EPA_NATIONAL_LEAD_LABORATORY_ACCREDITATION_PROGRAM_.pdf

EPA NATIONAL LEAD LABORATORY ACCREDITATION PROGRAM

LABORATORY QUALITY SYSTEM REQUIREMENTS (LQSR)

REVISION 3.0 (November 05, 2007)

The requirements in this document apply to all lead testing laboratories participating in the Environmental Protection Agency's (EPA) National Lead Laboratory Accreditation Program (NLLAP). In addition to meeting the Laboratory Quality System Requirements (LQSRs), the lead testing laboratory must also successfully participate in the Environmental Lead Proficiency Analytical Testing (ELPAT) Program.

NLLAP was established by the EPA Office of Pollution Prevention and Toxics (OPPT) under the legislative directive of Title X, the Lead-Based Paint Hazard Reduction Act of 1992 Sections 405 (a) and (b) requiring EPA to set minimum standards for laboratory analysis of lead in paint films, soil and dust.

Concerning any future revisions to the NLLAP Laboratory Quality System Requirements, laboratories currently participating in NLLAP will be given a period of eighteen months from the posting of the revision on the http://epa.gov/lead/nllap.htm to conform to any new requirements stated in the revision. For further information concerning NLLAP, please address your request in writing to:

Benjamin Lim U.S. Environmental Protection Agency Ariel Rios Building (7404T) Office of Pollution Prevention and Toxics 1200 Pennsylvania Ave., N.W.

Washington D.C. 20460

NLLAP LQSR Rev. 3.0 11/05/07

TABLE OF CONTENTS

Page:

1.0 SCOPE 1

1.1 LABORATORY TYPES 1

2.0 NORMATIVE REFERENCES 2

3.0 TERMS AND DEFINITIONS 2

4.0 MANAGEMENT REQUIREMENTS 2

4.1 ORGANIZATION AND MANAGEMENT 2

4.1.1 Technical Manager 3

4.1.1.1 Qualifications 3

4.1.1.2 Responsibilities 4

4.1.2 Quality Manager 4

4.1.2.1 Qualifications 4

4.1.2.2 Responsibilities 4

4.2 QUALITY MANAGEMENT SYSTEM 4

4.2.1 Quality Management System Establishment and Maintenance 5

4.2.2 Quality Policy Statement 5

4.2.3 Quality Management System Manual 6

4.3 DOCUMENT CONTROL 7

4.3.1 General 7

4.3.2 Document Approval and Issue 7

4.3.3 Document Changes 8

4.3.4 Document Review and Revision 8

4.4 REVIEW OF REQUEST, TENDER OR CONTRACT 8

4.5 SUBCONTRACTING OF TESTS 9

4.6 PURCHASING SERVICES AND SUPPLIES 9

4.6.1 Reagents and Standards 9

4.6.1.1 Reagent Grades Used 9

4.6.1.2 Reagents and Standards Tracking 9

4.7 SERVICE TO THE CUSTOMER 10

4.8 COMPLAINTS 10

4.9 IMPROVEMENTS 10

4.10 CONTROL OF NONCONFORMING TESTS 10

4.11 CORRECTIVE ACTION 11

4.11.1 General 11

4.11.2 Cause Analysis 11

4.11.3 Corrective Actions 11

4.11.4 Monitoring the Corrective Actions 11

Page:

