Photovoltaic Test Laboratory Quality Manual

PHOTOVOLTAIC TEST LABORATORY QUALITY MANUAL

(Version 1.3, July 15, 1999)

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TABLE OF CONTENTS

Table of Contents3

Introduction7

Summary of Quality Manual9

Development of a Quality Manual: Procedures and Examples31

PROCEDURES AND EXAMPLES

SECTIONS

I)Commitment to Quality33

II)Personnel: Roles, Responsibilities, Authority, and Interrelationships37

III)Management of the Quality Process41

IV)Quality System Procedures47

V)Sample Forms53

VI)Confidentiality and Proprietary Rights of Clients55

VII)Control of Documents and Data57

VIII)Qualifying Outside Vendors and Product Tracking61

IX)Control of Customer-Supplied Materials65

X)Product Tracking69

XI)Inspections and Testing73

XII)Controlling Measurement and Test Equipment 79

XIII)Process Status and Corrective/Preventive Action83

XIV)Component and System Handling87

XV)Management of Documents and Records91

XVI)Audit Planning93

XVII)Training97

XVIII)Statistical Analysis101

XIX)Safety103

ADDENDUM

IECQ Requirements105

APPENDICES

Appendix I: Forms115

Appendix II: Laboratory’s Scope of Tests117

Appendix III: Recommended Equipment119

Appendix IV: Glossary121

Appendix V: Standards123

Appendix VI: Bibliography125

INTRODUCTION AND SUMMARY

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INTRODUCTION

Purpose of this Manual

The purpose of this document is to assist laboratories testing photovoltaic (PV) components and systems in the implementation of an ISO/IEC Guide 25 quality system. It is not an attempt to create a new or redundant standard; this is a guide, and it is not intended as a standard.

This manual is provided as a tool, with examples, samples, and guidance to assist laboratories testing PV components and systems implementing the ISO/IEC Guide 25 system and in the review, use, and improvement of their existing testing quality processes. Consequently, qualification to an ISO/IEC Guide 25-type quality system may be submitted to an appropriate accrediting body and to the International Electrotechnical Commission’s Quality Assessment System for Electronic Components (IECQ), and to the Global Approval Program for PV (PV GAP) as evidence of an existing qualified quality manufacturing system.

The content of this Manual is not different from the requirements of the ISO/IEC Guide 25 Standard

This manual follows the requirements of ISO/IEC Guide 25 qualification documents in detail and scope. However, it is written in language that is less imposing and more straight forward; it contains examples of both the process steps and documentation forms for many of the quality steps; and, it has been tailored to be specific to the testing of PV component and systems.

Implementation of a Qualified System

To establish a qualified system requires that the Laboratory develop a Quality Manual, which either includes the Laboratory's quality system procedures or identifies where they are located. This requires that the company establish a quality system, write down what the Laboratory/employee does in each step of the testing process, and makes sure that that documentation is kept up to date.

Purpose of Quality Systems

Why is it important to develop, institute, and maintain quality processes and procedures for a testing laboratory? A documented quality system, meeting recognized standards,

Demonstrates the Laboratory's commitment to quality
Provides evidence of the Laboratory's internal discipline
Indicates consistency and efficiency of work processes
Provides a solid foundation for continuous improvement
Encourages customer confidence
Encourages automatic approval as an unbiased resource
Encourages marketplace recognition

In addition, such a defined system provides a testing laboratory with the opportunity to identify system inefficiencies, track and correct deficiencies, and continuously improve testing procedures, which should significantly improve its success in the market for testing services.

The development of an approved quality system involves a feed-back process of continuous assessment, documentation, validation, and revision. The development process may fall into three broad areas:

Review, assess, and document the Laboratory’s practices and operations
Implement the quality system
Improve the quality system

The key to developing a successful quality process program is to involve all employees in the development activities. These are the people who do the work on a daily basis; they are the people who are most familiar with what works and what doesn’t; and, they are the people who will be responsible for carrying out any new policies, procedures, and documentation practices.

