Table of Contents · Web viewNew Product Introduction Process..... 2

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Title: New Product Introduction Process and Checklists Revision: A

Originator: Date: Jan 2001

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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

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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:

a. Product Overviewi. Description of productii. Brief market overviewiii. Link to strategic plan

b. Market Analysisi. Market size/growthii. Applicationsiii. Competitive analysisiv. Product positioning and differentiationv. Features/benefits summary

c. Target Specificationsi. Appearance and user interfaceii. Performance/environmental specificationsiii. Compliance to standards/regulatory agencies

d. Product Development Plani. Project schedule and preliminary project teamii. Product cost/price/margin targetsiii. Service and documentation needsiv. Quality planv. ROI and financial analysis

2. Product Launch Plani. Marcom planii. 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

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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.

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II. Milestone Checklists Procedure and Criteria for Milestone Approval

b. PurposeThese 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.

3. ScopePersonnel: Managers of the following departments: Engineering,

Manufacturing Engineering, Materials/Purchasing, Manufacturing, Marketing, Quality, and Customer Service.

Product Line: All

4. ResponsibilitiesProject 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.

4.0 ReferencesTBD

5.0 Procedure

BEFORE THE MILESTONE MEETING

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_____________________________________________________________________________5.1 When the project team believes they are ready, the project leader

distributes the checklist form to the team members and announces a meeting date.

5.2 The 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).

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

AT THE MILESTONE MEETINGa. 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.

b. 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.

c. 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.

d. If the group agrees that the project has achieved the milestone, a Milestone Approval form is signed.

e. 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.

f. 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.

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_____________________________________________________________________________AFTER THE MILESTONE MEETINGg. 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.

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

5. Quality RecordsThe following are quality records relating to this procedure:

6. Signed Milestone Approval Form (see Appendix A)7. Milestone report, including answers to the checklist questions, and

minutes from the meeting, kept on file as a quality record.8. 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.

2. The preliminary ROI calculations in the CRD have been reviewed and approved by the division corporate staff.

Deliverables at Project Approval (PA):3. Preliminary CRD with approved ROI analysis.4. 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?

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1. What are the perceived market requirements for this project?

2. How does this product fit with the company’s strategic plans? How does it fit into its related product family?

3. What potential extensions are there for this product, or for the technology that will be developed?

4. What is the expectation of competitor response to this product?

5. What are the key areas, challenges, and assumptions for this technical innovation? What are the trade-offs?

6. How has the feasibility of risk been evaluated?

7. What are the key risk factors that may inhibit success of this product?

8. Does the anticipated financial return meet with company objectives? What alternative strategies might improve returns?

9. Is technical staff available to carry out this project? What will be the impact on other current and anticipated project developments?

10. Are additional testing or development tools required in Engineering or Manufacturing to meet schedule or product performance verification? How much will they cost?

11. 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?

12. Is the existing manufacturing organization and methodologies adaptable to this product? If not, what needs to be done?

13. What is the required time to market or market window date?

14. Characterize the top three risk areas for this project. What can be done to minimize them and what would it cost?

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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.2. Marketing and Engineering agree that the product’s performance will meet

necessary market requirements, as described in the CRD.3. Manufacturing and Quality agree that the proposed product will be buildable.4. 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: 5. The CRD and ECS are approved. If applicable, a software user-interface

prototype has been approved.6. 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.

7. Software and hardware are integrated into a working prototype. The prototype demonstrates the important features and performance promised by the CRD.

8. Design reviews have been held. This includes code and user-interface review for software, and design and function review for electronic and mechanical subsystems.

9. The industrial design concept or mockup has been approved by division management.

10. 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.

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_____________________________________________________________________________D.E.F. B. DESIGN RELEASE CHECKLIST

Product Description1. Briefly describe the product or item, its options, accessories, and any field service

or upgrade kits.

2. What are the standard and optional accessories? Which are new designs? Which are purchased items?

3. Has the project schedule been updated?

4. Who are the current members of the Project Team and the Engineering Team, and what are their responsibilities?

Product Performance vs. Specifications5. 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.)

6. Have any typical user-application measurements and operations been performed using the prototype?

7. Have firmware and software algorithms been reviewed for suitability and accuracy?

8. 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?

