly, normally every three years, unless there is sufficient supporting evidence that the assessor is continuing to perform competently. Citation(s): V2, M1, 6.3.2: Each assessor shall be observed on-site regularly, normally every three years, unless there is sufficient supporting evidence that the assessor is continuing to perform competently. Discussion/Rationale: This standard is new to the 2009 TNI Standard. Recommended Corrective Action: A process needs to be established to observe each assessor on-site regularly, normally every three years, unless there is sufficient supporting evidence that the assessor is continuing to perform competently. 10. Finding: Review of records maintained by the CA ELAP showed that Test America Sacramento exceeded a 2 and ½ year interval between assessments. Citation(s): V2, M1, 7.7.3: Accreditation bodies shall rely on either reassessment alone or a combination of reassessment and surveillance, as follows: (a) if based on reassessment alone, then the reassessment shall take place at intervals not exceeding 2 years; or (b) if the combination of reassessment and surveillance is relied upon, then the accreditation body shall undertake a reassessment at least every 5 years. However, the interval between the surveillance on-site assessments should not exceed 2 years.it is, however, recommended that the first surveillance on-site assessment be carried out no later than 12 months from the date of initial accreditation. and V2, M3, 5.1: After an initial assessment for accreditation, accreditation bodies shall perform reassessments at intervals of two years plus or minus six months. Once a CAB (i.e., environmental laboratory) is accredited, accreditation bodies reserve the right to assess a CAB at any time during the accreditation period. Recommended Corrective Action: The CA ELAP needs to make sure that assessments do not exceed the 2 ½ year time between assessments. 11. Finding: Records reviewed during the onsite evaluation show that several reports were not sent to the CAB within thirty calendar days of the last day of the on-site assessment. 9

10 Citation(s): V2, M3, : The accreditation body or its authorized representative shall present to the CAB within thirty calendar days of the last day of the on-site assessment a final assessment report identifying all confirmed findings. Recommended Corrective Action: The CA ELAP needs to make sure that time frames for reports are met. 12. Finding: During the evaluation of the onsite assessment the team did not ensure that PT samples were tracked, prepared, and analyzed in the same manner as routine samples. Citation(s): V2, M2, 6.1: The Primary AB shall assess the laboratory to ensure that PT samples are tracked, prepared, and analyzed in the same manner as routine samples. Discussion/Rationale: During the laboratory shadow of the assessment process the assessment team did not verify that PT samples are being handled like routine samples. Recommended Corrective Action: The assessment team during the process of a laboratory assessment needs to verify that PT samples are being handled like routine samples. 13. Finding: Records of assessor qualification statements were not available during the program evaluation. Citation(s): V2, M3, 4.3.2: Assessors shall sign qualification statements attesting the assessors meet the education and training required by this Standard. Accreditation bodies shall provide those statements to CABs (i.e., environmental laboratories) upon request. Recommended Corrective Action: The CA ELAP shall maintain signed qualification statements attesting the assessors meet the education and training required by this Standard. Accreditation bodies shall provide those statements to CABs (i.e., environmental laboratories) upon request. Observations : Observations are written when there is insufficient evidence to clearly write a finding or failure to follow the standard. These will not carry forward into the final recommendation to the Board. 1. Observation: During the program evaluation concerns about the laboratory s financial resources and budget were expressed. Citation (to standard): V2, M1, 4.5.2: The accreditation body shall have the financial resources, demonstrated by records and/or documents, required for the operation of its activities. The accreditation body shall have a description of its source(s) of income. Discussion/Rationale (if desired): With current state budget concerns and fee increases to the program it was unclear if the CA ELAP was financially stable. Recommended Corrective Action: The accreditation body shall have a description of its source(s) of income and resources to maintain the accreditation program. 10