SUMMARY OF QUALITY MANUAL

CONDITIONS FOR ACCREDITATION

(based on ISO/IEC Guide 58)

To attain and maintain accreditation, an applicant must agree to

1)Afford accommodation and cooperation as is necessary to enable the accrediting organization to verify compliance with the requirements for accreditation including provision for examination of documentation and access to all calibration and testing areas, records and personnel for the purposes of assessment, surveillance, reassessment and resolution of complaints;

2)Comply at all times with the criteria, requirements (including participation in proficiency testing as required), and conditions for accreditation;

3)Claim that it is accredited only in respect of services for which it has been granted accreditation and which are carried out in accordance with these conditions;

4)Pay such fees as shall be determined by the accrediting organization;

5)Not use its accreditation in such a manner as to bring the accrediting organization into disrepute and not make any statement relevant to its accreditation which the accrediting organization may consider misleading or unauthorized;

6)Upon suspension, withdrawal or expiration of its accreditation (however determined) discontinue its use of all advertising matter that contains reference thereto and return any certificates of accreditation to the accrediting organization;

7)Not use its accreditation to imply product approval by A2LA unless permitted by a specific program;

8)Endeavor to ensure that no certificate or report, nor any part thereof, is used in a misleading manner;

9)In making reference to its accreditation status in communication media such as advertising, brochures or other documents, comply with the requirements of the accrediting organization;

10) Inform the accrediting organization’s headquarters without delay and in writing of changes in any aspect of the laboratory’s status or operation that affects the laboratory’s legal, commercial or organizational status; organization or management (e.g., managerial staff); policies or procedures, where appropriate; premises; personnel, equipment, facilities, working environment or other resources, where significant; authorized signatories; or such other matters that may affect the laboratory’s capability, or scope of accredited activities, or compliance with the criteria, requirements and conditions for accreditation;

11) Inform the accrediting organization’s headquarters if the laboratory is denied, has suspended, or loses its accreditation for calibration or testing with any other recognized private or governmental accrediting body and provide an explanation for the reason the accreditation was denied, suspended or lost. Failure to inform A2LA within thirty (30) days of the denial, suspension or loss of an accreditation will be grounds for immediate suspension of the laboratory’s accreditation; and

12) Carry out any adjustments to its procedures in response to due notice of any intended changes by the accrediting organization to the criteria, requirements, or conditions for accreditation, in such time as in the opinion of the accrediting organization is reasonable.

In order to receive recognition as a qualified testing laboratory, the applicant laboratory’s AUTHORIZED REPRESENTATIVE, must agree to the above conditions for accreditation and must attest that all statements made on their application are correct to the best of their knowledge and belief. An accredited laboratory’s AUTHORIZED REPRESENTATIVE is responsible for ensuring that all of the relevant conditions for accreditation are met.

SCOPE

This document sets forth the minimum requirements with which a laboratory shall comply and operate to demonstrate its competence to test photovoltaic (PV) components and systems.

In addition to its use as a model for the development of a laboratory's quality system, and for maintaining the quality of a laboratory's services, these criteria are for use in aiding the assessment of a laboratory's quality program and services.

This document covers the organization and management criteria of the laboratory, the design of its quality system, the minimum content of the laboratory's Quality Assurance Manual, the implementation of internal auditing of its quality system, and internal quality checking of its data and instrumentation.

This document also covers the general qualifications of the Laboratory's management and testing personnel, the external and on-the-job training requirements of its test personnel, the laboratory's general accommodation and environment criteria, and general requirements for scientific and test instrumentation.

This document also sets forth the minimum requirements for calibration instrumentation and traceability of instrumentation and data, generic requirements for use of calibration and test methods, handling of items for test, documentation and record requirements (including retention requirements), minimum requirements for issuance of test reports, vendor qualifications for subcontracting of services and purchasing of supplies, and handling of complaints.