4.11.5 Special Audits 11

4.12 PREVENTIVE ACTION 12

4.13 RECORDS 12

4.13.1 Sample Records 13

4.13.2 Laboratory Quality Management System and Test Records 14

4.13.3 Electronic Data 14

4.14 INTERNAL AUDITS 15

4.15 MANAGEMENT REVIEWS 15

5.0 TECHNICAL REQUIREMENTS 16

5.1 GENERAL 16

5.2 PERSONNEL 16

5.2.1 Analysts and Technicians 17

5.2.1.1 Minimum Qualifications and Training for Analysts

and Technicians 17

5.2.1.2 Additional Requirements for Mobile and FSMO

Personnel 18

5.3 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS 19

5.3.1 Contamination Control 19

5.3.1.1 Laboratory Dust Wipe Checks 19

5.3.1.2 Labware Cleaning 19

5.4 TEST AND SAMPLING METHODS 20

5.4.1. Acceptable Methodology 20

5.4.2 Method Validation and Performance Demonstration

Procedures 21

5.4.3 Sample Preparation and Analysis Procedures 23

5.4.3.1 Standard Operating Procedures 23

5.4.4 Method Performance Characteristics 24

5.4.4.1 Method Detection Limits 24

5.4.4.2 Quantitation Limits 24

5.4.4.3 Bias and Precision 24

5.4.5 Sample Aliquots 24

5.4.6 Data Reduction and Review Process 24

5.4.6.1 Estimate of Uncertainty of Measurement 25

5.5 EQUIPMENT 25

5.5.1 Instrument Calibration and Performance Quality Checks 26

5.5.2 Instrument Calibration Performance Requirements 26

5.5.2.1 Initial Calibration 27

5.5.2.2 Independent Calibration Verification 27

5.5.2.3 Continuing Calibration Verification 28

Page

5.5.2.4 Continuing Calibration Blank (CCB) 28

5.6 MEASUREMENT TRACEABILITY 31

5.6.1 Reference Standards and/or Reference Materials 31

5.6.2 Documentation of Reagent and Calibration Solution

Preparation 31

5.7 SAMPLING 32

5.7.1 Sampling Media 32

5.8 SAMPLE HANDLING 32

5.8.1 Sample Control 32

5.8.2 Sample Acceptance, Documentation and Tracking Procedures 32

5.8.2.1 Sample Acceptance Policy 32

5.8.2.2 Sample Receipt Logs 33

5.8.2.3 Documentation on Questionable Samples 33

5.8.2.4 Sample Custody Procedures 34

5.8.2.5 Sample Tracking 34

5.9 ASSURING THE QUALITY OF TEST RESULTS 34

5.9.1 Quality Control Procedures 35

5.9.1.1 Bias Determination 36

5.9.1.2 Precision Determination 37

5.9.2 Control Charts or Quality Control Data Base 39

5.9.3 Procedures for Determination of Out of Control Situations 39

5.10 REPORTING THE RESULTS

Glossary 46

5.10.1 General 39

5.10.2 Test Reports 40

5.10.2.1 Reporting Results Below the Quantitation Limit 42

5.10.2.2 Opinions and Interpretations 42

5.10.3 REPORT REVIEW AND APPROVAL PROCESS 42

5.10.4 TEST REPORT CORRECTION PROCESS 43

5.10.4.1 Corrections and Amendments to Test Reports 43

5.10.4.2 Test Results Obtained from Subcontractors 43

5.10.4.3 Electronic Transmission of Results 43

Table 1 29 Table 2 30 Table 3 37 Table 4 38

APPENDIX I 44

Acronyms 44

NLLAP LQSR Rev. 3.0 11/05//07

NATIONAL LEAD LABORATORY ACCREDITATION PROGRAM (NLLAP)

LABORATORY QUALITY SYSTEM REQUIREMENTS

This document identifies the minimum requirements for use by accreditation organizations when evaluating laboratories performing environmental testing activities under NLLAP and is based on requirements of International Organization for Standardization and International Electrochemical Commission (ISO/IEC) Standard 17025: 2005 (E) "General requirements for the competence of testing and calibration laboratories". NLLAP recognizes laboratories that perform quantitative and/or qualitative analytical testing of paint chip (film), dust, and/or soil samples for lead analysis. NLLAP requires recognized laboratories to employ quality assurance/quality control systems that meet the requirements described in this document, to monitor for potential sample matrix and environmental interferences as well as laboratory operational deficiencies.

INTRODUCTION AND PURPOSE

1.0 SCOPE

The requirements described within this document must be met for an organization to attain recognition under the NLLAP as a lead testing laboratory, hereafter referred to in this document as a laboratory. An organization requesting recognition under this program shall possess a laboratory operation capable of performing sampling and lead testing. A laboratory shall have distinct staffing, instrumentation, sampling and test methods, as appropriate, and depending upon the type laboratory may have physical facilities and may use field test kits.

Laboratory accreditation under this program shall be based on its meeting the requirements listed in this document.

1.1 LABORATORY TYPES

For the purposes of NLLAP, a laboratory is defined as an operation that performs sampling and/or quantitative and/or qualitative analytical testing of paint chip (film), dust, and/or soil samples for lead analysis regardless of the number of personnel or the extent of the scope of testing activities.

NLLAP recognizes three types of laboratory operations: fixed-site, mobile and field sampling and measurement organization (FSMO). These types of laboratory operations are defined as follows:

Fixed-Site: An operation that performs analytical lead testing at a permanent location under controlled environmental conditions.

Mobile Facility: A transportable, self contained operation that can perform analytical lead testing under controlled environmental conditions.

Field Sampling and Measurement Organization (FSMO): An operation that performs on-site sampling and lead testing using portable testing technologies.

A laboratory may include one, two or all three of these types of operations. In cases where a laboratory does not perform one or more of the operations addressed above, the requirements relating to those activities do not apply.

2.0 NORMATIVE REFERENCES

The following normative documents were used in the writing of this set of requirements.

NLLAP LQSR Rev. 2.0 08/01/96.

ISO/IEC Standard 17025: 2005 (E) "General requirements for the competence of testing and calibration laboratories".

40 CFR Part 745 - Lead-Based Paint Activities.

Performance Characteristics Sheets (PCS), available at:

http://www.hud.gov/utilities/intercept.cfm?/offices/lead/guidelines/hudguidelines/ Allpcs.pdf

3.0 TERMS AND DEFINITIONS

A list of Acronyms and a Glossary of Terms used in this document is in Appendix 1.

4.0 MANAGEMENT REQUIREMENTS

4.1

The laboratory management shall accept legal responsibility for its actions and ensure that appropriate communication processes are established within the laboratory so that communication takes place regarding the effectiveness of the laboratory quality management

ORGANIZATION AND MANAGEMENT

http://www.hud.gov/utilities/intercept.cfm?/offices/lead/guidelines/hudguidelines/� http://www.hud.gov/utilities/intercept.cfm?/offices/lead/guidelines/hudguidelines/� system. In addition, policies and procedures needed to ensure that management and personnel are free from any conflicts of interest that might adversely affect the quality of work performed shall be documented and implemented in the quality management system manual (QMSM).

Procedures shall be implemented to ensure confidentiality of customer information and protection of proprietary rights.

