Maintaining quality data throughout the life of a project

Slides:



Advertisements
Similar presentations
Tips to a Successful Monitoring Visit
Advertisements

PRINCIPLES OF A CALIBRATION MANAGEMENT SYSTEM
The Principal Investigator’s Roles and Responsibilities Chicken Soup for the Busy Coordinator (May 2010)
UNDERSTANDING ENVIRONMENTAL LABORATORY/QC REPORTS Maya Murshak – Merit Laboratories, Inc.
AOC Services EPA Analytical Operations/Data Quality Center August 14 th, 2001 US Navy/NAVSEA Training Session.
Florida Department of Environmental Protection Looking Ahead.
Establish Verification Procedures (Task 11 / Principle 6)
GCP compliance for GenISIS  This presentation is intended for clinical staff involved in recruiting patients to the GenISIS (Genetics of Influenza Susceptibility.
Environmental Management Systems An Overview With Practical Applications.
EMS Auditing Definitions
Lecture 8. Quality Assurance/Quality Control The Islamic University of Gaza- Environmental Engineering Department Environmental Measurements (EENV 4244)
Importance of Quality Assurance Documentation and Coordination with Your Certified Laboratory Amy Yersavich and Susan Netzly-Watkins.
Quality Assurance/Quality Control Policy
Quality Assurance Plans (QAP)
QA/QC FOR ENVIRONMENTAL MEASUREMENT
Seafood HACCP Alliance for Training and Education Chapter 10 Principle 6: Establish Verification Procedures.
ISO STANDARDS TRAINING & CONSULTING
Environmental Impact Assessment (EIA): Overview
WWLC Standard Operating Procedures Presented by Frank Hall, Laboratory Certification Coordinator.
Assessment of Interchangeable Multisource Medicines Quality of BE Data Dr. Henrike Potthast Training workshop: Assessment of Interchangeable.
Present Development of a Regional Guidance Document for Dredged Material Evaluation Christopher McArthur, P.E. (US Environmental.
Appendix E – Checklist for Review of Performance Audits Presented by: Ashton Coleman Department of Defense Office of the Inspector General August 16, 2012.
QA/QC and QUALIFIERS LOU ANN FISHER CITY OF STILLWATER, OK
Introduction The past, the present and the future.
United States Department of Agriculture Food Safety and Inspection Service 1 National Advisory Committee on Meat and Poultry Inspection August 8-9, 2007.
Important informations
Laboratory Ethics – An Overview Part II What You Need To Know What You Need To Do.
Quality of Bioequivalence Data Alfredo García - Arieta Training workshop: Training of BE assessors, Kiev, October 2009.
4.3 Document control 4.4 Review of requests, tenders and contracts
| Data Validity and Usability in the RI/FS Process CHRISTINA MOTT FRANS, JOSH HOPP, CHRISTINE RANSOM.
SAAMF Roadshow Durban CSIR NML Eddie Tarnow Metrologist: Torque & Automotive 14 June 2006 ISO/TS 16949:2002 certification – Meeting the requirements of.
ISO MONITORING AND MEASUREMENT. ISO Environmental Management Systems2 Lesson Learning Goals At the end of this lesson you should be.
Specific Safety Requirements on Safety Assessment and Safety Cases for Predisposal Management of Radioactive Waste – GSR Part 5.
Part 11 Public Meeting PEERS Questions & Responses The opinions expressed here belong to PEERS members and not the corporate entities with which they are.
ECOS Information Session Draft EPA Quality Documents February 13, 2013 Presented by EPA Quality Staff, Office of Environmental Information For meeting.
United Nations Oslo City Group on Energy Statistics OG7, Helsinki, Finland October 2012 ESCM Chapter 8: Data Quality and Meta Data 1.
Copyright 2010, The World Bank Group. All Rights Reserved. Recommended Tabulations and Dissemination Section B.
Checking and Corrective Action EPA Regions 9 & 10 and The Federal Network for Sustainability 2005.
Data Driven Planning and Decision-making for Continuous School Improvement: Developing a Program Evaluation Plan Leadership for Innovative Omani Schools.
WHAT IS THE CHEROKEE NATION? Cherokee Nation Air Quality Data Management Concepts for Quality Data Collection Ryan Callison.
Session 6: Data Flow, Data Management, and Data Quality.
Improving performance, reducing risk Dr Apostolos Noulis, Lead Assessor, Business Development Mgr Thessaloniki, 02 June 2014 ISO Energy Management.
Why do I need a Chain of Custody (COC)? Presentation to: KWWOA Department for Environmental Protection Energy & Environment Cabinet To Protect and Enhance.
A LOOK AT AMENDMENTS TO ISO/IEC (1999) Presented at NCSLI Conference Washington DC August 11, 2005 by Roxanne Robinson.
Preparing for Title IIA Monitoring Review (FY15) November 9, 2015 Deborah Walker Meagan Steiner David LeBlanc.
Stages of Research and Development
Quality Assurance processes
Configuration Management
Software Quality Control and Quality Assurance: Introduction
Compliance with Framework of Quality Control - General & Specific Controls CA Vimal Chopra, Ex Chairman of CIRC of ICAI.
Areas Separate Approaches Parallel Approaches Joint Approaches
Water Quality Monitoring -Quality Assurance/Quality Control-
Configuration Management
Equality and diversity – session 2
Lesson 5: BRITE Seminar: GMP II
Quality Risk Management
Quality Systems in a Production Facility
Achieving ISO Compliance
IB Environmental Systems and Societies
Alignment Dr. Mary Clisbee
Considerations for the Paperless Laboratory
Topics in Microbiology Quality Assurance Project Plan Essentials
METHOD VALIDATION: AN ESSENTIAL COMPONENT OF THE MEASUREMENT PROCESS
Environmental Management Systems The ISO Approach Initial Environmental Review & Gap Analysis Presented by: NC Division of Pollution Prevention.
Emulsion Task Force Meeting
Eloise Forster, Ed.D. Foundation for Educational Administration (FEA)
Research Proposal and Report
The samples and the Error
Internal Control Internal control is the process designed and affected by owners, management, and other personnel. It is implemented to address business.
Good clinical practice
Presentation transcript:

