API TR 18TR1 pdf download

API TR 18TR1 pdf download Guidance on Changes to API Q1, Ninth Edition
5.3 Risk Assessment and Management
Intent of Section
The intent of this section is to establish requirements for identification and mitigation of risks associated with product quality and delivery.
Changes from Previous Edition
— This is a new requirement.
5.4 Design and Development
5.4.1 Design and Development Planning
Intent of Section
The intent of this section is to establish the minimum planning requirements for the design and development process.
Changes from Previous Edition
— Added the requirement to identify final design review requirements.
— Added the requirement to identify controls when design and development activities are performed at different locations within the same organization.
5.4.2 Design and Development Inputs
Intent of Section
The intent of this section is to establish required design and development inputs.
Changes from Previous Edition
— Use of the word “technical,” which was implied in Q1, 8th, is now made explicit as a design and development input.
— 5.4.2 b) API product specifications have been identified as a potential external source for design inputs.
— 5.4.2 c) the environmental and operational conditions are now specifically listed to form part of the inputs to the design and development process.
— 5.4.2 e) historical performance is now identified as an input.
— 5.4.2 g) the results from risk assessments are design inputs.
5.4.3 Design and Development Outputs
Intent of Section
The intent of this section is to establish requirements for design and development outputs.
Changes from Previous Edition
— Replaced product acceptance criteria by design acceptance criteria (DAC).
— Added the requirement 5.4.3 d) identification or reference to critical product/components.
.4.4 Design and Development Review
Intent of Section
The intent of this section is to establish the requirements for design and development reviews.
Changes from Previous Edition
— In 5.4.4 a), “suitability, adequacy and effectiveness” replaced “ability” of design and development results
to meet specified requirements.
5.4.5 Design and Development Verification and Final Review
Intent of Section
The intent of this section is to establish requirements for design and development verification and final review.
Changes from Previous Edition
— There are no changes from the previous edition.
5.4.6 Design and Development Validation and Approval
Intent of Section
The intent of this section is to establish the requirements for design and development validation and approval.
Changes from Previous Edition
— Specified that design approval is after design validation.
— Added the requirement for competent individuals to approve the final design.
5.4.7 Design and Development Changes
Intent of Section
The intent of this section is to establish requirements for the identification, review, performance, and approval of all changes to existing designs prior to implementation of the change.
Changes from Previous Edition
— There are no changes from the previous edition.
5.5 Contingency Planning
Intent of Section
The intent of this section is to ensure that contingency planning based on previously identified risks is conducted and communicated. The section requires a documented procedure for contingency planning with minimum requirements for planning output.