Schmeling + Consultants GmbH Heidelberg

www.schmeling-consultants.de Phone +49 (0) 62 21 / 58 50 47-0

Notes on how to use eDok and

(upcoming) IEC 82079-1 for

argumentation and practical work

How to create value

from eDok

and IEC 82079-1

Copenhagen, 2016-10-04

info@schmeling-consultants.de

14:00 – 15:00

Agenda

What is

IEC 82079-1

ISO IEC IEEE 26514

eDok

Initial notes on electronic documentation

Principles and information quality goals (IEC 82079-1 upcoming)

New: relevance, minimalism

Target group analysis

Required by IEC 82079-1

Guidance in ISO IEC IEEE 26514

Media concept

Building blocks from eDok

Risk assessment: risk of non-availability of media

Required by EU regulation 207/2012 on electronic instructions for use of medical devices

Detailed guidance in eDok

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What is IEC 82079-1 Preparation of instructions for use

Status • International Standard (IEC) – double logo standard IEC/ISO

• European standard (EN)

• Horizontal standard – getting more and more importance

Published • August, 2012

• Cancels and replaces IEC 62079:2000

Scope • All types of instructions for use

• Products of all kinds, ranging from a tin of paint to …

large industrial machinery, turnkey based plants or buildings

Content • Definitions (chapter 3)

• Principles on the preparation of instructions for use (ch. 4, 5, 6)

• Detailed requirements on

• Content of instructions for use (ch. 4, 5)

• Presentation (ch. 4, 6)

• Process of preparing instructions for use (ch. 4, 7, annex)

• Competence of technical writers, translators, proof readers, … (ch. 4.2)

• Evaluation of conformity to the standard (ch. 7)

• Informative annex D: process of preparation of instructions for use

• Informative annex E: Empirical methods ( lecture JTCA Tokyo 2014)

Outlook • Review Report 3/1177/RR (2014-02-14)

• Revision in progress

Structuring, content and presentation – Part 1: General principles and detailed requirements

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tekom spring survey 2013: considering DIN EN 82079-1?

Over 80 % oriented themselves to IEC 82079-1 or were planning it

No adherence to the norm in:

16–20 % of the industry and service companies

64.4 % of software companies

Possibly ISO IEC IEEE 26514 and other standards form the series were known

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4

Yes, DIN EN 82079-1 is binding for producing technical documentation 17.2 %

Yes, we are somewhat oriented to DIN EN 82079-1 when producing

technical documentation

39.8 %

We plan to follow DIN EN 82079-1 when producing technical documentation

in the future

16.9 %

No, DIN EN 82079-1 has no relevance for producing technical

documentation

26.1 %

Total 100.0 %

What is IEC 82079-1 Preparation of instructions for use

Structure completely reworked

Principles and quality criteria reworked

“Information management process”

“Professional competencies”

System documentation considered

System = “set of interrelated elements considered in a defined context as a whole and separated from their environment”, e.g. plants

Further improvements (review report):

Structure for information types

“Guidance needed on how to structure different information type like a ‘step-by-step instructions’, a ‘maintenance plan’ etc. which are addressed in the standards but no information is given how to do it.”

New media

“New media (e.g. mobile terminals) need to be addressed regarding their structural, conceptual and didactic specifications.”

Recommendations

• Applicate the current standard

• Observe edition 2 and applicate edition 2 after publication

Outlook to edition 2

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What is ISO IEC IEEE 26514: Systems and software engineering

Status • International Standard both ISO and IEC, and IEEE standard

Published • June, 2008

Scope • supports the interest of software users in consistent, complete, accurate, and

usable documentation

Content • User documentation process

• Project requirements

• Analysis and design

• Development and review

• Production, updating, maintenance

• Structure of documentation

• Information content of user documentation

• Presentational format of user documentation

• Annexes e.g. style guide content, checklists

Outlook • Going to be maintained

Requirements for designers and developers of user documentation

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What is eDok

Printed information is the common way of information delivery

Product information are more and more expected and delivered in electronic form

Legal situation is not clear

Guideline to support the choice of media for instructions for use with respect to the

needs including recommendations on the use of electronic media

Core team of 7 authors

More than 20 companies and experts

Communication with EU commission

Publication in November 2016 (German)

