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ISO 9001 QMS Policies, Procedures, and Forms Bizmanualz.com

Document #QP1100

TitleDESIGN AND DEVELOPMENT

Print Date:mm/dd/yy

Revision #0.0

Prepared ByPreparer’s Name/Title

Date Prepared: mm/dd/yy

Effective Date:mm/dd/yy

Reviewed ByReviewer’s Name/Title

Date Reviewed:mm/dd/yy

StandardISO 9001:2008, clauses 7.3, 7.5

Approved ByFinal Approver’s Name/Title

Date Approved:mm/dd/yy

Policy: The Company shall ensure the quality of its products and/or services by planning and controlling their design and development.

Purpose: To delineate approved procedures for the planning, design, and development of new products and changes/enhancements to existing products. (The word “product” may include the Company’s service offerings.)

Scope: This procedure applies to all new product development, as well as to developing significant changes to existing products.

Responsibilities:

All Employees are responsible for ensuring product and process improvement.The Engineering Manager is responsible for designing, evaluating, testing, and all technical aspects of product and process development.The Accounting Manager is responsible for evaluating and reporting on the financial aspects of product/process development.The Marketing Manager is responsible for coordinating product development with the customer base, supervising field trials, finding new markets for the Company's products/processes, and raising awareness of the Company's offerings.Top Management is responsible for final review and approval of design and development (D&D) projects.The Product Development Team is responsible for managing the product design-and-development process; may also be known as “the Project Team”.

Definitions: Design phase – The most important phase of the product life cycle, because inherent quality, effectiveness, and customer satisfaction of the product are established here. No matter how carefully a product may be manufactured or how perfect a quality control program, inherent qualities cannot be improved except through design enhancement.It is crucial that adequate planning and controls be established, implemented, and maintained during the design phase to optimize

QP1100 Design and Development of 26


quality, effectiveness, safety, and customer satisfaction prior to manufacturing. Achieving best intrinsic qualities is a direct function of:a. Awareness of the design goal by management, marketing,

engineering, production and quality assurance;b. Correct selection and application of parts and materials; c. Performance of normal and worst-case testing to evaluate and

assure that the product design and manufacturing processes will perform as intended under all reasonable circumstances; and

d. Thorough review and analysis of the product design. Product development should be managed in a way that ensures timely development of new products, to reach completion quickly and capitalize on market opportunities.Failure Mode and Effects Analysis (FMEA) – Technique for testing design of products in which failures are assumed to occur. FMEA is useful for evaluating reliability, safety, and general quality where the evaluator assumes that: Each component fails; Each subsystem or subassembly fails; The environment in which the product operates is problematic; The operator makes errors; and/or The power source is interrupted and immediately restarted.The probability of each failure occurring and the result of failure are analyzed. If possible, hazards and faulty performance are designed out of the device; if not, hazards/substandard performance are compensated, reduced, or prevented (by interlocks, warning signs, explicit instructions, alarms, etc.). Risk of failure cannot always be removed from products but can be understood and controlled to the extent possible with existing technology.Fault Tree Analysis – Deductive, top-down approach to failure mode analysis, where: System failure or safety hazard is assumed; Basic component failure or an event that could cause the

assumed system failure or safety hazard is identified; and Computational techniques are used to analyze basic defects,

determine failure probabilities, and establish the severity of failure effects.

Key characteristic – Feature of a material, part, or process, variation of which will significantly influence a product's fit, performance, service life, or manufacturability. Key characteristics essential to meeting product goals are identified so that the Company's resources can be focused on those items.



Objective – Something toward which effort is directed; an aim, goal, or end of action. In business terms, a well-worded objective is Specific, Measurable, Achievable, Result-oriented, and Time-bound (SMART).Quality Function Deployment (QFD) – Structured approach to defining customer needs or requirements and translating needs into specific plans to produce products to meet those needs. The "voice of the customer" (the term used to describe stated and unstated customer needs or requirements) is captured in a variety of ways (e.g., direct discussion or interviews, surveys, focus groups, customer specifications, observation, warranty data, field reports). This understanding of customer needs is then summarized in a product planning matrix – a "house of quality". Houses of quality are used to translate higher-level "whats" – needs – into lower-level "hows", product requirements or technical characteristics to satisfy these needs.Requirement – Condition that must be met in order to do something; something wanted or needed; something essential to the existence or occurrence of something else.Validation – Evaluating a system or component during or at the end of the development process to determine if it satisfies specified requirements.

