Attachment_2_NAVAIR_17_35QAC_01B.pdf

PCN 167 4733 0000

NAVAIR 17-35QAC-01B

NAVSEA 04-4734B

USMC TI-4733-35/23B

NAVY AND MARINE CORPS

CALIBRATION LABORATORY

AUDIT/CERTIFICATION

MANUAL

THIS PUBLICATION SUPERSEDES NAVAIR 17-35QAC-01A, NAVSEA 04-4734A,

USMC TI-4733-35/23A, DATED 11 FEBRUARY 2005

DEPARTMENT OF THE NAVY

METROLOGY AND CALIBRATION PROGRAM

01 December 2006

ACKNOWLEDGEMENT

Appendix A of this manual cites in full the American National Standard for Calibration - Calibration Laboratories and Measuring and Test Equipment - General Requirements, ANSI/NCSL Z540-1-1994.

Copyright © 1994 by National Conference of Standards Laboratories. All rights reserved.

With the permission of the National Conference of Standards Laboratories, Appendix A uses the ANSI/NCSL Z540-1-1994 in full, with Naval Criteria inserted between sections to specify Navy and Marine Corps policy, procedures, and processes.

This document is intended for Navy and Marine Corps/Department of Defense use only. It is not intended for commercial purposes and shall not be reproduced for commercial use. Commercial copies of ANSI/NCSL Z540-1-1994 should be obtained from the National Conference of Standards Laboratories Secretariat, 2995 Wilderness Pl Suite 107, Boulder, CO 80301-5404.

Comments and recommendations concerning this document should be forwarded to:

Commanding Officer Naval Surface Warfare Center Attention: Steve Doty

PO BOX 5000

Corona, CA 92878-5000 i

FOREWORD

The Chief of Naval Operations (CNO) and the Commandant of the Marine Corps have adopted the American National Standard for Calibration (ANSI/NCSL Z540-1-1994), Calibration Laboratories and Measuring and Test Equipment - General Requirements, approved by the American National Standards Institute (ANSI) and published by the National Conference of Standards Laboratories (NCSL), as the primary basis for criteria to ensure Navy and Marine Corps Calibration Laboratories/Activities and other service providers are capable of performing required calibration measurements. The Department of the Navy has been granted permission by the National Conference of Standards Laboratories to use in full the ANSI/NCSL Z540-1-1994 for the purpose of improving quality within the Navy and Marine Corps Calibration Program.

This manual will herein after be referred to as the “Standard.”

All Navy and Marine Corps Calibration Laboratories and Activities are established and authorized to calibrate to measurement accuracy levels necessary to meet mission requirements;

and shall be subject to audit/certification reviews in accordance with criteria set forth in this Standard. Navy and Marine Corps Calibration Laboratories/Activities that demonstrate compliance to this Standard may be issued a calibration certificate of competency, accompanied by the scope of competency attesting to calibration disciplines and parameters for which the certificate is issued.

This document is provided to sponsors, Navy and Marine Corps Calibration Laboratories, Field Calibration Activities (FCAs), and auditors for interpreting and applying the “Naval Criteria” of this Standard to the Navy and Marine Corps Calibration Programs.

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TABLE OF CONTENTS

Chapter Page

GENERAL....................................................................................................................... 1-1

1.1 Introduction...................................................................................................................... 1-1

1.2 Purpose............................................................................................................................. 1-1

1.3 Scope................................................................................................................................ 1-1

1.4 Responsibilities ................................................................................................................ 1-1

AUDIT PROCESS........................................................................................................... 2-1

2.1 Planning ........................................................................................................................... 2-1

2.2 Audit Team ...................................................................................................................... 2-1

2.3 Preparation ....................................................................................................................... 2-1

2.4 Quality Document Review............................................................................................... 2-1

2.5 Arrangements................................................................................................................... 2-1

2.6 On-Site Audit ................................................................................................................... 2-2

2.7 Reporting.......................................................................................................................... 2-2

2.8 Follow-up Actions ........................................................................................................... 2-2

2.9 Certificate......................................................................................................................... 2-2

2.10 Surveillance Evaluation ................................................................................................... 2-2

LIST OF APPENDIX

Appendix Page

A Navy and Marine Corps Handbook; Guide for the Interpretation and Application of ANSI/NCSL Z540-1-1994................................................................ A-1

1-1

CHAPTER 1

GENERAL

1.1 INTRODUCTION

OPNAVINST 3960.16( ) and MCO 4733.1( ) require that all Navy and Marine Corps Calibration Laboratories/Activities be reviewed at least once every three years. This Standard provides administrative and technical criteria for auditing and certifying calibration laboratories.

NOTE: Aviation Maintenance Management Team (AMMT) reviews of Aircraft Intermediate Maintenance Department (AIMD) include a thorough review of the Fleet Calibration Activities (FCAs). However, calibration requirements cited in AMMT reviews of FCAs must remain in conformance with the criteria of this Standard.

