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SEMI S2-0703a E © SEMI 1991, 2004 53 R1-5.3.2 Data — This should consist of summaries of data used to determine the safety aspects o f design features. R1-5.3.3 Hazard Analysis Results — This should consist of a summary …

SEMI S2-0703a

 Identification of subsystem, component, software

safety activities as well as integrated system level

activities (i.e., design analyses, tests, and

demonstrations) applicable to the EPS program but

specified in other engineering studies and

development efforts to preclude duplication.

R1-5.2.4 General EPS Guidelines and Criteria — The

EPSPP should:

 Describe general engineering requirements and

design criteria for safety.

 Describe the risk assessment procedures (see SEMI

S10). The hazard severity categories, hazard

likelihood categories, and the EPS precedence that

should be followed to satisfy the safety

requirements of the program.

 Describe closed-loop procedures for taking action

to resolve identified unacceptable risks including

those involving non-developmental items.

R1-5.2.5 Hazard Analysis — The EPSPP should

describe:

 The analysis techniques and formats to be used to

identify hazards, their causes and effects, hazard

elimination, or risk reduction requirements and

how those requirements are met.

 Recommended techniques for identification of

hazards and hazard scenarios include Preliminary

Hazard Lists, Preliminary Hazard Analysis,

HAZOPs, FMEA, FTA, “what if?” and process

control analyses. Other types of hazard analysis

techniques are discussed in a variety of sources,

such as EN 1050, Annex B. No single method is

the best for all types of systems, subsystems,

subsystem interaction or facilities. A combination

of techniques may be most appropriate.

 The integration of subcontractor or supplier hazard

analyses and safety data with overall system hazard

analyses.

 Efforts to identify and control hazards associated

with materials used during the system’s life cycle.

R1-5.2.6 System Safety Data — The EPSPP should

describe the approach for collecting and processing

pertinent historical hazard, incident, and safety lessons

learned, data.

R1-5.2.7 Safety Verification — The EPSPP should

describe:

 The verification (test, analysis, inspection, etc.)

methods to be used for making sure that safety is

adequately demonstrated. Identify any

requirements for safety certification, safety devices

or other special safety verification or

documentation requirements.

 Procedures for transmitting safety-related

verification information to the customer or others

for review and analysis.

R1-5.2.8 Audit Program — The EPSPP should

describe the techniques and procedures to be employed

to make sure the objectives and requirements of the

EPS program are being accomplished.

R1-5.2.9 Incident Reporting — The supplier should

describe in the EPSPP the incident alerting/notification,

investigation and reporting process including

notification of the customer.

R1-5.2.10 EPS Interfaces — The EPSPP should

identify:



The interface between EPS and all other applicable

safety disciplines.

 The interface between EPS, systems engineering,

and all other support disciplines such as:

maintainability, quality control, reliability,

software development, human factors engineering,

and others as appropriate.

 The interface between EPS and product design,

integration and test disciplines.

R1-5.3 Hazard Analysis Documentation

The hazard analysis process is used to identify hazards

and their controls. This information should be

documented in a closed loop tracking system to track

the implementation of the controls and may also be

required for presentation to management, the customer

and others. The safety documentation could include a

system description, the identification of hazards and

their residual risks, as well as special procedures and

precautions necessary for safety.

The documentation should include the following:

R1-5.3.1 System Description — This should consist of

summary descriptions of the physical and functional

characteristics of the system and its components.

Reference to more detailed system and component

descriptions, including specifications and detailed

review documentation should be supplied when such

documentation is available. The capabilities, limitations

and interdependence of these components should be

expressed in terms relevant to safety. The system and

components should be addressed in relation to its

function and its operational environment. System block

diagrams or functional flow diagrams may be used to

clarify system descriptions. Software and its role(s)

should be included in this description.

SEMI S2-0703a

R1-5.3.2 Data — This should consist of summaries of

data used to determine the safety aspects of design

features.

R1-5.3.3 Hazard Analysis Results — This should

consist of a summary or a total listing of the results of

the hazard analysis. Contents and formats may vary

according to the individual requirements of the

program. The following data elements may be used for

documenting the results of hazard analyses:

R1-5.3.3.1 System/Subsystem/Unit — The particular

part of the system that is the concern in this part of the

analysis. This is generally a description of the location

of the component being considered.

R1-5.3.3.2 Component/Phase — The particular

phase/component with which the analysis is concerned.

This could be a system, subsystem, component,

software, operating/maintenance procedure or

environmental condition.