APPROVAL AND ACCREDITATION

Accreditation requires recognition as an approved laboratory through a certificate of approval from an accreditation organization that has international recognition of its competence and has a quality system meeting the ISO/IEC Guide 58, Calibration and Testing Laboratory Accreditation Systems—General Requirements for Operation and Recognition. Approved laboratory accreditation bodies include those that are signatory to the APLAC Mutual Recognition Agreement, including NATA, HOKLAS, IANZ, SINGLAS, CNLA, A2LA, NVLAP, and bodies such as LCIE.

ORGANIZATION AND MANAGEMENT

The laboratory shall be legally identifiable. It shall be organized and operated in such a way that its permanent facilities, and any relevant temporary mobile facilities, meet the requirements of this model.

The laboratory shall

Have a managerial staff with the authority and resources needed to discharge their duties;
Have arrangements to ensure that its personnel are free from commercial or financial conflicts of interest and other pressures that may adversely affect the results of testing activities. The laboratory shall have a written policy relating to potential conflicts of interest, including the disclosure by staff of gifts from clients;
Be organized in such a way that confidence in its independence of judgment and integrity is maintained at all times;
Specify and document the responsibility, authority, and interrelation of all personnel who manage, perform, or verify work affecting the quality of testing or calibrations;
Provide supervision by persons familiar with the calibration and test methods and procedures, the objective of each such calibration or test, and the assessment of test or calibration results. The ratio of supervisory to nonsupervisory personnel shall be such as to ensure adequate supervision;
Have a technical manager (however named) who has overall responsibility for the technical operations of the laboratory. The technical manager must have sound knowledge of the principles of photovoltaic component and system testing and must have the ability to make critical evaluations of test results;
Have a quality manager (however named) who has responsibility for the laboratory's quality system, its implementation, and its maintenance. The quality manager's job may be a full-time or part-time job, depending on the size of the staff and the technical scope of the laboratory in disciplines other than photovoltaic testing. The quality manager shall have direct access to the technical manager and to the highest level of management at which decisions are taken for the laboratory on policy or resources or both;
Nominate and document the staff members who shall have full authority in the absence of the technical or quality manager or both; and,
Where interlaboratory comparison or proficiency testing programs are either not available, or otherwise not appropriate, have an internal program to assess proficiency using one or more of the following: correlation charting, statistical techniques, independent measurements or periodic checks of measured conditions using calibrated instruments.

QUALITY SYSTEM

The laboratory shall establish and maintain a quality system appropriate to the type and scope of photovoltaic testing required by the testing requirements for a certification and labeling program for photovoltaics components and systems. All elements of this system as listed below in the subsection entitled "Minimum contents of the quality manual," shall be documented. The quality documentation, including up-to-date referenced test procedures and operating documents, 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 practices and the quality of testing services. The laboratory management shall ensure that these policies and objectives are documented in a quality manual and communicated to, understood by, and implemented by all laboratory personnel engaged in photovoltaic component and/or system testing. The quality manual shall be maintained current under the authority and responsibility of the quality manager.

The laboratory's quality manual shall be specific to the laboratory physically involved in testing photovoltaic components and/or systems and shall therefore be unique to the laboratory; it shall not be a generic quality manual pertaining to a parent organization. The content, structure, and format of the manual shall reflect this uniqueness.

All copies of the manual shall be numbered, and a log shall be maintained with respect to the recipient of each control copy. The manual shall be a living document, i.e., each section shall be separately numbered, and each page shall contain the appropriate page number of that section and the following document control information: date of issue, authority, and amendment number.

The quality manual, and related quality documentation, shall state the laboratory's policies and operational procedures established to meet the requirements of this model.

Complete and detailed test and calibration procedures shall not be contained in the quality manual. The laboratory's specific requirements and wordings of the procedures in testing requirements for a certification and labeling program for photovoltaics components and systems shall be maintained in a separate test and calibration procedures manual or in separate manuals unique to the photovoltaic test laboratory;

Rules shall be developed and employed for the unique identification of all quality documentation, for changes to the documents, for their distribution, and for the registration of copies issued. The control information required on all documentation in the quality system shall include a unique identification of the document, the revision number, the date of issue, and the person authorizing the issuance of the revision so that the identity of the controlling document at any time is clear.

