Document Z474wvJZNEGq6r0mB6qdp7vjZ

IM A N A-G I N G L CONDUCT AND DATA QUALITY OF TOXICOLOGY STUDIES Sharing Perspectives Expanding H/ /o- rizons Conference Proceedings Raleigh, North Carolina November 18-20, 1985 Organizing/Editorial Committee: Industry: B. Kristin Hoover, ARC0 Chemical Company Judith K. Baldwin, Exxon Corporation Arthur F. Uelner, Monsanto Company National Insitute of Environmental Health Sciences/ National Toxicology Program Came E. Whitmire Christine L. Davies Douglas W. Bristol sponsors: National Institute of Environmental Health Sciences National Toxicology Program American Industrial Health Council American Petroleum Institute Chemical Manufacturers Association National Agricultural Chemical Association PRINCETON SCIENTIFIC PUBLISHING CO., INC. Copyright @ 1986 by Princeton Scientific Publishing Co., Inc. All rights reserved. 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 or otherwise, without permission in writing from the publisher. Printed and bound in the United States of America. PRINCETON SCIENTIFIC PUBLISHING CO., INC. P.O. Box 2155 Princeton, New,Jersey 08543 Tel.: 609/ 6834750- LIBRARY OF CONGRESS CATALOG CARD NUMBER: 8543837 ISBN 0-911131-93-0 Cover Art: Adapted from ah illustration by Alfred C. Laoang. See page 339. C -_ - - -- . . OF QUALITY ASSURANCE FOR ENVIRONMENTAL PROTECTION AGENCY Robert A. Scala Research and Environmental Health Division Exxon Corporation East Millstone, New Jersey ABSTRACT Quality assurancein toxicologicalstudiesis an important managementfunction for both industry and EPA. For the most part, quality means "doing it right the first time." Management has many incentives for that to happen. Using an analogy with safety, the importance of quality,the responsibilityfor quality and the consequences of poor quality are outlined. Scientist-scientist interactions with EPA are also discussed in terms of their impact on quality. The role of industry and EPA management in setting gods and insisting on adherence to them is viewed as a way of minimizing adversarial relations between scientists and quality assurance staff. A FABLE Once you have sat through presentations from NTP, FDA and the pharmaceutical industry on quality assurance in toxicology, there really isn't much more you want to hear, even if the topic is defined in terms of EPA's needs and regulations. For novelty's sake, I thought of reciting aloud the full set of EPA quality assurance regulations. (Our QA Manager expects us all to have them memorized anyhow.) The result of that would probably be lunch at 11: 10,not 12 noon as scheduled. Instead, I decided I would tell a fable. From that story I will attempt to extract the role of management in the quality process and close with an analogy that, in our organization, we feel well describes the purpose and status of quality assurance. "In an earlier, more peaceful time, the animals carried out the toxicity studies on new pesticides or industrial chemicals in an informal yet somehow orderly /, i 1 . Address correspondence to: Robert A. Scala, Ph.D., Research and Environmental Health Division, Exxon Corporation, P.O.Box 235, East Millstone, NJ 08873. 2. Key words: god adherence, industrial management, quality assurance,toxicological studies. -2 % I- E=2 gz o8 27 -- fashion. Many studieswere conducted in the samerather large house, often with more than one speciespresent. The animals assigned themselvesto their cages as they wished. They also assigned someone to snap the lights off each day for activitytime and on again laterfor rest time. The humans were permittecktoleave their offices each day and were trained to feed and care for the animals. Because humans were slow learners, many times the animals failed to receive the proper dose of agent, or failed to be provided with adequatefeed and water or failed to have their quarters cleaned. The leaders of the animals concluded that this way of doing the studies was wasteful, inefficient and could even produce misleading results. They were especially concerned at the number of humans who could not do simple mathematical computations correctly, operate simple weighing devices or even record numbers accurately. These leaders of the animals sought to bring order to the conduct of the studies by the humans, and they did so in the following way. Reasoning that it was their lives that were at risk in these experiments and yet these studieswere needed for new products, the leadersreviewed the work of the humans; assessed the needs and shortcomings;put in place the necessary facilities, training, procedures and controls; appointed several of their number to overseethe humans and found in a short time that there was avast improvement in the overall operation. This project became known as `Doing it right the first time.' Alas,however, not all animals in the house seemed to be interested in it. They found many excuses for not participating-`things were all right as they were,' 'whocared if there were occasionalerrors,'`it's too expensive.'The humans, of course, knewI nothing of this. They merely went about their daily tasks of feeding the animals, caring for the quarters, etc. Some were involved in the new project; the others associated with the nonparticipants, totally unaware of `Doing it right the first time.' So with time there came to be two classes of animals in the house. Most were active participants in the project; a few weren`t. The difficulty came in the utilization of the data from these studies. In the earliertimes, the principal users were other animalsin gray houses in a humid city by a river. They knew, because they themselves had done such studies,who was committed to `Doingit right the first time'and who wasn't. But with the passage of time and changes in circumstances, the animals in the gray houses changed and these, alongwith other animals,were not so likely to believe the humans had really learned. They began to talk about certain animals looking in on the humans to assure that they did their work properly. In time these `checking animals'wrote guidelines and procedures and ultimately convinced their fellows in the gray houses in the city by the river that only `checked' studies were acceptable. The rest is history. Today the animals are of three kinds. The first are those who were always `Doing it right the first time.' These are somewhat unfriendly to the `checking animals,'finding their role superfluous. The second group of animalsbecame convinced of the value of `Doingit right the fmt time' and saw the `checkinganimals'as a way to help them achievethat goal. The third group is fortunatelya diminishingtype. They never did comprehend that there is no market for their studies, and are slowly disappearing from the house. The animals in the gray houses in the city by the river take full credit for this improvement in quality." But then, this is only a fable. MANAGEMENT AND QUALITY Classical textbooks on management (meaning those written in an age of alliterationand before our heightened awareness of sexistlanguage) describethe role of managers in terms of men, money and machines. Management employs these resources in the most effective fashion to provide a needed product or service. Where does quality fit in? A shoddy product or service certainly stimulatesno repeat business. The marketplace is a fine discriminator of quality.In the fable, the value of "Doingit right the first time"was evidence to the "doers,"and there was in place the best of all quality systems. That consisted of a conviction from the bottom up and from the top down of the value and importance of quality. In the ideal case, the concept of qualitypermeates an operation. Workers strive for it, management encouragesand recognizes it, and the marketplaceselects on that basis. Management needs no lectures on the value of "Doing it right the first time. Waste, loss, inefficiency,downtime, rejection, user dissatisfaction, worker disaffection, loss of customer loyalty,the contagiousnature of sloppypractices in any endeavor, all flowfrom lack of quality. Management is aware of allthis. The cuttingedge of the issuefor managment is in the verification of quality,especially by third parties. Who will define quality? How is it recognized? At what point have things progressed beyond "Doing it right the first time" and into the realm of inappropriateexpectations?In the fable,the "checkinganimals"were valuable in seeingthat the studieswent alongproperly. If the "checking animals"1ose sight of their support role and wish their function to be the final product, then the animals may no longer have a quality problem, but they will have substituted a problem of scientific credibility and research purpose. Most managements view their responsibilities in the sense of team function, with leadership. Visualize a symphony orchestra. Each instrument makes its own contribution. The quality of the product is a function both of the quality of each performer and the ability of the conductor to blend and integrate so that the whole is harmonious. So as not to do violence to the published program, I would like to make some specific observations about the interaction of industry scientists with their counterparts in EPA. This is a quality assuranceitem on the broadest scaleand onein which management has a strong interest. At the outset, this interaction has a potential for conflict, but not of the sort which you would expect. We are long past the image of government scientists clanking about Washington in white armor defending a hapless public from sinister, fire-breathingindustrialdragons. Today, in my view, our conflicts are largely those of thoughtful scientistsseeing the samedata with different eyes. Conflict resolution, on the part of management in industry and the EPA, consists in large part of establishing open lines of dmrnunication, insisting on documentation and/ or verification of scientific positions, making possible the use of referees or other third-party participation, insisting that good science makes for sound regulation and realizing that bad . . . 29 science, especially bad toxicology, will haunt you for years. One of the best guarantees we have that EPA management will hold that position is the presence of Dr. John Moore as Assistant Administrator for Pesticides and Toxic Substances. He has consistentlyshown himself to be open to ideas, suggestions,new approaches, different interpretations, etc. fyou have the documentation.Are we that open? / CONCLUSION I'd like to close with a final analogy that is full of meaning for the petroleum and chemical industries. Management views quality in the conduct of toxicology studies the same way it views safety in the laboratory. (See Figure 1.) It doesn't take much imagination to substitute the word quality for safety in Figure 1 to have an unmistakable profiie of quality studies in toxicology. (See Figure 2.) Most of us believethis to our very core and have tried throughout our FIGURE 1. Management's View of Safety. 1. Safety is the responsibility of each individual in the laboratory. 2. An unsafe act can not only hurt you but your fellow worker as well, so everyone must take precautions. 3. Unsafe behavior can result in loss of life, limb and jobs. 4. Safety is a state of mind, an attitude, a constant presence influencing each person's behavior. 5. Safety is not inherent but must be learned by repeated training and reinforcement. ' 6. There is no excuse or justification for doing a job in an unsafe fashion. 7. The evaluation of a manager's performance should include safety as one of the job elements. FIGURE 2. Management's View of Quality. 1. Quality is the responsibility of each individual in the laboratory. 2. Poor quality can not only affect you but your fellow worker as well, SO everyone must be involved. 3. Poor quality can result in loss of jobs. 4. Quality is a state of mind, an attitude, a constant presence influencing each person's behavior. 5. Quality is not inherent but must be learned by repeated training and reinforcement. 6. There is no excuse or justification for doing a job in a sloppy fashion. 7. The evaluation of a manager's performance should include quality as one of the job elements. 4 ;I v.i `0 -: x3 ;-;x.,jB 4' 6: c .30 .. ." a -_- careers to put these attitudes and behaviors in place among our people. We were doing it not only before there were EPA QA guidelinesbut, for many people here in this room, before there was an EPA! For the most part, literalcompliancewith the guidelines is easy once the mind set is created in the individual. If we let the activity become adversarial or, even worse, if it becomes a contest between industry and EPA ("you'llnever find out what we're doing," or "I'll find somet h i g if1dig hard enough"),that's the time when management on both sides must exercise another of its functions-discipline-and be sure that the goals and priorities of the workers are consistent with the goals and priorities of the organimtion. The kind of behavior just illustrated is not on the priority list of either industry or EPA.