NOTE: Calibration Capability Audits (CCAs) of NAVSEA cognizant Intermediate and Organizational level calibration activities are conducted by NAVSEA designated Regional Maintenance Centers (RMCs). The calibration requirements cited in these reviews must remain in conformance with the criteria of this Standard.

1.2 PURPOSE

To state requirements that must be met in order to comply with OPNAV and Commandant of the Marine Corps (CMC) policy for Navy and Marine Corps calibration laboratories and Calibration Service Providers (CSPs) that provide calibration services to the Department of the Navy.

1.3 SCOPE

This Standard is applicable to all Navy and Marine Corps calibration laboratories and CSPs that provide calibration services to the Department of the Navy.

1.4 RESPONSIBILITIES

Sponsors ensure that the audit teams, program managers, and cognizant calibration laboratories are provided with the resources needed to carry out the program and correct deficiencies as required.

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CHAPTER 2

AUDIT PROCESS

2.1 PLANNING

Audits are performed based upon an established schedule. Laboratories will be assessed at least once every three years, or more often, as directed by the cognizant sponsor.

2.2 AUDIT TEAM

The audit team will be assembled, based on skill set requirements necessary to properly evaluate the laboratory. Members of the audit team will possess the education, training, and experience necessary to perform the Audits. The audit team will be comprised of not less than two qualified metrologists.

2.3 PREPARATION

The lead auditor forwards a pre-audit questionnaire to the laboratory. The laboratory submits the completed questionnaire and a copy of its quality documentation to the lead auditor. The pre-audit questionnaire and quality documentation provide information relating to the current operational conditions and quality procedures used by the laboratory.

2.4 QUALITY DOCUMENTATION REVIEW

The audit team reviews the submitted pre-audit questionnaire and quality documentation, and the lead auditor advises the laboratory of any deficiencies found. Deficiencies in documentation should be corrected to the satisfaction of the lead auditor prior to the on-site audit and based on the criteria set forth in Appendix A.

2.5 ARRANGEMENTS

Arrangements for meeting times, spaces, and other logistics needs are coordinated by the lead auditor and the laboratory prior to the on-site visit.

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2.6 ON-SITE AUDIT

2.6.1 An entry briefing is conducted by the lead auditor to present the objectives, purpose, and goals of the on-site audit. The briefing includes audit team and laboratory personnel introductions to establish key points of contact and effective working relations. A tour of the laboratory is conducted to familiarize the audit team with the laboratory layout.

2.6.2 The audit is performed to determine if actual practices comply with the laboratory’s quality system documentation and the criteria set forth in Appendix A. The audit team documents all resolved and unresolved deficiencies.

2.6.3 Proficiency testing of laboratory technicians shall be conducted as part of the audit to verify the laboratory’s scope of capability.

2.6.4 The audit team shall contact the laboratory’s customers and other command officials, wherever deemed appropriate.

2.6.5 An exit briefing is conducted by the lead auditor to laboratory’s management and other appropriate command officials. The exit brief summarizes the audit results.

2.7 REPORTING

A written audit report will be prepared by the lead auditor and provided to the cognizant authorities and the laboratory.

2.8 FOLLOW-UP ACTIONS

The lead auditor will monitor unresolved deficiencies and required corrective actions through their completion. Upon verification that all deficiencies identified during the Audit have been corrected, the lead auditor will recommend the issuance of a Certificate of Competency accompanied by a Scope of Competency to the laboratory.

2.9 CERTIFICATE

The Certificate/Scope of Competency is issued with a serial number and expiration date that will not exceed three years.

2.10 SURVEILLANCE EVALUATION

A surveillance evaluation will be conducted as determined by the SYSCOM during the period of certification to determine if the laboratory continues to comply with the requirements of the Standard and that the Scope of Competency remains accurate. A surveillance evaluation may consist of an on-site visit and/or review of internal audit results. The Scope of Competency may be amended based on the surveillance evaluation.

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APPENDIX A

Navy and Marine Corps Handbook

Guide for the Interpretation and Application of

ANSI/NCSL Z540-1-1994

General Requirements for

Calibration Laboratories and

Measuring and Test Equipment

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PREFACE

This document was written to assist Navy and Marine Corps Calibration Laboratories and other users of Test and Monitoring Systems (TAMS) when implementing the requirements of ANSI/NCSL Z540-1-1994. The requirements found in ANSI/NCSL Z540-1-1994 are shown in bold typeface. Where needed, Naval Criteria and Naval Notes are provided in normal typeface and italicized typeface, respectively. Naval Criteria are clarifications of the requirements as applied to Navy/USMC calibration activities. Naval Notes are general suggestions or examples of how a requirement may be satisfied. These are intended to enhance the user's understanding and application of the requirements and assist in providing for the uniform evaluation of a laboratory's compliance to the Navy and Marine Corps requirements.

