KAN Report 18

	Requirements concerning instruction handbooks in product standards in support of the EC Machinery Directive, 03/1999, A. Johannknecht (398 KB)
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Summary

Introduction

The study is intended to assist members of European standards bodies in the field of safety of machinery in the drafting of the "information for use/instruction handbook" section in product standards.

Based on the EC Machinery Directive, the term "technical documentation" is defined and distinguished from the instruction handbook which must be supplied with the machinery. The difference between the instruction handbook to be prepared by the manufacturer and the user instruction to be drafted by the employer is explained. The relevant stipulations of the EC Machinery Directive and the supporting sections of the generic European standards for drawing up instruction handbooks are quoted verbatim and further reference documents compiled. While all the necessary information is provided as far as content is concerned, the form, structure and drafting of information for use to be provided by the manufacturer is only dealt with in national and international guides; a relevant European standard, however, does not exist. Examples which can be considered successful as well as those which are classified as inadequate are used to ascertain which aspects should be taken into account in European machinery safety standards and which developments that have emerged in standardisation practice must be counteracted.

 

Deficiencies concerning the formulation of the section on instruction handbooks

Based on examples, the following deficiencies have been established in machinery standards:

1. Manufacturer obligations are shifted to the user to compensate for safety deficiencies. This happens when hazards are not eliminated by means of design modifications, but are simply identified by information directed at the user.

2. Standards often give the impression of being conclusive. However, they cannot be more than just a recommendation. Based on the stipulations of the directive and, if applicable, on additional standards, the manufacturer must check and decide whether specific supplementary instructions are necessary for his product.

3. The standardisation mandate is exceeded if not only the manufacturer, but also the user is addressed on topics concerning use or certification. The reason for this could be resolution BTS 2 79/1993 which recommends that a special "informative annexe" on the "Code of safe practice" be attached to the standard if necessary.

 

Recommendations to KAN

1. The resolution of the CEN/BTS 2 79/1993 should be modified. The interest which obviously exists among standards makers, namely to address the user in the actual standard with stipulations aimed at both employer and employee, is not the task of a standard. And since the manufacturer is the sole addressee of the standard, this information would not reach its target group anyway.

2. The section "information for use/instruction handbooks" may only be directed at the manufacturer. Due to the stipulations in the EC Machinery Directive, there is no provision for instructions aimed at the user which would in this respect also conflict with directives under Article 118a.

3. The section on "information for use" of a type C standard should include a note which makes it clear that the information and instructions presented in these standards cannot be conclusive and complete. For the manufacturer's instructions on safe practice must also include those aspects which are not part of the standard: e.g. general hazards according to DIN EN 292, specific technical solutions, supplementary safety equipment.

4. Measures described in the standard and intended for the user with regard to safe practice must be based on clear specifications concerning defined residual risks in the section "instruction handbooks". Appropriate substitute measures, procedures or operating methods for minimising risks should therefore be proposed by the standards body in the section "instruction handbooks".

5. General requests concerning the provision of personal protective equipment (PPE) or the setting up of first-aid or emergency stations without referring to existing residual risks are not considered useful information. Specific information on protecting against potential dangers, e.g. with regard to using PPE, is only useful if residual risks are defined. The employer's obligation to specify in detail individually adapted PPE or to provide special equipment results from relevant directives under Article 118a and does not need to be regulated in the standard.

6. Safety equipment to be provided to protect against other dangers according to point 1.5 of Annexe I to the EC Machinery Directive, which the standard imposes on the user, is not permitted if it serves to compensate for deficiencies in design.

7. Recurring inspections are not part of the Machinery Directive's area of application and cannot therefore by regulated in machinery standards. Machinery and plant requiring inspections and monitoring are subject to Article 118a of the EC Treaty.
On the other hand, machinery standards need to specify what information manufacturers must provide on maintenance and inspection work.

8. The term "information for use" as a sectional heading should be replaced by a more suitable term. This term is also a generic term for all types of directions (for use), instruction handbooks, user manuals, operating instructions and technical instructions provided by the manufacturer. This causes irritation as the contents of the section on "information for use" in standards are not identical with the instruction handbooks to be drawn up by the manufacturer.