Project of tekom Europe

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Initial notes on electronic

documentation

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Electronic documentation: Multi channel information delivery

9

Labels

Brief instructions

/ never tear

material

Video Download of

PDF

Embedded

information

App Online help (if

device available)

CD Classic printed

manuals

Focus on information channels with high value for the customer

• Aim for

acceptance

and

attractiveness

• Focus on the

informational

needs of the

customer, not

just publish

available

information

• Perform

usability

testing for new

media

• Interlink

information

cross-media,

not just

combining

media

• Promote

electronic

media

• CMS required

To manage the

consistency of all

information delivery

channels often is a

challenge because

in many companies

information

management is not

centralized but

scattered (technical

documentation,

marketing, training,

sales, service, ...).

Perspectives

Strategic

Save money, resources, time

Meet the organization’s

goals

Align organization to

common information

quality

Customer, User

groups

Available information

Usability

Acceptance

Legal/ authorities

No clear requirements

Trend to more acceptance of

electronic information

207/2012 on medical device gives guidance

Liability risks

Risk assessment

Available safety information

Accessibility and usability

TC perspective

Technical Communication:

Low effort

Required structures and

systems (software)

Implement concept

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Electronic documentation: 10 success factors

Analyze all requirements

Get a common understanding of

information quality

Focus on the informational needs of the

customer

Minimalize text, reduce

illustrations, optimize their coordination

Interlink information

cross-media, not just combining

media

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Analyze all requirements

Get a common understanding of information quality

Focus on the informational needs of the customer

Minimalize text, reduce illustrations, optimize their coordination

Interlink information cross-media, not just combining media

Electronic documentation: 10 success factors

Use responsive design

Implement appropriate

single source

Perform usability testing for new

media

Manage consistency of all

information channels

Promote electronic media

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Principles and information quality

goals

IEC 82079-1 2nd edition (in progress)

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IEC 82079-1 Preparation of instructions for use

Purpose of information for use

• Target audience(s) orientation

• Safe, efficient, and effective use

• Use of specific information types / standardization

• importance and quality of information as part of the product

• Compliance

Information quality

• Completeness

• Correctness

• Conciseness

• Consistency

• Comprehensibility

• Accessibility

Repeatable processes

Principles / quality criteria

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Recommendation: Achieve a common understanding of the required

information quality with management and stakeholders in written form

Target group analysis

Required by IEC 82079-1

Guidance in ISO IEC IEEE 26514

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eDok: Aspects of user perspective

Aspect Method Standard Criteria

Availability Risk assessment EU regulation

207/2012

Providing instructions for use in

electronic form maintains or

improves the level of safety

obtained by providing the

instructions for use in paper form;

Availability of appropriate devices

Usability Usability testing IEC 82079-1:2012

ISO 9241-110

ISO 14915-1:2012

Completeness

Correctness

Consistency

Comprehensibility

Controllability

Self-descriptiveness

…

Acceptance Empirical survey Key performance

indicators

Number of downloads, clicks,

Direct feedback

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Target audience profiles

Aspect Example

Background Ticket agents have knowledge of the travel industry, customers’ needs and

concerns, and other computer booking systems.

Languages Ticket agents may have a command of English, but not necessarily as their first

language.

Use of the

application

Ticket agents use the application while they are on the telephone to customers

or when the customer is present, and make ticket bookings immediately.

Learning stage All ticket agents will have attended a one-day training course;

consequently, no users are novices.

There is at least one expert user in each office all the time.

Frequency of

use

Ticket agents frequently use the application all the time throughout an eight-

hour shift (with breaks).

Working

environment

Offices may be noisy and very busy. Ticket agents sit at desks to work. Agents

have access to a computer throughout the shift but may share printers. Offices

usually have a photocopier, fax machine, and scanner. Ticket agents use

headsets for the telephone. Not all offices will have:

• shelf space to hold a small library of books;

• drawer space in the desks;

• wall space available for displaying wall charts.