9. Will all information, tools, and equipment necessary for testing be available when needed?

10. 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?

11. What is the plan for environmental testing? (Temperature, shake/shock, humidity, altitude, etc.)

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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 Documentation1. 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?

12. Has Materials/Purchasing reviewed the preliminary BOM?

13. Has Materials/Purchasing received preliminary material specifications, drawings, etc.?

14. Is the CRD approved? Has a user-interface prototype been reviewed and approved?

15. Is the ECS complete and approved? Is the hardware and software design documentation updated?

16. Are requirements established and documented for any programmed electronic devices (PGAs, PLDs, PALs, etc.)?

17. Is the design validation test suite complete and documented?

18. Have Manufacturing Engineering and/or Quality Assurance reviewed the design validation test methods for possible application in Manufacturing and Final Quality Assurance (FQA)?

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Mechanical Design Issues1. Have the industrial design and styling of the product been reviewed and approved

by division management?

19. Have design reviews been held on the mechanical subsystems?

20. Has Manufacturing reviewed the buildability of the proposed design? Have problems been identified, resolved? Have tooling releases been issued?

21. Does the product satisfy accepted standards for human factors design?

22. 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?

23. 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?

24. What transit pack will be used for early demo units?

Electronic Design Issues25. Have design reviews been held on the electronic subsystems?

Compatibility26. What other product under development affects the design of this product?

27. 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?

28. Is hardware/software compatibility required with the customers’ systems or with other vendors’ products?

29. Are there any known unresolved compatibility requirements, conflicts, or questions?

Software Development

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_____________________________________________________________________________30. Has Sales management been notified of the proposed software feature set and bug

fixes?

31. Are licenses for other vendors’ software required, and is Finance informed? Does the vendor software include encryption algorithms that would affect export licensing?

32. 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?

33. What are the physical parts of the software product as shipped (manuals, media, labels, license agreement, packaging, etc.)?

34. Was the DR build done on the network, with revision control?

35. Have design (functionality and user interface) and code reviews been done?

36. Are known bugs documented?

37. Is a draft of the Release Notes available?

Safety and Regulatory Requirements38. 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?

39. If the product contains a laser, what class is it? Is the project team following the Product Development Laser Safety work instruction?

40. 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?

41. 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?

42. Has preliminary safety-related product evaluation been documented? Are there any unresolved problems?

43. Have new part drawings and specifications been reviewed for safety-controlled part identification requirements?

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44. Have any changes been made to components, product nomenclature or labeling that require revision of safety certification documentation?

Patents, Trademarks, and Copyrights45. Has this product been reviewed for proprietary features and inventions? Which

do we intend to protect?

46. Have invention disclosures been submitted? Are others planned?

47. Is the proposed product nomenclature appropriate for registration as a trademark?

48. 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?

Manufacturing49. Has Manufacturing gone through their own NPI checklist?

50. Will Manufacturing be involved in building the validation prototypes?

51. Has Manufacturing reviewed the design for buildability and testability?

52. Will new assembly fixtures, processes, or controls be required for manufacturing?

53. 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?

54. Has Manufacturing reviewed the Design Validation Test Plan? Will any of the engineering design validation tests be adapted for use in manufacturing or FQA?

55. Are manufacturing staffing and facilities on schedule for introduction?

Material and NPI Planning56. Does the BOM meet Materials/Purchasing’s needs for planning? Is the forecast

available for loading? When?

57. Will this product be built to forecast or built to order?

58. Is farm-out production planned? Are arrangements on schedule?

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_____________________________________________________________________________59. Is material available to build the validation phase prototypes? Are options and

accessories available for testing?

60. Have specifications and drawings for special or precision electrical, mechanical, or optical devices been reviewed by potential vendors? When will parts be available?

61. Have all other new mechanical part designs been updated for DR? Will parts be available for the validation phase build?

62. Have part numbers and nomenclature been assigned to all new items? Are specifications or drawings available for procurement in the validation phase build?

63. Have purchased subassemblies been identified and specified (for example, power supplies, computer boards)? Will representative units be available for the validation phase build?

64. Are any parts at lead time for the pilot build or early production builds? Are any parts single-source, on allocation, or otherwise risky?

