Basic Training Project Plan Samples

Document Sample
Basic Training Project Plan Samples Powered By Docstoc
					QUALITY ASSURANCE
    PROJECT PLANS


          Overview




              qapp   1
Course Schedule




                  qapp   2
Course Objectives

After this training, you will be able to:

Discuss what information is required in a
QA
 Project Plan

   Describe your role and responsibility in the
    QA Project Plan development, review, and
    approval process
                                            qapp   3
What is meant by environmental
data?
Information that describes environmental
processes, locations or conditions, and
health effects or consequences. It can be:

 Collected directly from measurements
  (primary data)
 Produced from models, or

 Compiled from other sources (existing
  or secondary data)
                                   qapp   4
What is a Quality System?

A structured and documented
management system which has a system
in place for ensuring the quality of its work
process, products and services.
The QMP describes the policies,
objectives, principles, organizational
authority, responsibilities, accountability,
and implementation plan of the
organization
                                       qapp    5
Where can I find this information?
 INTERNAL
  • EPA Order 5360.1 A2 (the Order)
  • EPA Order 5360 A1(the Quality Manual)



 ANSI/ASQC E-4-1994 “Specifications and
  Guidelines for Quality Systems for
  Environmental Data Collection and
  Environmental Technology Programs”
                                 qapp   6
   Extramural Regulations – QA
         Documentation
48 CFR 46   Quality Management Plan (or
            equivalent) and a QA Project Plan (or
            equivalent)
40 CFR 30   Quality Management Plan and a QA
            Project Plan
40 CFR 31   Quality System must conform to the
            American National Standard
            (ANSI/ASQC-E-4, 1994). Submit a
            Quality Manual and a QA Project Plan
40 CFR 35   Comply with 40 CFR 31            7
                                      qapp
What is a QA Project Plan?

A document that describes the technical
and quality activities of an environmental
data operations project that should be
implemented to ensure that the results of
the work performed will satisfy the data
user’s needs.



                                    qapp     8
Why should I write a QA Project Plan?
QA Project Plans are prepared for all EPA
 projects and tasks involving
environmental data operations (generating
or using).

Non-EPA organizations which receive EPA
 funds need to satisfy those requirements
 defined in the Code of Federal
Regulations.
                                 qapp   9
Problem
Identification



                 Proposal




                            Plan
                              qapp   10
QA Project Planning and
        QA Project Plan Preparation

 A Team Effort




                            qapp   11
Project/QA Project Plan Development
   Scope
   Assemble a team
   Systematically plan
   Write the Plan
   Submit the Plan for review and approval
   Once approved, distribute the plan
   Start work, following the plan
   Revise when needed, get approval,
    then re-distribute the plan
                                    qapp   12
Systematic Planning      Conduct Study/    Data Verification
(e.g., DQO Process)       Experiment        & Validation




      QA               Standard
                                    Technical    Data Quality
  Project Plan        Operating
                                   Assessments   Assessment
                      Procedures

    Planning             Implementation             Assessment


                                                 qapp   13
 Four Main Topics:
A. Project Management              9
 elements
B. Data Generation/Acquisition 10
 elements
C. Assessment and Oversight        2
 elements
D. Data Validation and Usability 3
 elements
                                24
                                  qapp   14
References


Existing Documentation can be
Referenced and/or Attached!




                       qapp   15
Different Types of QA Project Plans
   Task-Specific QA Project Plans: those
    projects for which the environmental data
    operation is task, site or project specific.

 Generic or Programmatic QA Project
Plans: those projects for environmental
data operations conducted at multiple
locations and/or over a long period of
time.
                                        qapp   16
Level of Detail -
              the Graded Approach
The level of detail in each QA Project
Plan will vary according to the nature of
the work being performed and the
intended use of the data.
                 high road


                 low road




                                    qapp    17
QA Project Plan Review
   For EPA projects, the Project Manager and
    QA Manager, or designee, review the QA
    Project Plan.

For extramural projects, the funded
 organization reviews the plan, as well as
the
 EPA organization.

                                    qapp   18
Review to ensure that:
  The plan is accurate and complete,
 Sufficient data will be collected using
   appropriate measurement and data
   acquisition methods,
 Planned assessment procedures will be

   adequate to evaluate the project, and
 There is a process to identify any
 limitations on the data use.

                                   qapp   19
Reviewers should:
 Be timely in their review,
 Be consistent in their review,
 Have a process established to deal with

  revisions, and
 Have expertise in technical areas and
  recognize where they need advice.



                                   qapp   20
QA Project Plan Approval
   Is the responsibility of the EPA Project
    Manager and QA Manager, and

Indicates that the QA Project Plan is
accurate and complete, and that it
provides sufficient detail to identify the
project's technical and quality objectives.