Procedure:

1.0 DESIGN INPUTS1.1 The Product Development Team (see QP1090 PROJECT PLAN) shall identify

inputs having to do with product requirements and shall maintain a record of those inputs, in accordance with ISO 9001, clause 7.3.2. Design inputs may include, but need not be limited to:

Customer requirements, whether known or assumed;

Functional and performance requirements;

Statutory (regulatory) requirements that apply to the product/situation;

Information from a previous similar design, where applicable; and

Other requirements deemed essential to the product and/or the design and development process.

1.2 The Team shall identify, protect, and safeguard any design inputs belonging to the customer (e.g., technical drawings, documents) that are under the Company’s control for any length of time. The Team’s Manager/Chairperson shall report to the customer if the customer’s property is lost, damaged, or found otherwise unsuitable for use; a record of such incidents shall be kept in the Product Development file for later evaluation, in accordance with ISO 9001, clause 7.5.4.



2.0 DESIGN AND DEVELOPMENT2.1 Each activity in the Product Plan (see QP1090) will have assigned responsibilities

(may be individuals or a team, depending on the scope/complexity of the activity), a detailed description, and checkpoints (milestones). The description of the design activity should provide clear and definitive technical data for procurement, the execution of work, and verification of conformance of the product development to specification requirements.

2.2 Each activity team (or responsible individual) should be given authority to take actions for accomplishing their phase without repeated approval processes. Product development is a sequence of decisions. Shortening decision-making time by removing steps can dramatically speed product development.

Each team will be responsible for ensuring coordinated development by adequately communicating with other project teams at all times. Organizational and technical interfaces between different groups shall be maintained and the necessary information documented, transmitted, and regularly reviewed.

2.3 The Engineering Manager shall convert design requirements into specifications for materials, products or services, and processes to provide a product that provides customer satisfaction at a price that provides a satisfactory return on investment (ROI) for the Company.

Such specifications shall ensure that the product is producible, verifiable, and controllable under the proposed production, installation, operating, and servicing conditions.

D&D outputs are to be in a form enabling verification against design inputs and shall be approved by the Team during design reviews prior to product release. D&D outputs (in accordance with ISO 9001, clause 7.3.3) shall:

Meet D&D input requirements;

Provide appropriate information for purchasing, production, and service provision;

Contain – or reference – product acceptance criteria; and

Specify product characteristics essential for its safe and proper use.

During development of prototypes, the design team should continually review customer requirements. In addition, consideration should be given to requirements for safety, environmental, and other regulations. The quality aspects of the design should be unambiguous and adequately define characteristics important to quality, such as acceptance and rejection criteria. Both fitness for purpose and safeguards against misuse should be considered. Product definition may also include reliability, maintainability, and serviceability through a reasonable life expectancy.

2.4 The design team is responsible for assuring that all parts and materials used in product design have the reliability necessary to achieve their intended purposes and are practical and feasible for the application in question. For some parts and



materials, this assessment can be done in-house while for others, it may be necessary to contract with suppliers or outside test labs. The reliability goal should be based on the severity of use and importance of the part/material’s function. Manufacturing and Purchasing should be involved in at least one of these reviews.

The assessment should encompass the selection, specification, qualification, and ongoing verification of parts and materials quality, whether fabricated in-house or provided by suppliers. Quality assurance should extend to qualification of suppliers (see QP1120 VENDOR EVALUATION), to aid in ensuring that only quality parts and materials are used.

2.5 Parts and materials should be selected based on their suitability for the chosen application, compatibility with other parts and materials and the environment, and proven reliability (where applicable). Conservative choices in selection of parts and materials are characteristic of reliable products. Standard proven parts and materials should be used in lieu of unproven parts and materials.

A “preferred parts and materials list” should be established as a bill of materials during the preliminary design stage and refined as the design progresses. This list should include approved suppliers (also see procedure QP1120) for the parts and materials.

