Procedure: TBD

Title:New Product Introduction Process and ChecklistsRevision:A

Originator:Date:Jan 2001

Approval:TBDPage:1 of 32

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Table of Contents

I.New Product Introduction Process...... 2

II.Milestone Checklists Procedure and Criteria for Milestone Approval...... 4

III.Project Approval (PA) Criteria and Checklist...... 7

III.Design Release (DR) Criteria and Checklist...... 9

V.Engineering Release (ER) Criteria and Checklist...... 18

VI.Product Ship Release (PSR) Criteria and Checklist...... 26

APPENDIX A:Milestone Approval Form...... 31

IV.New Product Introduction Process

The New Product Introduction (NPI) process is a tool which is used to insure that any new Photonics product is released to the marketplace only after a very thorough series of product and quality checklists are completed and documented.

The process begins only after a new product idea has been developed and a reasonable customer interest justifies moving into the Project Approval (PA) stage. The product can be either a hardware or software product, or a combination thereof. PA requires that the product line manager has completed a preliminary Customer Requirements Document (CRD), which includes, at a minimum, the following:

  1. Product Overview
  2. Description of product
  3. Brief market overview
  4. Link to strategic plan
  1. Market Analysis
  2. Market size/growth
  3. Applications
  4. Competitive analysis
  5. Product positioning and differentiation
  6. Features/benefits summary
  1. Target Specifications
  2. Appearance and user interface
  3. Performance/environmental specifications
  4. Compliance to standards/regulatory agencies
  1. Product Development Plan
  2. Project schedule and preliminary project team
  3. Product cost/price/margin targets
  4. Service and documentation needs
  5. Quality plan
  6. ROI and financial analysis
  1. Product Launch Plan
  2. Marcom plan
  3. Beta site plan/product demonstrations

Upon successful completion of project approval, engineering is responsible for development of a complete Engineering Control Specification (ECS), which serves as the

detailed design document that defines the mechanical, electrical, and software specifications needed to properly build and test the end product.

Both the CRD and the ECS are living documents, under revision control, that change as the product evolves through the NPI life cycle.

At each milestone phase of the NPI cycle, signed checklists and supporting documentation, as well as the CRD and ECS versions approved at the milestone meeting, are to be kept on file for future use.

II.Milestone Checklists Procedure and Criteria for Milestone Approval

  1. Purpose

These criteria and questions are to be used as gatekeepers to ensure that the project team completes all the tasks and documentation necessary to produce quality product and services.

  1. Scope

Personnel:Managers of the following departments: Engineering, Manufacturing Engineering, Materials/Purchasing, Manufacturing, Marketing, Quality, and Customer Service.

Product Line:All

  1. Responsibilities

Project Leader:Schedules milestone meetings. Assures that the answers to the checklists are compiled in writing before the meeting and supporting documentation is provided. Chairs the meeting, assures that all relevant questions are reviewed, keeps the discussion focused, gathers signatures for milestone approval, distributes minutes of the meeting, announces milestone achievements to the external distribution list, and files the milestone report and supporting documentation with the quality department.

Department Mgrs:Managers of Engineering, Manufacturing Engineering, Materials/Purchasing, Manufacturing, Marketing, Quality, and Customer Service are responsible for participating in milestone meetings – or assuring that a representative participates. Each department representative prepares answers to the questions in advance of the meeting, attends the meeting, and approves/disapproves the milestone based on the information presented.

4.0References

TBD

5.0Procedure

BEFORE THE MILESTONE MEETING

5.1When the project team believes they are ready, the project leader distributes the checklist form to the team members and announces a meeting date.

5.2The project team collaborates on answering the checklist questions in writing (checklists can be electronically routed). The project leader generally takes the leadership role on this process for Design Release (DR) and Engineering Release (ER), but a team member from manufacturing may for Product Ship Release (PSR).

5.3The project leader schedules a room for the meeting, and notifies meeting participants.

AT THE MILESTONE MEETING

  1. The project leader or team member that took the leadership role in compiling answers to the checklist questions assures that copies of the answers are provided at the meeting.
  1. The checklist questions cover all aspects of a design. Some projects may not include hardware, tooling, etc. The project leader may choose to omit some sections of the checklist questions if they are not applicable.
  1. The purpose of the meeting is to identify any areas where the project falls short of the milestone requirements. If any problems are identified, they do not need to be solved in the milestone meeting, but should be documented and assigned as action items.
  1. If the group agrees that the project has achieved the milestone, a Milestone Approval form is signed.
  1. If, in reviewing the criteria and questions, the team and project leader determine that a few problems require more work, they may choose not to approve the milestone and schedule a later meeting for milestone approval once the action items are completed. If the unfinished items are determined not to affect the product quality and delivery, the meeting may be approved, conditional on meeting the milestones at a pre-determined date.
  1. Some projects do not include all departments. If a department is not involved, that will be noted on the Milestone Approval form and no signature is required.

AFTER THE MILESTONE MEETING

  1. The project leader gives a copy of the Milestone Approval form to the quality department, along with completed milestone checklist form and supporting documentation, for filing in the quality archives.