The Standard, as developed and approved by the ANSI accredited Standards Committee, Z540, on General Requirements for Calibration Laboratories and Measuring Test Equipment, was written to promote "confidence in calibration laboratories and measuring and test equipment when it can be shown that they are operated in compliance with its requirements".

AMERICAN NATIONAL STANDARD FOR CALIBRATION

CALIBRATION LABORATORIES AND MEASURING AND TEST EQUIPMENT

- GENERAL REQUIREMENTS

1. SCOPE:

1.1 Part I of this Standard sets out the general requirements in accordance with which a calibration laboratory must demonstrate that it operates, if it is to be recognized as competent to carry out specific calibrations. Part I applies to calibration laboratories in the development and implementation of their quality system.

1.2 Part II of this Standard sets out quality assurance requirements for a Supplier's system to control the accuracy of the measuring and test equipment used to assure that supplies and services comply with prescribed requirements.

1.3 The role of the Purchaser in monitoring a Supplier’s compliance with the requirements of this Standard may be fulfilled by a third party, such as an accreditation or certification body.

1.4 This Standard, and any procedure or document executed in implementation thereof, shall be in addition to, and not weaken or detract from, other contract requirements.

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2. REFERENCES:

ANSI/NCSL Z540-1-1994 – American National Standard for Calibration - Calibration Laboratories and Measuring and Test Equipment - General Requirements

NCSL Recommended Practices – RP-9: Calibration Laboratory Capability Documentation Guideline.

OPNAVINST 3960.16( ) – Navy Test and Monitoring Systems (TAMS)

MCO 4733.1( ) – Marine Corps Test and Monitoring Systems (TAMS)

NAVAIR 17-35MTL-1 – Metrology Requirements List (METRL)

NAVAIR 17-35NCA-1 – Navy Calibration Activities (NCA)

NAVAIR 17-35NCE-1 – Navy Calibration Equipment (NCE)

NAVAIR 17-35FR-06 – Facility Requirements for Naval Calibration Laboratories

NAVAIR 17-35TR-10 – Technical Requirements for Reports of Calibration and Certificates of Calibrations

OP 43P6B – Metrology Automated System for Uniform Recall and Reporting (MEASURE) User’s Manual

3. DEFINITIONS:

The relevant definitions from ISO/IEC Guide 2, ISO/IEC 8402, ISO/IEC Guide 30, and the international vocabulary of basic and general terms in metrology (VIM) are applicable, the most relevant being quoted below, together with further definitions applicable for the purpose of this Standard.

3.1 Calibration: The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, and the corresponding standard or known values derived from the standard.

NOTES:

1) The result of a calibration permits the estimation of errors of indication of the measuring instrument, measuring system, or the assignment of values to marks on arbitrary scales.

2) A calibration may also determine other metrological properties.

3) The result of a calibration may be recorded in a document, sometimes called a calibration certificate or a calibration report.

4) The result of a calibration is sometimes expressed as a calibration factor, or as a series of calibration factors in the form of a calibration curve.

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3.2 Calibration Certificate or Report: Document that presents calibration results and other information relevant to a calibration.

3.3 Calibration Laboratory/Activity/Facility: Body that calibrates or performs calibrations and verifications.

NOTES:

1) In cases where a laboratory forms part of an organization that carries out other activities besides calibration, the term "laboratory" refers only to those parts of that organization that are involved in the calibration process.

2) As used herein, the term laboratory refers to a body that carries out calibration at or from a permanent site.

3.4 Calibration Method: Defined technical procedure for performing a calibration or verification.

3.5 Interlaboratory Comparison: Organization, performance, and evaluation of calibrations on the same or similar items by two or more laboratories in accordance with predetermined conditions.

Naval Note: Examples of interlaboratory comparisons include Measurement Comparison Programs (MCPs), "Round Robins", or measurement correlations.

3.6 International (measurement) Standard: A standard recognized by an international agreement to serve internationally as the basis for fixing the value of all other standards of the quantity concerned.

3.7 Limits of Permissible Error (of a measuring instrument): The extreme values of an error permitted by specifications, regulations, etc., for a given measuring instrument.

NOTE: This term is frequently referred to as "tolerance" in the United States.

3.8 Measurand: A quantity subjected to measurement.

NOTE: As appropriate, this may be the "measured quantity" or the "quantity to be measured."

3.9 Measurement: The set of operations having the object of determining the value of a measurand.

3.10 Measurement Assurance: Measurement assurance is a technique that may include, but is not limited to: 1) use of good experimental design principles so the entire measurement process, its components, and relevant influence factors can be well characterized, monitored, and controlled; 2) complete experimental characterization of the measurement process uncertainty including statistical variations, contributions from all known or suspected influence factors, imported uncertainties, and the propagation of

A-4 uncertainties throughout the measurement process; and 3) continuously monitoring the performance and state of statistical control of the measurement process with proven statistical process control techniques including the measurement of well characterized check standards along with the normal workload and the use of appropriate control charts.