Manufacturing and the Engineering Manager should be involved in at least one of these reviews.

2.6 Changes made to specifications during the development process that are accepted as design changes will be documented (under change control or configuration management) and evaluated to assure that they accomplish the intended result and do not compromise product effectiveness (or safety, where that is a critical issue).

3.0 DESIGN AND DEVELOPMENT REVIEW3.1 At the completion of each design/development activity, a review of the results

should be performed. Reviews should be objective, unbiased examinations by appropriately trained employees who were not directly involved in that design activity. The design team shall keep a record of all such reviews and necessary actions that arise from them – in accordance with ISO 9001, clause 7.3.4.

Manufacturing and Purchasing should be involved in at least one design & development review.

3.2 The design review should identify and anticipate problem areas and inadequacies, and initiate corrective actions to ensure that the final design and supporting data meet customer requirements.

A Design Review Checklist, appropriate to the product, should be constructed (see QP1100-1 DESIGN REVIEW CHECKLIST for guidance). The checklist may include, but need not be limited to, the following:

a. Physical characteristics, constraints, and aesthetic specifications;b. Safety needs of the user, environmental compatibility, and the need for

failsafe characteristics;



c. Considerations of unintended uses and misuses;d. Compliance with regulatory requirements and industry standards;e. Labeling, including warnings, identification and traceability, operating and

maintenance instructions;f. Packaging, handling, shelf life, storage and stability requirements;g. Product fitness, reliability, serviceability, and maintainability

requirements;h. Producibility of the design (e.g., assembly requirements including any

special processes such as mechanization, automation, and installation of components);

i. Selection of materials, components, and subassemblies, including approved suppliers and availability;

j. Review and use of standard parts;k. Capability to inspect and test the product, including special inspection and

test requirements;l. FMEA or other testing and evaluation tools; andm. Acceptance criteria and permissible maximum and minimum tolerances.

The Product Development Team should refer to this checklist when periodic project reviews are conducted.

For electromechanical products, QP1100-2 DESIGN COMPLETION CHECKLIST FOR ELECTROMECHANICAL DEVICES should also be completed and evaluated. For other product types, QP1100-3 DESIGN COMPLETION CHECKLIST FOR NON-ELECTROMECHANICAL DEVICES should be used.

3.3 Review results and actions arising from them should be documented in report form and signed by Management employees as complete and accurate, in accordance with ISO 9001, clause 7.3.4. All changes made as a result of review findings should likewise be documented.

Reports should include conclusions and recommended follow-up and should be disseminated in a timely manner to appropriate organizational functions, including management. The Product Development Team shall keep all such reports in the Design & Development file.

4.0 DESIGN VERIFICATION4.1 The Team shall, in accordance with the Project Plan, conduct design verifications

to ensure that D&D outputs meet D&D input requirements.

4.2 The Team shall maintain records of verification results – and necessary actions arising from the results – in accordance with ISO 9001, clause 7.3.5. See QP1100-4 SAMPLE VERIFICATION CHECKLIST for guidance.

5.0 DESIGN VALIDATION AND TESTING5.1 The Team should periodically – and/or when the D&D process reaches a

significant checkpoint or a significant event occurs – conduct an evaluation of the product’s design.



Evaluation should include one or more analytical methods (e.g., FMEA, QFD).

Evaluation should include inspection and/or testing of prototypes and/or production samples.

5.2 The amount and degree of product testing should be related to the risks identified in the design-planning phase. Product tests may include, but need not be limited to:

Product testing (in-house or outsourced) to evaluate performance, durability, safety, quality, reliability, and maintainability characteristics under a range of expected storage and operational conditions, in accordance with regulatory and customer requirements;

User trials and/or field trials of the product, to verify that the product functions under actual conditions and to assess the customer's reactions and gain additional insight; and/or

Pilot production (in accordance with QP1140 MANUFACTURING), to test and refine the production process and help determine production costs and capabilities with greater precision.

Product testing shall be documented to the extent possible (see QP1100-5 PRODUCT TEST for guidance).

