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THE LABOATORY QUALITY' ASSURANCE SYSTEM Third Edition THE LABOMTORY QUALITY ASSURANCE SYSTEM Third Edition A Manual of Quality Procedures and Forms Thomas A Ratliff WILEYINTERSCI ENCE A JOHN WILEY & SONS PUBLICATION Copyright 2003 by John Wiley & Sons, Inc All rights reserved Published by John Wiley & Sons, Inc., Hoboken, New Jersey Published simultaneously in Canada No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning, or otherwise, except as permitted under Section 107 or 108 of the 1976 United States Copyright Act, without either the prior written permission of the Publisher, or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center, Inc., 222 Resewood Drive, Danvers, MA 01923,978-750-8400, fax 978-750-4470, or on the web at www.copyright.com Requests to the Publisher for permission should be addressed to the Permissions Department, John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, (201) 748-601 1, fax (201) 748-6008, e-mail: permreq@wiley.com Limit of Liability/Disclaimer of Warranty: While the publisher and author have used their best efforts in preparing this book, they make no representations or warranties with respect to the accuracy or completeness of the contents of this book and specifically disclaim any implied warranties of merchantability or fitness for a particular purpose No warranty may be created or extended by sales representatives or written sales materials The advice and strategies contained herein may not be suitable for your situation You should consult with a professional where appropriate Neither the publisher nor author shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages For general information on our other products and services please contact our Customer Care Department within the U.S at 877-762-2974, outside the U.S at 317-572-3993 or fax 317-572-4002 Wiley also publishes its books in a variety of electronics formats Some content that appears in print, however, may not be available in electronic format Library of Congress Cataloging-in-Publication Data: Ratliff, Thomas A The laboratory quality assurance system : a manual of quality procedures and forms /Thomas A Ratliff.-3rd ed p cm Includes bibliographical references and index ISBN 0-471-26918-2 (cloth) Testing laboratories-Quality control-Handbooks, manuals, etc I Title TA416 R37 2003 602.8’74~21 2002070206 Printed in the United States of America 10 Contents Preface / vii Section 27 Measurement, Analysis, and Improvement of the Quality System / 20 Section 28 Statistical Methods / 21 Section 29 Subcontracting Services and Supplies / 24 Section 30 Quality Audits / 24 Section Nonconformity / 25 Section 32 Customer Satisfaction and Complaints / 26 Section 33 Corrective and Preventive Action / 27 Section 34 Method Validation / 28 Section 35 Reliability / 28 Section 36 Quality Cost Reporting / PART 1: LABORATORY QUALITY SYSTEM ELEMENTS / Section Section Section Section Section Section Section Section Section Section 10 Section 11 Section 12 Section 13 Section 14 Section 15 Section 16 Section 17 Section 18 Section 19 Section 20 Section 21 Section 22 Section 23 Section 24 Section 25 Section 26 Introduction / Title Page / Letter of Promulgation / Quality Policies / Quality Objectives / Management of the Quality Manual / Control of Quality Documentation and Records / Customer Focus / Quality System Planning / Organization for Quality / Communications / Management Review / Human Resources / Laboratory Infrastructure / Work Environment / Quality in Procurement / Sample Handling, Identification, Storage, and Shipping / Chain-of-Custody Procedures / 10 Laboratory Testing and Control: Intraand Interlaboratory Proficiency Testing / 11 Design and Development (Excluded) / 14 Customer Property (Excluded) / 14 Control of Measuring and Test Equipment / 14 Preventive Maintenance / 17 Estimate of Uncertainty of Measurement / 18 Reference Standards and Standard Reference Materials / 18 Data Validation / 19 PART 2: HOW TO WRITE A LABORATORY QUALITY ASSURANCE MANUAL / 33 Section 37 Introduction / 33 Section 38 Organizing for Preparation of the Manual / 33 Section 39 Establishing Objectives and Priorities / 33 Section 40 Collection and Review of Existing Procedures / 34 Section 41 Preparation of a Flowchart / 34 Section 42 Identification of Program Requirements / 36 Section 43 Identification of Shortfalls and the Assignment of Priorities / 36 Section 44 Writing the Manual / 36 PART 3: XYZ LABORATORY QUALITY ASSURANCE MANUAL / 37 PART 4: SAMPLE QUALITY ASSURANCE FORMS / 181 Index / 235 V Preface The purpose of this book is to provide the user with the means to create a quality assurance manual which will satisfy the needs of his or her particular laboratory while meeting the requirements of any regulatory or accrediting body with which the organization may be associated This third edition has been prepared to assist laboratories seeking accreditation in the preparation of the quality assurance/control manual as required by American National Standard ANSI/ISO/ASQ 49001-2000, Quality management Systems-Requirements, and/or American National Standard ANSUISO 170251999, General requirementsfor the competence of testing and calibration laboratories New material has been added to cover increased requirements for expanding customer relationships, continual improvement, and other areas as set forth in ANSI/ISO/ASQ 9000-2000 Procedures are suggested to meet these requirements, and blank forms are provided to be used to record results of these activities The book seeks to achieve the goal of providing an easy-to-use, step-by-step explanation of the preparation of a manual by discussing in detail the elements of laboratory quality systems required by the standards referenced above, describing the mechanics of creating a manual, providing an example of a laboratory quality manual complete with sample forms and instructions for their use, and, finally, providing blank copies of all forms referenced in Part These blank forms may be reproduced, copied, or edited to meet the needs of a particular laboratory Although many of