The laboratory shall have job descriptions for all positions and an organizational chart or other means of identifying the functions of key personnel, their responsibilities, lines of supervision, and authority. Laboratory management shall be responsible for all personnel employed by the laboratory including those assigned to mobile laboratories and/or FSMOs and for ensuring that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the quality management system.

The laboratory shall also appoint (or contract out) one member of the staff to act as quality manager. The quality manager shall have the responsibility and authority for assuring implementation of the quality management system at all times, and shall be free of any conflict of interest.

All NLLAP recognized laboratories shall identify a responsible laboratory official who is authorized to release test reports on behalf of the laboratory. In a laboratory with one person, that person will be the responsible official for the release of the test report. That person may either serve as the technical manager or the quality manager, but cannot serve as both. In the case of a laboratory with only one employee, one of these positions shall be contracted out. See Sections 4.14, 5.4.6 and 5.10.3 below for requirements on one-person firms regarding internal audits and the release of test reports.

The following specific personnel requirements shall apply to NLLAP recognized laboratories. In laboratories with a limited number of personnel, individuals may be assigned more than one duty (except that no individual may be both the technical manager and the quality manager).

4.1.1 Technical Manager

4.1.1.1 Qualifications

The individual who functions as the technical manager (however named) of the laboratory shall have appropriate education, training, and experience, or combination thereof for the measurement technologies used by the laboratory, to 1) be able to design and implement the management system, and 2) enable that individual to identify the occurrence of departures from the implemented quality management system or test procedures and to initiate actions to prevent or minimize such departures.

4.1.1.2 Responsibilities

The technical manager or their designee shall be responsible for all technical operations and shall be available to address technical issues for laboratory staff and customers concerning NLLAP related analyses.

The technical manager shall ensure and document the competence of all who operate specific equipment, perform tests, evaluate results, and sign test reports. The competence determination shall be based on appropriate education, training, experience and/or demonstrated skills.

The technical manager shall ensure that adequate supervision is provided for all laboratory technical personnel.

4.1.2 Quality Manager

4.1.2.1 Qualifications

The individual who functions as the quality manager (or however named) of the laboratory shall have the education, training, and experience, or combination thereof, to enable that individual to identify the occurrence of departures from the implemented quality management system and to initiate actions to prevent or minimize such departures. The quality manager shall be knowledgeable of the quality management system and the technical and management system procedures used.

4.1.2.2 Responsibilities

The quality manager shall have defined responsibility and authority to implement and oversee the quality management system, implement new quality assurance and control practices, perform periodic audits of the quality management system, perform periodic review of test reports prior to issue, and to ensure laboratory quality management system deficiencies are documented and that corrective actions are implemented.

4.2 QUALITY MANAGEMENT SYSTEM

The laboratory quality management system shall include all the policies and procedures required by this document and the performance of the activities covered by its scope of accreditation. The quality management system manual (QMSM) shall contain all the required policies and must either contain or cite the related quality documentation and procedures to help ensure and document the quality of the analytical data.

The QMSM and related quality documentation shall state the laboratory's policies and operational procedures established in order to meet the requirements of this document.

All items in the laboratory's quality system shall be available for on-site inspection or audit by EPA NLLAP personnel and by accreditation organizations participating in NLLAP or, if applicable, to federal/state/tribal program certifying officials.

Laboratory management shall:

a. Provide evidence of its commitment to the development and implementation of the quality system and continually improving the effectiveness of the quality management system;

b. Ensure the integrity of the quality management system is maintained when changes to the quality system are planned and implemented; and

c. Communicate to the organization the importance of meeting customer as well as statutory and regulatory requirements.

4.2.1 Quality Management System Establishment and Maintenance

The laboratory shall establish and maintain a quality management system to ensure the quality of its testing.

a. The elements of this system shall be documented;

b. The quality documentation shall be available for use by laboratory personnel;

c. The laboratory management shall ensure that these policies and objectives are documented in a QMSM and communicated to, understood, and implemented by laboratory personnel; and

d. The QMSM shall be reviewed annually, updated as needed and maintained under the responsibility of the quality manager or however named. (see 4.3.4 below)

4.2.2 Quality Policy Statement

Laboratory management shall define and document the objectives and policies of the quality management system. These policies and objectives shall be documented in a QMSM.

The overall policy on quality management shall be provided in the QMSM, and shall denote the standard of performance to be obtained and maintained. The chief executive (person authorized to make decisions e.g. president, executive director) shall issue the quality policy statement. It shall include:

a. A statement of the standard of service the laboratory management intends to provide;

b. The purpose of the quality management system;

c. A requirement that all personnel involved with testing activities within the laboratory acquaint themselves with quality management system documentation and implement the policies and procedures used in their work;

d. The commitment of the laboratory to good professional laboratory practice and quality of service to the customer; and

e. The laboratory management’s commitment to compliance with the requirements of this document.

4.2.3 Quality Management System Manual (QMSM)

The QMSM shall include the defined roles and responsibilities of the technical manager and the quality manager, including each of their responsibility for ensuring compliance with the requirements of this document. The quality management system shall include an organizational chart identifying key personnel, responsibilities, lines of authority, and interrelationships of staff.

The QMSM shall include or make reference to the supporting procedures including technical procedures and shall outline the structure of the documentation used in the management system.

