API Spec Q1: 9th Edition

Section 5: Product Realization

Agenda:

5.1 Contract Review

5.2 Planning
5.3 Risk Assessment and Management
5.4 Design and Development
5.5 Contingency Planning
5.6 Purchasing
5.7 Production and Servicing
5.8 Control of Testing, Measuring, and Monitoring Equipment
5.9 Product Release
5.10 Control of Nonconforming Product
5.11 Management of Change (MOC)
 5.1 Contract Review
5.1.1 General
Maintain a documented procedure for the review of requirements related to
the provision of products and required servicing.
5.1.2 Determination of Requirements
The organization shall determine;
• Customer requirements (Documented)
• Legal & Applicable requirements
• Customer requirements (Undocumented but requirement for the product)
Where the customer provides no documented statement of the requirements,
the customer requirements shall be confirmed and records maintained.

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 5.1 Contract Review

5.1.3 Review of Requirements

Review occurs before commitment to the customer
Review takes place in 3 parts:
5.1.3(a) 5.1.3(b) 5.1.3(c)
Requirements are Differing requirements Organization is capable
Identified are resolved of meeting requirements

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 Assess Capabilities
Review whether your organization can meet requirements with your:

1. People and competencies

2. Supply chain / inventory
3. Manufacturing capacity
4. Infrastructure and raw materials
5. Import and export permitting considerations
6. Delivery /transportation

Where contract requirements are changed, ensure that relevant documents are
amended and that relevant personnel are made aware of the changed requirements.
Records of the results of the review, including resulting actions, shall be
maintained.

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 5.2 Planning
Identify and plan the processes and documents needed for product realization in
consistent with the requirements of the QMS processes.
Address the following in planning:
a) required resources and work environment management;
b) product and customer-specified requirements;
c) legal and other applicable requirements;
d) contingencies based on risk assessment;
e) design and development requirements;
f) required verification, validation, monitoring, measurement, inspection, and test
activities specific to the product and the criteria for product acceptance;
g) management of change (MOC); and
h) records needed to provide evidence that the processes meet requirements.
Output of planning shall be documented and updated as changes occur.

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 5. 3 Risk Assessment and Management

Work Environment
• lighting
• humidity
• temperature
Preventive Maintenance for
equipment needed to
• produce,
• move, and
• store product/raw materials

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 5.3 Risk Assessment and Management
Maintain a documented procedure to identify and control risk associated with
impact on delivery and quality of product.
–what could go wrong
–what has gone wrong in the past

The procedure shall identify the techniques, tools and their application for risk
identification, assessment, and mitigation.
Risk assessment associated with product delivery shall include:
a) facility/equipment availability and maintenance; and
b) supplier performance and material availability/supply.
Risk assessment associated with product quality shall include, as applicable:
a) delivery of nonconforming product;
b) availability of competent personnel.
Maintain records of risk assessment and management including actions taken.
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 5.4 Design and Development

5.4.1 Design and Development Planning

Maintain a documented procedure to plan and control the design and dev. of the product.
a) Design and dev. plan and control procedures must include the D&D plans and updates.
b) Identify the D&D stages in the plan and control procedure.
c) Identify the resources, responsibilities, authorities, and their interfaces to ensure effective
communication;
d) Identify the review, verification, and validation activities necessary to complete each D&D
stage; &
e) Identify the requirements for a final review of the design.
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 5.4.1 Design and Development Planning (Continuation)
• 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.
5.4.2 Design and Development Inputs
Inputs shall be identified and reviewed for adequacy, completeness, and lack of conflict.
Inputs shall include functional and technical requirements, and the following:

Records of design inputs shall be maintained.

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 5.4.3 Design and Development Outputs
Outputs shall be documented to allow verification against the design and
development input requirements. Outputs shall:
a) meet the input requirements for design and development;
b) provide appropriate information for purchasing, production, and servicing;
c) identify or reference design acceptance criteria (DAC);
d) include identification of, or reference to, products, components, and or activities
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.

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 5.4.4 Design and Development Review
At suitable stages, review(s) shall be performed:
a) to evaluate the suitability, adequacy, and effectiveness of 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 to be maintained.
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.
Records of design and development verification and the final review to be maintained.

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 5.4.6 Design and Development Validation and Approval
Design and development validation shall be performed in accordance with planned
arrangements to ensure that the resulting product can meet the specified requirements.
Complete validation prior to the delivery of the product, when possible. E. g.
– Hydrostatic Testing
– Drift Testing.
Factory Acceptance Test (FAT) can be both pre and post delivery
Post Delivery (typically on customer’s site)
– Systems Integration Test (SIT)
– Commissioning
The completed design shall be approved after validation by Competent individual(s)
other than the persons who developed the design.
Records of the design and development validation, approval, and any necessary actions
shall be maintained (see 4.5).

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 5.4.7 Design and Development Changes
Design and development changes shall be identified.
The changes shall be reviewed, verified, and validated, as appropriate, and approved
before implementation.
All changes:
• Go through the defined change process
• Evaluate impact on delivered product. Examples include:
 Drawings
 Dimensions
 Calculations
 Pressure ratings
 Size ratings
Design and development changes, including changes to design documents, shall
require the same controls as the original design and development.
Records of design and development changes, reviews of those changes, and any
necessary actions shall be maintained.
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 5.5 Contingency Planning
The organization shall maintain a documented procedure for contingency planning needed
to address risk associated with impact on delivery and quality of product.
Contingency planning shall be based on assessed risks (see 5.3), and output shall be
documented and communicated to the relevant personnel and updated as required
The contingency plan shall include, at a minimum:
a) actions required in response to significant risk scenarios to mitigate effects of disruptive
incidents;
b) identification and assignment of responsibilities and authorities and
c) internal and external communication controls.

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Thank you
Joseph M
[email protected]