the examples and references included herein relate to industrial hygiene laboratories, the principles set forth herein are applicable to any testing, analytical, or other laboratory, excluding those dedicated purely to research and development vii Laboratory Quality Assurance System, 3rd Edition Thomas A Ratliff Copyright 02003 John Wiley & Sons, Tnc 4SBN: 0-471-26918-2 Part LABORATORY QUALITY SYSTEM ELEMENTS SECTION INTRODUCTION to, and support for the laboratory’s quality program It should also stress the importance of individual responsibility for conduct which enhances and does not endanger the quality of laboratory performance Lastly, it should emphasize the fact that the policies and procedures published in the manual are binding on each individual and are the authority as well as the requirement for the conduct of the laboratory’s work The laboratory may wish to include an Introduction to its quality manual to explain its purpose and how and to whom it is to be distributed The Introduction may also be used to explain the background authority or standard on which the document is based and how the manual may differ from such a reference if there is any significant deviation from the authority or standard SECTION QUALITY POLICIES SECTION TITLE PAGE Quality policies are established by management to provide guidance to the organization on the pathway to continuous improvement of its quality performance, meet regulatory or accreditation requirements, or, in the case of larger organizations, to agree with previously established policies mandated by a higher authority within the company Quality policies may cover such matters as: The title page of the manual should contain the following information: @ The name and address of the issuing organization If the laboratory is a subordinate part of a larger company or organization, the parent body should be identified, together with its address The name and title of the responsible Quality Control Coordinator or Manager of the laboratory The name and title of the Laboratory Director, Chief Executive Officer, President of the Corporation, or other individual bearing the ultimate responsibility for the quality of the laboratory output The date of issue If the distribution of the quality manual is controlled, the copy number of the manual should be indicated on the title page Quality training Publication, distribution, and retention of current or obsolete documents such as methods, specifications, calibration procedures, instrument operating instructions, and so on Provide for the assurance of good quality, fresh reagents and chemicals, and appropriate calibrated glassware Participation in interlaboratory quality evaluationprograms Determination to reduce the costs of correction and evaluation by increasing preventive measures SECTION LETTER OF PROMULGATION If the laboratory desiresto issue the quality manual under the cover of a Letter of Promulgation, this letter should be written by and signed by the same person who signed off on the title page (i.e., the Laboratory Director, Chief Executive Officer, or Corporate President) The Letter of Promulgation serves to demonstrate and emphasize management’s interest in, commitment These are but a few examples of the kinds of policies that may be established by management in response to requirements generated by the considerations put forth above Quality policies should be issued by the highest authority available within the laboratory They should attest to management’s concern about and commitment satisfaction, or performance of internal audits, among others to the maintenance of a high level of quality in the laboratory’s work SECTION QUALITY OBJECTIVES References It is the responsibility of the laboratory’s management to identify and state, in writing, what the quality goals of the laboratory are to be The primary objective of a laboratory’s quality system is to improve and maintain at a high level the precision and accuracy of the laboratory’s “product.” Here, the laboratory’s product can be defined as “the report issued as the result of analytical, measurement, or testing activity conducted on a sample or samples received from some source.” Management, administrative, statistical, investigative, preventive, and corrective techniques are among those which may be used to maximize the quality of the reported data Secondary objectives which may be established to reach primary goals might be: July, 1983 Industrial Hygiene Laboratory Quality Control Cincinnati: National Institute for Occupational Safety and Health Juran, J M 1988.Juran’s Quality Control Handbook 4th Ed New York: McGraw-Hill Book Company SECTION MANAGEMENT OF THE QUALITY MANUAL Although the laboratory’s description of its quality system may be contained in more than one document, the usual format, and the one required by Paragraph 4.2.2 of ANSI/ISO/ASQ Q9001-2000, is the quality manual The principle use of the manual is to present, in one document, the laboratory’s policies and procedures which relate to the control of the quality of the laboratory’s output The manual should: To establish the level of the laboratory’s routine performance To make any changes in the routine methodology found necessary to make it supportive of the management policy regarding reduction of costs associated with corrective action and evaluation To set forth objectives associated with achieving management’s mandate to assure continuous improvement of quality performance To establish program goals for the laboratory’s quality and technology training efforts Include a Table of Contents Assign the responsibility for publishing and distributing the manual and keeping its contents current and upto-date and describe the procedures for recommending and making changes Prescribe the format for paragraphing and maintain the same format throughout the document Include copies of any reports, forms, tags, or labels to be used by the procedures described in the text of the manual Quality objectives should be quantified insofar as possible by establishing target dates for completion or by raising or lowering a numerical value to a