1 / 62

Quality Assurance Project Plan

Quality Assurance Project Plan. Topic 3. Topic 3 Objectives. DESCRIBE the documentation of the systematic planning process DESCRIBE the elements of the QAPP PRESENT the use of the QAPP worksheets EXPLAIN the review of the QAPP. Topic 3 - QAPP Elements. Project Management and Objectives

jenna
Download Presentation

Quality Assurance Project Plan

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Quality Assurance Project Plan Topic 3

  2. Topic 3 Objectives • DESCRIBE the documentation of the systematic planning process • DESCRIBE the elements of the QAPP • PRESENT the use of the QAPP worksheets • EXPLAIN the review of the QAPP SPP QAPP 05/11/06

  3. Topic 3 - QAPP Elements • Project Management and Objectives • Measurement/Data Acquisition • Assessment and Oversight • Data Review SPP QAPP 05/11/06

  4. Worksheet #1 Examples of completed worksheets are found in Example QAPP • Title and Approval Page • Site location • Document title • Lead organization • Preparer’s name and organizational affiliation • Preparer’s address, telephone number, and e-mail address • Preparation date (day/month/year) SPP QAPP 05/11/06

  5. Worksheet #1 • Title and Approval Page • Investigative organization’s project manager’s signature and printed name/organization/date • Investigative organization’s project QA officer’s signature and printed name/organization/date • Lead organization’s project manager’s signature and printed name/organization/date • Appropriate approval signatures and printed names/titles/dates SPP QAPP 05/11/06

  6. Worksheet #2 • Nine items • Lists pertinent information • Identifies references • Identifies UFP QAPP requirements that are not applicable to the project • QAPP Element Table • Reference to worksheets • Reference to other documents SPP QAPP 05/11/06

  7. QAPP Recipients Title Organization Telephone Number Fax Number E-mail Address Document Control Number Worksheet #3 Distribution List SPP QAPP 05/11/06

  8. Project Personnel Title Telephone Number Signature Date QAPP Read Worksheet #4 Project Personnel Sign-off Sheet SPP QAPP 05/11/06

  9. Worksheet #5 Organization Chart SPP QAPP 05/11/06

  10. Communication Drivers Responsible Entity Name Phone Number Procedure (Timing, Pathways, etc.) Worksheet #6 Communication Pathways SPP QAPP 05/11/06

  11. Name Title Organizational Affiliation Responsibilities Education and Experience Qualifications Worksheet #7 Personnel Responsibilities and Qualifications SPP QAPP 05/11/06

  12. Project Function Specialized Training – Title or Description of Course Training Provider Training Date Personnel/Groups Receiving Training Personnel Titles/ Organizational Affiliation Location of Training Records/ Certificates Worksheet #8 Special Personnel Training Requirements SPP QAPP 05/11/06

  13. Project Name: Projected Date(s) of Sampling: Project Manager: Site Name: Site Location: Date of Session: Scoping Session Purpose: Name Title Affiliation Phone E-mail Address Project Role Worksheet #9 Project Scoping Session Participants SPP QAPP 05/11/06

  14. Worksheet #10 Problem Definition • The problem to be addressed by the project • The environmental questions being asked • Observations from any site reconnaissance reports • A synopsis of secondary data or information from site reports • Possible classes of contaminants and affected matrices • Rationale for including chemical & nonchemical analyses • Information concerning various environmental indicators • Project decision conditions (If..., then... statements) SPP QAPP 05/11/06

  15. Worksheet #11 Project Quality Objectives/SPP Statements • Who will use the data? • What will the data be used for? • What type of data are needed? (target analytes, analytical groups, qualitative/semi-quantitative, quantitative using on-site analytical or off-site laboratory techniques, sampling techniques) • How good do the data need to be in order to support each decision along the way to achieve the desired project outcome? SPP QAPP 05/11/06

  16. Worksheet #11 (Continued) Project Quality Objectives/SPP Statements • How much data are needed? (number of samples for each analytical group, matrix, and concentration) • Where, when, and how should the data be collected/generated (or how to target the correct matrix population/sample support)? • Who will collect and generate the data? • How will the data be reported? • How will the data be archived? SPP QAPP 05/11/06

  17. Worksheet #12 1If information varies within an analytical group, separate by individual analyte 2Reference number from QAPP Worksheet #21 (see Section 3.1.2) 3Reference number from QAPP Worksheet #23 (see Section 3.2) Measurement Performance Criteria SPP QAPP 05/11/06

