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Radon Lab Quality Manual Template - ELAP Laboratory ID

By Henry Richardson,2014-05-19 22:01
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*laboratory test results that are supported by quality control data and The Quality Assurance Officer is responsible for the document control system

    Laboratory Name Laboratory Quality Manual

     Doc. No. 1 Rev. No. 2

     Date: 9/7/07 Page 1 of 21

ELAP Laboratory ID #

Laboratory Quality Manual

Technical Directors name

    Address (if different from above)

    Telephone Number

Approved: _____________________________________ ______________

    Technical Director’s Signature Name Date

Approved: ______________________________________ _____________

    Quality Assurance Officer’s Signature Name Date

Distribution List

    (list the departments, locations, and personnel that receive controlled copies)

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Revision Record

Rev Date Responsible

    Person Description of Change

     0 5/17/07 Name Initial Release

Annual Review (Performed if document has not been revised in the past 12 months)

______________________ ____________________ _______

    Signature Title Date (Responsible Person in Revision Record)

Training Record

    The following laboratory staff have read this Manual.

________________ ________________ ________

     Name Title Date

    ________________ ________________ ________

     Name Title Date

    ________________ ________________ ________

     Name Title Date

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     Table of Contents

    1. Quality Policy 4

    2. Accredited Test Methods 5

    3. Quality System 5

    4. Job Descriptions of Staff 6

    5. Document Control 7

    6. Traceability of Measurements 8

    7. Review of All New Requests, Tenders and Contracts 8

    8. Calibration/Verification of Test Procedures 9

    9. Sample Handling 9

    A. Sample Acceptance Policy 9

    B. Procedures for handling submitted samples 10

    10. Laboratory Environment 10

    11. Procedures for Calibration, Verification, and Maintenance of Equipment 11

    12. Verification Practices 12

    13. Internal Quality Control Measures 12

    14. Control of Non-Conforming Environmental Testing 12

    15. Corrective Action Procedures 17

    16. Exceptionally Permitted Departures From Documented Policies and Procedures 13

     Or From Standard Specifications

    17. Preventive Action 14

    18. Complaints 14

    19. Internal Audit and Data Review 14

    A. Data Review 14

    B. Internal Quality System Audits 15

    C. Managerial Review 15

    20. Training and Review of Personnel Qualifications 15

    21. Data Integrity 17

    22. Reporting Analytical Results 18

    23. Confidentiality and Proprietary Rights 19

    24. References 19

    Appendix A - Code of Ethics 20

    Appendix B - Organization Chart 22

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1. Quality Policy

It is the Laboratorys objective to produce technically defensible laboratory test results that

    accurately and precisely describe the sample for the purpose of reporting to the client (New

    York State for treatment plants). The Laboratory is committed to routinely performing

    laboratory work in conformance to the NELAC standard adopted by New York State ELAP,

    resulting in the overall improvement in laboratory quality over time. Demonstration of the

    laboratorys commitment to reach its objective will result in the following:

*adequately staffed and equipped laboratory facility,

*successful participation in the proficiency testing program operated by the New York State

     Environmental Laboratory Approval Program or another accredited provider,

*successful implementation of a NELAC compliant quality system,

*annual internal audits with management review,

*successful biennial assessments by the New York State Environmental Laboratory Approval

    Program, or Primary Accrediting Authority,

*timely reporting of laboratory test results to the regulating authorities/clients,

*laboratory test results that are supported by quality control data and documented laboratory

    testing procedures.

The quality policy is communicated to employees during the training of new hires. It is

    understood, implemented, and maintained by employees at all levels. This is documented by

    management through the employee evaluation process, the training procedure, the internal

    audit process, and the document control process. The technical director shall ensure that the

    labs policies and objectives for quality of testing services are documented in the Quality

    Manual. The technical director shall assure that the Quality Manual is communicated to,

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understood, and implemented by all personnel concerned. Documentation includes signed

    statements in each analysts training file.

    2. Accredited Test Methods

Test Method

Radon in Air Continuous Radon Monitor

    (EPA 402-R92-003 Protocols for Radon and radon decay products measurements in homes) (EPA 402-R92-004 Indoor Radon & Radon Decay Products measurement device protocols)

3. Quality System

The quality system defined in the quality manual applies to all personnel who perform activities

    affecting quality. All employees are responsible for the quality system. The individual

    documents define specific employee responsibilities.

