Establishing an EffectiveProduct SafetyManagement Program

by Kenneth Ross

© 2003 DRI. All rights reserved.

January 2003 17

Recent information on how many man-ufacturers have product safety programsand how they are organized is rarely availa-ble. In addition, it is difficult to find goodevidence that measures the effectiveness ofthese programs. Much of the evidence isanecdotal and common sense. As a result,many companies struggle with the ques-tion of whether to have a formal programand how many resources to devote to sucha program. What can be helpful in answer-ing this question is to look at the “best prac-tices” employed by manufacturers that careabout selling safe products and minimizingproduct liability.

A few studies over the years have pro-vided some answers. In addition, a recentsurvey and report confirms the conventionalwisdom on product safety management anddescribes what the authors deem to be a“world class” corporate approach to prod-uct safety. This article will describe some ofthese studies and then discuss the author’sideas on how to establish a product safetymanagement program.

The ideas in this article will hopefullyhelp in-house counsel and other productsafety personnel to implement a program intheir company. They should also help de-fense counsel to better evaluate the defensi-bility of their client’s management programs.

The Need for aProduct Safety AuditThe first questions to be answered by themanufacturer’s lawyer are does the com-pany need a formal product safety manage-ment program, and, if so, how much effort

is appropriate. Unless the company has lotsof claims and lawsuits, it is hard to knowwhere to focus a company’s efforts in devel-oping such a program. A company that isestablishing a new program or evaluatingthe adequacy of its current program wouldbe wise to first do an audit of its currentsituation.

Establishing a new product safety and li-ability prevention program in a manufactur-ing company can be difficult if the potentialhazards involved in the manufacture andsale of its products are not known. In addi-tion, determining the scope of the preven-tion program is very speculative without aclear understanding of the status of themanufacturer’s practices that affect safetyand liability.

Before and even after a prevention pro-gram is instituted, a good way to obtain use-ful information is to perform a product safetyand liability audit. If this audit is being donein response to claims and litigation, the com-pany and its lawyers obviously will analyzethose occurrences to determine the com-pany’s most immediate problems.

Much information can be gleaned frompresent and past claims and litigation. First,the company lawyer can identify the accidentmode and severity of injury. Then, he or shecan learn the theories of negligence and de-fect proposed by the plaintiff and his expert.Lastly, the lawyer can look to the results ofthe past litigation and claims to see how thecompany, the particular injured party, andpossibly a judge or jury viewed the litigation.

If there have been few claims or a mini-mal amount of litigation, the audit phase ofprevention is more difficult. The companylawyer needs to take a much broader look atthe product, the users, the environment ofuse, and the potential for injury to deter-mine the level and type of risks and whatcan be done to minimize them.

A company-wide or product line risk as-

sessment/audit must be done to first deter-mine what risks exist and how they can bekept down to an acceptable level. These canbe difficult analyses and decisions but theymust be performed in order to make ratio-nal decisions about policies and proceduresthat should be adopted to accomplish themanufacturer’s goals.

If the manufacturer wants to establishan attorney/client privilege over any of theaudit results, it is necessary to have the au-dit controlled or performed by lawyers. Agood argument can be made for the exist-ence of a privilege if the attorney directlyinterviews the company’s personnel and thecompany has retained the attorney to renderlegal advice about minimizing product lia-bility risks. It might also be possible to arguethat a privilege exists if the attorney requeststhat the safety professional interview em-ployees, analyze the product’s risks, and pro-vide a report to the attorney so that the lattercan provide legal advice. Where litigation isinvolved or anticipated, it may be possiblealso to invoke the work-product privilege.

Should either the attorney-client privilegeor work-product privilege be established,note that either protects only the oral orwritten communication between the lawyerand the client, and not necessarily the infor-mation given by employees of the client.Therefore, if an engineer feels that the cur-rent safety organization of the company isdeficient, the other party in the lawsuit canobtain that information during the discov-ery process, whether or not the informationwas given to the attorney doing the audit.

Product Audit QuestionnairesAudits can be performed in different ways.First, the company can employ safety profes-sionals to come to a particular division andinterview key personnel. Another approachis to have key employees fill out question-naires; safety professionals will then inter-view them about their responses. In bothprocedures, the safety professional will fol-low up with recommendations based on theresponses.