higher or lower level established as a goal Quality objectives should be attainable If they are not, they lose effect as a management tool since they will lead to frustration and a resulting lack of cooperation and enthusiasm among those charged with the responsibility for reaching established goals Quality objectives should be clearly defined and so stated that all concerned understand management’s exact intentions with regard to the goals to be reached Vaguely defined programs, or those not completely understood, are doomed to failure, especially if they are not vigorously supported by management and backed up by adequate follow-up and supervision Above all, quality objectives must support established policies The examples of objectives given above are by no means a complete list of quality objectives that might be selected by an individual laboratory Quality objectives should be based on the particular laboratory’s policies, priorities, and field of interest, results of audits, or requirements of regulatory or accrediting bodies Other subjects appropriate for selection as quality goals might have to with quality costs, dealing with customer If the distribution of the manual is controlled, then each copy should be numbered and a distribution list maintained showing to whom each numbered document has been issued Unnumbered copies may be distributed on an uncontrolled basis to potential customers, auditors, trainees, and the like SECTION CONTROL OF QUALITY DOCUMENTATION AND RECORDS The laboratory quality assurance system program will include provisions for maintaining necessary records and reports and for updating and controlling the issuance of technical documents and operating procedures DOCUMENT CONTROL The important elements of the quality assurance system to which document control should be applied include: Sampling procedures Calibration procedures Analytical and test methods Data collection and reporting procedures Auditing procedures and checklists Sample shipping, packaging, receiving, and storage procedures Computation and data validation procedures Quality assurance manuals Quality plans 10 Sampling data sheets 11 Specifications responsible for their preparation, distribution, and maintenance; the format in which they are published and maintained; the distribution list; and the retention period Such records include: Test and analytical results Reports on the results of data validation Internal and external quality audits Instrument and gauge record cards Quality cost reports Laboratory notebooks Chain-of-custody records for samples Each laboratory must maintain full control over the distribution and possession of such documents A file control should be established showing the following minimum information: While being stored for specified or required retention periods, documents should be protected from damage, tampering, loss, or degradation due to atmospheric conditions Document number Title Source of the document Latest issue date Change number List of addressees LABORATORY NOTEBOOKS The laboratory notebook is the primary source for documentation of the individual analyst’s, test engineer’s, or technician’s activities Laboratory notebooks are used for recording all experimental, testing, and analytical notes and data The issue of notebooks should be controlled by assignment of a serial number for each book Notebooks are issued to individuals and the serial number entered in a serial number issue log The serial number is placed on the cover of each notebook together with the recipient’s name and the date issued Upon completion, the notebook is returned for filing and the completion date noted on the cover Notebooks are hardcovered and bound Notebooks with removable pages (e.g., looseleaf notebooks) are not considered by many to be acceptable for use in the laboratory All entries should be made in ink The pages should be numbered and dated, and any entries made by an individual other than the person to whom the book was issued should be noted These notebooks are considered to be the property of the laboratory and are retained as a part of the laboratory’s files The notebook should contain all the information gathered by the analyst or test technician pertaining to the sample, including method response (raw data) for each sample Where appropriate, the laboratory number, field number, sequence number, or other identifying numbers should be noted The specific analysis or test requested, identification of the method, if known, modifications to the method, and the sample source should also be included A description of the sample, in as much detail as possible, should also be included Data such as blank values, recovery studies, or duplicate determinations should also be included Formulas and equations used to calculate results and all calculations should be shown The minimum data and description entered in the notebook should be sufficient to enable another test Whenever a change is made, the responsible organization should issue the new, changed document together with the change notice (see Fig 12-1, Part 4) Whenever practicable, recipients of new or changed documents should acknowledge receipt by signature Obsolete documents should be removed from points of use and destroyed immediately unless a copy is retained for record purposes In such cases, record copies must be clearly marked as obsolete Requests for technical document changes, such as changes to methods, sampling data sheets, calibration procedures, and the like, can be initiated by anyone within the organization, the request being made in writing on the technical document change notice (Fig 12-1) It should go through established approval procedures before publication and distribution Changes may be promulgated by (I) the issuance of entire new documents, (2) the issuance of replacement pages, or, in the case of minor changes, correction of errata and so forth, by (3) pen and ink posting on the original document, with this action noted on the change notice The Quality Control Coordinator should be designated as the individual responsible for ensuring that up-to-date documents