An End User s Perspective. Aleta Kennard & Janice Lam Snyder PQAO Training, Sacramento/Diamond Bar May 28-29, 2014 June 11-12, 2014

Transcription

1 An End User s Perspective Aleta Kennard & Janice Lam Snyder PQAO Training, Sacramento/Diamond Bar May 28-29, 2014 June 11-12, 2014

2 Key Questions: Why is it so important? What if I don t document? What do we mean by document? What are the requirements of documentation? How can I fulfill the requirements? Resources

3 The Process Regulatory Requirement DQOs Data Collection & Quality Control Quality Assurance Data Analysis & Studies Decisions/ Regulatory Action Improve Public Health

4 Data Assessment The data assessment process includes both internal and external quality control assessments of accuracy, precision, data completeness, and criteria that are specified in associated QMP, QAPPs, SOPs, and R&R Documents. Internal Assessments independent multi-level data review conducted by the monitoring organization External Assessments activities such as data, lab, performance, and technical system audits conducted by ARB, EPA or other PQAO. The data assessment process will be covered in more detail in Session 2 of the PQAO Training (Fall 2014)

5 Data Assessment ARB is committed to effective review, verification, validation, reporting, certification and assessment of all data generated by, on behalf of (such as contractors), or utilized within its PQAO (including secondary data) ARB and air monitoring organizations within its PQAO define and formalize these activities in a Roles and Responsibilities (R&R) Document -Patrick Rainey, Manager, Quality Management Section

6 Why is it so Important? Documentation is proof or evidence That all required procedures were carried out and carried out at the correct time What occurred during that time To ensure equipment is working properly Helps reconstruct the study (Legal Defensibility) Data is used for Regulatory Purposes Certify data is correct and accurate Creates confidence in the data

7 Who are the End-Users? Auditors Quality Assurance Personnel Site Operators Data Decision Makers Public Analyst Scientists

8 What happens if I don t document? If it wasn t documented, then it didn t happen Data may be lost Compromises integrity and accuracy (counts when it really shouldn t) A lot of wasted time for the end user Incomplete documentation may lead to invalidating an entire study Unable to replicate (document so they know what you did) Regulatory Action Difficulty in justifying that procedures were followed correctly and completed when it was supposed to

9 WHAT IS DOCUMENTATION? A description of what activities occurred at what time Who? What? Where? How? Activities that might influence data Procedures (Manuals, SOPs, & Safety Information) Results of measurements, QC checks, observations, troubleshooting, and activities associated with the activity and instrument Certifications (Calibrators and Gasses) Examples: Laboratory Notebook, Logbook, Forms, paper printouts, electronic records, databases, and photos

10 Benefits of Documentation Does not rely on memory Improves communication between operators and endusers Consistency Helps identify issues early or prevents bigger issues Proactive vs. Reactive Piece of the Puzzle Aids in Exceptional Event Requests, and Planning Helps Auditors Helps with Future Troubleshooting (instrument logs)

11 Regulatory Requirements 40 CFR 58 Appendix A: Quality Assurance requirements Quality Systems Requirements Measurement Quality Check Requirements Table A-2 of Appendix A to Part 58-Minimum Data Assessment Requirements for SLAMS Sites EPA QA Handbook Vol II, Appendix D Will be discussed in the key documents group

12 Requirements of Documentation Sign and Date Legible Promptness Identifiable Accuracy

13 Fullfill Requirements by: Make a single line through the error Record the correct entry above or next to the original entry with the reason for correction Sign/Initial and Date Error in writing JLS Mistake March-14

14 Type of Documentation Automated Auto Calibrations Data loggers Instrument Diagnostics Manual Check sheets Logbooks Chain of Custody Forms Calibrations Troubleshooting Corrective Action Notification (CANS)

15 On Site Documentation Station Logbook-required Instrument Log Books w/ monthly/bi-weekly checks Residence times posted Certifications SOPs Manuals Safety Information

16 Document Troubleshooting Document What happened, or what you suspected happened When? For how long? How did you find out? What you did to resolve the problem? Did you change out parts? Talk to the manufacturer? Saves time in the long run Resource for you and others Helps in budgets maybe its time to buy a new one!

17 Paper vs. Electronic Logs Paper Logs Uses a paper notebook Conventional ( Tried and True ) Requires storage space More convenient for quick notes End user access after the month Electronic Logs Uses a Computer Quick Remote Access Requires extra security measures/backup version control (Files could be corrupted) Need to fall back on paper logs (if no access to electronic logs) Share information with end-users faster & searchable database More Green Analysis on information

18 Summary-Recap Documentation is important because Its required Saves time Creates confidence Resource Improves communication Good documentation contains the following elements: Legible, Prompt, Sign/initial and date, Identifiable, and Accurate

19 Resources CARB PQAO Repository EPA Quality Assurance Handbook for Air Pollution Measurement Systems, Volume II CARB s Quality Assurance website: Documents and Records, Section 5.