Help Desk Review of Quality Assurance Project Plans

Transcription

1 Help Desk Review of Quality ssurance Project Plans May 2, 2011 pproved by Beverly H. van Buuren, Surface Water mbient Monitoring Program Quality ssurance Officer, on May 2, Purpose This document describes the process used by the Surface Water mbient Monitoring Program (SWMP) quality assurance (Q) Help Desk to review the Q project plans (QPPs) of projects seeking SWMP comparability. The review may include consultation with the Help Desk, and produces a completed checklist and narrative that may be used to make QPP updates prior to document approval. Reviews of SWMP-funded QPPs are more comprehensive, and are detailed in the SWMP process document Review of Program-funded Quality ssurance Project Plans. 2. Responsibilities Responsibility for SWMP Help Desk QPP reviews is shared by the Help Desk client, the SWMP Q Officer, and the SWMP Bioassessment Coordinator (if applicable). The Help Desk client is responsible for: Creating a QPP (the SWMP guidance document Creation and pproval of Quality ssurance Project Plans for SWMP-funded Projects may be used); Consulting with the Help Desk as necessary two hours maximum (unless specified otherwise by the SWMP Q Officer); ssigning and obtaining QPP approval; and Distributing the approved QPP according to the document s 3: Distribution List. The SWMP Help Desk is responsible for: Creating and maintaining tools for QPP development; Reviewing non-swmp-funded QPPs for programmatic comparability (at the discretion of the SWMP Q Officer); and Help Desk Review of Quality ssurance Project Plans May 2, 2011 Page 1 of 16

2 Cataloging Help Desk QPP reviews. The SWMP Quality ssurance (Q) Officer is responsible for: pproving additional Help Desk consultation beyond the default of two hours (as necessary). The SWMP Bioassessment Coordinator is responsible for: Providing consultation for bioassessment- and algae-related Help Desk QPPs (at the discretion of the SWMP Q Officer) 3. Procedure The Help Desk QPP review process is summarized in the diagram below. QPP submittal by project management to Help Desk Checklist/ narrative completion by Help Desk* QPP updates by project management (if needed) Follow-up by Help Desk (if needed) QPP approval by project designee(s) * May include SWMP Bioassessment Coordinator s technical review (if applicable), or other technical review if required by the SWMP Q Officer Consultation by the Help Desk may be utilized at any point in the above process. 3.1 Quality ssurance Project Plan Consultation During the QPP development and review process, projects seeking SWMP comparability may consult the SWMP Help Desk. These consultations may include: QPP review against the requirements of the Surface Water mbient Monitoring Program Quality ssurance Program Plan (QPrP); QPP review against the requirements of the SWMP SOP Collecting Benthic Macroinvertebtrate Samples and ssociated Physical and Chemical Data for mbient Bioassessments in California (for bioassessment- and algae-related projects only); and ssistance with QPP-writing tools. Help Desk Review of Quality ssurance Project Plans May 2, 2011 Page 2 of 16

3 There are also limitations associated with Help Desk QPP consultations: They are performed or denied at the discretion of the SWMP Q Officer. nless otherwise specified by the SWMP Q Officer, the consultation is generally limited to two hours. They are limited to the analytes and matrices appearing in QPrP ppendix : Measurement Quality Objectives and QPrP ppendix B: Sample Handling. They do not include QPP approval, which instead must be obtained at the project level. 3.2 Quality ssurance Project Plan Submittal QPP is submitted to the SWMP Help Desk by project management. The QPP must be finalized in every way short of approval. Draft or incomplete documents should not be submitted for review. t the time of submittal, the project is provided with a projected completion date for the QPP review. Typically, this is within 2-4 weeks of QPP receipt. However, the timeline varies depending on the size and complexity of the involved QPP and the current Help Desk workload. 3.3 Quality ssurance Project Plan Review The SWMP Help Desk reviews QPPs against Environmental Protection gency (EP) guidelines and the QPrP. The QPP review is documented using the SWMP QPP review checklist (see ppendix of this SOP). This checklist is based on EP s 24-element guidelines as described in EP Q/G-5: Guidance for Quality ssurance Project Plans, and EP Q/R-5: Requirements for Quality ssurance Project Plans. These elements include: Group : Project Management 1 Title and pproval Sheet Help Desk Review of Quality ssurance Project Plans May 2, 2011 Page 3 of 16