are being used and that obsolete documents are removed from use This includes materials from sources outside the laboratory such as standards, applicable regulations, specification sheets, and so on QUALITY RECORDS Records of other laboratory activities should be maintained in addition to those generated by use of the forms and reports listed above Such records should be controlled by specifying the individual or organization completed when the newly developed system is in place and running The second phase is a long-term, continuing process and involves constant appraisal, review, and planning to update, improve, or correct deficiencies in the system In order for the planner to communicate his plan to the person or persons expected to execute it, he must write it out in the form of procedures, together with the necessary criteria, flowcharts, diagrams, tables, forms, and so on Planning in the field of quality assurance or quality control for the laboratory must fundamentally be geared to the delivery of precise and accurate reports which meet customer requirements at a reasonable quality cost This objective is realized only by carefully planning and developing the many individual elements of the quality system, which relate properly to each other and are in consonance with the laboratory’s established quality objectives These elements, taken together, are those discussed at in other sections of P r The steps involved in initial quality planning are discussed in detail in Part of this book The final result of initial quality planning should be a written document which includes the most important information that the planner (normally the Quality Control Coordinator) feels should be communicated to the users of the document The resulting overall quality plan then becomes, after management approval, the quality manual The quality assurance plan, now called the quality assurance manual, has other important functions in addition to the primary purpose already discussed: engineer, technician, or analyst to derive the same results as the original worker, with no other source of unpublished information In addition to these minimum data, any other facts pertinent and appropriate to the sample test or analysis should be entered Deletion of mistakes should be made by drawing a single line through the error The line drawn should not render the deletion illegible A notation stating the reason for the deletion should be added and initialed by the person who made the deletion The recording of data on loose sheets is poor procedure, and, because of the possibility of transcription errors, should be avoided An analyst’s or test technician’s notebook is always subject to inspection by his colleagues, supervisors, or site visitors, assessors, surveyors, or auditors from outside the laboratory Therefore, it is imperative that the notebook be maintained in a professional manner and contain all the pertinent information that may be required by other parties, regardless of the importance of that information to the analyst or technician Furthermore, the notebook must be maintained in such a manner that it can withstand challenges as to the validity, accuracy, or legibility of its contents Entries should be timely and not accumulated for more than one day References 1975 Quality Assurance Handbook f o r Air Pollution Measurement Systems Research Triangle Park, NC: U.S Environmental Protection Agency July, 1983 Industrial Hygiene Laboratory Quality Control Cincinnati: National Institute for Occupational Safety and Health January, 1987 Qualty Assurance and Laboratory Operations Manual Cincinnati: National Institute for Occupational Safety and Health It is the culmination of a planning effort to design into a program or specific project provisions and policies necessary to assure accurate, precise, and complete quality data It is an historical record which documents the program or project plans in terms of measurement methods used, calibration standards, auditing planned, data validation requirements, and so forth It provides management with a document which can be used as an audit checklist to assess whether or not the quality assurance and control procedures called out in the manual are being implemented It may be used as a textbook for the training of new employees or for refresher training It may be used as a sales tool The existence and demonstrated use of a Laboratory Quality Assurance Manual is a powerful sales statement It may be used to demonstrate compliance with the requirements of regulatory or accreditation bodies SECTION CUSTOMER FOCUS The laboratory’s management must, at all times, keep in mind that a primary requisite for the production of the highest quality of laboratory services is to ensure that all concerned are aware of the customers’ needs and expectations and make every effort to satisfy and heighten customer satisfaction SECTION QUALITY SYSTEM PLANNING The act of planning is the thinking out, in advance, of the sequence of actions necessary to accomplish a proposed course of action to achieve certain quality objectives which support established quality policies For the quality professional, the task of planning generally presents itself in two phases, discussed below The initial phase is encountered when an organization must develop a quality system “from scratch.” It is The continuing phase of quality planning is kept simmering on the back burner at all times There should be constant review, appraisal, and surveillance of the quality system to seek out and identify departures from The job description for a Quality Control Coordinator should, as a minimum, include the responsibilities shown below procedures specified in the quality manual, omissions of expected conduct, neglect to cany out such procedures, or the introduction of new, unauthorized procedures into the system This oversight activity should be carried out in addition to the formal, internal audits periodically carried out by management JOB DESCRIPTION Title: Quality Control Coordinator Reference Basic function: The Quality Control Coordinatoris responsible for the conduct of