The important role of technical documentation in product liability

ht. .I. Pres. Vex & Piping 61 (1995) 213-228 0308-0161(94)00108-1 Elsevier Science Limited

Printed in Northern Ireland ELSEVIER 0308-0161/95/$09.50

The Important Role of Technical Documentation in Pro- duct Liabilitv

C. 0. Bauer, 42349 Wuppertal, Germany

Abstract

Technical documentation constitutes the headline for different internal and external documentated facts and datas. The EEC Directive machines set up detailed european-wide legal requirements as to the content of product-specific documentic actions. EN 292 and VDI 4500 as generally accepted technical rules give the necessary framework with technical details to which companies should model their specific procedures and processes. This demands a new and mostly additional organisatorical set-up covering nearly all sections of the company to prove necessary carefulness as to european-wide legal demands of strict product liability before various kinds of utilization.

213

214 C. 0. Bauer

Technical Documentation as a Comnlete Svstem

The headline "Technical Documentationl' is used for various and very different contents. Without being complete there should be mentioned:

technical information delivered with the machines for the operators, technical documents presented to supervisory boards or public agencies in case of damages, user information how to handle and service technical products and machines, certificates and tests about real technical values.

In certain public requirements, e.g. the EEC-Recommendation Machines and for special products the technical documentation is mentioned as an overall unidentified legal concept, leaving it to sometimes furious discussions between official agencies, constructing companies and users what content it should have specifically and what is regarded as sufficient.

These difficulties can be overcome only if a complete system of all technical documents is established within the companies, one document referring to another and allowing outside experts to follow up the company internal development, construction and testing of the products and establishing reliable sources for the conclusion that all necessary carefulness has been applied as this is the legal scale for final decisions, especially under strict product liability within all internal actions.

Mandatory Requirements

The main, very often neglected mandatory requirement for all technical documents is its explicitness for the technical evaluation of its content regarding all foreseeable loads and other using conditions of the appropriate product and its various applications.

Data and figures not being technically sufficiently explicit for the foreseeable and expected loads under foreseeable using conditions do not have any value

Z’echnical documentation in product liability 215

especially under legal aspects. Sufficient technical conclusiveness is mandatory to be legally relevant. There does exist a great number of documents in nearly all companies which do not come up to this necessary level.

Especially a great many of pure destructive material tests cannot be sufficiently evaluated for the expected behaviour of the complete finished parts and especially the total machines under various using conditions. They constitute therefore an unknown source for substantial savings.

Only the Systematic Apnroach is Economicallv Justified

Most technical documents are established independently in different departments as to their special outlook and are not part of an intelligently designed system for the whole company or the total single product. Documents of detail engineering are rarely based on research and development ideas and conform to the project sketches established therefore.

Systematical approach covering all documents of the whole company or their single products is necessary and it has to be regularly checked that each document is part of a system and conforms to the foregoing documents as well as establishing a necessary base for the later ones should prove the results.

Picture 1 shows such systematical approach to be diver- sified according to the products and the using conditions.

EEC-Recommendation Machines demands to keep on file a complete technical documentation to give outside experts a necessary base for their judgment about sufficient carefulness of development and construction and a complete insight into reliable constructive decisions. Not drawing details and single tolerances are explicit but the base of technical special figures as calculations, conditions evaluated in various formulas and the proof that these scales and formulas do conform to practical experiences of the foreseeable using conditions.

The development of technical documentation has to follow the processes from compulsory lists and their further discussion and development to construction requirements. The technique of construction as laid down in methodical process of design and development should be followed by a list of basic documents stating all single phases and steps presenting precisely the conditions, decisions and results being reached.

