Forum FM308: Policy ChangesTuesday June 5 10:00 a.m. AIHA Laboratory Accreditation

Policy Changes—ISO 17025

“How Do Changes Affect My Laboratory?”

“What Happens with the Site Assessment?”

James H. Nelson, Ph.D., CIH

AIHA Policies—2001 Fundamental Changes—Why?

ISO 17025 Continued:

Adaptation Improvement

How do changes affect my laboratory?

AIHA 2001 Policies The Program

What’s new?

The Site Assessment What new elements will the Site

Assessor consider and evaluate?

The New Policies:What to Do?

Organize in accordance with requirements

Sometimes no written policy document is required

Language “Shall”—You must do it

“Should”—You do not have to do it

Compare: “Shall include” “Shall ensure”

Include—Look for an itemEnsure—Look for performance

Language Consider these phrases:

“when feasible” (2.7.10) “where appropriate” (2.7.5) “where needed” (2.7.16.3) “if appropriate” (2.7.14) “where applicable” (B.4.4.1) “when necessary for interpretation” (2.7.9.4)

How does one interpret these?

Two Essential Considerations

Practices: Establish systems of execution and

record keeping Policy: If required--write

brief, new Standard Operating

Procedures or Directives

New Primary Issues of Concern Communication with Clients Candidates for Modified or New

SOPs Expanded Lists of Specific

Requirements Uncertainty Associated with Test

Results

Client Communication General (2.7.12.1, 2.7.12.3) Analytical Methodology (2.6.2) Problems (2.7.6.4) Subcontracting (2.7.6.7) Notification of Corrective Action

(2.7.11.2)

SOP

SOPs Do I need a new SOP? Do I need a modified SOP?

SOPs (Candidates to Consider)

Equipment or Materials Used at a Location Other than the Primary Facility

(2.4.6, 2.4.9, 2.4.10, 2.7.7.4)

SOPs (Candidates to Consider) Protection of

Data—Accuracy/Integrity/Confidentiality (2.4.11)

SOPs (Candidates to Consider) Use of Non-Standard Methods

(2.6.4) Deviations from:

Methodology (2.6) SOPs Sampling Plans (where relevant)

(2.7.5)

SOPs (Candidates to Consider) Procurement

General (2.7.8) Reagents and Standards (2.7.7,

2.7.7.1) Use of Subcontractors (2.3, 2.7.9.4)

SOPs (Candidates to Consider) Management Review and

Preventive Action (2.7.11.3, 2.7.11.4, 2.7.14)

Uncertainty in Test Results Uncertainty

Policy and Procedures for Estimation of Uncertainty of Measurement (2.7.10)

Identification and Estimation of Components of Uncertainty (2.7.10.7)

Factors of Influence (2.7.9.2) Reporting (2.7.9.4)

Resources (Uncertainty) EURACHEM/CITAC Guide NIST Technical Note 1297 Environmental Testing & Analysis

November/December 2000 Thomas Georgian

Program Modifications

Additional elements have been added to previous requirements

Expanded Requirements Equipment descriptions and logs

(2.4.4) Name and unique identifier Manufacturer name Model number Serial number Location

Expanded Requirements Records of Validation of Computer

Programs (2.4.11)

Expanded Requirements Quality Assurance Manual

(2.7.1) Three Specific Additions

Procurement Preventive Action (Management

Review) Client Communications

Expanded Requirements Review of test data (2.7.9.1)

Correlation of results for more than one parameter (same sample)

Expanded Requirements Final Report of Results (2.7.9.4)

Unique identification of report on each page Clear identification of the end of the report Documentation of condition of test samples Statement that results relate only to the

items tested (where relevant) Note (as applicable) that results are not

relevant to AIHA Accreditation Subcontractor results clearly identified

Expanded Requirements Policy pertinent to amended

reports (2.7.9.5) Quality Control Data

Records (2.7.10.6) Monitor Trends

Policy Charts

Expanded Requirements Internal Audits (2.7.11.1, 2.7.11.2)

Policy and Procedures Schedule Verification of Adherence to SOPs

and Other Directives (AIHA; ISO 17025)

Documentation of Results Documentation of Resolution

Corrective Action (2.7.13) A core element of success Policy and Forms

(Documentation) Resolution and Closure Follow-up

Corrective Action--Preventive Action

What is the difference?

IHLAP and ELLAP Dates of authorization to

perform specific tasks (B.3.2.1 and C.3.2.1)

IHLAP Reporting Limits (B.4.3.3)

Verified annually or with modification of method or procedures

Matrix specific MDL study or processing of a media-

spiked sample through the entire analytical scheme (preparation and instrumental analysis)

IHLAP Instrument Performance at the

Reporting Limit (B.4.3.4) A calibration standard processed

at the reporting limit Each analytical batch

ELLAP Reporting Limits (RLs) (C.4.1)

RL (greater than or equal to: 2MDL

For paint and soil: RL must be less than 20% of the relevant regulatory limit

For dust wipe samples: RL must be less than 50% of the relevant regulatory limit

ELLAP

Wipe sampling media—ASTM E 1792 Specifications

MDL Studies (C.4.3) Recognition of Results (C.4.4)

ELLAP Reporting Limit Verification

(C.4.10, C.5.6) Matrix spike at the reporting limit Each day of analysis Results must be +/-20% of target

ELLAP Assessment of Accuracy and

Precision for Wipe Samples and for Filter Samples (Air) (C.5.3) MS/MSD—Spiked Blank Medium Solid material must be used for

spiking Material must be traceable to

NIST or similar organization (CRM)

ELLAP Laboratory Control Samples (C.5.5)

Matrix-matched to samples Source is independent of calibration

standards and traceable to NIST materials or other similar reference material

Liquid spikes are not permitted except for filter (air) samples

Frequency: 5% of workload

Goals of the Laboratory Meet the Requirements of the Client Meet the Requirements of the

Laboratory Accreditation Organization (AIHA)

Provide a Stimulating Work Environment