the laboratory quality control program and for taking or recommending measures to ensure the fulfillment of the quality objectives of management and the carrying out of established quality control policies in the most efficient and economical manner commensurate with ensuring the continuing accuracy and precision of analytical or test data produced Responsibilities and authority: 2.1 Develops and carries out quality control programs, including the use of statisticalprocedures and techniques, which will help the laboratory to meet required or authorized quality standards at minimum cost and advises and assists management in the installation,staffing, and supervision of such programs 2.2 Monitors quality control activities of the laboratory to determine conformance with established policies, customer and regulatory or accreditation requirements, and with good laboratory practice He or she makes recommendations for appropriate corrective action and follow-up as necessary 2.3 Keeps abreast of and evaluates new ideas and current developmentsin the field of quality technology and recommends courses of action for their adoption or application wherever they fit into the laboratory’s area of expertise or policy requirements 2.4 Advises the purchasing section regarding the quality of purchased supplies, materials, instruments, reagents, and chemicals 2.5 Supervises the laboratory’s interlaboratory proficiency testing program 2.6 Monitors the shipping, delivery, packaging, and handling of samples and makes recommendations for corrective action when conditions are found that lead to damaged, contaminated, or mishandled samples received 2.7 Makes periodic reports to the Director of the laboratory as to the quality of the laboratory’s output performance and makes recommendations as to the necessary steps to be taken to ensure improvement 2.8 Continually seeks to make sure that customer expectations are being met, including promoting awareness throughout the laboratory as to what July, 1983 Industrial Hygiene Laboratory Quality Control Cincinnati: National Institute for Occupational Safety and Health SECTION 10 ORGANIZATION FOR QUALITY The establishment of a quality assumnce system in the laboratory,as described here in Part 1, will require the designation of a Quality Control Coordinator within the laboratory to carry out the monitoring, record-keeping, statistical, calibration, and other functions required in such a program Other titles, such as “Manager, Quality Assurance,” “Director, Quality Assurance,” “Quality Control Supervisor,” and others, may be used, but the title “Quality Coordinator” seems particularly appropriate in small organizations, such as laboratories are apt to be Regardless of the title, it is necessary to place on some individual the responsibilities for carrying out the quality policies prescribed by management This person may have these duties as his or her sole responsibility in a large organization, and may have a staff or clerical or technical assistance, but in a small organization may “wear” this position as another “hat.” The Quality Control Coordinator should be placed in the organization at a position where he reports to the highest level at which he can be effective, unbiased, and objective in serving the needs of the laboratory In no case, however, should the quality control coordinating function be subordinate to an individual responsible for the direct conduct of the testing or analytical work An example of a typical organization chart for a small analytical laboratory appears as Figure 5-1 in Part 3, XYZ Laboratories, Inc Quality Assurance Manual Note that the Quality Control Coordinator reports to the Laboratory Director The placement of names in position blocks in the organization charts is optional but often requires unnecessary paperwork due to frequent personnel changes In larger organizations, where the Quality Control Coordinator may have supporting staff, it is desirable to furnish an additional organization chart for the quality assurance section alone The Quality Manual should include a copy of the Quality Control Coordinator’sjob description, although this document may be prepared outside the Quality Control Department Other position descriptions may be included if required by an accrediting organization CATEGORY QUALITY PLANNING The responsibility for the quality planning function is clearly defined There is objective evidence that quality planning is an ongoing, continuous process The Quality Manual accurately reflects current quality system activities in the laboratory Total Applicable Points Total Survey Points Percentage CATEGORY QUALITY IN PROCUREMENT Inspection is performed by Quality Control Inspection instructions are available to inspection personnel Inspection personnel perform inspection operations in accordance with current instructions and procedures There is a system to maintain inspection instructions current There is a program for Quality Control approval of vendors and subcontractors Vendors and subcontractors are required to have a a system for quality control Inspection and test results are used to evaluate vendor quality performance Purchase orders, specifications, and vendors’ catalogs are available to receiving inspection 22 Inspection gages and test equipment are adequate to perform required inspection 10 Sampling inspection (when applicable) is performed to ANSUASQC Z 4-1981, ANSVASQC Z 9-1987, or other approved sampling plan 11 Approved laboratories are used for special tests and analyses outside the scope of the laboratory’s capabilities 12 All reagent stock is properly labeled, dated and marked with shelf-life expiration when necessary 13 Chemical/physical analysis, test specifications, or certifications are required when applicable Total Applicable Points Total Survey Points Percentage - CATEGORY SAMPLE HANDLING, STORAGE AND SHIPMENT The Quality Control Coordinator monitors the physical condition of incoming test samples Test and analytical samples are properly identified Sample Submittal Forms are completely and accurately filled out Total Applicable Points Total Survey Points