Qapp Student

7/31/2019 Qapp Student

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QUALITY ASSURANCEPROJECT PLANS

Overview


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Course Schedule


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Course Objectives

After this training, you will be able to:

Discuss what information is required in aQA

Project Plan

Describe your role and responsibility in the

QA Project Plan development, review, and

approval process


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What is meant by environmentaldata?

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)


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What is a Quality System?

A structured and documentedmanagement system which has a system

in place for ensuring the quality of its workprocess, products and services.

The QMP describes the policies,

objectives, principles, organizationalauthority, responsibilities, accountability,and implementation plan of theorganization


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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 forEnvironmental Data Collection and

Environmental Technology Programs


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Extramural Regulations QADocumentation

48 CFR 46 Quality Management Plan (or

equivalent) and a QA Project Plan (or

equivalent)

40 CFR 30 Quality Management Plan and a QAProject 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


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What is a QA Project Plan?

A document that describes the technical

and quality activities of an environmental

data operations project that should beimplemented to ensure that the results of

the work performed will satisfy the data

users needs.


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Why should I write a QA Project Plan?

QA Project Plans are prepared for all EPA

projects and tasks involving

environmental data operations (generatingor using).

Non-EPA organizations which receive EPA

funds need to satisfy those requirements

defined in the Code of Federal

Regulations.


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ProblemIdentification

Proposal

Plan


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QA Project Planning andQA Project Plan Preparation

A Team Effort


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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


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Systematic Planning

(e.g., DQO Process)

QA

Project Plan

Standard

Operating

Procedures

Conduct Study/

Experiment

Technical

Assessments

Data Verification

& Validation

Data Quality

Assessment

Planning Implementation Assessment


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Four Main Topics:

A. Project Management 9

elements

B. Data Generation/Acquisition 10elements

C. Assessment and Oversight 2

elementsD. Data Validation and Usability 3

elements

24


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References

Existing Documentation can beReferenced and/or Attached!


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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 environmentaldata operations conducted at multiple

locations and/or over a long period of

time.


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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 theintended use of the data.

high road

low road


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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.


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Review to ensure that:

The plan is accurate and complete,

Sufficient data will be collected using

appropriate measurement and dataacquisition methods,

Planned assessment procedures will be

adequate to evaluate the project, and There is a process to identify any

limitations on the data use.


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Reviewers should:

Be timely in their review,

Be consistent in their review,

Have a process established to deal withrevisions, and

Have expertise in technical areas and

recognize where they need advice.


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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 theproject's technical and quality objectives.


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Conditional Approval

May be given in situations where the

project may be started while "non-critical

deficiencies" are being resolved.


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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

implementedas approved.


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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 changebeing made.


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Regular Reviews

QA Project Plans for multi-year projects

should be reviewed annually and revised

when necessary.


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Project #/Name ___________

Revision No. ___________Date ___________Page ____ of ____


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List key personnel of all organizations who

need a copy of the approved QA Project

Plan and revisions


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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)


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Describe the underlying issue that led to

this project, including background/

historical information indicating the needfor this study.


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Summarize work to be performed, products

to be produced, and the schedule for

implementation


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Time

People

Materials


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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


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Precision

Accuracy/Bias

Representativeness

Comparability

Completeness

Sensitivity


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Representati eness


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Representativeness

Comparability

Completeness


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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 concentr at ion higher


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0

- - - - - - - - - - - - - - - - - - - - - - - - - - - - MDL

C

O

NC

E

N

T

R

A

T

I

O

N

SAMPLES

------------------------------------------------ Action Level?

------------------------------------------------- Action Level?


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Identify any special training or

certifications needed by personnel to

conduct project activities

State how this training will be

provided, assured and documented


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Describe process to ensure project

personnel have most current Plan

Itemize information/records to be includedin data report package

Identify any other reports/documents

to be produced

State specifications for final disposition

of records and documents


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B. Data Generation and Acquisition


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1. Sampling Process Design

(Experimental Design)Describe the data generation or datacollection

design for the project:

measurement parameters of interest,

indicating those critical and those

secondary

to the study


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rationale for the sampling design


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Sampling Design Testing &Estimation

- is the sampling matrix homogenous or

heterogeneous?

- do you care about average contaminationlevels, 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?


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rationale for the sampling design,

sampling locations and frequencies,

types and numbers of samples needed, an

sources of variability


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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.


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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


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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


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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


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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


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Examples of Quality Control Samples

Replicates

Splits

Blanks

Reference MaterialsMatrix Spikes


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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


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7. Instrument/Equipment Calibration

and Frequency Identify all equipment and instrumentationrequiring 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


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8. Inspection/Acceptance for Suppliesand Consumables

Identify all supplies that may directly or

indirectly affect the quality of the project

Describe the inspection and acceptance

testing criteria and procedures


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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 anylimitations,

for their usage


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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


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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)


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C. Assessment and Oversight


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Assessment Types Readiness Reviews

Technical System Audits

Surveillance

Performance Evaluations/Proficiency Testin


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1. Assessments and ResponseActions Describe each assessment needed,

including

frequency and type, information expected,

andcriteria for success

Identify potential assessors and theirauthority

Discuss how and to who findings will be


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2. Reports to Management

Identify frequency and distribution of

project

QA status reports

Identify preparer and recipients of these

reports


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D. Data Validation and Usability


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Questions & Answers

What is the difference between data review,

verification, and validation?


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1. Data Review, Verification, andValidation

Identify the project's criteria to review, verify,

and validate the data


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2. Verification and Validation Methods

Describe the process to be used for both

data verification and validation,

identifyingany calculations needed

Discuss how issues will be resolved and

identify the individuals responsible

Discuss how these results will be

conveyed to the data users


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3. Reconciliation with UserRequirements

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


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Summary

I C i i C id f


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Important Criteria to Consider forQuality 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.

I C i i C id f


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Important Criteria to Consider forQuality 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

theparticipants in the planning process.


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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

Wh i h l f h i


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What is the value of having anapproved QA Project Plan?

D i th Ri ht Thi th Ri ht W


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Doing the Right Things the Right Waythe First Time!

Documents

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