11 2. Observation: Significant concern was expressed over the programs management system and if it was being implemented successfully in accordance with the Standard. Citation (to standard): V2, M1, 5.1.1: The accreditation body shall establish, implement and maintain a management system and continually improve its effectiveness in accordance with the requirements of this International Standard. Requirements for the management system that take into account the particular nature of accreditation bodies are defined in 5.2 to 5.9. Discussion/Rationale (if desired): After the departure of George Kulasingam records show that the management systems was not being maintain and continually improved. There was little or no communication between the QAO and staff members about updates to program related documents or concerns. Recommended Corrective Action: Clear management responsibilities must be established. All CA ELAP procedures must be available to and used by CA ELAP staff. Summary: In order to continue the evaluation process, a written plan of corrective action for the above findings must be submitted to each member of the evaluation team within 30 days of your receipt of this report. Observations need not be addressed but may be used for quality improvement. If such corrective actions have not been completed at the time of your response, please include a schedule for their completion. All corrective actions must be satisfactorily completed within 30 calendar days of the receipt of this letter. Please refer to NELAP Standard Operating Procedure 3-102, for further details regarding the requirements and deadlines for renewal of recognition. Date of Report: 02/24/13 Signature of Lead Evaluator: Kristin Brown Utah Department of Health Environmental Laboratory Certification Program Kristinbrown@utah.gov 11

12 Attachment 1 12

13 Observation of On-site Laboratory Assessment: Assessment Performed by: Laboratory Name: California Environmental Laboratory Accreditation Program Kiff Analytical, LLC Dates of Observation: 5/1/12 Name of Observer: Kristin Brown, Jack Berges Assessors Observed: Jack Berges, Lead Assessor Karen Lee Wayne Tseng Laboratory areas assessed during this observation included: Wet Chemistry analyses, Volatile Organic Analyses by Gas Chromatography/Mass Spectrometry Mercury analysis by CVAA Ion Chromatography Quality Systems Comments: 1. The CA ELAP assessors utilized in-house method checklists that cover each of the test methods that the laboratory was accredited. The assessors also relied on copies of the regulated method and knowledge to perform the assessment. 2. The opening conference content conformed with the current requirements in TNI Volume 2, Module 3, Section The conduct of the on-site assessment was representative and a proper balance was achieved. 4. The closing conference content included an oral report of the findings and conformed to the requirements in TNI Volume 2, Module 3, Section (a) and (b) of the Environmental Laboratory Sector standards. 5. Finding 12 listed in the Program Evaluation refers to issues related to the laboratory observation. 13

14 Attachment 2 14

15 Name Technology Description Drinking Water Non-Potable Water Solids and Chemical Air Tissue AMP Amperometric Titration X X AS Alpha Spectrometry X X X ASC Alpha Scintillation Cell Counter ASV Anodic Stripping Voltammetry AUTO Auto Analyzer X X BETA Beta Spectrometery BGCS Beta/Gamma Coincidence Scintillation Counter COND Conductance X X COUL Coulometric Titration X X CVAAS Atomic Absorption-Cold Vapor Spectrometry X X X CVAFS Atomic Fluorescence - Cold Vapor Spectrometry X DCP-AES Atomic Emission - Direct Current Plasma Spectrometry DPP Differential Pulse Polarography X FAAS Atomic Absorption - Flame Spectrometry X X X FAES Atomic Emission - Flame Spectrometry FLUOR Ultraviolet or Visible Molecular Fluorescence Spectrometry X X GALV Galvanic Probe GC-ECD Gas Chromatography - Electron Capture Detection X X X GC-ECD/FID Gas Chromatography - Electron Capture/Flame Ionization Detectrion X GC-ELCD Gas Chromatography - Electrolytic Conductivity Detection X X GC-ELCD/PID Gas Chromatography - Electrolytic Conductivity/Photoionization Detection X X GC-FID Gas Chromatography - Flame Ionization Detection X X GC-FPD Gas Chromatography - Flame Photometric Detection X GC-FTIR Gas Chromatography - Fourier Transform Infrared Spectrometry X GC-HRMS Gas Chromatography - Mass Spectrometry - High Resolution X X X GC-MS Gas Chromatography-Mass Spectrometry X X X GC-NPD Gas Chromatography-Nitrogen/phosphorus Detection X X X GC-PID Gas Chromatography- Photoionization Detection X X X GFAAS Atomic Absorption-Graphite Furnace Spectrometry X X X GRAV Gravimetry X X GS-HR Gamma Spectrometry-High Resolution X X X GS-LR Gamma Spectrometry- Low Resolution X X X HGAAS Atomic Absorption - Hydride Generation Spectrometry X X X HPLC-ELEC High Performance Liquid Chromatography-Electrochemical X HPLC-FLUOR High Performance Liquid Chromatography-Ultraviolet/visible Molecular Fluorescence X X X HPLC-IR High Performance Liquid Chromatography-Infrared Molecular Absorption HPLC-PBMS High Performance Liquid Chromatography-Mass Spectrometry-Particle Beam HPLC-TSMS High Performance Liquid Chromatography - Mass Spectrometry-Thermospray X X X HPLC-UV High Performance Liquid Chromatography - Ultraviolet/visible Molecular Absorption X X X IC-COND Ion Chromatography Electroconductivity X X X IC-MS Ion Chromatography Mass Spectrometry IC-UV Ion Chromatography UV X X ICP-AES Atomic Emission - Inductively Coupled Plasma Spectrometry X X X ICP-MS Mass Spectrometry - Inductively Coupled Plasma X X X ISE Ion Selective Electrode X X IMM Immunoassay

