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P-830-A
Design and Development

1.0 Purpose/Scope

1.1 This procedure describes the process for controlling the design and
development of product or services to ensure the subsequent provision of
products and services at Your Company.

1.2 The procedure applies to the design and development projects that are initiated
and planned for new products or services.

2.0 Responsibilities and Authorities

2.1 The Research & Development / Technical manager has the prime responsibility
and approval authority for this procedure.

2.2 In support of the Research & Development / Technical manager, the Project
manager / design engineer are responsible for initiating the design plan, getting
appropriate approvals and holding design reviews.

2.3 Additional responsibilities for project manager / design engineer / design team /
sales and marketing personnel are detailed in relevant paragraphs of section 5.0.

3.0 References and Definitions

3.1 Reference

3.1.1 This document relates to clause 8.3 of the ISO 9001:2015 standard
covering, Design and development of products and services.

3.2 Definitions

3.2.1 Design Verification: Determination that the product meets requirements.

3.2.2 Design Validation: Determination of the product’s ability to meet user

needs.

3.2.3 Design Changes: Changes made to the inputs or plan during design and
development activities.

4.0 Resources

4.1 None

5.0 Instructions

5.1 In support of the planning procedures P-810 for Operational planning and
control, and P-910 for Monitoring, measurement, analysis and evaluation, design
and development projects are initiated and planned for new products or services,
or processes.
5.1.1 The need for a new product, service or process is based on customer
requests, market conditions, new product, service or process ideas, new
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equipment or other situation when the detailed requirements are not
already established or not defined by the customer or by other interested
parties,

5.1.2 Design projects detail the requirements for products and services so that
they are adequate for subsequent production or service provision.

5.2 The R&D manager designates a project manager / project engineer for the
project, assigns a project number, and logs the project in the log.

5.2.1 The project manager starts a Project plan in order to determine the
stages and controls for design and development.

5.2.2 The Design plan, form F-830-001 considers the:

 Nature, duration and complexity/simplicity of

the design and development activities,

 Responsibilities and authorities of the

design team involved in the design and development process,

 Internal and external resources needed for

design and development,

 Need to control interfaces between

individuals and parties involved in the design and development
process,

 Requirements that specify particular

process stages, including applicable design inputs and design and
development reviews,

 Required design and development

verification and validation,

 Need for involvement of customer and user

groups in the design and development process,

 Level of control expected of the design and

development process by customers and other relevant interested
parties,

 Necessary documented information and

approvals to confirm that design and development requirements have
been met.

5.2.3 The team assigns a timeline to the project, determines appropriate design
reviews, validation and verification activities and documents them on the
design plan. You may want to categorize the project on a scale of 1 to 10
where 10 indicates a complex project and 1 a simple project.

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5.3 The design team collects design inputs and documents the inputs on the design
plan or on an attachment to the design plan.

5.3.1 Inputs include:

 Functional and performance requirements essential to the

products and services,

 Applicable statutory and regulatory requirements,

 Standards or codes of practice;

 Internal and external resource needs for the design and

development of products and services,

 Potential consequences of failure due to the nature of the

products and services,

 Information from previous designs and developments,

 Estimated costs,

 Safety requirements,

5.3.2 The design team reviews the inputs to make sure they are complete and
adequate for design and development purposes. Incomplete, ambiguous
or conflicting inputs are resolved by the team.

5.4 Design and development controls.

5.4.1 The design and development process is controlled to ensure that the:

 Results to be achieved are clearly defined,

 Design and development reviews are carried out as

planned,

 Verification is conducted to ensure that the design and

development outputs meet the design and development input
requirements;

 Validation is conducted to ensure that the resulting

products and services are capable of meeting the requirements for the
application or intended use.

5.5 Design Reviews are conducted as scheduled in the project plan, and as needed.
5.5.1 The design review record form F-830-002 is used to document results of
design reviews.
 You may want to require a design review at this point in the
project. Have the R&D manager or similar function review the project

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and approve it to move into the development stage.
 Others identified as technical interfaces may also have approval
responsibilities at this point.
 Have these functions sign off on the project plan as evidence of
their approval.
5.6 Design outputs are documented and filed in the design project file. Design
outputs are documented in a manner that enables them to be verified against the
design inputs.