Percentage 222 - CATEGORY CHAIN-OF-CUSTODY PROCEDURES Is the Chain-of-Custody Documentation Form correctly and completely filled out? Does the Chain-of-Custody Documentation Form establish custody of the sample at all times? Total Applicable Points Total Survey Points Percentage CATEGORY LABORATORY TESTING AND ANALYSIS CONTROL Function checks are routinely performed by the operator The operator performs control checks during the analytical or testing procedures Tests for significance of difference are made when results indicate the need Control charts are used routinely for suspected or difficult method determinations, The Quality Control Coordinator is responsible for deciding which testing or analytical operations will be charted Total Applicable Points Total Survey Points Percentage CATEGORY 10 QUALITY DOCUMENTATION AND RECORDS CONTROL The quality documents to be controlled are listed in the Quality Manual Document retention policies are published in in the Quality Manual or elsewhere in writing 223 - The Quality System is adequately documented The Quality Control Coordinator issues periodic reports to management which reflect quality levels, quality costs, customer complaints, etc There is adequate control over the issue of new technical documents and changes Obsolete documents are retrieved from work stations and are not permitted to remain in the hands of users Total Applicable Points Total Survey Points Percentage - CATEGORY 11 CONTROL OF MEASURING AND TEST EQUIPMENT Quality Control procedures insure that instruments, gages, measuring devices and test equipment are periodically inspected and recalibrated at established intervals Working and reference standards of required accuracy that are periodically calibrated to primary standards traceable to the NIST are maintained in a suitable environment New or repaired test equipment and measuring devices are calibrated and proved satisfactory by Quality Control before release for use There are written calibration procedures for each type of instrument and measuring device Objective evidence includes calibration date and date next calibration must be performed on measuring instrumentation Record system provides for automatic recall of gages, instruments and test equipment due for calibration Total Applicable Points Total Survey Points Percentage 224 - CATEGORY 12 PREVENTIVE MAINTENANCE There is a planned, scheduled program tied in with the calibration system, that ensures that all measuring and test equipment undergoes periodic preventive maintenance Preventive maintenance checklists are in use and on file An adequate spare parts inventory is on hand - Total Applicable Points Total Survey Points Percentage CATEGORY 13 REFERENCE STANDARDS Laboratory policy requires the use of reference standards, when available The Quality Control Coordinator keeps on file a copy of NIST Publication 260 and copies of NIST Certicates of Analysis Total Applicable Points Total Survey Points Percentage CATEGORY 14 DATA VALIDATION Data validation is routinely employed to detect outliers or spurious values Manual data validation techniques are the only methods used to detect outliers and spurious values Both manual and computerized techniques are used for data validation 225 Sampling plans from ANSVASQC 21.4, 1981 are used when selecting samples for data validation of large quantities of data Total Applicable Points Total Survey Points Percentage CATEGORY 15 ENVIRONMENTAL CONTROLS The laboratory working environment is controlled to the extent prescribed by the Manual Total Applicable Points Total Survey Points Percentage CATEGORY 16 CUSTOMER SATISFACTION AND COMPLAINTS A record is kept of all customer contacts and the Quality Control coordinator is responsible for reviewing them and taking any necessary action One individual is charged with the responsibility for handling all complaints from customers, regulatory agencies, and accrediting organizations There is a system for providing feedback to all laboratory personnel concerned If required by contractual, regulatory, or accreditation bodies, the Quality Control Coordinator will arrange with an outside marketing analysis agency to conduct whatever surveys are necessary in order to appraise the effectiveness of the laboratory’s customer satisfaction efforts 226 One individual is charged with the responsibility for initiating corrective action, if this becomes necessary Total Applicable Points Total Survey Points Percentage CATEGORY 17 SUBCONTRACTING Contract laboratories are required to have a viable Quality Control System in place Provision is made for furnishing contract laboratories with “audit” samples to test laboratory proficiency When a new method is introduced, provision is made for furnishing contract laboratories with spiked samples to test the proficiency of the laboratory in performing the method Total Applicable Points Total Survey Points Percentage CATEGORY 18 PERSONNEL TRAINING, QUALIFICATION AND MOTIVATION The laboratory provides for employee indoctrination and training in Quality Control The laboratory has a program to test the effectiveness of the training effort Training records are available to indicate the status of individual training The laboratory conducts campaigns, supported by management, to promote the achievement of superior quality output Total Applicable Points Total Survey Points Percentage 227 - CATEGORY 19 STATISTICAL METHODS The laboratory employs the following statistical techniques in the routine conduct of analytical and testing work: a Tests of hypotheses b Treatment of outliers c Control Charts Sampling Plans e Tests for significance of differences Total Applicable Points Total Survey Points Percentage - CATEGORY 20 NONCONFORMITY The Quality Control System assures that positive action is taken, when a nonconforming event occurs, to ensure that all required tasks are performed in accordance with provisions of the Quality Manual Adequate records are kept of nonconformities - Total Applicable Points Total Survey Points Percentage 228 - CATEGORY 21 CORRECTIVE ACTION The laboratory has a method of recurrence control to prevent repetitive