Quality Control/ Quality Assurance Annabelle Allison ITEP/TAMS Center.

Slides:



Advertisements
Similar presentations
Why Lab. Certification? Laboratory certification tries to insure that the laboratory is qualified and capable of analyzing the sample and obtaining quality.
Advertisements

LABORATORY CERTIFICATION & DATA QUALITY MICHAEL W. MILLER, Ph.D. NJ-DEP Office of Quality Assurance
PRINCIPLES OF A CALIBRATION MANAGEMENT SYSTEM
Checking & Corrective Action
Overview of the Board’s Quality Management Plan. Topics in this Session  Quality System Overview  Overview of the contents of the Board’s Quality Management.
ORDER ENVIRONMENTAL PROTECTION PROGRAM WORKSHOP The Uniform Federal Policy for Implementing Environmental Quality Systems (UFP-QS) Emile I. Boulos.
Sampling: Your data is only as good as your field technicians.
Climate Change Committee WG1 QA/QC terminology and requirements from the IPCC Good Practice Guidance and the Guidelines for National Inventory Systems.
ORGANIZATION. 2 Purchasing & Inventory Assessment Occurrence Management Information Management Process Improvement Customer Service Facilities & Safety.
Module 61 Module 6: Uncertainty Don’t just calculate—first think about sources of error, and don’t double-count errors.
Data Collection Six Sigma Foundations Continuous Improvement Training Six Sigma Foundations Continuous Improvement Training Six Sigma Simplicity.
Laboratory Personnel Dr/Ehsan Moahmen Rizk.
Dr Samah Kotb Lecturer of Biochemistry 1 CLS 432 Dr. Samah Kotb Nasr El-deen Biochemistry Clinical practice CLS 432 Dr. Samah Kotb Nasr.
1 presented by: Tim Haithcoat University of Missouri Columbia QA/QC and Risk Management.
Statistical Process Control
Chapter 11 Quality Control.
Quality Management Systems
Short Course on Introduction to Meteorological Instrumentation and Observations Techniques QA and QC Procedures Short Course on Introduction to Meteorological.
Quality Assurance/Quality Control Policy
This teaching material has been made freely available by the KEMRI-Wellcome Trust (Kilifi, Kenya). You can freely download,
FPSC Safety, LLC ISO AUDIT.
Quality Control Rutendo Kuwana Technical Officer, WHO, Geneva Training workshop: Training workshop on regulatory requirements for registration of Artemisinin.
Quality Assurance Plans (QAP)
Instructions and forms
QA/QC FOR ENVIRONMENTAL MEASUREMENT
1 Standard Operating Procedures Their Development and Use with Quality Assurance Project Plans.
1 Guest Speaker: Bill Frietsche US EPA.  April 7: QA Systems, EPA definitions, PQAOs and common sense – Mike Papp  April 14: Routine Quality Control.
Guest Speaker: Jeremy Howe Little River Band Of Ottawa Indians The Measuring Sticks of Air Monitoring.
Field Analysis Quality Control
Debra Waller NJDEP-Office of Quality Assurance
What to compare against the validation templates (see templates in course webpage: Resources/Validation%20Templates%20from%20Red.
CHAPTER 5 Infrastructure Components PART I. 2 ESGD5125 SEM II 2009/2010 Dr. Samy Abu Naser 2 Learning Objectives: To discuss: The need for SQA procedures.
WWLC Standard Operating Procedures Presented by Frank Hall, Laboratory Certification Coordinator.
EPA Precursor Gas Training Workshop Precursor Gas Quality Assurance Implementation Dennis K. Mikel EPA Office of Air Quality Planning and Standards.
RAISING THE BAR Meeting CSA Guidelines And Preparing for Health Canada
Quality Assurance/ Quality Control
Unit 8 Syllabus Quality Management : Quality concepts, Software quality assurance, Software Reviews, Formal technical reviews, Statistical Software quality.