3.11 Measurement Standard: A material measure, measuring instrument, reference material, or system intended to define, realize, conserve, or reproduce a unit or one or more known values of a quantity to serve as a reference.

Naval Note: Generally, a measurement standard is listed in NAVAIR 17-35NCE-1.

3.12 Measuring and Test Equipment: All of the measuring instruments, measurement standards, reference materials, and auxiliary apparatus that are necessary to perform a measurement. This term includes measuring equipment used in the course of testing and inspection, as well as that used in calibration.

NOTE: In the context of the Standard, the term "measuring and test equipment" is taken to encompass "measuring instruments" and "measurement standards." Moreover, a "reference material" is considered to be a type of "measurement standard".

3.13 Measuring Instrument: A device intended to make a measurement, alone or in conjunction with supplementary equipment.

3.14 Mutual Consent Standard: An artifact or process that is used as a de facto standard by mutual consent of the supplier and customer when no recognized U.S. national standard is available.

3.15 National (measurement) Standard: A standard recognized by an official national decision to serve, in a country, as the basis for fixing the value of all other standards of the quantity concerned.

3.16 Proficiency Testing: Determination of the laboratory calibration performance by interlaboratory comparisons or other means.

Naval Note: Examples of proficiency testing may include:

(1) Participation in an Interlaboratory Comparison Program (ILCP), such as a Measurement Comparison Program (MCP), a “Round Robin”, or a Measurement Assurance Program (MAP).

(2) Direct observation of a measurement(s) conducted in the laboratory.

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3.17 (Quality) Audit/Assessment: A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.

NOTE: The quality audit/Audit typically applies to, but is not limited to, a quality system or elements thereof, to processes, to products, or to services.

Such audits are often called "quality system audit", "process quality audit", "product quality audit", and "service quality audit".

3.18 Quality Manual: A document stating the quality policy, quality system, and quality practices of an organization.

NOTE: The quality manual may call up other documentation relating to the laboratory's quality arrangements.

3.19 Quality System: The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

3.20 (Quality System) Review: A formal evaluation by management of the status and adequacy of the quality system in relation to quality policy and new objectives resulting from changing circumstances.

3.21 Reference Material: A material or substance of which one or more properties are sufficiently well established to be used for the calibration of an apparatus, the Audit of a measurement method, or for assigning values to materials.

3.22 Reference Standard: A standard, generally of the highest metrological quality available at a given location, from which measurements made at that location are derived.

3.23 Requirement: A translation of the needs into a set of individual quantified or descriptive specifications for the characteristics of an entity in order to enable its realization and examination.

3.24 Traceability: The property of a result of a measurement whereby it can be related to appropriate standards, generally national or international standards, through an unbroken chain of comparisons.

3.25 Uncertainty of Measurement: Parameter, associated with the result of a measurement that characterizes the dispersion of the values that could reasonably be attributed to the measurand.

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3.26 Verification: Evidence by calibration that specified requirements have been met.

NOTES:

1) In connection with the management of measuring equipment, verification provides a means for checking that the deviations between values indicated by a measuring instrument and corresponding known values are consistently smaller than the limits of permissible error defined in a standard, regulation or specification peculiar to the management of the measuring equipment.

2) The result of verification leads to a decision either to restore to service, or to perform adjustments, or to repair, or to downgrade, or to declare obsolete. In all cases documentation of the verification performed is kept on the measuring instrument's individual record.

3) The term "verification", as defined in this Standard is frequently referred to as "calibration" in the United States.

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PART 1 - GENERAL REQUIREMENTS FOR THE COMPETENCE OF

CALIBRATION LABORATORIES:

4. ORGANIZATION AND MANAGEMENT:

4.1 The laboratory shall be legally identifiable. It shall be organized and operate in such a way that its permanent, temporary, and mobile facilities meet the requirements of this Standard.

Naval Criteria: All Navy and Marine Corps calibration laboratories shall be officially established and authorized by its Navy or Marine Corps major claimant.

Calibration activities officially recognized by the Navy and Marine Corps are listed in NAVAIR 17-35NCA-1.

4.2 The laboratory shall:

a) have managerial staff with the authority and resources needed to discharge their duties;

Naval Criteria: Laboratory management shall have the authority to plan, organize, direct, and control to assure quality and protect integrity of results.

Laboratory management shall have the support of command sponsors and senior management in terms of budget, equipment, facilities, people, engineering resources, and the commitment to quality.

b) have arrangements to ensure that its personnel are free from any undue pressures, which might adversely affect the quality of their work;

Naval Criteria: Laboratory personnel shall be insulated from any work related pressures, which would compromise the quality of work. The source of undue pressure may be internal (management pressure, deadlines, etc.) or external (customer complaints, priority requests, etc).

c) be organized in such a way that confidence in its independence of judgment and integrity is maintained at all times;

Naval Criteria: Whether a laboratory is part of a larger organization or a stand-alone activity, it shall operate in such a manner so that quantity does not influence quality.

d) specify and document the responsibility, authority, and interrelation of all personnel who manage, perform, or verify work affecting the quality of calibrations;

Naval Criteria: The laboratory shall have an organizational chart depicting key positions and job descriptions for the calibration laboratory.