  18. Worksheet #13 Secondary Data Criteria and Limitations See Figure 18, page 55 of 149, UFP-QAPP Manual SPP QAPP 05/11/06

  19. Worksheet #14 • Summary of Project Tasks •  Sampling tasks •  Analysis tasks • Quality control tasks • Secondary data •  Data management tasks •  Documentation and records •  Assessment/audit tasks •  Data review tasks SPP QAPP 05/11/06

  20. Worksheet #15 Reference Limits and Evaluation SPP QAPP 05/11/06

  21. Worksheet #16 Project Schedule/Timeline SPP QAPP 05/11/06

  22. Worksheet #17 • Describe the project sampling approach • Rationale for selecting the approach • Rationale for selecting the number of samples and matrices • Describe or refer to Worksheet #18 for analytical groups, concentration levels, number of samples and rationale for each • Describe sampling frequency if applicable SPP QAPP 05/11/06

  23. Sample Location/ ID Number Matrix Depth (units) Analytical Group Concentration Level Number of Samples (identify field duplicates) Sampling SOP Reference Rationale for Sampling Location Worksheet #18 Sampling Locations and Methods/SOP Requirements SPP QAPP 05/11/06

  24. Matrix Analytical Group Concentration Level Analytical and Preparation Method/ SOP Reference Sample Volume Containers (number, size, and type) Preservation Requirements (chemical, temperature, light protected) Maximum Holding Time (preparation/ analysis) Worksheet #19 Analytical SOP Requirements SPP QAPP 05/11/06

  25. Matrix Analytical Group Concentration Level Analytical and Preparation SOP Reference No. of Sampling Locations2 No. of Field Duplicate Pairs Inorganic No. of Field Blanks No. of Equip. Blanks No. of PT Samples Total No. of Samples to Lab No. of MS Worksheet #20 1 Specify the appropriate reference letter or number from the Analytical SOP References table (Worksheet #23). 2 If samples will be collected at different depths at the same location, count each discrete sampling depth as a separate sampling location or station. Field Quality Control Sample Summary SPP QAPP 05/11/06

  26. Worksheet #21 Project Sampling SOP References SPP QAPP 05/11/06

  27. Field Equipment Calibration Activity Maintenance Activity Testing Activity Inspection Activity Frequency Acceptance Criteria Corrective Action Responsible Person SOP Reference1 Worksheet #22 1 Specify the appropriate reference letter or number from the Project Sampling SOP References table (Worksheet #21). Field Equipment Calibration, Maintenance, Testing and Inspection SPP QAPP 05/11/06

  28. Reference Number Title, Revision Date, and/or Number Definitive or Screening Data Analytical Group Instrument Organization Performing Analysis Modified for Project Work? (Y/N) Worksheet #23 Analytical SOP References SPP QAPP 05/11/06

  29. Instrument Calibration Procedure Frequency of Calibration Acceptance Criteria Corrective Action (CA) Person Responsible for CA SOP Reference1 Worksheet #24 1 Specify the appropriate reference letter or number from the Analytical SOP References table (Worksheet #23). Analytical Instrument Calibration SPP QAPP 05/11/06

  30. Instrument/Equipment Maintenance Activity Testing Activity Inspection Activity Frequency Acceptance Criteria Corrective Action Responsible Person SOP Reference1 Worksheet #25 1 Specify the appropriate reference letter or number from the Analytical SOP References table (Worksheet #23). Analytical Instrument and Equipment Maintenance, Testing and Inspection SPP QAPP 05/11/06

  31. Worksheet #26 Sample Handling System UFP-QAPP Appendix A SPP QAPP 05/11/06

  32. Worksheet #27 Field Sample Custody Procedures Laboratory Sample Custody Procedures Sample Identification Procedures Chain-of-custody Procedures Sample Custody Requirements SPP QAPP 05/11/06

  33. QC Sample: Frequency/ Number Method/SOP QC Acceptance Limits Corrective Action Person(s) Responsible for Corrective Action Data Quality Indicator (DQI) Measurement Performance Criteria Worksheet #28 Matrix Analytical Group Concentration Level Sampling SOP Analytical SOP Samplers Name Field Sampling Organization Analytical Organization No of Sample Locations QC Samples SPP QAPP 05/11/06