4 2 Table of Contents 3 Distribution List 4 Project/Task Organization 5 Problem Definition and Background 6 Project/Task Description 7 Quality Objectives and Criteria 8 Special Training/Certifications 9 Documentations and Records Group B: Data Generation and cquisition B1 Sampling Process Design (Experimental Design) B2 Sampling Methods B3 Sample Handling and Custody B4 nalytical Methods B5 Quality Control B6 Instrument/Equipment Testing, Inspection, and Maintenance B7 Instrument/Equipment Calibration and Frequency B8 Inspection/cceptance of Supplies and Consumables B9 Non-direct Measurements B10 Data Management Group C: ssessment and Oversight C1 ssessment and Response ctions C2 Reports to Management Group D: Data Validation and sability D1 Data Review, Verification, and Validation D2 Verification and Validation Methods D3 Reconciliation with ser Requirements Help Desk Review of Quality ssurance Project Plans May 2, 2011 Page 4 of 16

5 During review, checklist items relating to each element are assigned one of the following ratings: cceptable The item is completely addressed in the QPP or its attachments The item is present in the QPP or its attachments, but is somehow incomplete The item is not included in the QPP or its attachments pplicable The item is not applicable to the project For all checklist items rated cceptable or, QPP section and page number references are noted. For all items, a es section is available to the reviewer. The completed QPP review checklist is then used as the basis for the accompanying narrative. This narrative details and provides recommendations for checklist items that were rated or during review. Narrated items contain specific reference to the QPP element and checklist item that they describe. The narrative is intended for use during a QPP s update or revision. pon completion of the QPP review, the Help Desk forwards a completed QPP review checklist and supporting narrative to project management. 4. Documentation ll QPP reviews and consultations performed by the SWMP Help Desk are cataloged in a spreadsheet that is included in each QT annual report. 5. References Creation and pproval of Quality ssurance Project Plans for SWMP-funded Projects; Moss Landing Marine Laboratories, Moss Landing, C, Help Desk Review of Quality ssurance Project Plans May 2, 2011 Page 5 of 16

6 Environmental Protection gency Requirements for Quality ssurance Project Plans; EP Q/R-5;.S. Environmental Protection gency,.s. Government Printing Office: Washington, DC, Guidance for Preparing Standard Operating Procedures; EP Q/G-6;.S. Environmental Protection gency,.s. Government Printing Office: Washington, DC, Guidance for Quality ssurance Project Plans; EP Q/G-5;.S. Environmental Protection gency,.s. Government Printing Office: Washington, DC, Review of Program-funded Quality ssurance Project Plans; Moss Landing Marine Laboratories, Moss Landing, C, Surface Water mbient Monitoring Program Quality ssurance Program Plan; Moss Landing Marine Laboratories, Moss Landing, C, Help Desk Review of Quality ssurance Project Plans May 2, 2011 Page 6 of 16

7 ppendix : Quality ssurance Project Plan Review Checklist SWMP Name and Review spect cceptable N pplicable es PROJECT MNGEMENT 1 1 Title and pproval Sheet (s) Contains project title Indicates revision number, if applicable Indicates organization's name Dated signature of organization's project manager present Signature block for Organization s Project Manager Signature block for Organization s Q Officer Signature block for Contract Manager Signature block for Board Q Officer 2. 2 Table of Contents Lists Q Project Plan information sections Document control information indicated Provides lists of tables and figures, Provides contents of each ppendix Lists all attached SOPs (with names, not just numbers) 3. 3 Distribution List Includes all individuals who are to receive a copy of the Q Project Plan and identifies their organization. Help Desk Review of Quality ssurance Project Plans May 2, 2011 Page 7 of 16

8 SWMP Name and Review spect cceptable N pplicable es 4. 4 Project/Task Organization Identifies key individuals involved in all major aspects of the project, including contractors Discuss their responsibilities Project Q Manager position indicates independence from unit generating data Identifies individual responsible for maintaining the official, approved Q Project Plan Organizational chart shows lines of authority and reporting responsibilities Clearly identifies who is part of the Project Team and who is related to the Project in an advisory role (but is not responsible for delivery of any product) 5. 5 Problem Definition/Background States decision(s) to be made, actions to be taken, or outcomes expected from the information to be obtained Clearly explains the reason (site background or historical context) for initiating this project Identifies regulatory information, applicable criteria, action limits, etc. necessary to the project 6. 6 Project/Task Description Summarizes work to be performed, for example, measurements to be made, data files to be obtained, etc., that support the project's goals Provides work schedule indicating critical project points, e.g., start and completion dates for activities such as sampling, analysis, data or file reviews, and assessments Details geographical locations to be studied, including maps where possible Discuss resource and time constraints, if applicable Help Desk Review of Quality ssurance Project Plans May 2, 2011 Page 8 of 16