AMP255 – Precision and Bias Data Report 2008 AQS Conference The AMP255 Precision and Bias Data Report August 22, 2008 Presented by Jonathan Miller EPA.
Melinda Ronca-Battista, ITEP, TAMS Center Tribal Air Monitoring and QA Requirements for NAAQS- Comparable Data.
1 Guest Speaker: Brandy Toft Leech Lake Ojibwe.  Overview of FRM/FEM/ARM status, requirements, and reporting  QC (routine checks, audits, and method-
QA/QC and QUALIFIERS LOU ANN FISHER CITY OF STILLWATER, OK
 April 7: QA Systems, EPA definitions, PQAOs and common sense – Mike Papp  April 14: Routine Quality Control and Data Management (1-pt QC, flow rate,
Quality Control – Part II Tim Hanley EPA Office of Air Quality Planning and Standards.
Emission Inventory Quality Assurance/Quality Control (QA/QC) Melinda Ronca-Battista ITEP/TAMS Center.
EPA Region 9 Meredith Kurpius August 19, Status of Tribal Air Monitoring Value of tribal monitoring Used to protect public health on tribal land.
Laboratory QA/QC An Overview.
Appendix A: Calculations for Data Quality Assessment QC check statistics Precision calcs Bias calcs PM stats Reporting: quarterly and annual.
QUALITY MANAGEMENT PLAN OVERVIEW. Course Goals At the conclusion of this training, you will be able to: –Explain the basic considerations for Quality.
Geoffrey L. Beausoleil Assistant Manager, Office of Operational Support DOE Idaho Operations Office September 12, 2006 Presentation to DOE ISM Champions.
EPA Region  What are QAPPs?  Why are Quality Assurance Project Plans needed?  When are they needed?  How are they done?  Then…what do you do.
Principles of Internal Quality and External Quality Assurance Dr Kapil Yadav, Prof MG Karmarkar, International Council for Control of Iodine Deficiency.
1 Developed by U.S. Environmental Protection Agency (U.S. EPA) January 2014 Setting up a Sustainable National GHG Inventory Management System.
Biochemistry Clinical practice CLS 432 Dr. Samah Kotb Lecturer of Biochemistry 2015 Introduction to Quality Control.
Quality control & Statistics. Definition: it is the science of gathering, analyzing, interpreting and representing data. Example: introduction a new test.
Overview of EPA Quality System Requirements. Course Goals At the completion of this course, you will: Understand EPA's quality system requirements Understand.
Measurement Quality Objectives = Data Validation Requirements Excerpted from EPA QA Handbook Volume II (aka “Redbook”)
The system PROBLEM 1 FEIO Poor loading Insufficient number of facilities Small number of parameters Unaccountable methodology for taxes calculation Poor.
WHAT IS THE CHEROKEE NATION? Cherokee Nation Air Quality Data Management Concepts for Quality Data Collection Ryan Callison.
Module 11 Module I: Terminology— Data Quality Indicators (DQIs) Melinda Ronca-Battista ITEP Catherine Brown U.S. EPA.
 Principles;  Moral;  Beliefs;  Moral values; and  “A set of principles of right conduct”
P1 Document Control and Various Documents. P2 Learning Objectives What are documents and records? Documents Why are they important? What documents should.
Session 6: Data Flow, Data Management, and Data Quality.
? Training removes doubt, instills confidence, and lays the foundation for everyone’s skill and experience level.
DOCUMENTATION ISO/IEC 17025:2005 Documentation.
Welcome to Developing a Food Safety Program National Food Service Management Institute The University of Mississippi.
1 Ambient Monitoring Program PM 2.5 Data Lean 6 Sigma Air Director’s Meeting May 2015.
MEASURE Evaluation Data Quality Assurance Workshop Session 3 Introduction to Routine Data Quality Assessment.
Overview of Quality Assurance
Quality Assurance Documentation
Precision, Bias, and Total Error (Accuracy)
Presentation transcript:

Quality Control/ Quality Assurance Annabelle Allison ITEP/TAMS Center

2 Quality Assurance PLAN DO CHECK FIX KEEP DOING IT!

3 Quality Assurance Definitions Common sense written down “Integrated system of management activities involving planning, implementation, assessment, reporting, and quality improvement to ensure that a process, item, or service is type and quality needed and expected by client”

4 Quality System Structured, documented management system Describes policies, principles, organizational authority for ensuring quality needed in product Provides framework for planning, doing, documenting, & assessing work and for carrying out QA/QC activities

5 Quality Control (QC) Technical activities Measures performance of the process Compares against defined standards “Customer” sets standards & requirements QC is part of QA

6 Quality Control Check (Measure… compare with limits… graph it… document and report) Fix

7 Quality System: management (common sense) Assurance: policies (serve our community to produce needed result) Control: assessments (we check up on our work)

8 American National Standard ANSI/ASQC E Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs National consensus standard authorized by American National Standards Institute (ANSI) Developed by American Society for Quality Control (ASQC) Consistent with ISO standards EPA Guidance for Quality Assurance Project Plans: EPA QA/G-5 based on E4

9 Why is a QAPP Important? Saves money Saves time Helps communication No later misunderstandings Everything contained in or referenced in one document Public document in case of litigation

10 Using SOPs Easier to write than QAPPs Describe what is done Once SOPs are written, QAPP is much easier Reference and attach SOPs to QAPP

11 Using Existing Materials Plagiarism when writing QAPPs and SOPs is okay! Guidance for the Preparation of Standard Operating Procedures (SOPs) for Quality-related Documents: EPA QA/G-6 Use template QAPPs for BAM and TEOM in TAMS diskette

12 6 Elements of Data Management (1) Data processing and transmission (WHAT) (2) Data end use and integrity protection (WHY) (3) Data access (WHO)

13 6 Elements of Data Management (cont.) (4) Data dissemination (WHERE) (5) Data storage and retrieval (HOW) (6) Data disposal (WHEN) Document everything!

14 Error …the difference between your answer and the “truth”

15 Continuous PM QC Instrument stability checks (EPA calls this general QA in their 1995 memo; see Attachment A in the TAMS template QAPPs) Precision Bias

16 Instrument Stability Internal diagnostics conducted with each measurement (no error codes) TEOM uses standard filter kit available from dealer BAM uses standard foil or internal source Use these stability test kits more frequently at beginning of program, thereafter as necessary and at least twice a year

17 Results of Stability Checks Use dealer’s guidelines Within 2.5% for TEOM standard filter Within 7% for BAM foil Plot results on control chart (see Excel table and linked chart as figure 14-1 in TAMS template QAPPs)

18 Precision Error Unavoidable Sometimes up, sometimes down– “random” Estimated by measuring the same thing several times Minimized by carefully following procedures

19 Precision Collocated analyzers is too expensive, so use repeated measurements of the same thing to estimate precision Flow rate is the most important parameter for PM Flow rate changes with time—how much it varies is estimate of precision error

20 Two Ways To Estimate Precision of Flow Rate At beginning of program, use external flow rate transfer standard in field and compare flow rate transfer standard’s result with that shown (or set) on analyzer (one-point check) Conduct this check at least every 2 weeks

21 During the First Months Ensure external flow rate transfer standard is checked against another flow rate transfer standard at least once (every six months if you want to use second, easier way to assess precision) Record every check of analyzer’s flow rate, verify it’s within 4% of external flow rate transfer standard’s flow rate for 3 consecutive biweekly checks

22 Easier Way To Estimate Precision after Several Months Use “alternative procedure:” Record analyzer’s set point flow rate, assume same flow rate if measured by external flow rate transfer standard Record analyzer’s indicated flow rate Calculate relative percent difference, use value as precision error of flow rate (use relative percent difference calculation; see cells B5 – G28 in the Tribal Data Analysis spreadsheet, pg “PM 10 Automated”)

23 Bias Error Minimized by calibrating equipment against a standard Make sure standard is certified against NIST-traceable standard (keep certificate!) Compare transfer standard to field equipment Measures any bias in your equipment

24 Definitions EPA calls “accuracy” what others call “total error” Accuracy, or total error, combines both precision and bias errors

25 Continuous PM Accuracy Can estimate only accuracy of flow rate Most important parameter, so that’s okay Use external flow rate transfer standard to compare indicated (or set) flow rate of analyzer with that shown by transfer standard

26 Accuracy (cont.) Flow rate transfer standard must not be same used to calibrate analyzer Audit may be conducted by tribal staff, but not routine site operator Conduct flow rate audit at least once per year for each analyzer

27 Accuracy Calculations Relative percent difference between audit flow rate transfer standard and your analyzer’s flow rate is estimated accuracy of your flow rate No other (inexpensive) way to estimate accuracy, so this is your estimated accuracy, or total error