The QMSM and related quality documents shall include or address at least the following elements:

■ Title Page

■ Table of Contents

■ Management requirements

■ Organization (4.1)

■ Quality Management System (4.2)

■ Document control (4.3)

■ Review of requests, tenders and contracts (4.4)

■ Subcontracting of tests and calibrations (4.5)

■ Purchasing services and supplies (4.6)

■ Service to the customer (4.7)

■ Complaints (4.8)

■ Control of nonconforming testing and/or calibration work (4.9)

■ Improvement (4.10)

■ Corrective action (4.11)

■ Preventive action (4.12)

■ Control of records (4.13)

■ Internal audits (4.14)

■ Management reviews (4.15)

■ Technical requirements

■ General (5.1)

■ Personnel (5.2)

■ Accommodation and environmental conditions (5.3)

■ Test and calibration methods and method validation (5.4)

■ Equipment (5.5)

■ Measurement traceability (5.6)

■ Sampling (5.7)

■ Handling of test and calibration items (5.8)

■ Assuring the quality of test and calibration results (5.9)

■ Reporting the results (5.10)

The QMSM shall be updated whenever necessary and reviewed and approved by management at least annually. The QMSM shall be accessible to all laboratory personnel.

4.3 DOCUMENT CONTROL

4.3.1 General

The NLLAP recognized laboratory shall establish and maintain procedures for the control of all documents (both internal and external documents) that form the quality management system. Examples of external documents that may be included are standards, regulations, normative documents, test and/or calibration methods, drawings, specifications, instructions, and manuals. The laboratory document control system shall ensure that all standard operating procedures, manuals, and/or documents clearly indicate the time period during which the procedure or document was in force.

4.3.2 Document Approval and Issue

All documents in the laboratory shall be reviewed and approved before their release for use by authorized personnel. A system shall be implemented for identification of the current revision status of quality system documents to prevent use of invalid or obsolete documents.

Quality system documents generated by a laboratory shall be clearly identified. Included in the identification shall be the issue date, revision identification and the total number of pages or a clearly marked document end.

4.3.3 Document Changes

Document changes shall be reviewed by the same personnel that reviewed the original document, unless otherwise indicated. Where possible, changes to the document shall be noted in the document or in an attachment. Documents may be amended by hand pending re-issue of the most current version, where permitted. A revised document shall be re-issued as soon as practicable.

A system shall be established and used to record changes made in computerized systems.

4.3.4 Document Review and Revision.

The laboratory shall outline in its QMSM or document control standard operating procedure (SOP), the process for adopting and revising of quality management system documents. This process shall address when and how the laboratory’s documents are reviewed, identify the sign off authority, and state that the laboratory documents are reviewed at least annually and/or revised as needed.

4.4

a. The requirements including the methods to be used are adequately defined, documented, and understood;

REVIEW OF REQUEST, TENDER OR CONTRACT

Procedures shall be established by the laboratory for the review of requests, tenders, or contracts. The policies and procedures shall ensure that:

b. The laboratory has the capability and resources to meet the requirements; and

c. The appropriate test method is selected and capable of meeting the customer’s requirements.

Differences between the customer’s request and the contract offered to the customer shall be resolved based on the QMSM policies and procedures before any work commences. The contract shall be acceptable to both the laboratory and customer. Changes made at the contract review shall be recorded and maintained. Contract review shall also cover work to be subcontracted by the laboratory. If the contract requires amendment after work has begun, the same contract review process shall be repeated and amendments communicated to all necessary personnel. The customer shall be informed of any deviations from the contract.

4.5 SUBCONTRACTING OF TESTS

An NLLAP recognized laboratory shall only subcontract work when necessary and with the approval of the customer. Work shall only be performed by another NLLAP recognized laboratory. The laboratory shall be able to demonstrate that the subcontractor is accredited by an NLLAP recognized accrediting body for the methods in question. A list of all subcontractors used for tests shall be compiled along with records of the evaluation of the subcontractors’ qualifications.

4.6 PURCHASING SERVICES AND SUPPLIES

The laboratory shall implement policies and procedures for the selection and purchase of services and supplies that impact the quality of tests. Only services and supplies that satisfy and maintain the quality needed to produce acceptable test results shall be purchased. The laboratory shall have procedures for the purchase, receipt and storage of reagents and laboratory consumables that impact the quality of tests.

Purchasing documents shall clearly describe the product ordered. The laboratory shall ensure that supplies purchased are not used until properly inspected or otherwise verified for compliance with standard specifications or method requirements.

4.6.1 Reagents and Standards

Requirements for reagents and standards shall be specified in the documented QMSM and/or technical procedures.

4.6.1.1 Reagent Grades Used

Reagents shall be at least American Chemical Society (ACS) reagent grade or of the quality specified by the analytical methods in use by the laboratory.

4.6.1.2 Reagents and Standards Tracking

Upon receipt, purchased reagents and standards shall be inspected, dated and initialed or otherwise evaluated to verify the purchasing document specifications have been met. An expiration date shall be assigned to each reagent and standard. Reagents and standards shall not be used beyond assigned expiration dates nor used if damaged or contaminated or suspected to be damaged or contaminated.

When available, the laboratory shall maintain certificates of analysis or other documentation on the manufacturer's statement of purity, of the origin and traceability of all reagents and standards.

4.7

The laboratory shall have documented policy and procedures for the resolution of complaints received from customers or other parties about the laboratory's activities or results.