IEC 26514, 7.1.2, Figure 5 „Sample audience profile“

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Example of target audience analysis for a waste sorting plant

Result from a 3 hours online meeting

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Target audience

Recommendation

• Define goals and tasks hierarchically

Task analysis

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Example from ISO IEC IEEE 26514

Target audience: audience mapping matrix

ISO IEC IEEE 26514, 7.1.3 „Task analysis“ Table 1 — Audience mapping matrix

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Target audience and information products

ISO .. 26514: Figure 8 „Using audience information needs to determine document content“

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Media concept

Building blocks from eDok

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Target audience and information delivery

ISO .. 26514, Figure 9 „Using information type and usage to determine delivery method“

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Media concept

Content Medium 1:

Included printed

instructions

Medium 2: Embedded help

Medium 3: PDF for download

Medium 4: Video

Safety information X — X —

Overview of parts,

cables, and

accessories

X — X —

Connection

diagram X — X —

Instructions for

connecting X — X X

Selecting a

language — X X —

Setting a password — X X —

Login information

for connecting

devices to the WiFi

network

— X X

Only preconfigured

login

—

Reference to WEEE X — X —

Table 3: Content-media matrix for a WiFi router (extract)

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eDok

Interlink

from ↓ to Medium 1:

Included

printed

instructions

Medium 2: Embedded help Medium 3:

PDF for

download

Medium 4:

Video e.g.

on youtube

Medium 1:

Included

printed

instructions

Cross

references

within the

document

QR code to call up the software

for the router; basic reference to

the router software; no interlinking

on the use-case level

Listing the

internet page

for

downloading

Link and QR

code

Medium 2:

Embedded

help

— Cross references are links; links

to instruction video on action level Listing the

internet page

for downloading

Link and QR

code

Medium 3:

PDF for

download

— QR code to call up the software

for the router; basic reference to

the router software;

no interlinking on the use-case

level

Cross

references/li

nks within

the PDF

Link and QR code

Medium 4:

Video on

youtube.com

Printed

instructions

shown in the

video

The end of the video shows how

to call up the software — —

Table 4: Interlink matrix for a WiFi router (extract)

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Risk assessment: risk of non-

availability of media

Required by EU regulation 207/2012 on electronic instructions

for use of medical devices

Detailed guidance in eDok

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Risk assessment: Recommended overall proceeding (eDok)

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1. Analysis

Products and

the

possibilities of

displaying

information

Legal requirements

Element 1:

Clarifying

contractual

requirements

Element 2:

Product

liability

legislative

requirements

Element 3:

Product

safety

provisions of

target

markets

Element 4: Comparing requirements and

provisions, contractual clarification as needed

User groups Use cases

2. Media Concept

Definition

Assessing

the

default

risks

Testing

the media

concept

3. Implementation,

Improvement, and internal

documentation

Risk assessment

Type of failure Examples 1. Difficulty accessing information due

to lack of knowledge and experience

with the medium on the user’s part

User groups without experience with particular electronic media

2. Difficulty accessing information due

to characteristics of the use

environment

Lighting, background noise, weather conditions (such

as rain and wind)

3. Difficulty accessing information or

no access due to lack of medium

usability in the use case

A touchscreen can’t be operated while wearing work

gloves

In an emergency, information is not readily available

The type of emergency doesn’t allow the media to be

used, for example, paper during a fire or electronic

media when there is no electricity 4. Difficulty accessing the means of

displaying the information (hardware,

software, network)

The printed instructions are far away from the user’s

work area or is locked away.

Display software can’t be loaded or installed (no

internet access; no admin rights)

5. Non-availability of required

hardware or of the medium Medium is not available (e.g., due to lass, lack of

retention guidelines)

Use of medium forbidden; Examples: Labs in which use

of internet is not allowed.