Maintaining quality data throughout the life of a project National Environmental Monitoring Conference August 2017 Christina Hiegel, P.E.

SOLUTIONS YOU CAN COUNT ON. PEOPLE YOU CAN TRUST. Agenda SOLUTIONS YOU CAN COUNT ON. PEOPLE YOU CAN TRUST. Reporting Data Why is Quality Important? Auditing Definition and Planning of Data Quality Final Thoughts Storage

Why is Data Quality Important? Laboratory Certification Methodology Standard Operating Procedures Legal Defensibility Consultant/ End-User Regulatory Requirements Project Objectives Regulatory Agency Public Scrutiny Public Protection Consultant – Proving to clients and regulators that they are collecting representative data. Responsible Party – Ensuring that the client has legally defensible data when scrutinized by any regulatory agency. Regulatory Agency (ex. EPA, MDEQ) – To prove that data collected are appropriate for making decisions based on the collected data. Also, to protect human and ecological receptors from negative impacts when making decisions based on analytical data.

EPA General Assessment Factors (EPA QA/G-4) What is Data Quality? Definition EPA General Assessment Factors (EPA QA/G-4) Soundness: The extent to which the scientific and technical procedures, measures, methods or models employed to generate the information are reasonable for, and consistent with, the intended application. Applicability and Utility: The extent to which the information is relevant for the Agency’s intended use. Clarity and Completeness: The degree of clarity and completeness with which the data, assumptions, methods, quality assurance, sponsoring organizations and analyses employed to generate the information are documented. Uncertainty and Variability: The extent to which the variability and uncertainty (quantitative and qualitative) in the information or the procedures, measures, methods or models are evaluated and characterized. Evaluation and Review: The extent of independent verification, validation, and peer review of the information or of the procedures, measures, methods or models. These are the headers for DQOs