5.3 The Engineering Manager shall review the results of product tests and evaluations. Review of test results should include defect and failure analysis and indicate any resulting actions taken.

The Engineering Manager shall maintain records of results of validation and testing and any actions that arise from them in accordance with ISO 9001, clause 7.3.6.

5.4 The Accounting Manager should provide an updated financial analysis to verify the financial viability of the project, based on the latest and most precise revenue and expense figures.

5.5 Upon completion of testing and validation, the Product Development Team shall review test results and the financial analysis and prepare a final "go/no go" analysis and production plan for Top Management.

5.6 On receiving Top Management's approval, the Product Manager may need to obtain the customer's final approval (depending on the nature of the product, the extent of the design and development process, and the degree of design change), after which normal production (see QP1140 MANUFACTURING) shall be initiated, in accordance with terms of the production agreement.

6.0 PROJECT ASSESSMENT6.1 At the end of the project, the Product Development Team shall review all records

generated during the course of design and development, looking for opportunities for improvement.



6.2 Where necessary, the Team shall call for corrective and/or preventive actions, in accordance with QP1040 CORRECTIVE ACTION and QP1050 PREVENTIVE ACTION.

Effectiveness Criteria:

Customer, Company, regulatory, and other requirements are met

Project schedule and budget are met

References:

ISO 9001:2008, “Quality Management System - Requirements”, International Organization for Standardization (ISO), Nov., 2008.

Quality Procedures:

QP1010 QUALITY RECORDS

QP1040 CORRECTIVE ACTION

QP1050 PREVENTIVE ACTION

QP1090 PROJECT PLAN

QP1110 DESIGN CHANGE

QP1120 VENDOR EVALUATION

QP1140 MANUFACTURING



Forms/Records:

Form # Record/Form/Activity Name Satisfies ISO 9001 Clause

Required by ISO 9001:2008

Design input record(s) 7.3.2

QP1100-1 Design & development review records (e.g., Design Review Checklist, meeting minutes)

7.3.4

QP1100-2, QP1100-3, QP1100-4

Design/development verification records (e.g., Design Completion Checklist for EMD, Design Completion Checklist for Non-EMD, Verification Checklist)

7.3.5

QP1100-5 Design/development validation records (e.g., Product Test)

7.3.6

Record of lost, damaged, or unusable customer property

7.5.4

Other Forms/Records

Product design & development file (database)

Revision History:

Revision Date Description of changes Requested By

0.0 mm/dd/yy Initial Release



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QP1100-1 DESIGN REVIEW CHECKLIST

Date

Customer

Contract No.

Product

DESIGN REVIEW

Q ITEMS TO BE CONSIDERED RESPONSE1

1 Have work products to be reviewed been identified?

2 Has the type of review been selected? Alternatives include:

Informal walkthrough by several team members;

Technical review by project team members and stakeholders; and

Inspection by project team members (and possibly other stakeholders).

3 Have the goals of the review been established?

4 Have a moderator/facilitator and review team been selected?

5 Has a review package been developed and distributed to the participants with ample review time? The review package should at least include:

Work product to be reviewed;

Related templates, guidelines, and other background information; and

Forms on which to record defects, questions, and issues.

6 Has the product design been reviewed for compliance with overall design objectives, including:

A clear understanding of the user environment, requirements and system analyst specifications?

Use of “best practices” in design (e.g., effective design strategies, modularity, performance, and extensibility)?

Clear process flows?

1 While the response recorded on this form may be a simple “yes” or “no”, or a checkmark, you should include explanations in the “Comments” section and attach additional sheets, if needed.