discrepancies Corrective action requests on nonconforming events are initiated promptly Records provide for follow-up on all corrective action requests The responsibility for solving the problem by taking corrective action is clearly established The Suspense Date when the corrective action is expected to be completed is clearly established The Corrective Action Log controls the progress of the corrective action initiated by the Corrective Action Request Total Applicable Points Total Survey Points Percentage CATEGORY 22 QUALITY COST REPORTING Quality costs are accumulated for the following categories: a Prevention costs b Appraisal costs C Internal failure costs d External failure costs When actual costs figures cannot be obtained from the cost accounting component, reasonably accurate estimates are used Quality Cost reports are made management periodically Quality cost figures are used in the annual budgeting process to Total Applicable Points Total Survey Points Percentage 229 CATEGORY 23 QUALITY AUDITS Quality audits are performed on an announced, scheduled basis by individuals outside the quality organization All areas of the laboratory contributing to the quality of work output are audited The results of the audit are reported to management in writing Pre-audit and post-audit conferences are held prior to and after each audit Total Applicable Points Total Survey Points Percentage CATEGORY 24 RELIABILITY Reliability forecasts in terms of “Mean Time to Failure” (MTTF) are routinely provided by Quality Control for remotely situated recording instruments, Total Applicable Points Total Survey Points Percentage 230 - MAINTENANCE / SERVICE REPORT ITEM NAME TEST NO TIME STARTED MANUFACTURER TIME DATE MODEL OPERATOR FAILURE CONDITIONS I INTERVAL SINCE LAST SERVICE LOCATION I GENERAL DESCRIPTION OF FAILURE AND CAUSE ENVIRONMENTAL CONDITIONS DIAGNOSTIC TIME SPENT CORRECTIVE ACTION TAKEN FAILED COMPONENTS REPLACED FAILED COMPONENTS REPAIRED SERVICE REQUIREMENTS I NOT REQUIRED TAMPER-PROOF SEALING REQUIRED PREVENTIVE MAINTAINANCE COMPLETED OPERATIONAL TEST COMPLETED SIGNATURE FIGURE 26- 23 METHOD VALIDATION APPROVAL REPORT DATE: PATIENT TEST METHOD DESCRIPTION: SPECIMEN DESCRIPTION: ABSTRACT OF TEST METHOD: METHOD VALIDATION TYPE/S USED FOR THIS DETERMINATION: OF PERFORMANCE RESULTS ESTABLISHMENT STUDY: SPECIFICATION Accuracy b Precision c Analytical sensitivity d Analytical specifity (Interferences) e Reportable range of patient test results f Reference range(s) g Other performance characteristics as required METHOD VALIDATION PERFORMED BY: FOR DATA - SEE APPENDIX FOLLOWING APPROVED BY: TITLE DATE: Figure 27-1 232 OR OK a VERIFICATION FAIL Effective Date B Y Approved Subject Figure 28-1 233 Section No Page of Reviewed Laboratory Quality Assurance System, 3rd Edition Thomas A Ratliff Copyright 02003 John Wiley & Sons, Tnc 4SBN: 0-471-26918-2 Index Acceptance sampling, 20 Accreditation requirements, 12 Administrative support, AIHA Laboratory Accreditation CommitteeL'rogram, 13 Air conditioning system, Air Force Logistics Command (AFLC), 16 American Association for Laboratory Accreditation, 12 American Industrial Hygiene Association (AIHA), 12-13 American Society for Quality, 31 American Society for Testing and Materials (ASTM), 28 Analysis audits, 24-25 Analysis of variance (ANOVA), 11 Analyst proficiency, 13-14 ANSVASQC Standards: 2- I.4 19-20 Z- I.4-1993,23,25 Z-1.9-1981,23 ANS [/ISO/ASQ: 49001-2000,2,21 Q9004-2000, 12 Q10011-1994,25 Anuual reports, Appraisal costs, 31-32 ASTM E-1301-1995, 12 Audits, see Quality audits Award program, 21 Bell Telephone Laboratories, 20 Bonus program, 21 Bulk Asbestos, proficiency testing, 12 Calibration procedures/standards: interlaboratory proficiency testing, 11 intervals, 15 plan design, 14 procedures, 15-16 source, 17 standards quality, 14-15 Chaiii-of-custody procedures, 10-1 Chief Executive Officer, Chi-square test, 20, 22 Communications: customer complaints, 26 motivational, system guidelines, Complaints: handling procedures, 26 managerial review of, Consumer surveys, 26 Continual improvement, 20 Continuous Quality Improvement policies, 7,21 Control chart 22 Corrective Action: components of, 27-28 initiation of, 30-3 managerial review, quality control cost report, 32 Requests, Corrective Action Analyst, functions of, 27 Corrective Action Request (CAR), 27 Cost reporting, 31-32 Customer complaints, 26 Customer focus, 4-5 Customer Satisfaction: consumer surveys, 26 policies, Reports, 21 Customer service, 26 Daily service checklists, 30 Data processing audits, 24-25 Data validation: components of, 19-21 quality control cost report, 32 statistical testing, 22 SUbCOntrdCting laboratories, 24 Documentation, see Recordkeeping/records: control, 2-3 of quality policy, Eating arreas, Economic Control of Quality of Munufuctured Products (Shewhart), 20 Electric system standards, 15 ELPAT, 12 EMPAT, 12 Employee(s): recognition programs, training, 30 Environmental laboratories, 10 Equipment: contracts, 29-30 corrective/preventive action procedures, 27-28 failure rate, 29 maintainability, 30 measurement and test: calibration intervals, 15 calibration plan, 14 calibration procedures, 15-1 calibration source, 17 calibration standards quality, 14-15 environmental conditions, 15 Government-Industry Data Exchange Program (GIDEP), 16 labeling, 17 preventive maintenance, 17-1 reliability requirements, 29 testing procedures, 30 External-failure costs, 32 235 First-in, first-out (FIFO), Fitness facilities, Flowchart, quality assurance manual, 34-36 Forensic laboratories, I0 Format, for quality manual, 2, 36 F-tests, 11, 20, 22 Government-Industry Data Exchange Program (GIDEP), 16,29 Graphics, quality control cost report, 32 Handling samples, 9-10 Health facilities, Heating system, Housekeeping practices/standards, Human resources, responsibilities of motivation, overview, 6-7 qualification records, training evaluation, Independent study, Information resources, proficiency testing programs, 13 In-house training, Inspection procedures: destructive, 23 equipment, 30 nondestructive, 22-23 quality audits, 25 of supplies, 8-9 