216 C. 0. Bauer

I MECHANICAL HAZARDS

* stability under all foreseen operating conditions * break-up during operations * falling or ejected objects * surfaces, edges or angles * combined machinery * variations in speed of tools * moving parts * friction or wear and tear

ELECTRICAL HAZARDS

* electricity supply * static current * parts with faulty or insufficient isolation * contact with parts under current

I HAZARDS BY HEAT

* contact with parts by heat * contact with parts at high or very low temperatures * risks through high or very low’surrounding conditions

SPECIAL RISKS THROUGH

* vibration * noise * radiation * external radiation * explosion * later equipment * emissions of dust, gases etc. * combination of any of such single hazards * missing ergonomical principles in machine design

Hazards Through Machines EN 292 Part I Nov. 1991 Par. 4

4.00.17 e ZIH 494

Technical documentation in product liability 217

0 1

v v Determine limits : intended use, space limits, Paragraph time limits ii1

j 2 /

Identify hazards and assess all hazardous situations, considering: - the various aspects of the operator-machine relationship (see 52.1)

- the possible states of the machine (see 5.22) - foreseeable misuse (see 5.2.3)

Clause 4 and

wagraph 5.2

, , / Yes

Then, for each hazardous situation, proceed as explained in 5.3 to 5.5 and schematically expressed below:

1 Risk reduction

-Has the required level of safety been reached? (see clause 6 ‘Risk assessment’) - Is It certam that an equivalent level of safety cannot be obtamed more easily? - Is it cetin that the measures taken:

do not excesswely reduce the ability of the machine to periodic its fun&on? do not generate new, unexpected hazards or problems?

-Are there solutions for all operarlng conditions. for all intervention procedures (see 5.7.1)? -Are the solutions comoatible with each other? -Are the operators woiking conditions not Jeopardized by those solutions?

t

In addition to q , look for

need and usefulness

of additional precautions

Additional precautions

(clause 6

EN :2-2)

__-1

Schematic representation of the strategy for

selecting designed-in safety measures

4.00.13 E ZIH 892

218 C. 0. Bauer

Leoal Reauirements

Legal requirements are formulated only in unidentified general concepts. They will be decided by the courts in cases of damage only afterwards if and how far the documentation of the products, the various conditions of use and the categories of users are sufficient to state necessary carefulness. No detailed legal recommendation or requirements as to kind, content and explicity are available. Court decisions can cover only single cases and leave it to the companies to transfer from their content and conclusions to appropriate consequences to other products, users and activities. Any uncertainties fall into the responsibility of the companies.

Technical detailed explanation and evaluation of the content and conclusions of tests are the necessary base for any documented procedures or results to become legally relevant. Details not being proved to be sufficiently technically conclusive for the single application cannot reach legal relevance.

The best test to prove this explicitness of technical documents is a test by which outside experts check as to their knowledges the explicitness of such documents based upon assumed damages of the relevant product. Are the documents prepared and presented sufficiently explicit to give the necessary answers in cases of damages and their interrogation by outside experts?

This needs double check for the creation of all reliable values and their representation by test procedures. A great many tests do not conform to these mandatory conditions.

The disastrous example: The President of the United States ordered an expert commission to investigate the causes of the Challenger disaster. They found and published the following facts:

The connection bolts on the first rocket section are one of the most critical parts of the whole system. Did NASA engineers apply necessary carefulness in the evaluation of the functions and design of those bolts?

Prof. Robert Freynman describes in his memories the facts he discovered as a member of this commission: The connection bolts applied were taken from a lot where samples were tested up to lo x lo6 shakes in direction of the axis. The decisive question what relevance do ten million shake waves have in the direction of the axis of


Complete and unterstandable descriptions aimed at the knowledge and capability of the average foreseeable user about

- definite application

- technical and personal limits of application

- all necessary conditions to be observed during use.

Hints to and warnings for

- non-allowable conditions of use causing dangers and avoidable risks

- understandable explaination of their interrelations

- describing resulting possible risks and avoidable dangers

for users and bystanders.

Exploitable Instructions for

- maintenance - inspection - repair.

MD17 4.b Product Liability:

User's Informations (S 823 BGB)

1.20.14 c r- I ZIH 119:

220 C. 0. Bauer

the bolt to its behaviour and practice where it is under a single stroke load under 9o" to the axis? The answer can only be: There does not exist a glance of relevance between the shake wave testing procedure and the actual load conditions!

The following question, why did NASA test these bolts under this unconclusive test procedure? The convincing answer:

We did not have any other testing machines!

This warning of '@Challenger testing" should be printed in big letters over all test machines and remind engineers and test specialists to think first, a second and third time again about the conclusiveness of test procedures to the actual utilization conditions of the test parts before starting any kind of tests!

User information

"User informationtl is the overall headline for all information given to users about the structure, the performance of the product and necessary relevance of information to the effective use.