DESIGN REVIEW

Q ITEMS TO BE CONSIDERED RESPONSE

7 Have results of the review been used to update the work product?

8 Have the goals of the review been reviewed as a way of determining success?

9 Has the process been carefully scrutinized so as to identify improvement needs?

Additional Comments:


* The following comment abbreviations may be used to save time, attach additional sheets if necessary.U = Unsatisfactory NA = Not Applicable NI = Needs Improvement S = Satisfactory


QP1100-2 DESIGN COMPLETION CHECKLISTFOR ELECTROMECHANICAL DEVICES

Product Name: Model:

Project Leader: Date:

ITEM COMMENTS* (Inside the Device)

1. Primary Grounding Connection - 2. Dead Metal Grounding - 3. Overcurrent Protection - 4. Fuseholder Polarity - 5. 2-Wire On/Off Switch - 6. Abrasion, Strain Protect - 7. Circuit Spacing - 8. Wiring Dress - 9. Assembly, General - 10. Hardware Tight - 11. Cleanliness - 12. Control Labels - 13. Caution Labels - 14. Interlocks; Labels - 15. Barriers, Insulation - 16. Moving Part Clearance - 17. Fire Protection -

HARDWARE COMMENTS18. Device Specifications - 19. Connectors & Cables - 20. Connector Propriety - 21. Power Plug & Cord - 22. Cord Strain Relief - 23. General Construction - 24. Physical Stability - 25. Sharp, Hot, Moving, Pinching Parts - 26. Liquid & Dirt Protection - 27. Corrosion Resistance - 28. Maintainability - 29. Grounding Resistance Test - 30. Grounding Leakage Current - 31. Patient Circuit Leakage Current -



32. Power Dielectric Test 33. Patient Circuit Dielectric Test - 34. Transients Produced - 35. Transient Immunity - 36. Line, Signal, Static 37. Battery Charge & Life Test - 38. Line Voltage Tolerance - 39. Temperature Tolerance Test - 40. Humidity Tolerance Test - 41. Shock Tolerance Test - 42. Vibration, Ship. Test - 43. Failure Modes & Effects Analysis - 44. Performance Factors (add list for item being evaluated)

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45. Normal Inputs - 46. Abnormal Inputs - 47. Sensor Failures - 48. Output Device Failures - 49. Power Loss & Restart -

LABELING COMMENTS50. Fuse & Circuit Breaker Labels - 51. Control Labels - 52. Warning Labels - 53. Instruction Manual - 54. Maintenance Manual - SOFTWARE COMMENTS55. Specifications - 56. Annotated Code - 57. Flow Diagrams - 58. Displays -



59. Printouts - 60. Code Review - 61. Changeable - 62. Error Handling - 63. Operator Prompts - 64. Operator Error Prevention - 65. Normal Inputs - 66. Abnormal Inputs - 67. Sensor Failures - 68. Output Device Failures - 69. Power Loss & Restart - 70. Performance Tests (add list for item being evaluated)

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HUMAN FACTORS COMMENTS71. Hardware (add list for item being evaluated)

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72. Software (add list for item being evaluated)-

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REGULATORY COMMENTS73.

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QP1100-3 DESIGN COMPLETION CHECKLISTFOR NON-ELECTROMECHANICAL DEVICES

Product Name: Model:

Project Leader: Date:

ITEM COMMENTS*1) Product Specification - 2) Performance Factors - 3) Accuracy - 4) Precision - 5) Specificity 6) Sensitivity - 7) Range - 8) Linearity - 9) Shelf-life Studies - 10) Preservative Performance - 11) Reconstitution Studies - 12) Temperature Tolerance Test - 13) Humidity Tolerance Test - 14) Shipping Test - 15) Verified Standards/Controls

Re Low, Normal & High Values -

16) Inner Containers - 17) Outer Packaging - 18) Package Insert - 19) Process Validation - 20) Processing Procedures - 21) Verified Test and Inspection Procedures - 22) Data Forms - 23) Finished Dev. Storage - 24) Purchase Specifications - 25) Supplier Evaluations - 26) Other -

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* The following comment abbreviations may be used to save time, attach additional sheets if necessary.U = Unsatisfactory NA = Not Applicable NI = Needs Improvement S = Satisfactory


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QP1100-4 SAMPLE VERIFICATION CHECKLIST

Input Requirement Verified By Date



QP1100-5 PRODUCT TESTTest Date:

Customer:

Contract No.:

Product Tested:

Test Conducted By:

Description of Test:

Test Purpose (include goals):

Test Location, Environment:

Test Conditions:

Observations/Comments (attach additional sheets/data, if necessary):

Results (attach additional sheets/data, if necessary):

Test Supervisor: Date:

Engineering: Date:


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