Though a formal documented system of planned activities, the quality system meets of the

    relevant requirements of ISO guide 17025, NELAC Chapter 5, July 2002, and the New York

    State Department of Health, Environmental Laboratory Approval Program. The quality

    manual is maintained current and up-to-date by the Quality Manager (QAO) to reflect changes

    to the system. The laboratory defines it policy for each applicable standard element in the

    quality manual. For each element, as appropriate, the laboratory has documented procedures

    that further describe how the specific policy objectives and goals are met. The quality manual

    references these documented procedures. Where applicable, work instructions are referenced

    in the documented procedures and the quality manual.

Quality procedures and instructions are implemented as written. The procedures explain how

    the laboratory implements the standard requirements in accordance with its quality policy.

    They are revised, as necessary, to reflect the actual objectives, flow of tasks, and staff

    responsibilities. Quality records include reports from internal audits and management

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reviews as well as records of corrective and preventive actions.

Work instructions are maintained in the laboratory methods manual. They specify the

    equipment and fixtures required the resources and skills, what tests and verifications will be

    performed to measure process and product quality, the records and written documentation

    used by personnel, and standards of acceptability. Work instructions are approved by the

    affected managerial staff and are maintained in the document control system.

3.1 Document Structure

    Level 1 Quality Manual

    Level 2 Quality Procedures

    Level 3 Work Instructions and Test Procedures

    Level 4 Quality Records

4. Job Descriptions of Staff

Technical Director - The technical director has overall responsibility for the technical operation of

    the lab. The technical director is also responsible for arranging and overseeing all support services

    including instrument service contracts, subcontracting sample analyses, and physical maintenance of

    the laboratory. The technical director also interacts with departmental, interdepartmental and

    appointed/elected officials to participate in coordination of lab participation in departmental/

    interdepartmental projects. The technical director reports directly to the department head.

The technical director is responsible for providing supervision to all laboratory personnel to ensure

    adherence to lab documented procedures. When the technical director is not present in the lab, an

    employee who is familiar with test procedures, the objective of the testing and the assessment of

    results will be appointed by the technical director to supervise.

The technical director shall certify that personnel with appropriate educational and/or technical

    background perform all tests for which the lab is accredited. Documentation can include New York

    State Treatment Plant Operators licenses for government municipal treatment plant labs.

    Quality Assurance Officer - The quality assurance officer has responsibility for the quality system

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    and its implementation. The QA officer has direct access to the highest level of management at which decisions are taken on lab policy and/or resources, and to the technical director. (For a small lab, the QA officer may also be the technical director.) When the QA officer is not present, a deputy shall be appointed.

Laboratory Technician -

5. Document Control

    All operating procedures, manuals including this quality manual, and documents are subject to document control. Distribution of controlled documents is limited to those indicated on the document distribution list. Controlled documents are indicated by the paper color indicated in the footer. Uncontrolled copies are indicated by reproduction on any other type paper. The Quality Assurance Officer controls the supply of paper used to produce controlled copies.

    The purpose of the document control system is to ensure that only the most recent revisions are available to the appropriate personnel, revisions are timely, and receive the required approvals. All internal regulatory documentation, standard operating procedures, work instructions, service manuals, and product instructions are under document control. The Quality Assurance Officer is responsible for the document control system and keeps a master list of the location of all documents and their current revision. The Laboratory Director and the Quality Assurance Officer approve all newly released documents and revised documents. Any employee can request a change to a document. Where necessary, obsolete documents may be retained for legal reasons or for knowledge preservation. The Quality Assurance Officer stores retained obsolete documents. Each page of documents produced by the laboratory will contain the effective date, revision number, Document number, and Document title. Controlled documents will have an approval signature page, a revision (change record) history page, and a distribution list.

    All SOPs and internal controlled documents are reviewed once per year. If a document is revised during the year the revision record in the document shall demonstrate review. If a document has not been revised during the year, the review record shall be the signature of the person responsible for the document and the date of the review. Amendment of documents is allowed pending formal re-issue. Such revisions will be dated and initialed, and the document will be formally revised when practicable.

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All data, including original observations, calculations and derived data, calibration records, QC

    records, and copies of the test reports, resulting from the analyses of samples are recorded and kept

    for five years to allow historical reconstruction of the final result.

