Founder's Articles on IEC 61508 and ISO 9000
Published in April, 2004
E/E/PES development documentation (Objective 2) - Article #7
This is the seventh in a series of short articles on IEC 61508.
IEC 61508 is required whenever a computer-based system is used to carry out a safety
function. The purpose of these articles is to give the reader an appreciation
for this international standard.
IEC 61508-2, clause 7 requires an understanding of the development
processes of the Electrical/Electronic/Programmable Electronic System (E/E/PES)
lifecycle. The objectives of IEC 61508-2, clause 7 are:
1. define the processes of the E/E/PES development to achieve the required functional safety.
2. document all information relevant to the functional safety of the E/E/PES development.
The previous article in this series addressed the E/E/PES
development processes, item 1 above. This article addresses the E/E/PES safety
development documentation, item 2 above. The E/E/PES safety development
documentation is required as objective evidence that the particular development
process is complete and represents the value added for the consecutive dependent
processes. This data is retained to support E/E/PES safety product maintenance
and to prove due diligence to IEC 61508. The E/E/PES development documentation
is: E/E/PES Safety Requirements Specification, E/E/PES Design Document, E/E/PES
Implementation Documentation, E/E/PES Integration Documentation, E/E/PES
Verification Results, and E/E/PES Validation Results.
The purpose of the E/E/PES Safety Requirements Specification
is to prove that the functional requirements and safety integrity requirements
allocated from the E/E/PES proposal or other customer documents, are compliant
to IEC 61508-2, subclause 7.2, and IEC 61508-7, B.2.1. The application of an
E/E/PES Safety Requirements Specification Standard aids the development of the
E/E/PES Safety Requirements Specification by including requirements methods that
address the requirements of IEC 61508-2, subclause 7.2, and IEC 61508-7, B.2.1.
IEC 61508-7, B.2.1, requires a structured specification. Computer Aided Systems
Engineering (CASE) tools are available to assist the development of a structured
specification. All of the E/E/PES Safety Requirements Specification need not be
completed before the E/E/PES design process can begin. However, a critical amount,
(transition criteria) of the E/E/PES Safety Requirements Specification must be
complete to permit the start of the E/E/PES design process. The E/E/PES Safety
Requirements Specification is complete when it documents enough requirements to
permit the E/E/PES design to be completed.
The purpose of the E/E/PES Design Document is to prove that the
E/E/PES safety requirements are developed into the E/E/PES design, and are compliant
to IEC 61508-2, subclause 7.4, and IEC 61508-7, B.3.2. The application of an E/E/PES
Design Document Standard aids the development of the E/E/PES Design Document by including
design methods that address the requirements of IEC 61508-2, subclause 7.4, and IEC 61508-7,
B.3.2. IEC 61508-7, B.3.2, requires a structured design. CASE tools are available to
assist the development of a structured design. All of the E/E/PES Design Document need
not be completed before the E/E/PES implementation process can begin. However, a critical
amount, (transition criteria) of the E/E/PES Design Document must be complete to permit the
start of the E/E/PES implementation process. The E/E/PES Design Document is complete when
it documents enough design to permit the E/E/PES implementation to be completed.
The purpose of the E/E/PES Implementation Documentation is to prove
that the E/E/PES design was built from the E/E/PES Design Document and is compliant
to IEC 61508-2, subclause 7.4.7, and IEC 61508-7, B.3.3. The application of an
E/E/PES Implementation Standard aids the development of the E/E/PES implementation
by including implementation methods that address the requirements of IEC 61508-2,
subclause 7.4.7, and IEC 61508-7, B.3.3. IEC 61508-7, B.3.3, requires the use of
well-tried components. All of the E/E/PES Implementation Documentation need not
be completed before the E/E/PES integration process can begin. However, a critical
amount, (transition criteria) of the E/E/PES Implementation Documentation must be
complete to permit the start of the E/E/PES integration process. The E/E/PES
Implementation Documentation is complete when it documents enough implementation
to permit the E/E/PES integration to be completed.
The purpose of the E/E/PES Integration Documentation is to prove
that the E/E/PES Executable Object Code (if software is required) was loaded into
the integrated E/E/PES as described in the E/E/PES Implementation Documentation,
and is compliant to IEC 61508-2, subclause 7.5, and IEC 61508-7, B.3.4. The
application of an E/E/PES Integration Standard aids the development of the
E/E/PES integration by including integration methods that address the requirements
of IEC 61508-2, subclause 7.5 and IEC 61508-7, B.3.4. IEC 61508-7, B.3.4,
requires the use of modularization. The integration of each validated hardware
module from the E/E/PES Implementation Documentation is documented in the E/E/PES
Integration Documentation. The software configuration items are integrated also.
All of the E/E/PES Integration Documentation need not be completed before the
E/E/PES validation process can begin. The E/E/PES Integration Documentation is
complete when all validated modules are integrated into the E/E/PES.
The purpose of the E/E/PES Verification Results is to prove
that the E/E/PES safety development processes and associated E/E/PES safety
development documentation are compliant to IEC 61508-2, subclause 7.9, and
IEC 61508-7, B.1.1. The application of an E/E/PES Verification Standard
aids the development of the E/E/PES Verification Results by including verification
methods that address the requirements of IEC 61508-2, subclause 7.9 and IEC 61508-7,
B.1.1. The E/E/PES is assessed for Safety in IEC 61508-2, subclause 8, Functional
safety assessment. All of the E/E/PES Verification Results need not be completed
before the E/E/PES validation process can begin. The E/E/PES Verification Results
is complete when it permits an assessment of the E/E/PES for safety.
The purpose of the E/E/PES Validation Results is to prove
that the E/E/PES safety development documentation is compliant to IEC 61508-2,
subclause 7.7, and IEC 61508-7, B.6. The application of an E/E/PES Validation
Standard aids the development of the E/E/PES Validation Results by including
validation methods that address the requirements of IEC 61508-2, subclause 7.7
and IEC 61508-7, B.1.1. The E/E/PES is assessed for Safety in IEC 61508-2,
subclause 8, Functional safety assessment. All of the E/E/PES Verification
Results need not be completed before the Functional safety assessment process
can begin. The E/E/PES Validation Results is complete when it permits the
completion of the E/E/PES verification in support of an assessment of the E/E/PES
for safety.
This article presented the E/E/PES safety development processes
with their trace abilities to IEC 61508-2. The E/E/PES safety development engineer
should become familiar with these IEC 61508-2 subclauses to fully understand how to
comply with this international safety standard. The next article in this series will
address software compliance (IEC 61508-3).
Paul Bodeau is a member of the Safety Division with over 25 years of diversified
engineering experience, mostly in safety firmware development for military and
civilian aviation. Mr. Bodeau can be reached at (661) 260-1210, or
pbodeau@WhyNotEngineering.com.
|