In a multi-divisional manufacturing con-cern, the audit can be a two-stage process.The inside and outside safety and legal pro-fessionals should draft a fairly simple audit

Kenneth Ross is Of Counsel to Bowman and Brooke LLP, in Minneapolis,and a member of the DRI Product Liability Committee. Mr. Ross has helpedcompanies develop and implement safety management programs for 27years. Portions of this article first appeared in the December 2002 issue ofProduct Liability Law & Strategy, an American Lawyer Media publication.

18 For The Defense

Product stewardship

includes proactive

management practices

that integrate regulatory

compliance, and health,

safety, and environmental

considerations, into

product development and

product maintenance.

questionnaire to be answered by corporateand manufacturing division personnel. Thisaudit should elicit preliminary informationso that a decision can be made as to whichdivisions need to perform a more compre-hensive audit.

While the size and structure of a manufac-turing division can change the audit proce-dure, generally the preliminary questionnaireshould be directed to the division’s manage-ment. These individuals include the generalmanager and heads of marketing, safety, en-gineering, service and manufacturing, plusany in-house or outside attorney familiarwith the division’s claims, litigation, andsafety practices. Responses to the question-naire should help quantify the risks and iden-tify personnel who should be interviewedduring the comprehensive audit.

The questionnaire to be used in the au-dit of a manufacturing division is dividedinto a number of areas. First are questionspertaining to the management of the divi-sion as it relates to safety. Next are questionsrelating to the performance of the division’sproduct safety coordinator. A large sectionof the audit questionnaire pertains to thedevelopment of product safety standards.

In the “design and development” area arequestions about preparing design specifica-tions, risk analyses and design reviews, andengineering evaluations to verify compliancewith safety requirements. This design anddevelopment section also asks about labelingspecifications for warnings and documen-tation concerning installation, operation,and maintenance.

Other sections of the product safety ques-tionnaire ask about purchasing, manufac-turing, and quality standards. For example,in the purchasing section, there are ques-tions about inserting “hold harmless” andindemnification clauses in purchase agree-ments and ensuring that there are appropri-ate warranties from suppliers.

Questions asked about manufacturingmay include: Have standards been preparedto define handling and storage of the prod-uct as it is being manufactured? Are proce-dures in place to prevent the introduction ofunreasonable hazards into the product? Thequestionnaire asks numerous questions aboutthe quality function and whether the com-

pany ensures that appropriate product safetyinspections and tests are performed anddocumented.

Questions are asked about marketing ef-forts, advertising and promotional material,and instructional literature. The audit nextasks about procedures for handling productsafety problems, including dealing with cus-tomer complaints. It may even ask about themore drastic steps of product withdrawalor recall.

Records documenting each affected divi-sion’s product safety program should be cre-ated and retained. The audit questionnaireelicits such information. The last parts ofthe audit pertain to education and training ofdivision personnel, performing the productsafety audit, and creating a product safetycompliance manual.

Uses of the AuditOnce the comprehensive audit is finished, theauditors should be able to propose the estab-lishment of a product safety managementprogram, including policies, procedures, andduties of affected personnel. Or, the compre-hensive audit can be used to evaluate theadequacy of a company’s current program.

The audit is defined as a managementtool for determining whether the division iscapable of designing, producing, and deliv-ering safe products. The audit determineswhether, for instance, the manufacturingdivision’s procedures comply with estab-

lished company safety policies and direc-tives, as well as statutes, regulations, and in-dustry standards.

One U.S.-based multinational corpora-tion with an extensive prevention programhas a policy requiring that its internal prod-uct safety committee conduct an audit atleast once per year. The committee then dis-cusses the recommendations arising out ofthe audit with the management of the rele-vant division of the corporation. The reporton the audit and a consolidated list of agreedcorrective actions are then submitted to thedivision’s attorney for review and advice. As aresult of the review, the necessary improve-ments must be implemented within a de-fined time schedule.

Studies on Best ProgramsMaking recommendations about the ele-ments of a product safety program can bedifficult without knowing what other suc-cessful companies do in the product safetyarea. Thankfully, there have been some schol-arly studies over the years that give someguidance on what elements to include in aprogram and the rationale to support them.Let’s look at a few of those studies before weproceed with the practical steps of settingup a product safety program within a man-ufacturing company.

