Validation versus Verification

Australian Regulatory Summary

All facilities within Australian Commonwealth fall under The Offshore Petroleum
Act 2006 (OPA 2006). The National Offshore Petroleum Safety and Environmental
Management Authority (NOPSEMA) is the government body which administers this.
Supporting this act are the Offshore Petroleum and Greenhouse Gas Storage
(Safety) Regulations [OPGGS(S)R] 2009 which set out the requirements for the
contents of safety cases and set out general requirements for Validation
and Verification.

Australian Regulatory Summary -
Key Requirements
1. N
 OPSEMA requests validation (this is
their stated policy for all new facilities
and significant modifications).
2. N
 OPSEMA / Operator reach agreement
on the scope of validation, i.e. what
safety-critical elements of the facility
are required to be validated and
against which codes and standards.
3. T
 he scope of validation is agreed by
NOPSEMA in writing and Validation
commences (if not already under way).
4. O
 perator submits facility safety case.
5. Safety
 Case assessment underway
(including formal comment from
NOPSEMA).
6. V
 alidation finalised and “clean”
Statement delivered.
7. Safety case final decision-making.
8. V
 erification is a separate process which
applies throughout, in parallel with
and continuing after Validation.
The validation process (as detailed in
NOPSEMA Validation Guideline N-04200-
GL0525, section 4.4)
Validation is primarily a process
undertaken by an independent
competent party, namely the Validator,
to ensure that the design, construction
and installation of the Safety Critical
Elements – SCEs - (safety-critical
hardware, firmware and software,
including instrumentation, process
layout and process control systems) of
the facility will incorporate appropriate
measures that will protect the health
and safety of persons at the facility.
Note that Validation activities related to
construction and installation are limited
to a review of related documentation
(for example inspection and test plans,
welding plans, etc), and do not include
physical survey of equipment.
Validation, as referred to in the
legislation, should not be confused
with verification. Validation is a purely
documentation review exercise that can,
in theory, be completed before or by the
early stages of construction, provided
sufficient documentation on the design,
construction and installation of the SCEs
has been made available to the Validator
and all comments resolved. Verification
generally requires someone to physically
check that, for example, safety-critical
equipment has been installed correctly
and in-situ is fit for its function and use
and is, in the main, a surveillance, witness
and manufacturing/test documentation
review activity. The inclusion of elements
of verification within a Validation scope
is potentially problematic, particularly for
fixed facilities.
For example, verification that a piece
of safety-critical equipment is fit for
its function and use often can only be
conducted once the equipment has
been installed.

Working together
for a safer world
However, this equipment cannot be
installed until a safety case, which
provides for the installation of
equipment, has been accepted by
NOPSEMA, and any acceptance of a
safety case related to such a proposed
modification to a facility can only occur
if the operator has provided a suitable
Validation statement as part of the safety
case assessment process.
Consequently, NOPSEMA require that
verification be documented as a separate
and distinct process from Validation and
generally should be addressed within
the safety case for the facility rather
than documented in combination
with Validation.
Regulations on safety case contents
requirements, such as Regulations
2.12, 2.14(2), 2.18 and 2.22(3), detail
verification requirements that must be
addressed in the safety case for a facility.
Scope of Scope of
Validation Validation
Submitted to agreed by
NOPSEMA NOPSEMA
by operator
NOPSEMA
Review and
comment
period
Validator performs Validation
Verification
NOPSEMA’s Legislation and Regulations web link: http://www.nopsema.gov.au/legislation-and-regulations/
NOPSEMA’s Validation web page: http:// www.nopsema.gov.au/safety/safety-case/validation/
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NOPSEMA require that Validation be
documented as a separate assurance
process, provided for by the regulations
and tied to safety case decision making.
What is Validation?
Validation is the process required in
order for an operator to obtain Safety
Case acceptance. The operator will
produce a Scope of Validation (SoV) to
be agreed by NOPSEMA. A Validator
will perform a Validation in accordance
with this scope and issue a Validation
Statement which allows NOPSEMA to be
assured that the design, construction and
installation of safety critical systems will
incorporate measures that protect the
health and safety of persons to the extent
required by the scope of Validation,
provided the agreed codes and standards
are implemented as specified in the
documentation reviewed by the Validator.
Validation of design, construction and
installation can be defined as follows.
Safety Case Safety Case
Submitted to acceptance by
NOPSEMA NOPSEMA
NOPSEMA
Review and
comment
period 90
Validation
Statement issued
to operator by
Validator for
submission to
NOPSEMA to
Validation of:
– design is the review of design
documentation against nominated
codes and standards in order to form
a view about the appropriateness of
the standards for the safety critical
elements and to confirm that they
are consistent with the Formal Safety
Assessment (Safety Case).
– construction and installation are
reviews of documentation to ensure
that the intent of the design is specified
to be carried forward into actual
facility build. Typically this would
include construction and installation
specifications such as piping or
structural fabrication specifications,
procedures such as anchor pile
installation procedures, and inspection
and test plans. Again, the codes and
standards must be appropriate
and consistent with the Formal
Safety Assessment.
As such, it is possible for Validation
to be completed before construction
is complete and prior to installation
as it covers forward-looking
project documentation.
The scheduling and relationship
between the Scope of Validation, the
Validation and Safety Case acceptance
is illustrated.
What is Verification?
Verification is not required in relation to
the acceptance of a Safety Case but is a
requirement within the Safety Case. The
Safety Case will contain a commitment
from the Operator that a suitable
verification process has been performed.
Verification is the determination that
“the safety critical elements have actually
been designed, constructed, installed,
tested and commissioned in accordance
with the nominated codes and
standards”. It is the ‘physical’ survey of
the onshore procurement, construction,
testing and pre-commissioning and the
offshore installation, testing and final
commissioning.