 

Line of argument for comments

A line of argument based on the German Consensus Statement against machinery standards containing instructions for the user is unsuitable as these standards are prepared under the mandate of the Machinery Directive based on Article 100a of the EC Treaty. The German Consensus Statement, however, only refers to areas covered by Article 118a. The line of argument could, for example, be as follows:

1. Neither employer nor employees are the addressees of the standard and would not even be reached by it.

2. A specification in a standard aimed directly at the employee would undermine the employer's right to issue instructions to employees.

3. If a standard intervenes in the employer's legally regulated responsibility for occupational health and safety, legal consequences could be expected if a damaging event were to occur.

 

 

KAN's recommendations

Overall evaluation

The study provides a good working basis for assisting members of European standards bodies for machine safety in the drafting of the "information for use/instruction handbook" section in product standards. The compilation of all specifications relevant to C standardisation provides a quick overview of the documents which must be taken into account. Other guides are named in addition. Recommendations for standards makers as to which aspects should be taken into account in European machine safety standards from the point of view of German occupational health and safety are derived from negative and positive examples.

KAN has decided to publish the study as a KAN Report.

 

Recommendations to DIN (German Standards Institute)

KAN requests DIN to exert influence on CEN for the modification of the BTS 2 resolution 79/1993 with the following recommendations:

1. It is not the task of standardisation to address the user in the actual standard with stipulations aimed at both employer and employee. And since the manufacture is the sole addressee of the standard, this information would not reach its target group anyway.

2. The section "information for use/instruction handbook" may only be directed at the manufacturer. According to the EC Machinery Directive, there is no provision for instructions aimed at the user (Code of safe practice), which would in this respect also conflict with directives under Article 118a.

3. Information and instructions in product standards cannot be conclusive and complete. The following formulation should therefore be included in the section on "information for use" in type C standards:
"The following points describe by way of example the structure and contents of an instruction handbook to be drawn up by the manufacturer and should be supplemented or extended to take account of the specific machinery concerned."

4. In the section on "information for use/instruction handbook", reference to residual risks may only be made if the specific types of hazards have already been mentioned in the section on "list of significant hazards" and dealt with in the section on "safety requirements and/or measures". Measures defined by the manufacture and aimed at the user with regard to safe practice must be based on clear specifications concerning defined residual risks specific to each individual product in the section on "instruction handbook". Appropriate substitute measures, procedures or operating methods for minimising residual risks should therefore be suggested by the standards body.
General requests concerning the provision of personal protective equipment (PPE) or the setting up of first-aid or emergency stations without referring to residual risks are not considered useful information. Specific information on protecting against potential dangers, e.g. with regard to using PPE, is only useful if residual risks are defined. The employer's obligation to specify in detail individually adapted PPE or to provide special equipment is the result of relevant directives under Article 118a and does not need to be regulated in the standard.

5. Safety equipment to be provided by the user to protect against other dangers according to No. 1.5 of Annexe I to the EC Machinery Directive, which the standard imposes on the user, is not permitted if it serves to compensate for deficiencies in design.

6. Recurring inspections are not part of the Machinery Directive's area of application and cannot therefore by regulated in machinery standards. Machinery and plant requiring inspections and monitoring are subject to Article 118a of the EC Treaty.
On the other hand, machinery standards are responsible for specifying what information manufacturers must provide on maintenance and inspection work. In this context, recommendations given by the manufacturer can be considered for testing.

 

Recommendations to KAN

7. When commenting on machinery standards with instruction handbook, the KAN Secretariat is instructed to adopt the line of argument presented in the study (see result-oriented summary: Line of argument for comments).

8. The KAN Secretariat is instructed to examine information for use in European machinery standards processed at CENELEC in a further KAN Study, taking account of the results of this study.

9.The KAN Secretariat is instructed where possible to apply the results of the study to European standards which refer to other EC single market directives.
It is necessary to clarify whether a European standard (B standard) is useful with regard to the form, structure and the drafting of information for use. The KAN Secretariat is instructed to take account of this aspect in future investigations.