Minimum Contents of the Quality Manual

The minimum contents of the quality manual shall include the following:

A quality policy statement, including objectives and commitments, that is prepared, issued, and endorsed by top management;

The organization and management structure of the laboratory, its place in any parent organization, and relevant organizational charts. The organizational charts shall include all positions and names. These should be consistent with job descriptions and training records;

The responsibility, authority, and interrelation of all personnel who manage, perform, or verify work affecting the quality of tests and calibrations. These relationships should be further identified by use of a separate organizational chart;

Procedures for control and maintenance of the quality system and related operating procedures documentation. These shall include, in addition to the requirements specified in the second bullet directly above:

The procedures, responsibilities, and authorities for drafting, changing, approving, and issuing documents in the quality system, and documents for performing testing and calibration (test methods, calibration procedures, job orders and travelers);

Procedures for preventing obsolete or superseded documents from being used shall be documented;

Complete historical files of all quality documents issued shall be maintained and the location of these files shall be documented in the quality manual;

The quality manual shall contain a master list of all quality documents with current issue dates and identities of copy holders (where relevant).

The job descriptions of the management and key operating staff shall be listed in the appendix of the quality manual. Job descriptions of all other operating and support staff and training records shall be prepared and their location identified in the quality manual;

The laboratory's approved signatories for test reports and certifications shall be identified. The criteria for selecting the approved signatories shall be as specified in a model for a third-party certification and labeling program for photovoltaic components and systems;

The laboratory's policy and reference procedures for achieving traceability of all measurements;

Arrangements for ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing such work. The manual shall describe facilities and resources before commencing such work. The manual shall describe policies and procedures to screen incoming test requests to determine whether it is within the laboratory's capacity to accept the job. Evidence of this review shall be documented.

The laboratory’s scope of tests, listed in tables (whether in the body or in an appendix of the manual) covering the test procedures in one, and the calibration procedures in another. The documents pertaining to test and calibration procedures, respectively, shall be identified and their distribution noted;

The procedures for handling test items. This policy shall describe the system of work flow through the laboratory and shall be supported by a flow chart indicating the key elements of the overall test program;

Reference to major test and calibration equipment used in the laboratory. This reference shall be supported by an appended listing, in tabular form, of all such instrumentation. Information provided in the listing shall include the items required in the section on maintenance of records on equipment, reference materials, and reference instruments, below;

Reference to procedures for the calibration, verification, and maintenance of instrumentation and equipment;

Reference to current verification practices including interlaboratory comparisons and proficiency test programs (if made available for photovoltaic testing), use of reference materials and reference physical standards, and internal quality control, or procedures;

Procedures to be followed for feedback and corrective action whenever testing discrepancies are detected, or departures from documented policies and procedures occur;

The laboratory management's policy and arrangements for exceptionally permitting departures from documented policies and procedures, or from standard practices;

Policy and procedures for resolution of complaints received from clients or other parties about the laboratory's technical testing activities;

Procedures for protecting the confidentiality and proprietary rights of clients;

Procedures for audit and review of the quality system, as described in the following section of this document (Audit and Review, and Verification Practices);

Procedures for training of the staff in the implementation and application of, and compliance with, the quality system and related operating procedures;

Copies of or reference to procedures for the management of personnel (staff) and personnel records, and their location;

If work is subcontracted, procedures to ensure that subcontractors are competent and comply with the requirements of this guide, as described in the section of this document (below), entitled "Subcontracting of Testing";

Copies of or reference to procedures to ensure that outside support services and supplies are of adequate quality, according to the section of this document (below) entitled "Outside Support Services and Supplies";

Copies of or reference to procedures for avoiding deterioration or damage to test and calibration items during storage, handling, preparation, and test;

Copies of or reference to procedures for the receipt and retention or safe disposal of test and calibration items, including all provisions necessary to protect the integrity of the laboratory;

Copies of or reference to procedures to ensure that purchased equipment, materials, and services comply with specified requirements when no independent assurance of the quality of outside support services or supplies is available.

AUDIT AND REVIEW, AND VERIFICATION PRACTICES