5.6.1 The design team ensures that design and development outputs:

 Meet the input requirements,

 Are adequate for the subsequent processes of products

and services,

 Reference monitoring and measuring requirements, and

acceptance criteria,

 Ensure products to be produced, or services to be

provided, are fit for intended purpose and are safe and proper for use.
5.6.2 Outputs include:
 Product specifications,

 Documented processes including manufacturing specifications,

inspection and test methods and criteria,

 Product quality plans

 Engineering prints, drawings and diagrams

 Prototypes

 Product inspection and process monitoring information (to be

documented in the work instruction column of the Product Realization
Monitoring and Analysis Table F-910-001)

5.7 The design team verifies the design output against design input by the method
identified in the design plan.

5.7.1 Verification may include:

 Laboratory experiments

 Line Trials

 Prototype evaluation

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 Calculations

 Inspection and Test

5.7.2 Verification is documented and filed in the design project file.

5.8 The team holds a design review meeting to review verification results.
5.8.1 When verification is acceptable, the project will proceed to design
validation.
 If results are not acceptable, the team will determine if a design
change is required, if the project will go back to the development
stage, or if the project is to be terminated.
 Decisions are documented in the design review record F-830-002.
5.9 Design validation is performed according to the project plan.

5.9.1 Validation activities may include:

 Customer Trials

 Production Trials

 Beta Testing

 Production scale-up

5.9.2 Results of validation activities are documented and filed in the design
project file.

5.9.3 The team holds a design review meeting to review validation results and
determines if they are acceptable.

 If they are acceptable, the design output documents are approved

and released. If results are not acceptable, the team determines if a
design change is required, if the project will go back to the
development stage, or if the project is to be terminated.

 Decisions are documented in the design review record F-830-002.

5.10 Design Reviews are conducted as scheduled in the project plan, and as needed.
5.10.1 The project plan identifies required participants for design review. In
addition to the design team, this may include sales and marketing,
production, or even the customer. Different participants may be required
for different stages of the design.
5.10.2 Design review may be conducted as a meeting, a conference call or by
circulation of e-mail. The project manager is responsible to make sure all
required functions are involved in the design review and feedback is
obtained from all participants.

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5.10.3 Design review is documented in the form of meeting minutes, conference
call minutes or hard copy of e-mails sent and received. Documentation
includes decisions, authorizations and all action items assigned. The
project manager files design review documentation in the design project
file.
5.11 When changes to design inputs and outputs are needed, the team identifies,
reviews, and controls the changes. The project manager documents the
proposed change and the reason for the change on a design change, P-830-003.

5.11.1 When a design change is made the project goes through verification and
validation before being released to ensure there is no adverse impact on
the conformity to requirements.

5.11.2 A design change is verified and validated as necessary before approval.

5.11.3 The change is approved by the original approvers of the project plan.

5.12 Documented information resulting from the whole of the design and
development process, (that is, the planning, the inputs, the controls, the outputs,
the design changes, the reviews, the authorization of changes, and actions taken
to prevent adverse impacts) are controlled and retained with procedure P-750
Control of documented information.

5.12.1 When the design project is complete and all output documents are
approved and released, the project manager closes the project.

5.12.2 The project manager reviews the design project file to make sure the file
complete, containing all required records.

5.12.3 The project manager dates the project log and closes the project.

6.0 Forms and Documented Information

6.1 Forms

6.1.1 F-830-001 Design Plan

6.1.2 F-830-002 Design Review Record

6.1.3 P-830-003 Design Change

6.1.4 P-910-001 Product Realization Monitoring, Measuring and Analysis Table

6.2 Documented information / Related processes

6.2.1 P-600 Planning for the Quality management system

6.2.2 P-750 Control of documented information

6.2.3 P-810 Operational planning and control,

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6.2.4 P-910 Monitoring, measurement, analysis and evaluation

7.0 Opportunities and Risks

7.1 The planning procedure P-600 for Planning for the Quality management system
addresses opportunities and risks (risk-based thinking).
7.2 As applicable to your company, make use of your organizational knowledge,
lessons learned and experience with the activities associated with Design and
development to determine the opportunities and risk that need to be addressed
and that can:

 Give assurance that the procedure can achieve its intended result(s),

 Enhance desirable effects, and prevent or reduce undesired effects,

 Achieve improvement.

8.0 Revision History

Rev Date Section Paragraph Summary of change Authorized by

A Initial issue

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