Types of failure of a medium for instructions for use (eDok), 1/2

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Risk assessment

Type of failure Examples 6. Non-availability of required software (with electronic information)

Display software not available in the required version in the user‘s country

7. Non-availability of required network

(with electronic information) either on

the provider or the user’s side

Wi-Fi of user down

8. Functional failure of the medium on

the provider side Hardware or software error in products with built-in use

information

Error in the IT infrastructure of the provider of use

information, such as a server being down on the

information provider side 9. Functional failure of the medium on

the user side No internet connection for internet-based information or

other errors in the required IT infrastructure of the user

Wear and tear of the medium for printed information or

information on the product surface

Fading of printed information 10. User error in using the information Accidentally deleting files

Pages in the wrong order in the folder 11. Wrong or obsolete information Information was not updated when the product was

updated

Printed information was not exchanged correctly

Types of failure of a medium for instructions for use (eDok), 2/2

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Risk assessment

Type of failure Medium 1:

Printed,

complete

instructions,

approx. 350

A4 pages, paperback

Medium 2:

Printed,

laminated quick guide

Medium 3: PDF

as a download

from the website

Medium 4:

Video (internet)

Measures

Availability of required hardware

— — Screen with at

least 800 pixels

and 8‘‘ width

required;

can be assumed

in the office, but

not at location of use

Availability of required software

— — PDF reader

required; can be

assumed where

the hardware is available

Availability of required network

— — Internet required;

can be assumed

in the office, but

not at location of use

Risk assessment by assessing media along types of failure (eDok), 1/2

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Risk assessment

Type of failure Medium 1:

Printed,

complete

instructions,

approx . 350

A4 pages, paperback

Medium 2:

Printed,

laminated quick guide

Medium 3: PDF

as a download

from the website

Medium 4:

Video (internet)

Measures

Ease of loss Medium risk High risk No risk No risk Add a place for

printed instructions to the product

Wear and tear of medium

High risk Medium risk — — Suitable print and

paper quality,

protective

container,

protective envelope

Updatability Can only be

exchanged with

on-site service

or shipping (1 week)

Exchange

through on-site

service or shipping (1 week)

Anytime Anytime Issue date of

printed

instructions,

exchange of

instructions with larger updates

Risk assessment by assessing media along types of failure (eDok), 2/2

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Further types of failure: Availability of required user knowledge, accessibility, retrievability, replaceability

Risk assessment

No. Use case Failure risk of the

mediums, causes and

probability

Possible

consequences Objective and

measures

1 Restart after

temporary

failure of the

control software

Electronic instructions not

available during failure of

the control software

Not safety relevant - Print instructions

to restart after

failure and make

available for

download 2 Error message:

Diagnose error

in material flow

on machine and

solve the problem

Printed instructions not

available (lost, locked

away): possible to probable

User tries to solve on

own;

information about

precautions during

troubleshooting not

available;

Clearing blockages

without stopping the

machine beforehand

is life threatening

Must ensure

availability of

instructions on the

machine

- Add measures to

the electronic

error display

- Warning on all

access points to

material flow

Task-based (use-case-based) risk assessment

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I am looking forward

your e-mail Or SMS

Or your visit on our

hompepage

Thank you for your attention!

Schmeling + Consultants GmbH Heidelberg

www.schmeling-consultants.de Phone +49 (0) 62 21 / 58 50 47-0

info@schmeling-consultants.de

Dipl.-

Technikredakteur

Tilo Ried

Senior

Consultant

Prof. Robert

Schäflein-

Armbruster,

Partner

Consultant

Dipl.-Phys.

Roland

Schmeling,

CEO, Partner

Consultant

Dipl.-Wirtsch.-Ing.

Mareike von der

Stück

Senior Consultant

Sarah Fancy,

MBA

Senior

Consultant

Dipl.-Ing. (FH)

Marco Hattemer,

Senior Consultant

Dr. Annika

Lehmann,

Consultant

Simone

Heidemann,

Assistant

methodical.

independent.

reliable.

MANAGING

INFORMATION

QUALITY.

(c)

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2007 established

8 consultants

150 customers

300 projects

8 countries

Product

data

quality

Systems Learning

Automotive – Services– Electronics – Energy – Components – Logistic –

Machinery – Media and Broadcasting – Software – Administration – Plants

Content

and

information

quality

Business

processes