P ittiglio Rabin Todd McGrath, a U.S. basedmanagement-consulting firm, issued a

“white paper” in 2002. In this study, PRTMsurveyed 52 companies, including 15 con-sumer product manufacturers. The remain-ing companies supply raw materials (e.g.,chemicals) or component parts to the con-sumer product manufacturers or to the com-ponent part suppliers. Forty of the companiesare U.S.-based and the rest are based in Eu-rope. Some of the key findings are as follows:• There is currently no standard approach

to product safety management.• Only a small percentage (20 percent) of

consumer product companies surveyedby PRTM felt they handled safety issuessuccessfully.

• The world-class companies (only 25percent of 52 companies) have insertedproduct safety into their strategies, orga-nization, processes, and systems. Smaller

January 2003 19

and less successful companies have somebut not all of the practices the study’s au-thors deem important for success.

• The world-class companies spend twiceas much money on product safety, have50 percent fewer recalls, and are four timesless likely to have a recall than a less suc-cessful company.Despite the fact that the number of com-

panies ranked as world-class manufacturersby the PRTM study was very small, the au-thors were able to identify the “best practices”that they believe allow these companies tosuccessfully manage their safety issues.

The authors of the PRTM study use abroader concept than just product safetywhen discussing the best practices of theworld-class companies. They call it “prod-uct stewardship,” which includes proactivemanagement practices that integrate regu-latory compliance, and health, safety, andenvironmental considerations, into productdevelopment and product maintenance. Theauthors found that world-class companiesintegrate safety, regulatory, and environ-mental initiatives into their corporate strate-gies. Senior management is more involved inproduct stewardship issues; they have manydedicated safety professionals working inproduct development and in top-level deci-sion-making. This accounts for the increasedspending on safety and related issues.

The PRTM study found that, organiza-tionally, virtually all of these world-classcompanies have a dedicated senior level per-son (usually a vice president) focusing onsafety, regulatory and environmental issues.And these companies provide monetary andnon-monetary incentives to get companypersonnel to cooperate in the implementa-tion of these programs.

In addition, world-class companies haveformal processes in place to address stew-ardship issues. Some of these processes are:(1) full documentation; (2) milestones aredefined at the start of product developmentefforts; (3) milestones are completed beforedevelopment continues; and (4) productstewardship personnel have the power tohalt or delay a development project if thesemilestones are not met or there is some in-adequacy in compliance with safety, regula-tory, or environmental requirements.

The PRTM study provides some usefulinformation. It shows that few companieshave implemented a full range of processes,procedures, strategies, and personnel to ef-fectively manage product safety during theproduct development and after-sale phases.

The study also estimates that it costs con-sumer product manufacturers, on average,$8 million per recall for the recall and relatedlitigation. And, the study indicates that world-class companies have had 50 percent fewerrecalls than the average manufacturer. Theymay spend twice as much on product safety,but the low recall rate means millions ofdollars in savings.

The savings are potentially even higher,since the study made no attempt to quantifythe reduction in accidents or lawsuits re-sulting from safer products. This of coursewould be difficult to calculate, unless themanufacturer had a number of accidentsbefore a safety improvement was made.

The bottom line, which should be of nosurprise to anyone, is that product safetymanagement efforts pay for themselves,sometimes many times over. These effortscan, in part, result in fewer accidents, fewerdissatisfied customers and product users,better goodwill up and down the distribu-tion chain, and less chance that a plaintiff ’sverdict will include an award of punitivedamages.

The PRTM study confirms what was sus-pected all along. Those companies that spendmore time and money during the develop-ment phase will have fewer safety problems,accidents, lawsuits, and recalls. Proactivemanagement is the key. Reacting to productsafety problems is also important, but maybe too late to prevent major problems. Con-vincing management to try to prevent prob-lems before they occur is a challenge. Usingsome of the findings of this report may makethe job easier.

I n 2000, the Manufacturers Alliance sur-veyed 30 members of the Alliance’s Prod-

uct Liability and Product Safety Counciland issued a public report on its findings,entitled Benchmarking Product Safety in Se-lected Manufacturing Companies. The mostimportant relevant findings are as follows:• Almost two-thirds of the companies have

a separate department or function respon-sible for product safety and compliance.

• In 60 percent of those companies thathave a separate safety department, it iscentralized in the corporate offices, andin one-third of these companies, it re-sides in the corporate law department.