Responsibilities and authorities should be clearly defined, including the relationship of the laboratory to engineering resources. This is normally accomplished through local commands/local instructions, standard operating procedures, or mission statements.

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e) provide supervision by persons familiar with the calibration methods and procedures, the objective of the calibration, and the Audit of the results.

Management practices shall be such as to ensure adequate supervision;

Naval Criteria: Individuals assigned direct supervisory responsibilities over laboratory personnel shall be knowledgeable in the methods, practices, and procedures of the calibrations being performed and of assessing calibration results. The responsibilities for these supervisory personnel should not be so extensive as to limit their effectiveness.

f) have a technical manager (however named) who has overall responsibility for the technical operations;

Naval Criteria: There shall be an individual designated whose job description includes the authority to make decisions regarding the technical aspects of the laboratory operations and responsibility to engage engineering resources when required.

g) have a quality manager (however named) who has responsibility for the quality system and its implementation. The quality manager shall have direct access to the highest level of management at which decisions are taken on laboratory policy or resources and to the technical manager. In some laboratories, the quality manager may also be the technical manager or deputy technical manager;

Naval Criteria: Responsibility for the quality system of the laboratory shall be assigned to an individual who is free from pressures, which represent a conflict to the quality of calibrations. Normally, depot and regional laboratories have an independent quality function, such as a Quality Assurance Representative (QAR). QAR responsibilities at Fleet level activities may be a collateral duty.

h) designate alternates in case of absence of the technical or quality manager;

Naval Criteria: Individuals who have the required knowledge and expertise to assume the duties of the technical or quality manager shall be assigned in writing as alternates to provide continuity of operations during absences of the technical or quality manager.

i) where relevant, have documented policies and procedures to ensure the protection of customer’s confidential information and proprietary rights; and, Naval Criteria: Confidential information applies to classified items (e.g.

confidential, secret, etc.). In such cases, local security instructions would apply. Proprietary rights apply to business sensitive information that is exclusive to that supplier/customer.

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j) where appropriate, participate in interlaboratory comparisons and proficiency testing programs.

Naval Criteria: Laboratories are encouraged to participate in intercomparison programs between laboratories, and proficiency-testing programs, which provide increased confidence in laboratory competence. The extent to which a laboratory participates depends on capability, echelon, size, and customer workload requirements. The Sponsor will determine the level of proficiency testing based upon the established mission and calibration echelon and/or level of the laboratory.

5. QUALITY SYSTEM, AUDIT, AND REVIEW:

5.1 The laboratory shall establish and maintain a quality system appropriate to the type, range, and volume of calibration activities it undertakes. The elements of this system shall be documented. The quality documentation shall be available for use by the laboratory personnel. The laboratory shall define and document its policies and objectives for, and its commitment to, good laboratory practice and quality of calibration services. The laboratory management shall ensure that these policies and objectives are documented in a quality manual and communicated to, understood, and implemented by all laboratory personnel concerned. The quality manual shall be maintained current under the responsibility of the quality manager.

Naval Criteria: The laboratory shall have a quality system, documented in a quality manual that defines the policies and procedures, which must be followed in day-to-day operations. Laboratory management is responsible for ensuring that all laboratory personnel are aware of, understand, and implement the elements of the quality system. The laboratory Quality Manager, or designated equivalent, is responsible for maintaining the quality manual.

5.2 The quality manual and related documentation shall state the laboratory's policies and operational procedures established in order to meet the requirements of this Standard. The quality manual and related documentation shall also contain:

a) a quality policy statement, including objectives and commitments, by top management;

Naval Criteria: A statement from the highest level of laboratory management expressing the commitment to and intent of management and staff to provide sound and reliable services to its customers shall be included. The Secretary of the Navy and the Chief of Naval Operations are committed to quality, which will be adopted and reaffirmed by all Naval/Marine Corps commands/activities.

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b) the organization and management structure of the laboratory, its place in any parent organization, and related organizational charts;

Naval Criteria: A chart, outline, or description of the organizational structure of the laboratory within a parent command shall be included.

c) the relations between management, technical operations, support services, and the quality system;

Naval Criteria: A description of how the various organizational components of the laboratory interrelate to create a single, cohesive laboratory program shall be included (e.g., flowcharts or SOP’s defining the responsibilities of, and demonstrating interactions between, the various organizational/functional units, including the relationship to engineering resources).

d) procedures for control and maintenance of documentation;