Laboratory Perspective What is Data Quality? Laboratory Perspective Soundness Audits Certification Applicability/Utility Client Expectations Usability Clarity and Completeness Uncertainty and Variability Evaluation and Review These are the headers for DQOs

Consultant and End User Perspective What is Data Quality? Consultant and End User Perspective Soundness Regulatory Scrutiny Intended Use of Data Applicability/Utility USABILITY CURRENT/FUTURE USE OF DATA Clarity and Completeness TIME AND BUDGET EASY TO INTERPRET AND USE Uncertainty and Variability REGULATORY SCRUTINEY DATA VALIDATION TIME/BUDGET Evaluation and Review REGULATORY SCRUTINY These are the headers for DQOs

Regulator Perspective What is Data Quality? REGULATOR Regulator Perspective Soundness Regulatory Scrutiny Intended Use of Data Applicability/Utility Usability Current/Future Use of Data Clarity and Completeness Easy to Interpret and Use Easy to Explain Uncertainty and Variability Public Scrutiny Decision Making Evaluation and Review These are the headers for DQOs

Steps to Ensure Data Quality Field Use approved collection methods Keep things clean and organized Follow the preservation requirements Use updated instrumentation Keep track of your samples and field results Be thorough in your documentation

Steps to Ensure Data Quality Field Strict chain-of-custody Know your primary field contaminants and target analytes Be diligent in following approved collection method Use the bottles required for each method Take safety seriously

Steps to Ensure Data Quality Laboratory Use approved/peer reviewed methodology Address audit concerns Maintain and update instrumentation Take client questions and concerns seriously Run control charts Ask for regular feedback on performance Keep things clean and organized

Steps to Ensure Data Quality Laboratory Be thorough in your documentation Keep strict chain-of- custody Conduct a thorough review of the data Understand your client’s end goals Take safety seriously

Data Validation Plan how Data will be Managed Determine how Records will be kept Plan the sample and location names Naming conventions – ORIGINAL, SHORT, MEANINGFUL

Validator’s Duties May Include: Review the chain-of-custody Review compliance of field and/or laboratory methodology Review results in comparison to expected results Determine result bias or inconsistencies Determine instrumentation problems Result: Communication of the Data Quality to the End User via Report, Qualifiers, and/or Narrative

Future Use Looking Ahead How is the data going to be used in the future, and what is the best way to maintain it? Looking Ahead Other than the current intended purpose, how can this data be used in the future? What should this data NOT be used for? How long is the data usable for? What would cause this data to not be usable in the future?

Maintaining Data Quality

Storage Store data so that the: Field data Field notes Final signed (legal) laboratory report Final chain-of-custody Final EDD Final data validation Data qualifiers

Storage Example

Resulting Data Qualifiers Store qualifiers so that they are used when the data is used Store reasons for qualifiers with the final data records Make sure that end users can understand why qualifiers were added. It may affect the final use of the data

Qualification Storage

Report the Data Figures Tables Reports Appendices Laboratory Reports

Analytical Report

Why Audit?? Multiple laboratory reports and versioning EDDs Accidental change Validation report and flagging versioning

How Do We Maintain Quality? DEFINE: Determine what quality data look like for your project and how is it obtained? PLAN: Plan for quality data Put a plan into place Communicate what quality data will involve to field/laboratory/consultant/etc… Know all and any potential future uses of the data (other than your current intentions) STORAGE: Keep all of the data evidence together in one place. Field Notes, Data, Laboratory Reports, EDDs, etc… REPORTING: Maintain qualifications and reasons in figures and tables.

How Do We Maintain It? AUDITING: Determine a method to track changes to data and files. Multiple lab reports EDDs Unintentional Changes Data Validations ACCESS: Make sure that any end-users have access to the data and the qualifications.

Questions? WHAT WHY WHERE WHEN WHO HOW