• Well over half of these companies includesafety and regulatory compliance in theirgeneral business strategic planning.

• Around 80 percent have developed or arein the process of developing a formal pol-icy for product safety.

• Around 40 percent of the respondents havea product safety manual or procedures.

• Two-thirds of the companies integrateproduct safety and regulatory compli-ance into their existing product develop-ment processes.

• Around 75 percent of the respondentsaudit their programs.The conclusions in the Manufacturers Al-

liance study are that centralized leadership isimportant, product safety is emerging as akey component of strategic planning, andformal policies and procedures are crucialto implementing a program. None of theseconclusions are surprising; the literaturementioned below confirms that these be-liefs about product safety programs havebeen around for many years.

I n 1979, the Conference Board issued oneof the first studies on product safety

management programs. It is based on sur-vey responses of about 300 manufacturingcompanies; supplemental information wasobtained by interview and correspondence.There has not been an update of this study.

Despite its age, the Conference Boardstudy does provide some good insights. Itfound that most manufacturers have electedto use a mixed organizational structure, es-tablishing full or part-time product safetyassignments at corporate and other levels.At the corporate level, the functions are pri-marily consultation and coordination. Somecompanies have chosen to completely de-centralize the product safety function—i.e.,delegating the responsibility to the relevantdivisions. Most, however, favor a combinedapproach that brings together the company’sdifferent levels to address the product safety

20 For The Defense

functions. One of the most frequent arrange-ments is to establish a full-time productsafety office at headquarters, with part-timesafety assignments at operating levels. Inaddition, a majority of companies have aformal product safety policy.

The Conference Board study contains achapter on the product safety audit. It re-ports that reliance on a formal audit hasgained in popularity; its worth in establish-ing product safety is recognized.

The study contains recommendationsfrom the respondent companies as to howto establish a product safety function. Theyare (in rank order of frequency of mention):• Obtain full support from the company’s

top management.• Centralize authority and responsibility

for product safety.• Involve all company units in product

safety.• Develop an extensive safety database.• Construct a company-wide safety policy.• Develop a product safety committee.• Make operating units responsible for

safety performance.• Develop a capacity to measure and moni-

tor safety performance.

I n 1983, the Rand Institute for Civil Jus-tice published Designing Safer Products:

Corporate Responses to Product Liability Lawand Regulation. While only nine manufactur-ing companies were interviewed, the authorsperformed further interviews and a literaturesearch and provided some insightful conclu-sions on product safety management. Theyfound that safety professionals believe that ev-ery corporation needs an organization withinthe firm specifically devoted to safety issues.These company people argue that without aformal organization, improved knowledgeof product safety will not be appropriatelyused and the proper amount of safety infor-mation will not be generated.

The Rand Institute study found that aseparate product safety organization is ap-propriate to deal with product complexity,hazard subtlety, and organizational pres-sures. Product safety problems may not bediscovered during normal safety design re-views because of their complexity and theinteraction of the product, its packaging,

and the production/distribution environ-ment. Hazards are very subtle, particularlygiven the necessity to consider reasonablyforeseeable misuse.

The realities of organizational pressureswithin a large corporation indicate that aproduct safety group should be formed. Themulti-divisional form of corporate organiza-tion insulates top management from minordetails. These minor details, unintentionally,may work to prevent them from learningabout safety problems. Subordinate parts ofan organization, operating semi-autono-mously under the influence of limited finan-cial controls, may not be trusted to discoverand satisfactorily resolve all significant safetyhazards without specific oversight to ensurethat they do. Also, if there is an attitude thatsafety problems are being handled by some-one else and that safety is not a problem aslong as competent engineers are involved,there is likely to be resistance to taking thenecessary time and resources to surface subtleor complex hazards and then redesign and re-test to be sure that they have been properlydealt with. For all of these reasons, a separateproduct safety group is an essential part ofthe corporate structure.

All of the companies interviewed for theRand study agreed that a corporate level prod-uct safety department plays a critical role inthe company’s overall safety effort even ifmost of the actual safety management isdone at the divisional level. The corporate of-fice can serve as a liaison or coordinator. Itcan facilitate the distribution of knowledgefrom one division to another, especially whendivisions are geographically separated; learn-ing from other divisions’ successes or failuresis important within a large corporation. Also,the corporate level office can transmit andreinforce top management’s commitmentto product safety.