R1-5.3.3.3 Hazard Scenario Description — A

description of the potential/actual hazards inherent in

the item being analyzed, or resulting from normal

actions or equipment failure, or handling of hazardous

materials.

R1-5.3.3.4 Effect of Hazard — The detrimental effects

that could be inflicted on the subsystem, system, other

equipment, facilities or personnel, resulting from this

hazard. Possible upstream and downstream effects can

also be described.

R1-5.3.3.5 Recommended Action(s) — The

recommended action(s) that are necessary and sufficient

to eliminate or control the hazard. Sufficient technical

detail is required in order to permit the design engineers

and the customer to adequately develop and assess

design criteria resulting from the analysis. Include

alternative designs and life cycle cost impact where

appropriate.

R1-5.3.3.6 Risk Assessment — A risk assessment for

each hazard (classification of severity and likelihood).

This may include an assessment of the risk prior to

taking any action(s) to eliminate or control the hazard

and a separate assessment of the risk following

implementation of the Recommended Action(s). (See

SEMI S10.)

R1-5.3.3.7 Remarks — Any information relating to the

hazard not covered in other blocks; for example,

applicable documents, previous failure data on similar

systems, or administrative directions.

R1-5.3.3.8 Status — The status of actions to

implement the recommended control, or other, hazard

controls. The status should include not only an

indication of “open” or “closed,” but also reference to

the drawing(s), specification(s), procedure(s), etc., that

support closure of the particular hazard. The person(s)

or organization(s) responsible for implementation of the

control should also be recorded.

SEMI S2-0703a

RELATED INFORMATION 2

ADDITIONAL STANDARDS THAT MAY BE HELPFUL

NOTICE: This related information is not an official part of SEMI S2 and was derived from practical application by

task force members. This related information was approved for publication by vote of the responsible committee on

October 21, 1999.

Table R2-1

International Standards Title

IEC 60204-1 Safety of Machinery - Electrical Equipment of Machines, Part 1

IEC 60417 Graphical Symbols for Use on Equipment

IEC 60664 Insulation Coordination for Equipment within Low-voltage Systems

IEC 60825-1 Safety of Laser Products, Part 1: Equipment Classification, Requirements and User’s

Guide

IEC 60950 Safety of Information Technology Equipment, including Electrical Business Equipment

IEC 60990 Methods of measurement of touch current and protective conductor current

IEC 61310-1 Safety of Machinery - Indication, Marking and Actuation - Part 1: Requirements for

Visual, Auditory and Tactile Signals

ISO 3461-1 General Principles for the Creation of Graphical Symbols - Part 1: Graphical Symbols for

Use on Equipment

ISO 3864 Safety Colours and Safety Signs

ISO 7000 Graphical Symbols for Use on Equipment - Index and Synopsis

USA Standards Title

ANSI Z535.1 to ANSI Z535.5 Labeling and Marking

ANSI/UL 94 Tests for Flammability of Plastic Materials for Parts in Devices & Appliances

ANSI/UL 499 Electric Heating Appliance

ANSI/UL 508 Industrial Control Equipment

ANSI/UL 991 Tests for Safety-Related Controls Employing Solid-State

UL 1012 Power Units Other than Class 2

ANSI/UL 1778 UPS Equipment

ANSI/UL 1950 Information Technology Equipment

ANSI/UL 1998 Safety-Related Software

ANSI/UL 3101-1 Electrical Equipment for Laboratory Use; Part 1: General Requirements

ANSI Z136.1 American National Standard for Safe Use of Lasers

ASTM Volume 10.03 Electrical Protective Equipment

ISA S82.02 Electrical and Electronic Test and Measuring Equipment

ISA S82.03 Electrical and Electronic Process Measuring and Control

Factory Mutual Data Sheet 7-7 Semiconductor Fabrication Facilities

FMRC 3810 Electrical and Electronic Test, Measuring and Process Control Equipment

NFPA 70 National Electrical Code

NFPA 70E Electrical Safety Requirements for Employee Workplaces

NFPA 79 Electrical Standard for Industrial Machinery

NFPA 318 Standard for the Protection of Cleanrooms

NEMA 250 Enclosures for Electrical Equipment (1000 Volts Maximum)

NEMA ICS 1.1 Safety Guidelines for the Application, Installation, and Maintenance of Solid-State

Control

OSHA 29 CFR 1910.132-138 Personal Protective Equipment

OSHA 29 CFR 1910.147 The control of hazardous energy (lockout/tagout)