DESIGN AND

DEVELOPMENT
API Q1 9TH EDITION
CLAUSE 5.4
WHO, WHAT, WHEN,
API Q1 9th
5.0
WHERE, WHY & HOW
PRODUCT REALIZATION
Edition

5.3 5.7
5.11
Risk Production
Management
Assessment and
of Change
and Servicing
(MOC)
Management Provision

5.8
5.10
5.4 Control of Testing,
5.2 5.6 Control of
Design and Measuring, and
Planning Purchasing Nonconform
Development Monitoring
ing Product
Equipment

5.1 5.5 5.9

Contract Contingency Product
Review Planning Release
 API Q1 9th
Edition
5.4
Design and Development

5.4.5
5.4.6
5.4.1 5.4.2 5.4.3 5.4.4 Design and 5.4.7
Design and
Design and Design and Design and Design and Development Design and
Development
Development Development Development Development Verification Development
Validation
Planning Inputs Outputs Review and Final Changes
and Approval
Review

WHO, WHAT, WHEN, WHERE, WHY & HOW

 API Q1 9th
5.4 Design and Development Edition

1. 5.4.1 Design and Development Planning

2. 5.6.2 Design and Development Inputs

3. 5.6.3 Design and Development Outputs

4. 5.6.4 Design and Development Review

5. 5.6.5 Design and Development Verification and Final Review

6. 5.6.6 Design and Development Validation and Approval

7. 5.6.7 Design and Development Changes

5.4.1 Design and Development Planning API Q1 9th
Edition
The organization shall maintain The procedure shall identify:

a documented procedure to a) the plan(s), including plan updates, used for design development;
plan and control the design and b) the design and development stages;
c) the resources, responsibilities, authorities, and their interfaces to
development of the product. ensure effective communication;
d) the review, verification, and validation activities necessary to
complete each design and development stage; and.
e) the requirements for a final review of the design (see 5.4.5).

When design and development activities are performed at different

locations within the same organization, the procedure shall identify
the controls required to ensure that the designs meet the
requirements of 5.4.
When design and development are outsourced, the organization shall
ensure the supplier meets the requirements of 5.6.1.6 .
NOTE Design and development review, verification, and validation each have distinct purposes but can be conducted and recorded separately or
in any combination, as suitable for the product and the organization.
5.4.2 Design and Development Inputs API Q1 9th
Edition
Inputs shall be identified and Inputs shall include functional and technical requirements, and
the following, as applicable:
reviewed for adequacy,
completeness, and lack of a) customer-specified requirements (see 5.1);
conflict. b) requirements provided from external sources, including
API product specifications;
c) environmental and operational conditions;
d) methodology, assumptions, and formulae documentation;
e) historical performance and other information derived
from previous similar designs;
f) legal requirements; and
g) results from risk assessments (see 5.3).

Records of design inputs shall be maintained (see 4.5).

 API Q1 9th
5.4.3 Design and Development Outputs Edition
Outputs shall be documented to Outputs shall:
allow verification against the
a) meet the input requirements for design and development;
design and development input
b) provide appropriate information for purchasing,
requirements. production, and servicing;
c) identify or reference design acceptance criteria (DAC);
d) include identification of, or reference to, products and/or
components deemed critical to the design;
e) include results of applicable calculations; and
f) specify the characteristics of the product that are essential
for its safe and proper use.
Records of design outputs shall be maintained (see 4.5).

NOTE Identification of criticality of products and/or components can be maintained outside of the design and
development process.
 API Q1 9th
5.4.4 Design and Development Review Edition
At suitable stages, review(s)
a) to evaluate the suitability, adequacy, and effectiveness of
shall be performed:
the results of design and development stages to meet
specified requirements; and

b) to identify any problems and propose necessary actions.

Participants in such review(s) shall include representatives of functions

concerned with the design and development stage(s) being reviewed.
Records of the results of the review(s) and any necessary actions shall
be maintained (see 4.5).
 API Q1 9th
Edition
5.4.5 Design and Development Verification
and Final Review

To ensure that the design and development outputs have met the design and
development input requirements, design and development verification and a final
review shall be conducted and documented in accordance with planned arrangements
(see 5.4.1).

Records of design and development verification and the final review shall be
maintained (see 4.5).
 API Q1 9th
5.4.6 Design and Development Validation Edition
and Approval

Design and development validation shall be performed in accordance with

planned arrangements (see 5.4.1) to ensure that the resulting product is
capable of meeting the specified requirements. Validation shall be
completed prior to the delivery of the product, when possible.

The completed design shall be approved after validation. Competent

(see 4.3.2.2) individual(s) other than the person or persons who
developed the design shall approve the final design.

Records of the design and development validation, approval, and any

necessary actions shall be maintained (see 4.5).
 API Q1 9th
5.4.7 Design and Development Changes
Edition
Design and development The review of design and development changes shall
changes shall be identified. include evaluation of the effect of the changes on product
The changes shall be and/or their constituent parts already delivered.
reviewed, verified, and
Design and development changes, including changes to
validated, as appropriate, design documents, shall require the same controls as the
and approved before original design and development.
implementation.
Records of design and development changes, reviews of
those changes, and any necessary actions shall be
maintained (see 4.5).
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