5.11The project leader informs applicable individuals via email whether the milestone was/was not achieved.

  1. Quality Records

The following are quality records relating to this procedure:

  1. Signed Milestone Approval Form (see Appendix A)
  1. Milestone report, including answers to the checklist questions, and minutes from the meeting, kept on file as a quality record.
  1. CRD and ECS versions used at each milestone meeting.

III.Project Approval (PA) Criteria and Checklist

A.PROJECT APPROVAL CRITERIA

Project Approval cannot occur until:

  1. The project proposal has been presented to and reviewed by the division corporate staff (VP, Engrg Mgr, Mfg Mgr). The review minutes will note any exceptions, conditions, or limits placed on the project.
  1. The preliminary ROI calculations in the CRD have been reviewed and approved by the division corporate staff.

Deliverables at Project Approval (PA):

  1. Preliminary CRD with approved ROI analysis.
  1. Preliminary product development schedule with target dates for Design Release (DR), Engineering Release (ER), and Product Ship Release (PSR).
B.PROJECT APPROVAL CHECKLIST

1.What is the purpose of this project? Who is requesting that this project occur?

2.What is the general functional description of the product, and the environment in which it will be used?

  1. What are the perceived market requirements for this project?
  1. How does this product fit with the company’s strategic plans? How does it fit into its related product family?
  1. What potential extensions are there for this product, or for the technology that will be developed?
  1. What is the expectation of competitor response to this product?
  1. What are the key areas, challenges, and assumptions for this technical innovation? What are the trade-offs?
  1. How has the feasibility of risk been evaluated?
  1. What are the key risk factors that may inhibit success of this product?
  1. Does the anticipated financial return meet with company objectives? What alternative strategies might improve returns?
  1. Is technical staff available to carry out this project? What will be the impact on other current and anticipated project developments?
  1. Are additional testing or development tools required in Engineering or Manufacturing to meet schedule or product performance verification? How much will they cost?
  1. Will existing sales and service staff be able to successfully introduce, sell, and service this product without adverse impact on other current products? If not, what needs to be done?
  1. Is the existing manufacturing organization and methodologies adaptable to this product? If not, what needs to be done?
  1. What is the required time to market or market window date?
  1. Characterize the top three risk areas for this project. What can be done to minimize them and what would it cost?

IV. Design Release (DR) Criteria and Checklist

C.A.DESIGN RELEASE CRITERIA

Design Release cannot occur until:

  1. Design verification testing is complete, a report on test results is available, and known bugs/problems are defined and documented.
  1. Marketing and Engineering agree that the product’s performance will meet necessary market requirements, as described in the CRD.
  1. Manufacturing and Quality agree that the proposed product will be buildable.
  1. All agree that the project plan and schedule to Engineering Release (ER) and Product Ship Release (PSR) are satisfactory and achievable.

The system DR milestone occurs when the following applicable criteria have been met:

  1. The CRD and ECS are approved. If applicable, a software user-interface prototype has been approved.
  1. The Engineering ECS is up to date and represents the prototype as demonstrated for DR, and Engineering’s expectation of the product performance will be achieved at ER.
  1. Software and hardware are integrated into a working prototype. The prototype demonstrates the important features and performance promised by the CRD.
  1. Design reviews have been held. This includes code and user-interface review for software, and design and function review for electronic and mechanical subsystems.
  1. The industrial design concept or mockup has been approved by division management.
  1. Initial specifications are available for purchase of validation phase parts, components, modules (including required drawings, schematics, etc.). Negotiations have been initiated for necessary license agreements.

NOTE: “System DR” means DR for both Software and Hardware – the entire system is working properly. Either software or hardware may reach DR status first, and a partial DR approved. In that case, the questions relevant to that area are asked. The second DR meeting then becomes the “system DR”. In order to have a partial DR, the product must be sufficiently functional for design verification. For example: for Hardware DR (HDR) to be approved, the software must be sufficiently functional to verify the performance of the hardware.

D.
E.
F.B.DESIGN RELEASE CHECKLIST

Product Description

  1. Briefly describe the product or item, its options, accessories, and any field service or upgrade kits.
  1. What are the standard and optional accessories? Which are new designs? Which are purchased items?
  1. Has the project schedule been updated?
  1. Who are the current members of the Project Team and the Engineering Team, and what are their responsibilities?
Product Performance vs. Specifications
  1. Does the DR prototype’s performance meet the ECS specifications? Has a summary of test results been distributed? Are there any unresolved conflicts between the design and the specifications? (Consider all areas: electrical, optical, mechanical, environmental, software, safety, regulatory, etc.)
  1. Have any typical user-application measurements and operations been performed using the prototype?
  1. Have firmware and software algorithms been reviewed for suitability and accuracy?
  1. Has a Design Validation Test Plan for ER been written and reviewed? Is there sufficient time in the schedule to complete evaluation of the product, options, and accessories by ER?
  1. Will all information, tools, and equipment necessary for testing be available when needed?
  1. Are field test sites planned? What are the test objectives? Are host system requirements clear, and is hardware arranged for? How and when will the results be available?
  1. What is the plan for environmental testing? (Temperature, shake/shock, humidity, altitude, etc.)