65. Has a planned quantity of demo units been approved? How many pilot-build units will be required for Quality and Customer Service loaner and training units, for 3rd party lab evaluations, and for Manufacturing fixtures?

Quality1. Has IQA begun identifying parts to be inspected? Will they require any new

fixtures, training, etc.?

66. Will IQA be inspecting any of the parts for the validation prototypes?

Marketing1. What is the current forecast of annual demand (units and revenue) for this

product, its options and accessories, by quarter? Has it changed since the project was approved?

67. Is a draft Quotation template available?

68. Is there a proposed price for the total product package and for each option?

69. Provide a matrix with estimated cost, price, and margins. Have margins changed since project approval?

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70. Is a demo plan approved?

71. When will the product first be demonstrated, both domestically and internationally? Is Engineering informed, and able to get laser safety certification done in time? What are the pre-PSR domestic and international demo requirements?

72. When will sales channels be notified of product availability and when will training be done?

73. Is a preliminary data sheet available? Does it have laser safety information?

74. Are upgrades required? What is the upgrade plan?

75. Has the warranty been established? Is a warranty notice written/approved?

76. What is the plan to support major account contracts that require evaluation units, engineering change information, software/firmware change support, source code support, etc. Are plans in place?

77. What is the export control (ECCN) classification?

78. Are field test sites planned and is Engineering informed?

Technical Publications79. What technical documentation (user and/or service manuals, programmer’s

reference guides, etc.) is planned? Who will review and approve drafts?

80. Is any pre-PSR documentation required? When?

81. Will new test or calibration fixtures or diagnostic software be listed in the service documentation?

82. Is the warranty statement in the user manual?

83. Are plans in place to have release notes, customer upgrade information, done by a technical writer?

Export Classification and Compliance84. Does the software include any encryption algorithms that would preclude export?

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85. Will any special actions be necessary to obtain export control numbers for this product, its options, or accessories?

86. Are there any known export control related problems with this product that may critically affect marketing strategy and/or sales potential?

Customer Service and Product Support87. Has Customer Service reviewed the design for serviceability?

88. If upgrades are planned, who will compile the list of customers to be upgraded, and who will place orders?

89. Has a Service Plan been drafted?

90. Is Train-the-Trainer training scheduled/planned? Is training planned for the Technical Response Center, field service staff, and any off-site service facilities? Is a customer training class planned? When does it need to be ready?

91. If this is a software-only product release, have the installation instructions been reviewed?

92. Will new test equipment, tools, and fixtures be required for service? Who is responsible for designing, building, or purchasing? Are they required for service depots?

93. Will special field-service kits be needed for support of the product? Will purchase contracts for replaceable modules or subassemblies cover service requirements? Who is responsible for determining requirements?

94. Have all expendables and user-replaceable items (paper, program disks, lamps, connectors, fiber pigtails, etc.) been specified and part-numbered? Who will forecast customer support requirements?

95. What service concerns remain?

Project Milestones1. What are ER and PSR targets? Have any DR criteria not been met? If so, when

will we re-convene this review?

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_____________________________________________________________________________V. Engineering Release (ER) Criteria and Checklist

G. A. ENGINEERING RELEASE CRITERIA

Engineering Release cannot occur until:1. Design validation testing is complete, a report on test results is available, and

“acceptable” bugs/problems are defined and documented.2. Manufacturing, Quality, and Engineering agree that the product can be

consistently built, tested, and supported to meet its specified performance and service requirements.

3. Customer Service agrees that the product can be supported in the field, if field service is planned.

4. Manufacturing, Quality and Engineering agree that the forecast and manufacturing plan are satisfactory and achievable.

5. Marketing agrees that the product’s performance meets the goals as described in the CRD.

The system ER milestone occurs when the following applicable criteria have been met: 6. The product meets the requirements of the ECS.7. All related software has been integrated and tested with the hardware, and meets

performance specifications. If we’re using OEM software, licenses have been negotiated.

8. Engineering BOMs have been verified, and final manufacturing or purchasing specifications are available for all parts, including necessary drawings, schematics, etc.

9. The forecast has been loaded, pilot phase prototypes have been scheduled, and the PSR date has been approved.

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

H.I.J. B. ENGINEERING RELEASE CHECKLIST

Product Description

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_____________________________________________________________________________1. Describe any post-DR changes to the product, its options or accessories.