6. Traceability of Measurements

Equipment shall be traceable to the US Dept of Energy Environmental Measurements Laboratory

    or equivalent national standard. All monitors shall be calibrated annually by the manufacturer.

7. Review of All Requests, Tenders and Contracts

All new work is initiated by the technical director who delegates responsibilities for the new work

    according to available resources. Staff meet prior to initiation of new work in order to determine if

    appropriate facilities and resources are available. The plan for any new testing shall be reviewed and

    approved by the technical director before commencing such work. If the review uncovers any

    potential conflicts, deficiencies, inappropriate accreditation status, and/or inability to perform the

    work, the laboratory shall notify the client. In cases where differences exist between the

    request/tender and contract they shall be resolved prior to starting work.

The review shall document that facilities and resources are organized to efficiently perform the work,

    including subcontracted work. The record of contract review includes pertinent discussions with the

    client regarding their requirements and results submitted during the contract period. For routine

    reviews of ongoing work a date and a signature of the laboratory official responsible for the contract

    is sufficient. For any new testing requirements, the designated official shall ensure that standard

    operating procedures and demonstration of capability to perform those tests prior to reporting

    results are available. The SOP(s) shall be under document control and a Demonstration of

    Capability statement(s) shall be on file. Copies are held in the contract review file.

Clients are notified immediately in situations where the laboratory cannot conform to the contract

    and if the there is a change in laboratory accreditation status.

8. Calibration/ Verification of Test Procedures.

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A. Calibration and/or verification procedures are designed to ensure that the data will

    be of known quality and be appropriate for a given regulation or decision. Details of

    instrument calibration and/or test verification procedures including calibration range,

    standardizations, calculations and acceptance criteria are included or referenced in

    each test method SOP.

B. Sufficient raw data are retained to reconstruct the calibration used to calculate the

    sample result.

C. All calibrations are verified with a second source standard which is traceable to a

    national standard, when available.

D. Calibration standards include a concentration at or below the regulatory/decision

    level but above the laboratorys detection limit.

E. Results of samples must be within the calibration range (bracketed by standards) or

    the results must be flagged as having less certainty.

F. No data associated with a calibration that is out-of-control will be reported.

G. Lower Limit of Detection (LLD) and Limit of Quantitation (LOQ):

    The lower limit of detection (LLD) must be less than 1.0 pCi/L. This

    limit is initially specified and verified by the device manufacturer. This

    level is monitored by the laboratory through the use of background

    measurements which are incorporated into the annual device calibration.

    The limit of quantitation (LOQ) for a single deployment is a function of

    the detector efficiency and the count time. When the uncertainty of the

    measurement exceeds 10%, it is no longer considered quantitative and

    the data may be expressed as less than the level corresponding to an

    uncertainty of 10%. Likewise, the relative standard deviation of two

    results from co-located devices must be less than 10% RSD. These

    parameters are monitored on an ongoing basis.

    9. Sample Handling

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A. Sample Acceptance Policy - Designated employees and trained sample collectors are

    the only official collectors of samples. Samples that have not been properly stored

    during transport to the laboratory shall not be accepted. Monitors that are found at

    receipt to be compromised will not be accepted. Each monitor test will be uniquely

    identified with property address when downloaded. For this laboratory, address,

    collection date, and time will be used to mark the samples submitted. The non

    interference agreement policy is available to the sample collectors. If any samples do

    not meet any requirements of the acceptance policy, the samples are not accepted for

    testing, and resampling is requested. The client is notified.

B. Procedures for handling submitted samples

    1. The sample acceptance policy is documented and available to the sample

    collectors. If any samples do not meet any requirements of the acceptance

    policy, the data is flagged in an unambiguous manner clearly defining the

    nature and substance of the variation.

    2. The sample receipt protocol is documented. The condition of the sample,

    including any abnormalities or departures from standard condition as

    prescribed in the relevant test method, is recorded.

    3. Receipt of all samples is recorded in a permanent chronological computer

    record. The record contains project name, date and time of laboratory

    receipt, laboratory ID, initials of recorder

    10. Laboratory Environment

A. Testing occurs only within the field, at temperatures between 45 degrees and 90

    degrees, with SOP conditions maintained.

B. All equipment and reference materials required for the accredited tests are available

    in the laboratory. Records are maintained for all equipment, reference

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