8.Will predicted Mean Time Between Failures (MTBF) be calculated? Will adequate testing be done by ER to demonstrate reliability of critical components, circuits, modules, micropositioning mechanisms, etc.?

9.What software reliability goals have been established? How will software reliability be evaluated or demonstrated?

10.How many validation phase prototypes will be built for use by Engineering? How many additional units will be built for Marketing? Will any of these be loaned or sold to customers? How will they be updated, serviced, or controlled? Will they be replaced by production units?

Specifications and Design Documentation

1.Has the Engineering Control Specification (ECS) been started? Have preliminary specifications been reviewed and approved by Marketing, Engineering, and Manufacturing?

2.Is the Bill of Material (BOM) at least 80% complete? Are BOMs drafted for upgrade and service kits?

  1. Has Materials/Purchasing reviewed the preliminary BOM?
  1. Has Materials/Purchasing received preliminary material specifications, drawings, etc.?
  1. Is the CRD approved? Has a user-interface prototype been reviewed and approved?
  1. Is the ECS complete and approved? Is the hardware and software design documentation updated?
  1. Are requirements established and documented for any programmed electronic devices (PGAs, PLDs, PALs, etc.)?
  1. Is the design validation test suite complete and documented?
  1. Have Manufacturing Engineering and/or Quality Assurance reviewed the design validation test methods for possible application in Manufacturing and Final Quality Assurance (FQA)?

Mechanical Design Issues

1.Have the industrial design and styling of the product been reviewed and approved by division management?

  1. Have design reviews been held on the mechanical subsystems?
  1. Has Manufacturing reviewed the buildability of the proposed design? Have problems been identified, resolved? Have tooling releases been issued?
  1. Does the product satisfy accepted standards for human factors design?
  1. Do the hardware and software terminology and graphics differ from past practice or industry convention? Have they been reviewed and approved by Marketing and Engineering?
  1. When will the product be evaluated for packageability and shippability? Will it require a new transit pack? Who is responsible for transit pack design and testing? Including hard and soft cases?
  1. What transit pack will be used for early demo units?

Electronic Design Issues

  1. Have design reviews been held on the electronic subsystems?

Compatibility

  1. What other product under development affects the design of this product?
  1. What compatibility with existing items/products is required? Provide a matrix, including compatibility with other product lines, and with options within this product line. Are all of these combinations covered in the Design Validation Test Plan?
  1. Is hardware/software compatibility required with the customers’ systems or with other vendors’ products?
  1. Are there any known unresolved compatibility requirements, conflicts, or questions?

Software Development

  1. Has Sales management been notified of the proposed software feature set and bug fixes?
  1. Are licenses for other vendors’ software required, and is Finance informed? Does the vendor software include encryption algorithms that would affect export licensing?
  1. Are we providing software to be installed and run on the user’s host computer? If so, will it include diagnostic, and/or customer-acceptance test software to be used for installation?
  1. What are the physical parts of the software product as shipped (manuals, media, labels, license agreement, packaging, etc.)?
  1. Was the DR build done on the network, with revision control?
  1. Have design (functionality and user interface) and code reviews been done?
  1. Are known bugs documented?
  1. Is a draft of the Release Notes available?

Safety and Regulatory Requirements

  1. What is the status of laser-safety certification (CDRH, CE)? Is the laser safety test procedure and form ready for testing the validation phase prototypes?
  1. If the product contains a laser, what class is it? Is the project team following the Product Development Laser Safety work instruction?
  1. Have all required laser-safety and other safety warnings and labels been identified? Are the Technical Writer and the Mechanical Engineer on the project aware of them?
  1. What is the status of other safety and regulatory compliance (MSDS, UL, VDE, FCC, CE Mark, etc.)? Will an evaluation model be needed for third-party testing? When?
  1. Has preliminary safety-related product evaluation been documented? Are there any unresolved problems?
  1. Have new part drawings and specifications been reviewed for safety-controlled part identification requirements?
  1. Have any changes been made to components, product nomenclature or labeling that require revision of safety certification documentation?

Patents, Trademarks, and Copyrights

  1. Has this product been reviewed for proprietary features and inventions? Which do we intend to protect?
  1. Have invention disclosures been submitted? Are others planned?
  1. Is the proposed product nomenclature appropriate for registration as a trademark?
  1. Have plans been made to include licensing, copyright, patent, or other legal notices in the firmware and/or software code or on the product media or hardware?

Manufacturing

  1. Has Manufacturing gone through their own NPI checklist?
  1. Will Manufacturing be involved in building the validation prototypes?
  1. Has Manufacturing reviewed the design for buildability and testability?
  1. Will new assembly fixtures, processes, or controls be required for manufacturing?
  1. Will new test and calibration equipment or procedures be required for manufacturing? Who will design and build any new equipment? Will any be setup as field service equipment, or as salable items?
  1. Has Manufacturing reviewed the Design Validation Test Plan? Will any of the engineering design validation tests be adapted for use in manufacturing or FQA?
  1. Are manufacturing staffing and facilities on schedule for introduction?

Material and NPI Planning