The policy shall include the notice that “Any complaint about the quality of reported results may be referred to the accrediting body if such complaints cannot be resolved directly with the customer.” See the NLLAP web page at:

SERVICE TO THE CUSTOMER

The NLLAP recognized laboratory shall cooperate with the customer. This may include providing the customer or customer’s representative reasonable access to areas of the laboratory to witness work performed for that customer or providing test or sample items needed by that customer for purposes of verification. The laboratory should also maintain contact with the customer throughout the period of work and inform the customer of any delays and/or deviations in performance of the tests. Laboratories are also encouraged to seek feedback from the customer for improvement of the quality system.

4.8 COMPLAINTS

www.epa.gov/lead/nllap.htm for the contact information of the recognized accrediting bodies. A record shall be maintained of all complaints and of the actions taken by the laboratory. Where a complaint, or any other circumstance, raises doubt concerning the laboratory's compliance with policies its own procedures, the requirements of this document, the quality management system and/or the quality of the laboratory's analyses, the laboratory shall ensure that those areas of activity are promptly audited.

4.9 IMPROVEMENTS

The laboratory shall continually improve the effectiveness of its quality management system through the use of its quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

4.10

The laboratory shall have documented policy and procedures for handling nonconforming tests and for describing and recording actions taken when nonconforming tests are identified. No data shall be reported until the cause of the problem is determined and corrected, or the laboratory demonstrates that the root cause of the nonconformance was a random event. The laboratory shall maintain records of all nonconforming tests or out-of-control events, the determined cause(s), and corrective action(s) taken. The laboratory shall respond to customer

CONTROL OF NONCONFORMING TESTS

http://www.epa.gov/lead/nllap.htm� complaints and maintain records of corrective action. Once corrective action(s) have been implemented, the laboratory shall monitor the results to make sure the actions taken have been effective at addressing the problem(s) of nonconformance.

4.11 CORRECTIVE ACTION

4.11.1 General

A policy and procedure for corrective action shall be established and implemented for use by appropriate laboratory authorities when nonconforming work is identified. Required changes to the operational procedures resulting from corrective action investigations shall be properly documented and implemented. When reported results have been affected by nonconforming tests all affected customers shall be contacted and informed of the corrective action taken and the amended results (see 5.10.4).

4.11.2 Cause Analysis

Corrective action procedures shall begin with an investigation to determine the root cause(s) of the problem.

4.11.3 Corrective Actions

Once the root causes have been identified, the laboratory shall identify possible corrective actions. The action(s) most likely to eliminate the problem and prevent its recurrence shall be selected and implemented.

4.11.4 Monitoring the Corrective Actions

Once corrective action(s) have been implemented, the laboratory shall monitor the results to make sure the actions taken have been effective at addressing the problem(s) that caused the nonconformance.

4.11.5 Special Audits

If there is doubt that the laboratory is complying with its own policies and procedures or those of relevant standards, then the laboratory shall ensure that the appropriate areas of activity are audited.

4.12 PREVENTIVE ACTION

Needed improvements and potential sources of nonconformance, either technical or concerning the quality management system, shall be identified. When improvement opportunities are identified or if preventive action is required, action plans shall be developed, implemented and monitored to reduce the likelihood of the occurrence of such, nonconformities and to take advantage of the opportunities for improvement.

4.13 RECORDS

The records for each laboratory activity shall contain sufficient information so that it may be repeated or otherwise verified. The record keeping system shall allow historical retrieval of all laboratory activities that were used to produce the associated test report. The record keeping system shall facilitate the retrieval of all records. Additional record keeping guidance is available from ASTM: E 2239 “Standard Practice for Record Keeping and Record Preservation for Lead Hazard Activities.”

a. All records (including those pertaining to calibration and test equipment, certificates, and reports) shall be safely stored, held secure and treated as confidential;

b. All records of the laboratory associated with its work activities shall be retained for a minimum of five years. All hardware and software necessary for the historical retrieval of data must be maintained by the laboratory. These records shall include a history of the locations of mobile laboratory and FSMO operations, including a specific description of where the sampling and testing work activity was performed and these records shall be maintained for at least five years;

c. Access to archived records shall be controlled using an access log. All records shall be stored and retained in readily accessible facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. Records may be in hard paper copy or electronic media;

d. In the event that a laboratory goes out of business, the laboratory shall have a plan to ensure that its records are maintained or transferred according to the customer's instructions and applicable regulations;

e. The records shall include the identity of all personnel involved in sampling (if known), sample preparation, calibration, analysis, final reporting. Also, a record of the signature and initial for the name of employees shall be created and maintained; and

f. Entries in records shall not be obliterated by methods such as erasures, overwritten files, or markings. All corrections and/or amendments to records shall be made with a single strike out line through the error and/or the correct data or value added alongside, as appropriate. All handwritten data shall be recorded using permanent ink. The individual making the correction shall sign (or initial) and date the correction.

4.13.1 Sample Records

A record of all procedures to which sample is subjected (sampling, preparation and testing) while in the possession of the laboratory shall be maintained for a period of at least five years as a readily retrievable hard copy or electronic media that can be generated without change.