Interlaboratory audits, 12 Interlaboratory proficiency: appraisal costs, 31 performance evaluation and, I quality policy, testing for, 11-12 Internal-failure costs, 32 Intralaboratory proficiency testing program, 13-14,21,31 Inventory, first-in, first-out (FIFO), ISO/IEC Guide 43-1-1997, 12 Japanese managerial techniques: Kaizen, 21 types of, Job descriptions, 5-6 Joint Commanders of the Army Materiel Command (AMC), 16 Joint Commission on Accreditation of Health Care Organizations (JCAHO), 12 Kaizen, 21 Laboratory Director: Quality Control Coordinator, relationship with, Quality Improvement Board, I quality manual, recognition of, Laboratory infrastructure, Laboratory notebooks, Laboratory Quality Assurance Manual, benefits of, Laboratory Stores Clerk, functions of, Laboratory testing: interlaboratory proficiency, 11-12, 21, 31 intralaboratory proficiency testing programs, 13-14,21,31 Lead, OSHA requirements, 12 Letter of Promulgation, I , 36 Lighting design, 8, 15 Logs: equipment maintenance, 18 of inventory, Lunchrooms, Maintainability factor, 30 Management review, Mean time-to-failure rates, 29 Meawrement uncertainty, estimate of, 18 Merit Awards, 21 Method Validation, 21, 28 MIL-STD-105, 20 Monitoring guidelines, 21 Motivational campaigns, National Institute for Occupational Safety and Health (NIOSH), 13, 28 National Institute of Science and Technology (NIST): calibration standards, 14-15, 17 special publications, listing of, 18 Standard Reference Material Program, 11,18 Naval Materiel Command (NMC), 16 Nonconformity, 25, 28 Objectives, types of, Occupational Safety and Health Act of 1970 (OSHA), 10, 12-13,28 On-the-job (OTJ) training, Operations guidelines, 30 Organization considerations, 5-6 Pathological laboratories, 10 PAT proficiency testing program 12-1 Performance evaluation, Planning guidelines, 4-5 President of Corporation, in quality manual, Prevention costs, 1-32 Preventive Action: components of, 27-28 managerial review, Preventive maintenance, 17-1 8, 30 Primary objectives, Procurement quality control, 32 See also Purchasing guidelines Program Manager, Government-Industry Data Exchange Program (GIDEP), 16 Project team management, functions of, 21 Purchase orders, 8-9 Purchasing Department, functions of, 8-9 Purchasing guidelines purchase orders, 8-9 Qualified Outside Laboratory Source List, 24 Quality assurance manual: elements of, overview, 1-2,5 introduction section, Letter of Promulgation, 1, 36 management of, page numbering, 36 quality objectives, quality policies, 1-2 table of contents, 36 title page, writing guidelines: documentation, 36 existing procedure$, 34 flowchart preparation, 34-36 format, 2, 36 new procedures, 36 objectives, 33-34 preparation organization, 33 priorities, 33-34 program requirements, identification of, 36 Quality assurance plan development, 4-5 Quality Assurance Hundhook,4th Edition (Juran), 7, 18 Quality audits: components of 24-25 importance of 6, 21 of vendors, 8-9 Quality Circles, 7, 20 Quality Control Coordinator: functions of: corrective action, 27 document control, employee training programs, overview, 5-6 preventive action, 27 purchase orders, qualification records, Quality Improvement Board, 21 reliability procedures, 28-29 state of laboratory quality assurance system report, in system planning, writing quality assurance manual, 33-36 job description, 5-6 Quality Cost Reports, 6, 21 Quality Improvement Board, functions of, 21 Quality is Free program, 20 Quality manual, see Quality assurance manual Quality objectives, Quality policies, 1-2, 21 Quality system: analysis of, 20-21 elements of, overview, 1-2 improvement of, 20-21 monitoring, 21 measurement, 20-2 performance evaluation, I Quality System Survey Evaluation Checklist, Receiving report, Recordkeeping/records: chain-of-custody procedures, 10-1 I equipment maintenance, 18, 30 guidelines for, 2-3 quality audit inspections, 25 reliability programs, 30-3 X-R charts, I I, 22 Reference materials, standard, 18-19 Reference standards, 18-1 236 Reliability programs: employee training, 30 equipment contracts, 29-30 equipment failure rate, 29 equipment tests, 30 influential external factors, 29 maintainability, 30 operations guidelines, 30 planning process, 29 recordkeeping guidelines, 30-3 Restrooms Safety practices/standards, Samples, handling, identification, storage, and shipping, 9-10 Sampling audits, 24-25 Sampling techniques, 22 Secondary objectives, Sequential analysis, 20 Services, subcontracting, 24 Shewhart, Walter, 20 Shipping standards for samples, 9-10 Simon, Colonel Leslie E., 20 Soviet Saratov System, Standard Reference Materials (SRMs), 11 18 Statistical methods, 21-23 Statistical tests, 20 Storage, of samples, 9-10 Subcontracting labot'dtorieS, 24 Summary Quality Cost Report Supplies, subcontracting, 24 Target Health Hazard Program (THHP), 13 Test audits, 24-25 Total Quality Control, 20 Total Quality Control policies, Total Quality Management, 20 Training programs: employees, 6-7, 30 evaluation of, quality policie\, types of, 6-7 t-tests, I , 20, 22 U.S EPA Environmental Monitoring and Support Laboratory, 12 United States Standard MIL-Q-9858A 12 Vendors: purchase orders, 8-9 quality assurance manual, Ventilation system, Work environment, Work station ergonomics, Writing guidelines for manual: documentation, 36 existing procedures, 34 flowchart preparation, 34-36 format, 2, 36 new procedures, 36 objectives, 33-34 preparation organization, 33 priorities, 33-34 program requirements, identification of, 36 X-R charts I 1, 22 Zero Defects programs, 7, 20 ... of the Corporation, or other individual bearing the ultimate responsibility for the quality of the laboratory output The date of issue If the distribution of the quality manual is controlled, the. .. for the use of government agencies, with the FAA, DOE, NASA, and others also co-sponsoring, together with their contractors, others outside these bodies may participate, provided they meet the. .. the production of the manual, the reason for writing the documents, so that the contents will enable the organization to satisfy the requirements for which the manual is produced Basically, the