16 IMS-FA Filtration-Immunomagnetic Separation - Immunoflourescence Assay IR Infrared Spectrometry X X X LSC Liquid Scintillation Counter X X X LP Lasar Phosphorimetry NAA Neutron Activation Analysis PC Proportional Counter X X X PCM Phase Contrast Microscopy PLM Polarized Light Microscopy X POL Polarographic Probe SEM Scaning Elecron Microscopy TEM Transmission electron microscopy X X TITR Titrimetry - Visual Indicator X X TOC-FID Total Organic Carbon - Flame Ionization Detector TOC-IR Total Organic Carbon - Nondispersive Infrared Detector TURB Turbidity X X TOX Total Organic Halide UV-VIS Ultraviolet or Visible Molecular Absorption Spectrometry X X XRF X-Ray Fluorescence Spectrometry XRT X-Ray Transmission Spectrometry Other Other CF-QL Chromofluorogenic-Qualitative X CF-QN Chromofluorogenic-Quantitative C-QN Chromogenic/MPN-Quantitative C-QT-QN Chromogenic/Quantitray FB-LE-QL Fermentation Broth-Qualitative X FB-PAE-QL Fermentation Broth(PA)-Qualitative X FB-PAF-QL Fermentation Broth(PA)+Fluorogenic-Qualitative FB-F-QN Fermentation Broth+Fluorogenic-Quantitative FB-QN Fermentation Broth-Quantitative X X FB-A1-QN Fermentation Broth(A-1)-Quantitative X X FFIFV Filtration/FA/IMS/FA/Viability F-HPC-QN Fluorogenic(HPC)-Quantitative X F-QN Fluorogenic/MPN-Quantitative X F-QT-QN Fluorogenic/Quantitray X MF-QL Membrane Filtration-Qualitative X MF-E-QL Membrane Filtration+Fermentation Broth-Qualitative X MF-QN Membrane Filtration-Quantitative X X MF-2S-QN Membrane Filtration(2-Step)-Quantitative MF-MEI-QN Membrane Filtration(Mei)-Quantitative X MF-F-QL Membrane Filtration+Fluorogenic-Qualitative MF-F-QN Membrane Filtration+Fluorogenic-Quantitative MF-MTEC-QN Membrane Filtration(m-TEC)-Quantitative PQ-2S-QN Plaque Counts(2-Step)-Quantitative PQ-SL-QN Plaque Counts(Single Layer)-Quantitative PP-QN Pour Plate-Quantitative X X SP-QN Spread Plate-Quantitative BioTox Toxicity Testing X X

17 MF-E-QN FB-F-QL TOC-UV GC-TEA Membrane Filtration+Fermentation Broth-Quantitative Fermentation Broth+Fluorogenic-Qualitative Total Organic Carbon - UV Spectrometer Gas Chomatography - Thermal Enery Analyzer (method 8070A CF-MUG Chromogenic/Fluorogenic with 4-methylumbelliferyl-B-D-glucuronide substrate X MF/Mtec Membrane Filtration and mtec agar X MF/MI Menbrane Filtration and MI medium X MF/NA+MUG Menbrane Filtration, nutient agar with 4-methylumbelliferyl-B-D-glucuronide substrate X MF/EC+MUG Menbrane Filtration, EC broth with 4-methylumbelliferyl-B-D-glucuronide substrate X SETA Seta Flash X PENSKY Pensky-Martin X GPC Alpha/Beta Gasflow Internal Porportional Counter X X X