These records shall include, but are not limited to, records of:

a. Sample identification, receipt, acceptance or rejection and log-in;

b. Sample storage and tracking including shipping receipts, where applicable;

c. Sample preparation, instrument printouts, and calculations, where applicable;

d. Sample analysis logs;

e. Standard and reagent origin, receipt, preparation, and use;

f. Equipment and instrument operating conditions;

g. Calibration criteria, frequency and acceptance criteria;

h. Data and statistical calculations, review, confirmation, interpretation, assessment, and reporting conventions;

i. Method performance criteria;

j. Quality control protocols and assessment;

k. Storage and retention; and

l. Sample disposal procedures and schedule.

4.13.2 Laboratory Quality Management System and Test Records

In addition to documenting all the above mentioned activities, the following shall be retained:

a. All original raw data, hard copy or electronic, for sampling and testing activities to include: calibrations, samples, and quality control measurements, work sheets and data output/instrument response readout records;

b. A written description or reference to the specific method used which includes a description of the specific steps in the calculation used to translate parametric observations into a reportable analytical value;

c. Copies of final reports;

d. Archived standard operating procedures;

e. Correspondence relating to laboratory work activities;

f. All corrective action reports, audits, and audit responses;

g. Performance evaluation results and raw data; and

h. Data review and cross checking.

4.13.3 Electronic Data

Where computers or automated equipment are used for the capture, processing, manipulation, recording, reporting, storage or retrieval of data, the laboratory shall ensure that:

a. Electronic computer records can satisfy the record keeping requirement without hard copy files if hard copies can be generated without changing the information;

b. The computer programs are validated before they are used and whenever the programs are changed;

c. Computer file backup procedures are completed in accordance with a predetermined schedule; and

d. Records that are stored or generated by computers have a hard copy or write-protected backup copies.

4.14 INTERNAL AUDITS

At least annually, the laboratory shall, in accordance with a predetermined schedule and procedure, conduct internal audits of its activities to ensure that operations comply with the requirements of this document and the established quality management system. The quality manager shall be responsible for the planning and implementation of such audits. Such audits shall be carried out by trained and qualified staff that are, whenever possible, independent of the activities to be audited. All relevant information pertaining to the audit activity shall be recorded. In a one-person organization, the annual audits may be conducted by the one member of the laboratory if that person follows independent third-party guidance for conducting a quality system audit, such as ISO 19011, Guidelines for quality and/or environmental management systems auditing or similar third party guidance published by organizations such as ASTM (American Society for Testing and Materials) or ANSI (American National Standards Institute) and creates and maintains a written audit report of the audit findings in its record system.

Alternatively, the one-person organization may choose to contract out the internal audit to an independent person or firm that is competent and has the experience and training to conduct an audit of a quality system.

When the audit finds doubt on the correctness or validity of the laboratory test results, timely corrective action shall be taken by the laboratory. If the audit indicates that laboratory results may have been affected, customers shall be notified and informed of the corrective action taken and the amended results.

4.15 MANAGEMENT REVIEWS

The quality system adopted to satisfy the requirements of the NLLAP LQSR shall be reviewed at least once a year by the laboratory management to ensure its continuing suitability and effectiveness and to introduce any necessary changes or improvements (see 4.9). Such reviews shall be carried out by the laboratory management in accordance with a predetermined schedule and procedure. The review shall take account of:

■ The suitability of policies and procedures

■ Reports from managerial and supervisory personnel

■ The outcome of recent internal audits

■ Corrective and preventive actions

■ Assessments by external bodies

■ The results of interlaboratory comparisons or proficiency tests

■ Changes in the volume and type of the work

■ Customer feedback

■ Complaints

■ Recommendations for improvement

■ Other relevant factors, such as quality control activities, resources and staff training

All relevant information pertaining to the management review shall be recorded. The laboratory management shall ensure that necessary changes or improvements are carried out within an appropriate and agreed timescale.

5.0 TECHNICAL REQUIREMENTS

5.1 GENERAL

Many factors contribute to the correctness and reliability of lead measurements performed by a laboratory. These factors include contributions from:

■ Human factors (personnel) (5.2)

■ Accommodation and environmental conditions (5.3)

■ Test and sampling methods (5.4)

■ Equipment (5.5)

■ Measurement traceability (5.6)

■ Sampling (5.7)

■ Sample handling (5.8)

These factors shall be taken into account by the laboratory in developing test and calibration methods, in training personnel, and in the selection of equipment used.

5.2 PERSONNEL

Laboratory management shall ensure that all laboratory personnel performing NLLAP recognized analyses are educated, trained, experienced, skilled and competent in performing lead sampling and testing activities, as appropriate. Staff assigned to operate equipment, perform tests, evaluate results, and sign test reports shall be qualified and authorized in writing by management to do so. When using staff in training, adequate supervision shall be provided. A record of all employees and their associated competence, training, skills, experience, authorizations and professional qualifications shall be clearly defined, documented, and maintained on file. The criteria and training requirements for laboratory personnel shall be clearly defined, documented, and readily available. Training records shall include a description of training program contents, the duration of the training, qualifications of the trainer, and evidence that the analyst and/or technician has successfully demonstrated their competence, such as described in Section 5.2.1.1.

Goals for the laboratory training program shall be formulated by laboratory management and a training program shall be in place to address the training needs of laboratory employees and shall be relevant to the present and anticipated needs of the laboratory. The effectiveness of the training shall be evaluated. The laboratory shall maintain current job descriptions for managerial, technical, and key support staff involved in sampling and testing activities, as appropriate.

The NLLAP recognized laboratory shall use permanently employed staff or those under contract to the laboratory. When additional support or technical personnel (such as temporary employees) are needed, the laboratory shall ensure that such personnel are competent, supervised and work within the quality management system.