Naval Criteria: The procedures, responsibilities, and authorities for drafting, changing, approving, issuing, and deleting documents needed for conducting the laboratory’s business (procedures, drawings, schedules, work plans, job orders, test methods, etc.), including the quality manual and related quality documentation shall be documented and referenced. The control of documents shall ensure that:

i. Pertinent issues of appropriate documents are available at all locations where operations essential for the functioning of the quality system are performed.

ii. Invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use.

iii. Any obsolete documents retained for legal and/or knowledge-preservation purposes are suitably identified (as defined in the quality documentation).

e) job descriptions of key staff and reference to descriptions of other staff;

Naval Criteria: Job descriptions of personnel in positions of responsibility shall be included. Job descriptions of all other personnel, whose duties affect the quality of the service provided, (i.e., engineering support) should be referenced as to where details might be found.

f) identification of the laboratory's approved signatories (where this concept is appropriate);

Naval Criteria: Signature authority must be in writing, specific to an individual by name (not position). The designation shall identify the specific documents authorized to be signed (e.g., Reports/Certificates of Calibration, SOP’s, Quality Assurance documentation, shipping, receiving, etc.).

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g) the laboratory's procedures for achieving traceability of measurements;

Naval Criteria: Laboratories shall have documented procedures that define how the laboratory maintains measurement traceability. Naval and Marine Corps calibration laboratories/activities shall reference existing traceability paths to the National Institute of Standards Technology, National Measurement Institutes, or intrinsic standards.

h) the laboratory's scope of calibrations and/or verifications;

Naval Criteria: The laboratory's scope of calibrations shall adequately define the measurement capabilities of the service it provides. As a minimum, the laboratory’s statement of capability should include: (1) measurement area, (2) parameter, (3) sub-parameter (it is at the discretion of the laboratory to identify terms that best describe the measurement capability), (4) range, and

(5) measurement system and/or method.

Naval Note: Where approved, if Navy Instrument Calibration Procedures (ICPs) are not used measurement uncertainties must be included in the statement of capabilities. Further guidance for developing a statement of capability may be found in NCSL Recommended Practices RP-9; Calibration Laboratory Capability Documentation Guideline. The laboratory's scope of calibrations will vary, depending on the size, mission, and echelon of the laboratory.

i) arrangements for ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing such work;

Naval Criteria: The quality documentation shall contain procedures, which ensure the laboratory has the personnel, facilities, equipment, standards, and technical expertise necessary to handle proposed work before it is accepted.

j) reference to the calibration and verification procedures used;

Naval Criteria: Laboratories above the Organizational and Intermediate levels, with appropriate engineering support, may develop or use calibration procedures other than those identified in the METRL if authorized by SYSCOM policy. It is incumbent upon the laboratory to ensure that all procedures used in the performance of calibrations meet the requirements of section 10.2 of this Standard.

k) procedures for handling calibration and verification items;

l) reference to the major equipment and reference measurement standards used;

Naval Criteria: A general description of the measurement system and measurement standards used by the laboratory shall be included in the quality documentation. Normally, this may be accomplished with reference to the Scope of Competency.

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m) reference to procedures for calibration, verification, and maintenance of equipment used;

Naval Criteria: "Equipment used " refers to all laboratory equipment having an affect on the results on the calibration services provided. More specifically, this refers to procedures for the proper care, handling, and maintenance of laboratory equipment, to include assurance that all equipment used by the laboratory in conjunction with a calibration is operating correctly and, if required, has a current calibration label affixed.

n) reference to quality assurance practices including interlaboratory comparisons, proficiency testing programs, use of reference materials, and internal quality control schemes;

Naval Note: Quality assurance practices are used to: 1) determine agreement between laboratories, 2) demonstrate compliance to certain specifications, 3) indicate that the measurement processes are under statistical control, 4) demonstrate traceability, and 5) ensure the quality of results.

o) procedures to be followed for feedback and corrective action whenever measurement discrepancies are detected, or departures from documented polices and procedures occur;

Naval Criteria: Policies and procedures shall describe the actions to be taken when it is discovered that an error has occurred or procedures were not followed. The documented procedure should describe, at a minimum, the Audit of the impact on the results of measurements and describe how appropriate corrective action (scope of recall, sample size, root cause analysis, etc.) should be determined and completed. This requirement pertains to discrepancies or departures discovered after they have occurred.

p) the laboratory management arrangements for exceptionally permitting departures from documented policies and procedures or from standard specifications;

Naval Criteria: Laboratory management is responsible for ensuring that laboratory policies and procedures are adhered to. The quality documentation shall include the required process to be followed when departing from Navy METCAL Program policies and procedures. Examples of these deviations may include: 1) extensions of calibration intervals, internal audits, or management reviews; 2) special calibrations; or 3) any other deviation from documented policy.

q) procedures for dealing with complaints;

r) procedures for protecting confidentiality and proprietary rights;

Naval Criteria: The laboratory's procedures for identifying and protecting any customer information or material shall be included in the quality documentation.