9 SWMP Name and Review spect cceptable N pplicable es 7. 7 Quality Objectives and Criteria Provides parameter lists with data quality objectives for all field measurements and lab analyses, including laboratory target detection limits, which are as good as the SWMP DQOs or better. Identifies project action limits for all parameters of interest Identifies acceptance criteria for all previously collected information Discuss precision ddresses bias Discuss representativeness and how it will be assessed and controlled Identifies the need for completeness 8. 8 Special Training/Certifications Identifies any project personnel specialized training or certifications States that the Contractor s Q Officer is responsible for overseeing training Discusses how this training will be provided Indicates personnel responsible for assuring these are satisfied Identifies where this information is documented 9. 9 Documentation and Records Identifies report format and summarizes all data report package information Lists all other project documents, record, and electronic files that will be produced Identifies where project information should be kept and for how long Discusses back up plans for records stored electronically Help Desk Review of Quality ssurance Project Plans May 2, 2011 Page 9 of 16

10 SWMP Name and Review spect cceptable N pplicable es States how individuals identified in 3 will receive the most current copy of the approved Q Project Plan, identifying the individuals responsible for this B 10 DT GENERTION ND CQISITION B B B B B B B B B B Sampling Process Design (Sampling Design and Logistics) Provides the design information, or a reference to a specific document that contains it, at the required level of detail to enable the reader to tell whether the data will achieve the objective. Describes and justifies design strategy, indicating size of the area, or time period to be represented by a sample Details the type and total number of sample types/matrix or test runs/trials expected and needed Indicates where samples should be taken, how sites will be identified located Discusses what to do if sampling sites become inaccessible [logistics] Identifies project activity schedules such as each sampling event, times samples should be sent to the laboratory, etc. [logistics] Specifies what information is critical and what is for informational purposes only Identifies sources of natural variability and how this variability should be reconciled with project information Identifies potential sources of bias or misrepresentation and how their contribution can be minimized B Sampling (sample collection) Methods B B Identifies all sampling SOPs by number, date, and regulatory citation, indicating sampling options or modifications to be taken. SOPs for sample collection should be attached, unless they are the original SWMP SOPs. Indicates how each kind of matrix and each sample type should be collected Help Desk Review of Quality ssurance Project Plans May 2, 2011 Page 10 of 16

11 SWMP Name and Review spect cceptable N pplicable es B B B B Indicates how samples are to be homogenized, composited, split, or filtered, if needed Indicates what sample containers and sample volumes should be used Identifies whether samples should be preserved and indicates methods that should be followed Indicates whether sampling equipment and samplers should be cleaned and/or decontaminated, identifying how this should be done and by-products disposed of B Identifies any equipment and support facilities needed B ddresses actions to be taken when problems occur, identifying individual(s) responsible for corrective action and how this should be documented B Sample Handling and Custody B B B B States maximum holding times allowed from sample collection to extraction and/or analysis for each sample type Identifies how samples or information should be physically handled, transported, and then received and held in the laboratory or office (including temperature upon receipt) Indicates how sample or information handling and custody information should be documented, such as in field notebooks and forms, identifying individual responsible Identifies chain-of-custody procedures and includes form to track custody B nalytical Methods and Field Measurements B B Identifies all SOPs (field and/or office) that should be followed by number, date, and regulatory citation, indicating options or modifications; SOPs should be attached unless they are the original SWMP SOPs. Lists all the Instruments and Kits that will be used in the field and describes the measurement principle (e.g., nephelometric or transparency) and the major attributes (e.g., automatic temperature compensation, Help Desk Review of Quality ssurance Project Plans May 2, 2011 Page 11 of 16

12 SWMP Name and Review spect cceptable N pplicable es range and resolution, etc.) B B B B If in situ monitoring, indicates how instruments should be deployed and operated to avoid fouling and ensure maintenance of proper data If continuous monitoring, indicates how instruments should store and maintain raw data Identifies all laboratory SOPs that should be followed by number, date, and regulatory citation, indicating options or modifications to be taken, such as subsampling and extraction procedures Identifies equipment or instrumentation needed for laboratory analyses B Specifies any specific method performance criteria B Identifies procedures to follow when failures occur, identifying individual responsible for corrective action and appropriate documentation B Identifies sample disposal procedures B Specifies laboratory turnaround times needed B B Provides method validation and information and SOPs for nonstandard methods and PBMS Indicates where PBMS method development records are stored and how they can be accessed B Quality Control B B B For each type of sampling, analysis, or measurement technique, identifies QC activities which should be used, for example, blanks, spikes, duplicates, etc. Details what should be done when control limits are exceeded, and how effectiveness of control actions will be determined and documented Identifies procedures and formulas for calculating Data Quality Indicators or applicable QC statistics, for Help Desk Review of Quality ssurance Project Plans May 2, 2011 Page 12 of 16