                                        qapp   21
Conditional Approval
May be given in situations where the
project may be started while "non-critical
deficiencies" are being resolved.




                                    qapp   22
QA Project Plan Implementation
   Data collection may not be started until the
    QA Project Plan has been reviewed,
    approved and signed.

 The QA Project Plan should be
 implemented
  as approved.


                                      qapp   23
Revisions - After Approval
When changes are needed, the QA Project
Plan should be revised and re-approved by
the approving official(s) prior to the change
being made.




                                     qapp   24
Regular Reviews
QA Project Plans for multi-year projects
should be reviewed annually and revised
when necessary.




                                  qapp   25
A. Project Management




                        qapp   26
1. Title & Approval Sheet




                            qapp   27
2. Table of Contents




                       qapp   28
Document Control Notation



                 Project #/Name   ___________
                 Revision No.     ___________
                 Date             ___________
                 Page             ____ of ____




                                       qapp      29
3. Distribution List
List key personnel of all organizations who
need a copy of the approved QA Project
Plan and revisions




                                   qapp   30
4. Project/Task Organization
   Identify individuals and state their roles
    and responsibilities in the project

   Attach an organizational chart and
    indicate lines of communication
    (include data users and
    subcontractors)


                                        qapp   31
5. Problem Definition/Background
Describe the underlying issue that led to
this project, including background/
historical information indicating the need
for this study.




                                    qapp     32
6. Project/Task Description
Summarize work to be performed, products
to be produced, and the schedule for
implementation




                                qapp   33
    Resource Limitations

• Time

• People

• Materials




                           qapp   34
7. Quality Objectives and Criteria
State the quality objectives for the project
and the performance criteria to achieve
these objectives, i.e., the quality of data
needed to support your decision

- Decision quality is based on data/
  information quality


                                     qapp   35
Data Quality Indicators

    Precision
    Accuracy/Bias
    Representativeness
    Comparability
    Completeness
    Sensitivity
                          qapp   36
qapp   37
Representativeness
  Comparability
  Completeness




                     qapp   38
          Impact of Detection Limit and
           Contaminant Concentration

Relative Positions of
MDLs and CC                        Consequence

   MDL           CC                Non-Detects and Detects
                                   Useable

          MDL CC                   Possibility of False Positives
                                   and False Negatives

                CC        MDL      Non-Detects Not Useable
                                   Detects Useable
                                   Possibility of False Negatives
  lower   concentration   higher

                                                                qapp   39
Detection Limits/Sensitivity


C
O   ------------------------------------------------ Action Level?
N
C
E
N   - - - - - - - - - - - - - - - - - - - - - - - - - - - - MDL
T
R
A
T   ------------------------------------------------- Action Level?
I
O
N
                                                       0
                SAMPLES
                                                            qapp   40
8. Special Training/Certification
   Identify any special training or
    certifications needed by personnel to
    conduct project activities

   State how this training will be
    provided, assured and documented



                                     qapp   41
9. Documents and Records
 Describe process to ensure project
  personnel have most current Plan
 Itemize information/records to be included

  in data report package
 Identify any other reports/documents

  to be produced
 State specifications for final disposition

  of records and documents

                                   qapp   42
B. Data Generation and Acquisition




                             qapp   43
1. Sampling Process Design
   (Experimental Design)
Describe the data generation or data
collection
design for the project:

measurement parameters of interest,
  indicating those critical and those
secondary
  to the study

                                  qapp   44
1. Sampling Process Design
   (Experimental Design)
Describe the data generation or data
collection
design for the project:

   measurement parameters of interest,
   rationale for the sampling design



                                   qapp   45
Sampling Design Testing &
Estimation
   - is the sampling matrix homogenous or
heterogeneous?
  - do you care about average contamination
levels, hot spots, or the proportion of site
contaminated?
  - do you want composites samples or
grabs?
  - are you looking for trends over time?
  - will there be a reference site?
                                   qapp   46
1. Sampling Process Design
   (Experimental Design)
Describe the data generation or data
collection
design for the project:

   measurement parameters of interest,
   rationale for the sampling design,
   sampling locations and frequencies,
   types and numbers of samples needed, and
   sources of variability
                                  qapp   47
2. Sampling Methods
  Describe sample collection and
 preservation methods, and equipment
 preparation and decontamination
 procedures
 Indicate any performance specifications

 Identify sample equipment and support
 facilities needed
 Address what to do when things go wrong.