A corporate level product safety officercan introduce safety performance indicatorsinto the performance measurement of oper-ating divisions so that the consequences ofpoor—or outstanding—safety perform-ance are reflected in the division’s profit-ability. The corporate level officer can alsoact as a mediator, or even a “court of ap-peals,” in resolving differences between di-visions on safety matters.

The Rand study found that an organizedproduct safety effort may improve a firm’sdefensive posture in several ways. Units atthe division level may be expected to knowabout individual products against whichclaims or suits have been filed. Since they willknow how these products were designed,they will be better able to deal effectivelywith the defense of claims. Where liabilitysuits involve many different products, a cor-porate level product safety officer can serveas an aggregator of corporate experiences.

What appeared to the Rand study authorsto be the most effective product safety orga-nizations were those that were sized, located,and financed at a level consistent with thesafety problems inherent in the manufac-turer’s products. They also recognized theneed for higher level supervision or moni-toring of safety-related design decisions.

A lean product safety organization thathas the ear of the CEO and a good workingrelationship at various levels of the corpora-tion is the optimal arrangement, accordingto the authors of the Rand Institute study.Such an organization is likely to be muchmore effective than a highly visible unit thatestablishes procedures, but lacks either theresources to impose them. Finally, it is im-perative that the safety office has the strongsupport of the company’s top officers whensuch support is necessary.

Establishing theProduct Safety ProgramAfter a company has performed a risk as-sessment and audit of its organization, prod-ucts, and procedures, it can then considerwhat kind of a product safety managementprogram is appropriate. The procedures arewell known, but the hard part is to decidewhat level of resources should be devoted toa particular company’s program.

The decision is based on the perceivedlevel of risk from the company’s productsand practices and the risk the company iswilling to assume. The following is a dis-cussion of specific components of a prod-uct safety management program.

Product Safety PolicyEvery manufacturer should have a statementof a policy that is intended to ensure that the

January 2003 21

continued on page 50

Those companies that

spend more time and

money during the

development phase

will have fewer safety

problems, accidents,

lawsuits, and recalls.

products it makes are safe for consumer use.The company’s lawyer can help the com-pany draft such a statement. As an example,one large U.S.-based multinational com-pany, which has had in effect a corporateproduct safety policy since the early 1970s,adopted a statement of policy, the essenceof which is:

Actions shall be taken to identify andminimize potential product hazards dur-ing all phases of the product’s life includ-ing development, design, manufacture,marketing, installation, service, use anddisposal. Reasonable measures shall betaken to minimize the risk of injury to per-sons and damage to property and the en-vironment, giving full regard to applicablefederal, state, local and industry safetystandards, regulatory requirements,technology, state-of-the-art and conven-tional standards of care and use requiredby society.This safety directive also states that it is

company policy to provide quality productsand services that perform their intendedfunctions safely, reliably, and with minimumeffects on the environment. The policy goeson to say that each functional department inan operating unit is supposed to integratequality, safety, and reliability into its depart-mental practices and procedures, and thatthere should not be a separate safety pro-gram set up in each operating unit.

From a lawyer’s standpoint, having a cor-porate product safety policy of any kind issimilar to endorsing motherhood and applepie. There are very few reasons why a policyis not necessary or helpful; the survey resultsdescribed above confirm that most manu-facturers do have a policy. Whether you area manager or a defense attorney, it is help-ful to point to a document, endorsed by theboard of directors, the chief executive of-ficer, or the president, that confirms thissafety concern. In addition, the policy can bepresented in court or before a governmentregulatory agency to confirm the company’sinterest in safety.

The safety policy may also clarify the safety-related responsibilities of each companydepartment concerned with safety, such asGeneral Management, Marketing, Engineer-ing, Quality Assurance, Manufacturing, Pur-

chasing, Field Service, Risk Management, Fi-nance, Safety Management, and Legal, andtheir inter-relationships within the company.Each of the manufacturing divisions in thecompany may wish to have its own statementof product safety policy, in addition to the cor-porate policy. The division policy may differ inthat it is more customized to the division’sstructure, product line, and culture.

Many smaller companies will scoff at theidea that a product safety policy is needed.

be expressed in broad terms and not attemptto cover every contingency. A balance has tobe achieved; it must not be so vague nor sodetailed as to stifle initiative.”