5.2.1 Analysts and Technicians

Personnel who function as analysts and/or technicians (however named) in the laboratory shall have the education, training, experience and/or demonstrated skills or combination thereof, to enable them to adhere to the implemented quality system and to competently perform test procedures, operate laboratory equipment, evaluate test results and sign test reports (when authorized).

5.2.1.1 Minimum Qualifications and Training for Analysts and Technicians

5.2.1.1.1 NLLAP analysts and/or technicians shall have hands on experience conducting lead sampling and testing activities, as appropriate, before being authorized to work on NLLAP related samples.

5.2.1.1.2 Analysts and technicians shall complete an external and/or internal training program for lead sampling and testing activities, as appropriate, prior to performing those activities on NLLAP related samples. Courses on sample selection, collection, preparation (when applicable) and instrumental analysis may be taken separately or combined. The criteria and training requirements for laboratory personnel shall be clearly defined, documented and maintained on file.

A description of the training program content, the duration of the training, qualifications of the trainer, and objective evidence that the analyst and/or technician has successfully selected and/or collected samples and prepared and tested, as appropriate, known reference samples of the matrices of concern within the specified acceptance criteria must be maintained by the laboratory.

5.2.1.1.3 The analyst and/or technician trainee shall complete a minimum of four independent test runs of sample preparation (when applicable) and/or instrumental analysis for each matrix. An independent run is defined as analysis of at least five samples of known lead content, one of which is a certified reference material or proficiency testing material and is separated by a period of time sufficient to evaluate the performance of any previous independent run. For sample preparation training, the recoveries of the associated reference materials or proficiency training samples for each run must be within the requirements of Table 3. For instrumental analysis training, the recoveries of the associated reference materials or proficiency training samples for each run must be within either Table 3 or 4 as applicable.

For some analytical testing technologies it may not be possible to separate the sample preparation techniques from instrumental analyses. In such cases, the training requirements shall be based upon the minimum requirements stated for both analysts and technicians.

The reference material/proficiency test samples utilized shall: 1) be similar to matrices the analyst and/or technician will encounter during routine lead sample analysis, and 2) cover the sample mass/concentration range for which the analytical SOP has been validated.

5.2.1.1.4 Analyst and/or technicians shall periodically demonstrate their ability to proficiently test samples for lead at least every six months.

5.2.1.2 Additional Requirements for Mobile and FSMO Personnel

5.2.1.2.1 All mobile laboratory and FSMO personnel involved in the selection of samples or sampling areas as a part of a lead-based paint risk assessment and/or clearance testing in target housing and/or child occupied facilities shall also be certified by EPA or an authorized state or tribal program as a risk assessor/inspector/sampling technician as pursuant to Section 402 of the Toxic Substance Control Act (TSCA) and its implementing regulations.

5.2.1.2.2 All mobile or FSMO technicians shall be evaluated by a competent supervisor for their first two NLLAP-related job sites.

5.3

Cleaning procedures for labware shall be specified by the laboratory in a written Standard Operating Procedures (SOP). The procedure shall include, where applicable, a specified frequency for monitoring of lead concentrations in cleaning baths, the monitoring of glassware

ACCOMMODATION AND ENVIRONMENTAL CONDITIONS

Any fixed site or mobile laboratory operation shall have, as appropriate, the space, equipment, instruments, ventilation, utility services, storage space, safety equipment, and documentation and references necessary to accomplish the analyses for lead concentrations in the matrices of concern (see 29 CFR § 1910.1450 for information). FSMOs shall have appropriate storage facilities to maintain the integrity of the testing equipment when not in use. The use of non mercury containing temperature measuring devices traceable to the NIST standards shall be encouraged.

Temperature, humidity, ventilation, dust, and vibration shall be controlled and/or monitored to meet instrument and/or sample analysis requirements. Tests shall be terminated when environmental conditions jeopardize the results of the test.

Incompatible activities in the laboratory shall be separated to prevent cross-contamination. Access to areas affecting the quality of test and/or calibrations shall be controlled. The integrity of the laboratory shall be maintained with good housekeeping practices. For laboratories operating portable testing technologies, sample collection and field testing shall be conducted so as to minimize the chance of cross-contamination. Site access shall be controlled to the extent possible while sampling and testing are taking place. Activities at the site shall be conducted to minimize the possibility of creating a hazard during or after testing, or contaminating the site from sampling and testing.

5.3.1 Contamination Control

5.3.1.1 Laboratory Dust Wipe Checks

For fixed-site and mobile laboratory facilities, contamination control by wipe sampling of sample preparation and testing area surfaces shall be conducted at least quarterly to determine surface concentration levels of lead. Sample preparation and analysis is not to proceed until surface contamination is below the specified maximum allowable concentration of 50 percent (%) of the lowest regulatory limit for dust wipe samples (See 40 CFR Part 745 Final Rule, Federal Register, Vol. 61, no. 169, August 29,1996, page 45793). For FSMO, appropriate contamination control blank samples shall be run in order to monitor potential lead contamination as outlined in the QMSM.

5.3.1.2 Labware Cleaning

contamination during the analysis of reagent or other blanks, and periodic monitoring of disposable labware contamination by analyzing of reagent or other blanks. To assess possible contamination, glassware used for the method blanks should be processed through acid baths used by the laboratory for labware cleaning.