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s) procedures for audits and reviews;

Naval Note: An audit is a detailed evaluation of the compliance with the quality system. It attempts to find out if the system is in fact working the way it is documented. A review is a comparison of the system with the general standard, other quality needs, and the general business of the laboratory to determine is something needs to be changed in the system.

t) a statement of the lab's policy for establishing and changing calibration intervals for equipment it controls; and, Naval Criteria: Calibration intervals are established, maintained, and published in the NAVAIR 17-35MTL-1.

u) a statement of the laboratory's policy concerning the technique(s) to be used for determining measurement uncertainty and calibration/verification adequacy.

Naval Criteria: Measurement uncertainties shall be calculated in accordance with guidance provided by NAVAIR 17-35TR-10.

5.3 The laboratory shall arrange for audits of its activities at appropriate intervals to verify that its operations continue to comply with the requirements of the quality system. Such audits shall be carried out by trained and qualified staff who are, whenever possible, independent of the activity to be audited. Where the audit findings cast doubt on the correctness or validity of the laboratory's calibration results, the laboratory shall take immediate corrective action and shall immediately notify, in writing, any customer whose work may have been affected.

Naval Criteria: Laboratories shall arrange for both internal and external audits of their quality system. The purpose of these audits is to determine if the laboratory’s quality system and actual practices comply with established policies/requirements and whether they are suitable to achieve stated objectives.

As directed by OPNAV and CMC, external audits of all Naval and Marine Corps Calibration laboratories will be conducted at intervals not to exceed three years.

Actual audit interval assignment shall be made by the laboratory’s cognizant sponsor and will be derived from an analysis of factors such as, but not limited to, risk, size/complexity of the quality and/or measurement systems, and documented failure rates.

In addition to external audits, the laboratory shall conduct annual internal audits of its activities. As directed by senior management, the quality manager may be responsible for conducting the audit and ensuring that all components of the laboratory's activities are audited. These audits shall be conducted by laboratory personnel possessing the knowledge and skills necessary to understand the activity being audited as well as the process of auditing quality systems. Audit

A-14 responsibilities should be assigned to personnel who are independent of the functional area being audited. As a minimum, the audit process shall include:

a) A planned schedule for the audits. This schedule shall identify the activity to be audited and the date on which the audit is to be conducted.

b) A documented audit plan.

c) Documentation of nonconformances and observations.

d) Corrective actions that are to be implemented within a reasonable timeframe for all nonconformances identified during the audit.

e) Preparing a report of all audit findings.

Naval Criteria: All documentation generated as a result of the internal audit (i.e., schedule, plan, findings, corrective actions, and report) is governed by Section 12 of this Standard.

5.4 The quality system adopted to satisfy the requirements of this Standard shall be reviewed at least once a year by the management to ensure its continuing suitability and effectiveness and to introduce any necessary changes or improvements.

Naval Criteria: The results of the activity’s internal audit of its quality system shall be reviewed at least once a year by senior management to ensure its continuing suitability and effectiveness and introduce any necessary changes or improvements. The review should take account of reports from managerial and supervisory personnel, the outcome of recent internal audits, and corrective and preventive actions, Audits by external bodies, the results of interlaboratory comparisons or proficiency tests, any changes in the volume and type of the work undertaken, feedback from clients, including complaints and other relevant factors, such as quality control, facilities, resources, and staff training. Root cause analysis should be conducted for all nonconformances. Management shall be responsible for ensuring the effectiveness of all corrective actions.

5.5 All audit and review findings and any corrective actions that arise from them shall be documented. The person responsible for quality shall ensure that these actions are discharged within the agreed timeframe.

Naval Criteria: Documentation shall be maintained, in a form suitable for Audit, for all management reviews of the quality system and resulting corrective actions, if any. Corrective action is required whenever evidence arises that the quality system is not functioning properly. The person responsible for quality is designated by management and is normally the Quality Manager, or an equivalent.

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5.6 In addition to periodic audits, the laboratory shall ensure the quality of results provided to customers by implementing checks. These checks shall be reviewed and shall include, as appropriate, but not limited to:

a) internal quality control using, whenever possible, statistical techniques;

NOTE: Measurement assurance techniques are acceptable means to control the measurement process and consistently produce the highest quality measurements.

b) participation in proficiency testing or other interlaboratory comparisons;

c) regular use of certified reference materials and/or in-house quality control using reference materials;

d) replicate measurements using the same or different methods; and/or,

e) correlation of results for different characteristics of an item.

Naval Criteria: Quality control techniques adopted by the laboratory to satisfy this requirement shall be applied in all measurement disciplines (both on-site and off-site, as applicable). Documentation review alone does not satisfy this requirement.

6. PERSONNEL:

6.1 The calibration laboratory shall have sufficient personnel, having the necessary education, training, technical knowledge, and experience for their assigned functions.

Naval Criteria: The laboratory shall maintain a staff of sufficient size and knowledge to satisfy the capacity and technical capabilities needed to support its workload.