Legal requirements demand that all user information is aimed at the prospected average user and his foreseeable knowledges and experiences with those products under the various using conditions. This unidentified concept is left to be filled out by the selling company to the necessary extent to enable the average user to handle the products effectively and moreover safely without avoidable danger for the user and any third person.

It is the pure obligation of the seller to transform these legal recommendations sufficiently for his different products and their various utilizations. If by appropriate understandable information misuse or damage could have been prevented, defects or failures in user instructions are as important as any technical defects in construction or during production establish the producer's liability.

This is a complicated intersection between manufacturer experiences, knowledges and those of completely differently acting users. To fulfil these responsibilities includes psychological as well as intellectual and administrative problems at large. All requirements and their necessary details have to be differentiated according to the various products - product specific - and the different applications.


EEC-Recommendation Machines as Guideline

The EEC-Recommendation Machines has established a minimum level of criteria which producers - and importers - have to observe. Picture 2 and 3 give the concentrated content. It is not sufficient to fulfil these minimum requirements in respect of the overall legal demands on product liability. But still these minimum requirements are not yet overall practice for many manufacturers and importers of third country products.

It has to be recalled that from June 29th 1994 on the EEC- Recommendation about General Safety for Consumer Products is valid in addition. Legal demands for all products intended to be used by private consumers have to reach the same safety levels as machines. The EEC-Recommendation does not contain specific and detailed technical data to be observed, its article 3 demands very simply: "The manufacturer has to supply only safe products.t8

Draft Recommendation VDI 4500 "Users Information1fi Febr. 1994

Systematical approach

This highly complicated and often dangerous situation for the manufacturer and the lack of any reliable and detailed standards have caused the German Association of Engineers (Verein Deutscher Ingenieure, VDI) to establish in 1990 the committee: Technical Documentation. Members came from producing and distributing companies, universities, agencies, insurance companies and practising technical writers. As far as possible all groups involved were represented with interest in and obligations to the various fields of technical documentation.

After intensive committee work the committee presented in February 1994 the draft recommendation VDI 4500 concentrat- ing in its content on problems and possible and approved solutions of user information. A second and third part will describe the internal technical documentation where standards with specific solutions already do exist.

Extensive content

Picture 5 shows the content of VDI 4500. It starts with a short explanation of different legal requirements and the limits which are set for users information from product liability as well as by contractual law. It is followed by

222 C. 0. Bauer

(3) All machinery must be accompanied by insrruczions including ar lcasc the foilowing:

- 3 repcsc of tic information with which the mac:?ine.ry is marked (set 1.72 ), toge&cr wirh an.y appropriate additional iniormacion to iaciiirate mainrenancc (e.g. addresses oi the lmporrcr, repairers, Cc.),

- forcsccn USC of chc machinery within chc meaning of 1.1.2 (c),

- workstation(s) likely co be occupied by opcrarors,

- insuucrions for safe:

- pucring into service,

- use,

- handling, giving rhc mass of chc machine? and its various parrs where they arc rcgulariy to be transported separately,

- assembly, dismanding,

- adjusrmcnc.

- maintenance (servicing and repair),

- where ncccssary, training insrruaions.

Where nccesszy, the instructions should draw arrcnrior. co ways in which the machinery should not be used.

(b) The instrutions must be drawn up by chc manufacrurcr or his authorized representative established in the Community in one of rhc languages of the counrry in which chc machinery is to be used and should preferably be accompanic,d by the same instructions drawn up in another Community language, such as rhar of the country in which the manufaccurcr or his authorized representative is established. By way of dcrogxion from this requirement, rhc mainrcnancc insmxrions for use by rhc specialized personnel frequently employed by the manufacrurcr or his authorized rcprcxntarive may be drawn up in only one of rhe official Community languages.

(c> The insuu’crions must contain the drawings and diagrams necessary for purring into service, mainrcnanct, inspection, checking of correct opera&n snd, where approprrarc, rtpair of rhc machinery, and all uscfuul insrmcrions in particular. wirh rcgsrd to safety.