After the policy is created, it needs to bedisseminated widely and featured in com-pany publications, compliance manuals, andtraining programs.

Product Safety ManagerThe company’s culture, structure, risk toler-ance level, and personnel policies will helpdictate whether a separate employee knownas the product safety manager/director isnecessary. Manufacturers have said for yearsthat it is everyone’s job to make a safe prod-uct. And it really is. But, product safety is toodifficult to be accomplished by people withoutany additional training and responsibility.

Product safety managers can be found atcorporate headquarters as well as at the di-vision level. When there is litigation regard-ing a product, the corporate managers aretypically involved; these managers are alsoresponsible for reporting problems to gov-ernment agencies, such as the ConsumerProduct Safety Commission. A divisionalsafety manager is appropriate when a divi-sion’s products can cause serious injury orwhen safety problems can be reported to agovernment regulatory agency.

At either the corporate or division level,the manager need not devote full time toproduct safety matters; he or she can com-bine this assignment with another job suchas the quality or product reliability function.It is also possible to have one product safetymanager for a group of divisions which makesimilar products.

Whether it is a full-time or part-time man-ager, it is an open question as to which de-partment that person should be placed. Atthe division level, the conventional wisdom isthat product safety pervades engineering,manufacturing, purchasing, quality, parts,sales, and field service. Yet, placing productsafety personnel in one of those departmentsmay narrow the focus of his or her responsi-bilities too much. It may also put that personin possible direct conflict with a supervisorwho may not appreciate the safety manager’sactivities or the criticism they generate.

But, most divisions of big companies act likesmall companies, especially when it comesto product safety. There are few companieswith competent and adequate product safetyresources at corporate headquarters thatcan do many of the things required by everydivision or product line. Therefore, having apolicy or policies, especially when the com-pany has policies in many other areas, is ahelpful prelude or foundation for a productsafety program.

The content of the product safety policycan be very detailed or very sketchy. Thereare many examples of such policies in var-ious publications on product safety. From alegal standpoint, the main precaution is thatthe policy should contain goals that are gen-erally achievable. It is not necessary for themto be achieved today or achieved to perfec-tion. They can be aspirational, but they mustbe achievable at some time in the future.Don’t raise the bar too high, but also don’tmake it look like the company’s policy wascreated for one set of eyes—the jury’s.

A well-known safety professional in Eu-rope summarized it neatly when he said that“[a] corporate product safety policy should

50 For The Defense

Product Safety Program, from page 21The product safety manager could report

to the engineering manager or the manufac-turing manager. However, either assignmentcould lead to conflicts in the event of designmodifications, recalls, or changes in manu-facturing procedures. Reporting to the gen-eral manager of the manufacturing entity maybe a better arrangement. It may serve to con-firm the company’s commitment to safety—i.e., the safety manager is representing seniormanagement in trying to encourage all per-sonnel to be concerned about making safeproducts. Of course, it is possible to have dualreporting where the manager reports to thegeneral manager on a dotted line basis andthe engineering manager on a solid line basis.

However organized, it is essential that some-one is clearly in charge of product safety. Inany division that makes products that can hurtpeople, someone should be given the productsafety function, even if there is also a productsafety manager at the corporate level. Work-ing together, these two can provide adequateproduct safety input with a minimum of ad-ditional resources.

What sort of credentials should be soughtfor the product safety manager position? It isnot necessary for the manager to have a de-gree in safety or engineering, or have workedin safety for many years, or be a member of anysafety management society. Still, some safetytraining and experience is advisable. First,training and experience will most probablyassure that person’s successful performancein this important job. Second, no “on-the-jobtraining” will be needed. Finally, in the eventof claims or litigation, it is helpful to have aprofessionally-trained safety manager to con-vince the other side of the company’s com-mitment to safety.

Product Safety CommitteeA manufacturing company may wish to setup a product safety committee comprised ofindividuals from various departments of thecompany. This committee, like the productsafety manager, may be at both the corporateand division level. The responsibilities of sucha committee could include the following re-sponsibilities:• Establish guidelines and criteria for the iden-

tification and quantification of producthazards.

• Perform design reviews and other analysesto minimize product risk to an acceptablelevel.

• Establish guidelines and criteria for creatingwarning labels and instruction manuals.