13 SWMP Name and Review spect cceptable N pplicable es example, for precision, bias, outliers and missing data B B B Instrument/Equipment Testing, Inspection, and Maintenance Identifies field and laboratory equipment needing periodic maintenance, and the schedule for this Identifies testing criteria [This information is instrument-specific and may be already included in the SOP for each Instrument] B es availability and location of spare parts B B B Indicates procedures in place for inspecting equipment before usage [This information is instrument-specific and may be already included in the SOP for each Instrument] Identifies individual(s) responsible for testing, inspection and maintenance Indicates how deficiencies found should be resolved, re-inspections performed, and effectiveness of corrective action determined and documented B Instrument/Equipment Calibration and Frequency B B B B B Identifies equipment, tools, and instruments (used in the field or in the lab) that should be calibrated, and the frequency for this calibration describes how calibrations should be performed and documented, indicating test criteria and standards or certified equipment [This information is instrumentspecific and may be already included in the SOP for each Instrument] Identifies how deficiencies should be resolved and documented Inspection/cceptance for supplies and Consumables Identifies critical supplies and consumables for field and laboratory, noting supply source, acceptance criteria, and procedures for tracking, storing and retrieving these materials Help Desk Review of Quality ssurance Project Plans May 2, 2011 Page 13 of 16

14 SWMP Name and Review spect cceptable N pplicable es B Identifies the individual(s) responsible for this B09 18 Non-direct Measurements B B B Identifies data sources, for example, computer databases or literature files, or models that should be accessed and used Describes the intended use of this information and the rationale for their selection, i.e., its relevance to project Indicates the acceptance criteria for these data sources and/or models [re-iterated or referred to 7) B Identifies key resources/support facilities needed B Describes how limits to validity and operating conditions should be determined, for example, internal checks of the program and Beta testing B Data Management B B B B B10.05 B Describes data management scheme from field to final use and storage, for field measurements, continuous monitoring files, and lab analyses Verifies that all continuous monitoring raw data will be kept in the original Sonde file (and stored on a PC); endpoints (e.g. verages) can be calculated in the office after downloading and trimming records logged out of the water. Discusses standard record-keeping and tracking practices, and the document control system or cites other written documentation such as SOPs Identifies data handling equipment/procedures that should be used to process, compile, analyze, and transmit data reliably and accurately Describes how field measurement, continuous monitoring, and laboratory analyses data will be formatted and entered - or prepared for upload - into the SWMP database Identifies individual(s) responsible for each step and task Help Desk Review of Quality ssurance Project Plans May 2, 2011 Page 14 of 16

15 SWMP Name and Review spect cceptable N pplicable es B B Describes procedures to demonstrate acceptability of hardware and software configurations (??) ttaches checklists and forms that should be used [or refers the reader to other QPP elements where the forms are shown, or refers to SOPs] C 20 SSESSMENT ND OVERSIGHT C1. 20 ssessments and Response ctions C C C C Lists the number, frequency, and type of assessment activities that should be conducted, with the approximate dates Identifies individual(s) responsible for conducting assessments, indicating their authority to issue stop work orders, and any other possible participants in the assessment process Describes how and to whom assessment information should be reported Identifies how corrective actions should be addressed and by whom, and how they should be verified and documented C2. 21 Reports to Management C C Identifies what project Q status reports are needed and how frequently Identifies who should write these reports and who should receive this information D 22 DT VLIDTION ND SBILITY D1. 22 Data Review, Verification, and Validation D Describes SWMP criteria that should be used for accepting, rejecting, or qualifying project data; reiterates or refers to element 7 D2 23 Verification and Validation Methods D Describes process for data verification and validation, providing SOPs and indicating what data validation software should be used, if any Help Desk Review of Quality ssurance Project Plans May 2, 2011 Page 15 of 16

16 SWMP Name and Review spect cceptable N pplicable es D D D Identifies who is responsible for verifying and validating different components of the project data/information, for example, chain-of-custody forms, receipt logs, calibration information, etc. Identifies issue resolution process, and method and individual responsible for conveying these results to data users ttaches checklists, forms, and calculations including electronic formulae if using spreadsheets D3. 24 Reconciliation with ser Requirements D D D Describes procedures to evaluate the uncertainty of the validated data [or refer them to previous elements] Describes how limitations on data use should be reported to the data users Identifies how the data will be used in the context of the SWMP umbrella and the SWMP database Help Desk Review of Quality ssurance Project Plans May 2, 2011 Page 16 of 16