5.4 TEST AND SAMPLING METHODS

5.4.1. Acceptable Methodology

The test methods or written SOPs, dated and approved by the appropriate authority, shall be available for use where work activities are performed. The laboratory shall have demonstrated that the test and/or sampling methods used are suited for the intended use. In addition the laboratory shall have records of method performance demonstration and validation for developed or modified laboratory procedures, which include method detection limit (MDL), bias and precision.

a. Methods shall not be used for sample analysis until the laboratory has confirmed and documented its proficiency in using these methods. Competency in using test methods shall be demonstrated over the lead concentration and sample mass ranges for each matrix stated by the method, as appropriate;

b. Where sample preparation and analysis methods are not specified by regulatory programs, the laboratory shall, whenever possible, use validated procedures published by federal agencies such as EPA, HUD or NIOSH, state agencies, or nationally or internationally recognized consensus standards organizations such as ASTM International. For methods under consideration for analytical testing the laboratory shall demonstrate it can achieve a quantitation limit equal to or less than 20 % of the lowest relevant action level or regulatory limit of interest for paint and soil and 50 % of the lowest action level for dust wipe samples.

Laboratory SOPs for sample analysis may require additional QC procedures to those stated in the published methods in order to meet requirements of this document. Acceptable sampling methods are cited in 40 CFR Part 745 - Lead- Based Paint Activities;

c. New, alternative or modified analytical methods and/or new testing technologies may be used by a laboratory if they have been validated by the laboratory or a third party, and shown to meet the minimum performance requirements stated in 5.4.1(b). The method validation must be documented by the laboratory or qualified third party. In the case where validation is done by a party other than the laboratory, the laboratory shall confirm its competency utilizing the method as described above in Section 5.4.1(a);

Acceptable operating characteristics for non-numerical or pass-fail technologies

(positive or negative screen technologies) shall be appropriate to the associated regulatory limits (e. g., the measured value including its 95 percent (%) uncertainty of measurement must be less than the associated regulatory limit); and

d. When a laboratory offers analyses of composite dust wipe samples, the laboratory analytical method for composite dust wipe samples shall address increase of sample mass. The laboratory shall meet the minimum performance requirements stated in 5.4.1(b) and demonstrate its competency utilizing the method as described above in Section 5.4.1(a).

5.4.2 Method Validation and Performance Demonstration Procedures

A list of guidance documents that should be helpful in dealing with method validation and performance demonstration that include good professional laboratory principles and practices are listed below:

■ AOAC International operates method validation programs. Information on these programs is available at: http://www.aoac.org/vmeth/page1.htm

■ U.S. EPA Office of Solid Waste “Guidance for Method Development and Method

Validation for the RCRA Program, June 1995” at: www.epa.gov/SW- 846/methdev.htm

■ “Guidelines for Collaborative Study Procedure to Validate Characteristics of a

Method of Analysis,” J. Assoc. Off. Chem., Vol. 72, No.4, 1989, p. 694

■ "Meeting the Traceability Requirements of ISO 17025-An Analyst's Guide," 2nd

Edition, at: www.vam.org.uk/

■ “Preparation of Calibration Curves-A Guide to Best Practice,” September 2003, LGC/VAM/2003/032, at: www.vam.org.uk/

■ “New Eurachem/CITAC guidance on traceability of chemical measurements: A paradigm for practical traceability,” April 2003, LGC/VAM/2003/016, at:

www.vam.org.uk/

■ “Quantifying Uncertainty in Analytical Measurement, 2nd Edition,” QUAM2000-

1, 2000, at: www.vam.org.uk/ http://www.aoac.org/vmeth/page1.htm� http://www.epa.gov/SW-846/methdev.htm� http://www.epa.gov/SW-846/methdev.htm� http://www.vam.org.uk/� http://www.vam.org.uk/� http://www.vam.org.uk/�

■ “EURACHEM/CITAC Guide: Traceability in Chemical Measurement-A Guide to Achieving Comparable Chemical Measurement,” 2003, at: www.vam.org.uk/

■ “In-house Method Validation: A Guide for Chemical Laboratories,” 2003, at:

www.vam.org.uk/

■ “A Practical Guide to Analytical Method Validation,” Analytical Chemistry 1996,

(68) 305A-309A, published at: http://pubs.acs.org/hotartcl/ac/96/may/may.html

■ “The Fitness for Purpose of Analytical Methods-A Laboratory Guide to Method

Validation and Related Topics,” EURACHEM Guide 1998, at:

www.eurachem.ul.pt/

■ “Standard Practice for Determining the Precision of ASTM Methods for Analysis and Testing of Industrial and Specialty Chemicals,” ASTM International Practice Designation E 180, at: www.astm.org

■ “Standard Practice for Conducting an Interlaboratory Study to Determine the

Precision of a Test Method,” ASTM International Practice Designation E 691 at:

www.astm.org

■ “Standard Guide for Demonstrating and Assessing Whether a Chemical

Analytical Measurement System Provides Analytical Results Consistent with Their Intended Use,” ASTM International Guide Designation D 6956-03 at:

www.astm.org

■ “Standard Guide for Conducting Ruggedness Tests,” ASTM International Guide

Designation E 1169 at: www.astm.org

■ “Standard Guide for Evaluating Laboratory Measurement Practices and the

Statistical…