• Establish guidelines for creating advertising,promotional brochures, and other printedsales material.

• Establish guidelines for the creation of prod-uct warranties, exculpatory clauses, andcontractual disclaimers in contracts andpurchase orders.

• Analyze product problems and determine aneed to notify government agencies and/orthe need to recall products, retrofit prod-ucts or issue safety warnings.

• Create a document retention policy andprocedure as it relates to safety and relia-bility.Individual members of the product safety

committee can develop and administer auditsof the product safety program, and set up train-ing sessions for company personnel. They candevelop an accident or incident reporting sys-tem with guidelines for follow-up by appropri-ate personnel. They can assist attorneys in theinvestigation and defense of product liabilityclaims and litigation, and administer recall/retrofit/warning letter programs. Members ofthe committee can also represent the companyin industrywide or governmental groups re-lated to product safety.

A product safety manager should chair thecommittee, whether the manager is part-timeor full-time. Lawyers can have an integral rolein the running of this committee. They canprovide legal input on design, manufacturing,and marketing questions, review minutes ofthe committee meetings, and try to ensurethat proper documentation concerning prog-ress made in solving safety problems is beingcreated and retained.

Since lawyers are trained to be good com-municators, their legal role can be expandedto assist product safety committee membersto express themselves more clearly about safetyproblems, about the ways in which theseproblems are managed and solved, and aboutways to improve communications throughoutthe design, manufacturing, and marketingprocess.

Product Safety ProceduresWhen the risk assessment and audit is com-pleted, the manufacturer is ready to institutethe prevention and safety program. The com-pany should be sure that it follows throughseriously and carefully to establish and imple-ment its policies and procedures, and that itinforms all affected employees that it believes

are necessary to ensure reasonable safety inits products. If a company establishes a policy,and then does nothing to implement it, an in-jured claimant can argue that it does not se-riously care about safety and only created the“paper policy” to impress a jury.

It is beyond the scope of this article to dis-cuss in detail the procedures to be employedby manufacturers in implementing a productsafety program. The author has written exten-sively on some aspects of this subject in ForThe Defense. For more information, see: Ross &Adams, “Legally Adequate Warning Labels: AConundrum for Every Manufacturer,” October1998 For The Defense 7; Ross, “The Importanceof a Proactive Document Management Sys-tem,” October 1999 For The Defense 24; Ross& Main, “Foreseeable Hazards and Misuse:Risk Assessment and Product Liability,” April2001 For The Defense 34; and Ross, “The In-creased Duty to Take Post-Sale Remedial Ac-tion,” April 2002 For The Defense 37.

As a general matter, product safety pro-cesses recommended by safety experts and bycompanies experienced in product safety allinclude extensive research and analysis at thefront end, before the product’s design specifi-cations are even drafted. The company shouldhave a very good idea of the risks it is assum-ing with a particular product when it is still inits conceptual stage.

Then, a product safety analysis should beperformed as the product makes its way throughthe development of specifications, making aprototype, and final production. Various well-known analytical techniques can be used toassist throughout the process: risk assessment,hazard analysis, FMEA, fault tree analysis, anddesign review will assist the manufacturer inidentifying and evaluating risk before the prod-uct is approved for production. Applying thesetechniques, management will have a chanceto decide for itself how much risk it is willingto assume.

ConclusionNo matter what a manufacturer does, it is al-ways possible that the elements of the productsafety program and its implementation arelacking and could arguably constitute evidenceof a disregard for safety. To combat that chance,any program must be able to show a high re-gard for safety. If this showing is made, even ifthe jury believes that the manufacturer couldhave done more, it should also believe that themanufacturer tried to do the right thing andwill not be inclined to award punitive dam-

January 2003 51

ages. One manufacturer of heavy equipmentjustifies its extensive and costly safety pro-gram on the belief that no jury will ever makean award of punitive damages against it.

As companies better organize themselvesfor the world-wide challenges of providing safe

products, the bar will be raised. Companieswho do not follow the lead will be at great riskof further product safety, product liability,and regulatory problems, in the United States,in Europe, and in other foreign countries. Thetechniques are well-known; the difficult part

is to analyze what is appropriate and then in-corporate it into the company’s organization,culture, and processes. Doing so should payfor itself, either by preventing future problemsthat could arise or giving the manufacturer amuch better defense if accidents do occur.