2. Is the Quote template/ordering information approved and distributed?

Product Performance vs. Specifications3. How many prototypes were built and tested?

4. Do the prototypes meet the performance specs in the ECS?

5. Are marketing specifications for the brochures/data sheets finalized?

6. Have the hardware and software been integrated and tested as a system? Have all options and accessories been tested?

7. Has the software been verified to meet requirements? Has a summary of the test results been distributed?

8. Have typical user-application measurements and operations been performed using the prototypes?

9. Do the prototypes meet the environmental and reliability specifications outlined in the ECS?

10. What are the results of other testing, such as at field test sites?

11. What will be done with the engineering prototypes after PSR? Are any in demo inventory? Will they be sold?

12. How 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.)

Specifications and Design Documentation13. Is the Engineering Control Specification (ECS) up to date and sufficiently

complete to support the Pilot phase? Has it been reviewed by Marketing, Engineering and Manufacturing to start pilot production?

2. Is the Bill of Material (BOM) complete? Are BOMs complete for upgrade and service kits?

14. Has Materials/Purchasing reviewed the BOM?

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15. Have all specifications, drawings, information on hardware devices (PGAs, PLDs, PALs, etc.), software revisions, been archived and documented?

16. Have material source specifications been transmitted to Purchasing/Materials?

17. Are software, firmware, and programmed parts codes and tools archived?

18. Has the Test Plan been documented and archived?

19. Does the documentation meet Quality and Customer Service’s needs?

20. Has Engineering written all upgrade/installation instructions for Quality and Customer Service to review?

Mechanical Design Issues1. Have the industrial design and styling of the product changed since DR?

21. Have all tooling releases been made? Have all graphics film packages been released?

22. Have all transit cases been designed and tested? Will they be available for PSR?

23. Are there any unresolved buildability concerns? How will they be settled?

Software Development24. Are software BOMs complete?

25. Does this release obsolete any earlier version(s) of software? Has an ECN been written?

26. Are licenses for other vendors’ software completed, and is Finance informed? Does the vendor software include encryption algorithms that would affect export licensing?

27. For software being installed to run on the user’s host computer, has diagnostic, and/or customer-acceptance test software to be used for installation been completed?

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_____________________________________________________________________________5. Have the physical parts of the software product as shipped (manuals, media,

labels, license agreement, packaging, etc.) been part-numbered?

6. Was the ER build done on a “releases” directory on the network, with revision control?

7. Were design (functionality and user interface) and code reviews completed?

8. Are known bugs documented and do they have a resolution status?

28. Are the Release Notes complete?

Safety and Regulatory Requirements29. What is the status of laser-safety certification (CDRH, CE)? Will it be completed

by the time the first customer demonstrations are made? Is the laser safety test procedure and form ready for the pilot build?

30. Are all required laser-safety and other safety warnings and labels documented in the user manual and applied to the pilot build units?

31. What is the status of other safety and regulatory compliance (MSDS, UL, VDE, FCC, CE Mark, etc.)? Are these requirements met for the pilot build?

32. Has all safety-related product evaluation testing been documented?

33. Have all safety-controlled parts been identified and documented in the MRP system?

34. Have any changes been made to components, product nomenclature or labeling that require revision of any safety-certification documentation?

Patents, Trademarks, and Copyrights35. Since DR, have any additional inventions been identified for this product?

36. What is the status of invention disclosures previously submitted?

37. Have trademarks been searched and applications filed?

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_____________________________________________________________________________38. Have appropriate licensing, copyright, patent or other legal notices been

incorporated in the firmware and/or software code or applied to the product media or hardware?

Manufacturing39. Has Manufacturing gone through their own NPI checklist?

40. Does manufacturing have the information and training needed from Engineering to complete the pilot build?

41. Does the BOM meet Manufacturing’s needs?

42. Will assembly and test procedures be ready for the pilot build?

43. Is test software required/done? Has its performance been verified? Does it need to be transferred to repair depots?

44. Will any new assembly fixtures, and test and calibration equipment be ready for the pilot build?

45. Are manufacturing staffing and facilities on schedule for the pilot build?

46. Will a unit be “shipped” to someone in Marketing or Quality and Customer Service to confirm that the product or system as shipped can be successfully setup and readied for operation at the level of the intended customer?

