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Lord Consulting - Quality Assurance Manual

Section 04 - Design Control

SCOPE

This section describes the procedures that Lord Consulting has in place to control and verify the design of product to ensure that the specified requirements are met.

The initial approach toward design and development planning is undertaken according to the project conforming to one of the following three categories:

  1. An entirely new design
  2. An improvement to an existing design
  3. An existing design obtained from another supplier for manufacture under license.An existing design obtained from another supplier for manufacture under license.

CONTENTS

04.01 An Entirely New Design
04.02 An Improvement to an existing Design
04.03 An Existing Design Obtained from Another Supplier under Licence
04.04 Design Process


04.01 An Entirely New Design

SCOPE

This procedure describes the approach to entirely new designs.

04.01.01

The requirement for an entirely new design is formally identified by the Managing Director following input from sources comprising:

  • CAR Forms indicating a gross market inadequacy with a present design;
  • Formal market research exercises suggesting the market need for such a new design;
  • Customer or market requests for such a product;
  • The noted successful introduction of such a product by a competitor;
  • A formal purchase order from a customer for such a design.

04.01.02

Upon identifying the requirement for such a product, the Managing Director convenes a Product Evaluation Meeting attended by The General Manager, and, as appropriate, the Quality Manager, and the Commercial Manager. At this meeting the concept of the proposed new product is presented by the Managing Director and discussed fully as to it's compatibility with the Company's existing products and market, it's market size and broad marketing strategy, it's general commercial ramifications and it's known design and production requirements. Minutes of all Production Evaluation Meetings are taken and held by the General Manager in a Design Folder created for each new design.

04.01.03

Further Product Evaluation Meetings may be held on the same basis for the purpose of a more in depth evaluation of the new product in principle prior to a minuted decision being finally recorded as to whether or not to proceed further.

04.01.04

In the event that a decision is made to proceed further, a suitably qualified Design Leader is appointed by the Managing Director, the position being to take overall charge of the design project, the position reports to the Managing Director. Unless extraordinary circumstances dictate otherwise, the Design Leader is appointed from within the Company and the appointment is for the duration of the design process per se.

04.01.05

The Design Leader is given a full written brief of the proposed design, this brief being prepared by the Product Evaluation Meeting as a faithful documentation and interpretation of the design input source information and design expectation criteria, determined from the Product Evaluation Meeting itself, as well as detailing design output criteria, as outlined in Section 04.04. This brief is approved by the signatures of both the Managing Director and the General Manager. As the product evolves, the design brief may be revised, copies of all briefs issued are retained by the General Manager in the Design Folder. If the design is purely a customer commissioned one, the process of Contract Review (Section 3 of this Manual) is followed in preparing the written design brief.

04.01.06

Regular Design Meetings, convened by the Managing Director, are held at appropriate intervals sufficient both to keep the above named staff fully informed of the design process and to permit the design leader to gain the constructive input of those staff members. The General Manager minutes all Design Meetings and retains those records. Other staff or appropriately qualified outside expertise is co-opted or retained as deemed necessary, by the Design Meetings via the Processes of Section 6 of this Manual.

04.01.07

All concept and plans of the new design are retained in a secure place by the Design Leader and ultimately passed to the General Manager for filing in the Design Folder. Final drawings are commissioned via an approved supplier, these being prepared using the medium of Computer Aided Design. Master design software disks are retained by the General Manager and issued only with his express permission.


04.02 An Improvement to an existing Design

SCOPE

This procedure describes the approach to improvements/modifications of existing designs.

04.02.01

The requirement for an improvement or a modification to an existing design is formally identified by the Managing Director following input from sources comprising:

  • CAR Forms indicating the need for a design review;
  • Customer or market requests for such a review;
  • A written notification from the designated Project Production Manager indicating the need for such a review:
  • The inability to continue sourcing any component or sub assembly originally specified in the design.

04.02.02

Should the requirement call for a minor review, the design review is conducted by way of a simple Design Review Meeting convened by the Managing Director. All Design Review Meetings are minuted by the General Manager and the proceedings held by him in a Design Review Folder, held with the original Design Folder for that product. Having conducted the Design Review Meeting, the General Manager issues promptly a written instruction to the Design Leader to arrange for the necessary revisions to drawings and Process Procedures: at this juncture, the Quality Manager is also informed of these alterations by the General Manager.

04.02.03

In the event that the Managing Director identifies the requirement for a major design review, a Major Design Review Meeting is convened following the identical procedure for that of Section 04.01.


04.03 An Existing Design Obtained from Another Supplier under Licence

SCOPE

This procedure describes the approach to an existing design obtained from another supplier under license.

04.03.01

If a new product design is offered to Lord Consulting for manufacture under license the Managing Director convenes a Product Evaluation Meeting as in Section 04.01.

04.03.02

Should a decision be made to proceed further, a Design Leader is similarly nominated and a full brief of desired testing, production and modification requirements is issued via the Managing Director, approved by the Managing Director.

04.03.03

The Design Evaluation process follows that of Section 04.01 with the major difference being that the design effort itself is confined to minor revisions necessary to comply with market and regulatory requirements and that Type Approval/Testing organisations external to the Company may be commissioned to solicit critical judgement or issue safety approval, as the case may be.


04.04 Design Process

SCOPE

This procedure describes the design process.

04.04.01 Design Input

The Design Leader is responsible for the identification and documentation of any relevant Statutory, Regulatory or Contract Review requirements that may have relevance to the design. The Design Meeting carries the overall burden of verifying the validity and adequacy of the identified requirements.

04.04.02 Design Output

Final designs are presented to a duly convened design meeting whereupon the meeting conducts a final critical assessment of the design documentation and proposed process procedures against the terms of the current version of the written design brief. This assessment verifies the following points of compliance:

  1. The design output conforms to the written brief;
  2. The design output complies with the brief's documented acceptance criteria;
  3. The design output contains clearly identified statements as to the safe and proper functioning of the product (e.g. full and clearly understood operating instructions, also documenting any regular maintenance needed, stated procedures for any special storage or handling requirements the product may have, and any special other requirements e.g. safe disposal after use).

    Should the design conform fully, the meeting formally approves the design and the final version Design Documentation is approved by the dated signature in red ink of the Managing Director, the Design Leader and the Managing Director.

    The Design Output Documents are then released for production.

04.04.03 Design Review

At the regular Design Meetings, formal documented reviews of the design output are conducted against the criteria of the written design brief, these reviews being recorded in the meeting minutes.

04.04.04 Design Verification

During the process of the regular Design Meetings, verification is performed and minuted to document that the design stage output is meeting the specified requirements. Any design verification measures used are also recorded and include any or all of the following:

  1. Comparison of the design with a similar proven design;
  2. The presentation of test results;
  3. The conducting of demonstrations;
  4. Reviewing design stage documents on a regular basis prior to final release.

04.04.05 Design Validation

The end product of the design process is validated to ensure that it conforms to the requirements of Design Input (Section 04.04.01) and the Contract Review process, as applicable. Validation follows successful design verification under Section 04.04.04 and is performed under specific defined operating conditions as may be required under the terms of the design input. Validation is performed on the final design product wherever possible, unless documented circumstances dictate it is carried out prior to completion.

04.04.06 Design Changes

All design changes are identified, documented, reviewed and approved by authorised personnel prior to implementation (Section 04.01).

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