Instructions for Machinery 6.01% e

Minimum Content I § 1.7.4, Directive 89392 EEC ZIH 1193


(d)

(cl

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>.ny sales litcrarure describing :hc mac%nc?j musk not contradic: the insrrucrions as regards saicv aspecs; ir must glvc information :cg~ding rhe airborne noise missions rcie.y:d to in (0 and, h the c;~se of hand-hcid and/or hand-yided mac.iinc-7, iniorrnarion re+garding vibration as reiczcd

IO in 2.2,

Whcrc necessary, the inst-utions must give rhe rcquircmczrs relating to insrallation and assembly for reducing noise or vibrarion (e.g. USC oi d~~pcrs, ypc and mass of foundation block,

CCC.).

The insrrucdons must give the foilowing inforrnacion conc:ming airborne noise emissions by rhc ma&incrj, ci&cr the aczuai vaiuc or a vaiuc csza’biishcd on rhc basis of mcasurcrncnts made on idcncical machinery:

- cquivaIcn[ continuous A-wci$YtCd sound pressure ICvCI a; worksrations, where :his cxcccds 70 d&A); where this lcvci dots not excc:d 70 a(A), this iac; must be indicated,

- pc& C-weighted insrantancous sound pressure vaiuc ac worksradons, w:?c-c this cxc:cds 63 Pa . (130 cLB in relation to 20 uPa),

- sound power Ievci c.&. -itccd by the ma&incry whcr: L rlc cquivalcnr continuous A-weighted sound pressure lcvcl :c workadons CXCCC~S 85 dE(A).

In the case of vc-ry large machir.c.ry, insrcsd of the sound power icvci, t:lc cquivalcnr continuous sound pressure lcvc!s at specified posirions around LX macllincry may be indicated.

Sound lcvcis must be measured using C-X mosz approptiatc mcr&od for the ma&incry.

The manuiasurcr‘nus; indiczrc the cp-crating con&dons of ::?c mac.iincrl during mcasurcmar and

what mcchods have been used for kc mcasurcmczc.

Whcrc - hc workstation(s) arc und&cd or cannot ‘bc dc.Sncd, sound prcssurc lcvc!s must be mcascrcd ar 3 dkancc of 1 mcrrc kom &c suriace 0”’ . .nc ma&inc-ry and at height of 1,50 mczcs from c&c floor 0: kcss pladorrr. Tnc posirion ;?d value oi chc maxi.mum sound pressure must be indiuccd.

(g) If &: manuiacy<rcr foresees -haI &c ma&kc-ywiil be used in a pofe~tially cx?losivc amosphcrc, c)..c insrd&onf must give 41 Chc r,cccssary iniOti3tion

(h) In the case of machine-y which may aiso be intended for use by non-profession4 operators, L% wording and layouc of tic inscdtions icr USC, whiisr respcting chc orhcr csscnrial rcquircmncs mcncioncd a’bovc, musi :a& into acccu,?i :kc icvc! of ge~cral cducsdon and acJmcr, :har czn reasonably be cxpcCe d from SC&I opcrarors.

Instructions for Machinery

Minimum Content II

I § 1.7.4, Directive 89392 EEC /

6.01.16 e

1193 ] ZIH

224 C, 0. Bauer

the principles of formulation with wording, construction and - one of the most decisive elements --of appropriate language evaluating the understanding and knowledge of the different user groups. The organizational requirements establishing understandable users information as a wide field, systematically not really organized by companies of various sizes, products and for varying user groups. The organizational necessities are described as part of a steering process in marketing, sales and service. This is part of the freedom of organization by the companies to form their internal processes, but at the same time the companies must be able to prove that they have evaluated to the necessary extent all unspecific legal demands to reasonable caution and reliability of information and evaluation of product observation upon short notice.

The users service is one of the most decisive elements as mandatory part of users information. Human interface design is therefore explained with its necessities as part of users information, to integrate a due and often overseen modern tool which makes unnecessary in a broad extent descriptions and information incorporated already in its design.

Modern techniques to produce users information are in a rapid change; it is therefore important to give an overall summary of all available techniques with their hardware and software at the moment of printing or even for a short period thereafter. General characteristics for selection and use therefore constitute the framework in which the companies have to make their own selection as to their requirements and products of available and economical hardware.

Unrealistic assumptions about costs are the reason for much too many unsufficient and unacceptable solutions for user information in many companies. Calculation schemes and principles for economical control are given to help the companies to find the best individual solution which fulfils the legal demands with economically justifiable costs.