Material and NPI Planning1. Does the BOM meet Materials/Purchasing’s needs for planning? Has the forecast

been loaded?

2. Are any materials being obsoleted by this release? Is an ECN written?

3. Are farm-out arrangements on schedule, if applicable?

4. What is the expected lead-time of the product?

47. What are the longest lead-time parts? Are any parts single-source?

48. Are there any remaining part selection decisions to be made? What are the risks to the project?

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49. Are all parts (mechanical, optical, components, boards, etc.) available for the pilot build and early production builds?

50. Are costs in the MRP system for all parts? Labor costs rolled?

51. Has demand been placed in the MRP system for demos and upgrade kits?

Quality52. When will assembly drawings and samples be available?

53. Are inspection drawings, parts, specs, equipment, and staff available for IQA for both pilot build and early production units?

54. Are incoming inspection procedures written?

55. Have the necessary FQA procedures been written/drafted? Will they be ready for PSR?

Marketing1. Has the forecast changed since DR? If it has, what is the new forecast of annual

demand (units and revenue) for this product, its options and accessories, by quarter?

56. Have prices been approved?

57. Has the demo plan been approved and communicated to Sales?

58. Are beta sites to be planned using pilot build units?

59. Has Sales training been scheduled?

60. Are final brochures/documentation ready for printing? Do they have laser-safety information?

61. Does this product obsolete another? What is the obsolescence plan? Who will notify affected customers?

62. Are upgrades required? What is the upgrade plan? Is the ECN written?

63. Are Sales and Marketing requirements for user manuals entered in the system?

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_____________________________________________________________________________64. Has Marketing approved the warranty text in the user manual?

65. What is the status of plans to support major account contracts that require evaluation units, engineering change information, software/firmware change support, source code support, etc.? Is there an impact to existing contractual agreements?

66. Are there any know problems related to international marketing and distribution?

Technical Publications1. Has all user and service documentation been reviewed, verified, and approved?

2. What is the status of printed user manuals, reference cards, etc.?

3. Have release notes, customer upgrade instructions, etc. been reviewed by the project team?

Export Classification and Compliance67. Have export control numbers been obtained for the product?

68. Are there any known export control problems with this product that may critically affect marketing strategy and/or sales potential?

Customer Service and Product Support1. If upgrades are planned, has a list of customers to be upgraded been compiled,

and have the customers been informed and scheduled?

2. Is the Service Plan completed?

69. Has Train-the-Trainer training been completed? Is training planned for the Technical Response Center, field service staff, and any off-site service facilities? Is a customer training class planned? When does it need to be ready?

70. Has a spares list been generated and priced?

71. Have any new test equipment, tools, and fixtures required for service been completed and documented? Are they required for service depots?

72. Does Customer Service plan to stock loaner units? Are they ordered?


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_____________________________________________________________________________Project Milestones1. What is the PSR target? Have any ER criteria not been met? If so, when will we

re-convene this review?

VI. Product Ship Release (PSR) Criteria and Checklist

K. A. PRODUCT SHIP RELEASE CRITERIA

Product Ship Release cannot occur until:1. Engineering, Marketing, Manufacturing, Quality, and Customer Service agree that

the product meets specifications as built, is ready for release to customers, and can be supported in the field.

2. Marketing and Manufacturing agree that the manufacturing production plan is acceptable.

PSR is achieved when the following applicable criteria have been met: 3. The product as produced in the manufacturing environment meets its announced

design and performance specifications.4. Manufacturing can meet planned production output schedules.

Procedure: TBD




_____________________________________________________________________________5. Marketing has reviewed and accepted the product for customer delivery.6. The product and all options and accessories have been costed and priced.7. Laser safety certification and any other regulatory requirements have been met.8. All required legal notices have been incorporated into the product (safety, patent,

copyright, warranty).9. Sales and Customer Service are prepared to sell and support the product.10. Manufacturing Engineering is prepared to support the product.11. Design archiving is complete.12. User manuals are in stock.13. All necessary ECO’s to release model numbers, etc. have been written and

approved. L. B. PRODUCT SHIP RELEASE CHECKLIST

Product Description1. Any changes in the product, its options/accessories since ER?