6.2 The calibration laboratory shall ensure that the training of its personnel is kept up-to-date, consistent with employee assignments and development.

Naval Criteria: Training requirements will vary based on the size, echelon, and complexity of laboratory's range of calibrations. There shall be procedures in place for identifying training needs and for ensuring that personnel are properly trained. Technical and non-technical training shall be documented and maintained current for all laboratory personnel.

6.3 Records on the relevant qualifications, training, skills, and experience of the technical personnel shall be maintained and be available to the laboratory.

Naval Criteria: A current listing of technical personnel and their relevant skills, work experience, formal education, technical training, on-the-job training (to include type/model number, duration, and trainer), technical license, certifications, and degrees shall be maintained. The training records need to be accessible to the audit team during the audit.

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7. ACCOMMODATION AND ENVIRONMENT:

7.1 Laboratory accommodations (facilities), calibration areas, energy sources, lighting, temperature, humidity, and ventilation shall be such as to facilitate proper performance of calibrations/verifications.

Naval Criteria: Management shall ensure that calibration facilities meet the specifications for their assigned functions in accordance with NAVAIR 17-35FR-06 and the approved calibration procedure. Environmental criteria specified by the manufacturer may be applicable if more stringent than the NAVAIR 17-35FR-06.

7.2 The environment in which these activities are undertaken shall be specified and not invalidate the results or adversely affect the required uncertainty of measurement. Particular care shall be taken when such activities are undertaken at sites other than the permanent laboratory premises.

Naval Criteria: Refer to NAVAIR 17-35FR-06.

7.3 The laboratory shall effectively monitor, control, and record environmental conditions as appropriate. Due attention shall be paid, for example, to biological sterility, dust, electromagnetic interference, humidity, line voltage, temperature, sound, and vibration levels, as appropriate to the calibration concerned.

Naval Criteria: The environmental conditions of the laboratory must be monitored in accordance with the requirements established in NAVAIR 17-35FR-06. Due attention shall be paid to the accuracy and area of coverage of the monitoring device. Applicable environmental records shall be retained for a period specified in the laboratory’s quality manual for audit/traceability purposes.

7.4 There shall be effective separation between neighboring areas when the activities therein are incompatible.

Naval Criteria: Activities in neighboring areas may have an adverse affect on the calibrations/verifications in another area. If activities are incompatible, they shall be effectively separated by shielding or isolated by distance. Each physically separate area shall have a dedicated monitoring device.

7.5 Access to and use of all areas affecting the quality of these activities shall be defined and controlled.

Naval Criteria: Uncontrolled access to environmentally controlled areas may have an adverse affect on the quality of measurements being performed. Areas where this potential exists shall be identified and procedures shall be established to define controls.

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7.6 Adequate measures shall be taken to ensure good housekeeping in the laboratory.

NOTE: It is the laboratory's responsibility to comply with the relevant health, safety, and environmental requirements. This aspect, however, is outside the scope of this Standard.

Naval Criteria: Poor housekeeping practices may have a negative impact on the quality of the calibrations/verifications being performed. Good housekeeping factors such as cleanliness, storage, and space shall be adequately controlled.

8. EQUIPMENT AND REFERENCE MATERIALS:

8.1 The laboratory shall be furnished with all items of equipment (including reference materials) required for the correct performance of calibrations/verifications. In those cases where the laboratory needs to use equipment outside its permanent control, it shall ensure that the relevant requirements of this Standard are met.

Naval Criteria: The calibration laboratory shall ensure that all equipment used in conjunction with calibrations meet the requirements of this Standard; i.e., traceable to national, international, or intrinsic standards of measurement. The laboratory technical manager (however named) shall institute a documented process to engage competent engineering authority to certify equipment of unknown or suspect capability to safely and correctly perform its intended function.

8.2 All equipment shall be properly maintained. Maintenance procedures shall be documented. Any item of the equipment which has been subjected to overloading or mishandling, or which gives suspect results, or has been shown by verification or otherwise to be defective, shall be taken out of service, clearly identified, and wherever possible stored at a specified place until it has been repaired and shown by calibration or verification to perform satisfactorily. The laboratory shall examine the effect of this defect on previous calibrations.

Naval Criteria: In addition to the processes for handling suspect equipment, the laboratory shall: 1) identify equipment that requires periodic maintenance, other than that identified in the ICP; 2) follow a documented procedure to perform maintenance according to a prescribed schedule; and 3) maintain records of maintenance performed.

8.3 Each item of equipment, including reference materials, shall, when appropriate, be labeled, marked, or otherwise identified to indicate its calibration status.

Naval Criteria: Any item that can make a quantitative measurement or provide a known reference shall be labeled/tagged to show its calibration and service status.

If calibration labels/tags cannot be applied to the item (such as Gage Blocks), the label/tag should be applied on the equipment container.

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8.4 Records shall be maintained of each item of equipment and all reference materials significant to the calibrations/verifications performed.