How to organize the process of preparing users information is in many companies an example of trial and error, just resulting from varying chances rather than by rational constructed administration. The state of the art as to organizational practical necessities is presented as guideline against which company internal practices could be evaluated that management as well as by external "notified organizational units", if EEC conformance certificates have to be issued.


I

1

1.1 1.2 1.3

2 Principles of Formation 2.1 Guidlines 2.2 Structure 2.3 Formation Elements 2.4 Language

3

4 Organisatorial Requirements 4.1 Internal Requirements 4.2 External Requirements 4.3 Personal Qualifications 4.4 Internal Test Procedures 4.5 External Tests 4.6 Information and Alteration Services

5 Human Interface Design 5.1 User and Users Needs 5.2 Design 5.3 Construction Principles 5.4 Simulation 5.5 Acceptance Test

6 Technique of Documentation 6.1 Conventional Documentation 6.2 Documentation with Data Processing Units 6.3 Technical Requirements 6.4 Standards to be Observed 6.5 Guidlines for Selection of Hardware

7 Economical Aspects 7.1 Cost Planing 7.2 Calculation 7.3 Control of Result

8 8.1 8.2

9

Preface

Foundation General Public Demand Limit of Content for User's Information

Organisatorial Criterias

Production of User's Information Process Planing Acceptance Tests

Checklists

Appendix Definitions Literature Catalogue of Catchwords

Draft Recommendation VDI 4500 2194

6.0120 e

ZIH 1193

226 C. 0. Bauer

The draft standard contains a selection of check lists for the content, the process of composition and all those criteria which should be observed during planning, production and testing user information. Check lists alone are of no help as long as they are not systematically constructed and take into account all the various aspects of the aims of users information. Opinions alone may be of interest in social discussions, but they are not helpful in discussions about workable organizational set-ups. Only if their basic knowledges are solid and as extensive as possible to constitute a sound foundation for solutions which will stand up if they might be tested by experts or in courts it has reached reliable management targets. These aspects were integrated as far as possible.

Evaluation in other reaions

This draft standard was composed and drawn up regarding the very specific conditions and demands in Germany. It did not try to include the differences which might occur applying it to other regions or states inside or outside the EEC as it is a mandatory request of the EEC-Recommendation Machines, too.

Many of the legal demands and requirements are universal and constitute generally accepted conditions in many countries. Others may differ in their limits and border- lines from state to state. For the conditions of other regions or states it is foreseeable that additional conditions and aspects have to be added and observed as to regional specific criteria especially of understandability and the level of knowledges and experiences of user groups.

To initiate discussions about positive and workable solutions this draft recommendation is presented to experts in other countries causing their interest and hoping of their discussing part. To compete with legal demands and to fulfil users expectations for safe products coming up to the intended value under the various different applications is a universal task. The results of such discussions should be formulation, definition of means and ways to give sound solutions for universe questions and tasks - with the necessary differentiation to various products, different local attitudes with necessary technical substances.

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228 C. 0. Bauer

Conclusions

Legal requirements to prove conformity with european- wide legal requirements constitute an important demand on company-wide organisatorial set-up. To establish a conformity declaration by the company, as required from January 1, 1995 on for all kinds of machinery as declaration of conformity with all technical requirements of all applicable EEC Directives, it is mandatory to support its conclusions by a detailed internal documentation by which it can prove that all the general health and safety demands have been ful- filled, all applicable generally accepted technical rules were observed in internal thinking and actions and that product-specific tests showed the necessary figures for the fulfillment of all these legal requirements. With the European standard EN 292 and the draft guideline VDI 4500 user informations for all characteristics are available by which internal company activities can be measured if and how far they conform to these legal requirements.

This leads to new organisatorial paths to be organized including various departments and sections to establish the result as a teamwork, which stands up - in the case of damages and controlling by state au- thorities - as to give sufficient evidence about carefulness in design, manufacturing, testing and instructions.

Some kind of - mostly isolated - documented facts are a part of any company organization. But isolated facts do not constitute the necessary base for an overall complete and explicable system demanded by European legal rules.

To know and to evaluate the European standards and the German VDI guideline for users' information will ease this problem for companies of all sizes and branches and help them to come to reliable and practical solutions.