Product Performance vs. Specifications1. Do the pilot build units meet all specifications per the CRD and ECS? Do they

meet internal (unpublished) specifications?

2. Does the product make typical end-user measurements as expected?

3. Have calibration and test processes been reviewed to ensure all products will meet the published specifications?

4. Will any long-term testing take place after PSR?

Specifications and Design Documentation1. Has the ECS been filed with the Quality department? Has the CRD been filed with

the Quality department? 2. Has the BOM been updated with all post-ER changes?

3. Is all documentation complete and archived (material specifications, drawings, software files, archive tapes, purchase specifications, programmed-parts codes, Test Plan and results)?

Mechanical Design Issues5. Are there any unresolved transit packaging and shipping concerns?

Procedure: TBD




_____________________________________________________________________________6. Have they been reviewed and approved by Marketing and Engineering?

7. 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?

8. What transit pack will be used for early demo units?

Software Development1. Are help files available and documented? Are all bug fixed documented and

readied for consideration in the first software upgrade?

9. Are final agreements in place for vendor software?

10. Is final “released” software archived on the network?

11. Are release notes approved and available?

Safety and Regulatory Requirements1. Has the CDRH report been filed by Quality?

2. Is Manufacturing storing the laser safety test procedure forms for each unit?

3. Have all required regulatory issues been resolved?

Patents, Trademarks, and Copyrights1. Have all invention disclosures been submitted?

2. Have product trademarks been registered?

Manufacturing3. Will the pilot units ship to customers?

4. Are the manuals ready to ship?

5. Are present assembly/test procedures, fixtures, and equipment satisfactory for continuing production?

6. Is present test/calibration software satisfactory? Is it under revision control?

Procedure: TBD




_____________________________________________________________________________

7. Are there any assembly, calibration, or test concerns?

8. What’s the estimated manufacturing labor cost of the product, options, and accessories? Has it been taken into account in margin calculations?

Material and NPI Planning1. Are there any problems in the continued availability of parts and/or components?

2. Are any parts single-source or risky and is a plan in place to find second sources?

9. What is the scheduled delivery for demo units and upgrade kits?

Quality1. Are IQA and FQA procedures adequate?

2. Are any of the validation phase prototypes in salable condition? Can they be used to fulfill demo equipment needs?

3. Are all milestone forms and supporting documentation for this project on file?

Marketing1. Has the product description changed since ER?

2. Has Marketing approved the loaded forecast and insured that material procurement follows the sale forecast?

3. Have sales channels been notified and sales groups trained?

4. Is all product literature available and approved?

5. Are upgrade plans in place?

6. Has the product lead-time been adjusted to match manufacturing schedules?

7. What is the strategy for demo builds versus customer orders?

8. Are major account contracts being adequately supported?

Procedure: TBD




_____________________________________________________________________________9. Are there any remaining problems related to either domestic or international

marketing or sales?

Technical Publications1. Are all final manuals available to support PSR as planned?

Export Classification and Compliance2. Are all export control numbers approved?

3. Are there any known export control related problems with this product that may critically affect marketing strategy and/or sales potential?

Customer Service and Product Support4. Are all upgrade plans in place and being supported?

5. Is the Service Plan approved?

6. What is the status of any remaining training (Train-the-Trainer, Customer training, Field Service training)?

7. Is maintenance documentation required? Available?

8. Are all spare parts and prices approved and provided with the quote template?

9. Are all post-ER changes incorporated into the service documentation?


Project Milestones1. Have project targets been achieved? Have any PSR criteria not been met? Who

is responsible for meeting them and when? Will we need to reconvene this review?

11. Is a post-PSR project review planned to evaluate the project’s successes and failures? If so, who is responsible for arranging it?

Procedure: TBD




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V. APPENDIX A

MILESTONE APPROVAL FORM

Product/Project:

Milestone:

Date:

_______ APPROVED FOR RELEASE

_______ NOT APPROVED

_______ APPROVED, Conditional on completing the action items listed below

Signatures:

Engineering: ____________________________________________

Marketing: _____________________________________________

Materials/Purchasing: _____________________________________

Manufacturing: __________________________________________

Quality: ________________________________________________

Customer Service: ________________________________________

Action Items:

Procedure: TBD




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Documents

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