                                 qapp   48
3. Sample Handling and Custody
  Describe how samples are to be handled
 in the field, in the lab, and during
 transport,
   and who is responsible
 Detail how samples are to be transported

 so maximum holding time conditions are
 met
 Indicate sample identification scheme
 and      chain of custody specifications
                                  qapp   49
4. Analytical Methods
  Identify all analytical methods and
 equipment
   needed for both field and lab
 List method performance standards, such
 as
   MDL, Precision, Accuracy, PQL, %
 recovery


                                 qapp   50
4. Analytical Methods (continued)
   Include method validation information for
    nonstandard methods

   State what to do when a failure occurs

   Describe sample disposal procedures

   Specify laboratory turnaround time

                                     qapp    51
5. Quality Control
   Identify QC activities for each sampling,
    analysis, or measurement technique

   State the frequency and control limits of
    each QC activity, and how corrective
    actions will be documented

   Describe procedures and formulas for
    calculating QC statistics
                                     qapp   52
Examples of Quality Control Samples
Replicates
Splits
Blanks
Reference Materials
Matrix Spikes




                            qapp   53
6. Instrument/Equipment Testing,
   Inspection, and Maintenance
  Identify equipment requiring periodic
   maintenance, the schedule for such, and
   availability of critical spare parts
 Describe inspection and acceptance
 testing
   to be performed, and how documented
 Identify how deficiencies will be resolved,
 and
   effectiveness determined and documented
 Identify who will do it          qapp   54
7. Instrument/Equipment Calibration
   and Frequency
  Identify all equipment and instrumentation
   requiring calibration in field or lab
 Document calibration method and

 frequency, and test criteria and certified
 equipment
   and/or standards to be used
 Identify how deficiencies will be resolved
 Indicate how records will be maintained
 and
   traceable to the instrument      qapp   55
8. Inspection/Acceptance for Supplies
   and Consumables
   Identify all supplies that may directly or
    indirectly affect the quality of the project

   Describe the inspection and acceptance
    testing criteria and procedures




                                        qapp   56
9. Non-Direct Measurements
   Identify data needed from computer
    databases, programs, literature files, and
    historical databases

   Describe the intended use of the data

 Cite acceptance criteria, and any
limitations,
  for their usage
                                      qapp   57
10. Data Management
  Describe data management scheme from
   generation in the field to final use/storage
 Discuss procedures for record-keeping,

   document control system, and data
 storage/
   retrieval on electronic media
 Discuss methods and equipment for
   detecting/correcting errors, and
 preventing
   data loss                          qapp   58
10. Data Management (continued)
   Describe procedures to demonstrate
    acceptability of hardware/software
    configuration

 Identify how applicable information
resource
  management specifications are met (for
EPA
  personnel)
                                   qapp   59
C. Assessment and Oversight




                              qapp   60
Assessment Types
   Readiness Reviews

   Technical System Audits

   Surveillance

   Performance Evaluations/Proficiency Testing


                                    qapp   61
1. Assessments and Response
Actions
 Describe each assessment needed,
including
  frequency and type, information expected,
and
  criteria for success

Identify potential assessors and their
authority

   Discuss how and to who findings will be
                                     qapp   62
2. Reports to Management
 Identify frequency and distribution of
project
  QA status reports

   Identify preparer and recipients of these
    reports



                                      qapp   63
D. Data Validation and Usability




                              qapp   64
Questions & Answers
What is the difference between data review,
verification, and validation?




                                  qapp   65
1. Data Review, Verification, and
    Validation
Identify the project's criteria to review, verify,
and validate the data




                                        qapp   66
2. Verification and Validation Methods
  Describe the process to be used for both
     data verification and validation,
 identifying
   any calculations needed

   Discuss how issues will be resolved and
    identify the individuals responsible

   Discuss how these results will be
                                               67
    conveyed to the data users          qapp
3. Reconciliation with User
    Requirements
  Describe how the results of the study will
 be evaluated to determine whether the
 project's objectives have been satisfied
 Outline proposed methods to analyze the
   data
 Describe how limitations in data use will
 be      reported


                                     qapp   68
Summary




          qapp   69
Important Criteria to Consider for
Quality Assured Data
Anything that compromises data
 representativeness compromises data
quality.

Make room for independent checks along
the
  way, and use them.

Use methods that have been well
established and/or well documented.qapp   70
Important Criteria to Consider for
Quality Assured Data (continued)
 Most important: figure out what you need
to
     know, and how well you need to know it.

 Then, plan how to get it, including all of
the
   participants in the planning process.

                                      qapp   71
Remember
There are four basic project groups that
should be discussed in a QA Project Plan.
These are:

 - management
 - data generation/acquisition
 - assessment/oversight
 - data validation and usability

                                   qapp   72
What is the value of having an
approved QA Project Plan?




                                 qapp   73
Doing the Right Things the Right Way
the First Time!




                             qapp   74

				
DOCUMENT INFO
Description: Basic Training Project Plan Samples document sample