  34. Sample Collection Documents and Records On-site Analysis Documents and Records Off-site Analysis Documents and Records Data Assessment Documents and Records Other Worksheet #29 Project Documents and Records SPP QAPP 05/11/06

  35. Matrix Analytical Group Concentration Level Analytical SOP Data Package Turnaround Time Laboratory/Organization (Name and Address, Contact Person and Telephone Number) Backup Laboratory/Organization (Name and Address, Contact Person and Telephone Number) Worksheet #30 Sample Location/ID Numbers Analytical Services SPP QAPP 05/11/06

  36. QUIZ! • How do you plan for project assessments and oversight activities? SPP QAPP 05/11/06

  37. QUIZ! • How do you plan for project assessments and oversight activities? • Define types needed to ensure project is performed as planned or deviations documented • Define frequency to ensure dollars are budgeted • Define procedure to ensure resources are available • RPM specifies type, frequency, process to provide confidence in the data collection, generation and review SPP QAPP 05/11/06

  38. Assessment Type Frequency Internal or External Organization Performing Assessment Person(s) Responsible for Performing Assessment, (Title and Organizational Affiliation) Person(s) Responsible for Responding to Assessment Findings (Title and Organizational Affiliation) Person(s) Responsible for Identifying and Implementing Corrective Actions (CA) (Title and Organizational Affiliation) Person(s) Responsible for Monitoring Effectiveness of CA (Title and Organizational Affiliation) Worksheet #31 Planned Project Assessments SPP QAPP 05/11/06

  39. Assessment Type Nature of Deficiencies Documentation Individual(s) Notified of Findings (Name, Title, Org.) Contact Information Time frame of Notification Nature of Corrective Action Response Documentation Individual(s) Receiving Corrective Action Response(Name, Title, Org.) Contact Information Time frame for Response Worksheet #32 Note: Comments and Narrative may be added to the worksheet to document the rationale, detail process or provide clarification to the worksheet information. Assessment Findings and Corrective Action Responses SPP QAPP 05/11/06

  40. Type of Report Frequency (daily, weekly monthly, quarterly, annually, etc.) Projected Delivery Date(s) Person(s) Responsible for Report Preparation, Title and Organizational Affiliation Report Recipients, Title and Organizational Affiliation Worksheet #33 QA Management Reports SPP QAPP 05/11/06

  41. Data Review Process • Step I Data Verification • Review for completeness and define data qualifiers • Step II Data Validation • IIa Review for compliance to method • IIb Review for compliance to QAPP • Step III Data Usability Assessment • Assess results from above to determine usability of data for making decision SPP QAPP 05/11/06

  42. Verification Input Description Internal/ External Responsible for Verification (Name, Organization) Worksheet #34 Verification Process (Step I) SPP QAPP 05/11/06

  43. Step IIa/IIb Validation Input Description Responsible for Validation (Name, Organization) Worksheet #35 Validation Process (Steps IIa and IIb) SPP QAPP 05/11/06

  44. Step IIa/IIb Matrix Analytical Group Concentration Level Validation Criteria Validator (title and organizational affiliation) Worksheet #36 Validation Summary (Steps IIa and IIb) SPP QAPP 05/11/06

  45. Worksheet #37 • Summarize the usability assessment process • Describe evaluative procedures to assess measurement error • Identify responsible personnel • Describe the documentation of the usability process SPP QAPP 05/11/06

  46. QUIZ! • How do I use the worksheets? SPP QAPP 05/11/06

  47. QUIZ! • How do I use the worksheets? • Completed during meetings - as part of the planning - not at the end • Do not complete them in number order • Modify worksheets to meet project needs • Provide applicable worksheets to personnel performing work SPP QAPP 05/11/06

  48. Final Project Reports • Narrative and timeline of project activities • Summary of PQO development • Reconciliation of project data with PQOs • Summary of major problems encountered and their resolution • Data summary, including tables, charts, and graphs with appropriate sample identification or station location numbers, concentration units, percent solids (if applicable), and data quality flags • QA Section - Management Report • Conclusions and recommendations SPP QAPP 05/11/06

  49. Exit Strategy • Define project completion • Agreement by all parties - upfront • List contingencies We can’t let costs continue to escalate! When is this project done? SPP QAPP 05/11/06

  50. Elements of QAPP Review Where do I get help? • Define frequency for review • Document the review • Site closure requires exit strategy in QAPP • Documentation of comments • Initial review or on-going review SPP QAPP 05/11/06

More Related