Design Control Guide Outline (1 of 2)

1

Design Control Guide Outline (1 of 2)

Page 4 Product Commercialization Process (PCP)

Page 5 Core Team and Product Approval Committee

Page 6 Core Team and PAC Contract Summary

Page 7 Core Team and Extended Team

Page 8, 9,10 Project Contract Example

Page 11 PCP Deliverables

Page 12 Types of Design Control Reviews

Page 13 Decision to Investigate (DtI)

Page 14 Decision to Commercialize (DtC)

Page 15 Design Control Purpose & Benefits

Page 16 Quality Management System (QMS)

Page 17 Design Control Regulatory Standards

Page 18 Design Control Deliverables Comprising eDHF

Page 19 Design Control Procedures

Page 20, 21, 22 Content of eDHF Deliverables

Page 23 Triple Constraint

Page 24 Verification Deliverable Requirements

Page 25 Verification vs. Validation

Page 26 Validation Deliverable Requirements

Page 27 Design Review

Page 28 Design Review Occurrences

2Design Control Guide

Design Control Guide Outline (2 of 2)

Page 29 Design Review Record for eDHF

Page 30 Design Transfer

Page 31 Process Validation

Page 32 Validation Protocol

Page 33 Validation Report

Page 35 Change Control

Page 36 Design History File


Product Commercialization Process (PCP)


Dtl

Decision to Investigate

•CONCEPTPHASE

Decision to Commercialize

•DEFINITION PHASE

SDC Start Development

Checkpoint

•DEVELOPMENT PHASE

SMC Start Manufacturing

Checkpoint

•MANUFACTURING

PHASE

CTC Confirmation test

Checkpoint

•CONFIRMATION PHASE

PRC Product Release

Checkpoint

•COMMERCIAL PHASE

PCC Project Closure

Checkpoint

•LESSSONS LEARNED

PCP governs how products are executed.Passing DtI or DtC is not committing to commercializing a new product.

Core Team and Product Approval Committee Product Approval Committee (PAC)

o Clearly-defined decision makers with domain experience

o Govern effective resource allocation

o Manages the development pipeline

o Selects Core Team Lead

• Core Team

• Small and cross-functional and manage their extended team members

• Posses effective communication and coordination

• Product development project focus with clear responsibility and authority

• Each Core Team Member represents extended team members having depth of technical knowledge

• Core Team Lead & Program Manager

• The Core Team Lead is responsible for the deliverables of the Core Team and manages the program

• Selects the Core Team Members


Core Team Lead

Quality Assurance

R&D ManufacturingProduct

DevelopmentEngineering

Core Team & PAC Contract Summary

Project Parameter Target Variance

Key Performance Requirement 1 8 runs/day ≥6 runs/day

Key Performance Requirement 2 95% call accuracy >90% call accuracy

PRC Date OCT 2019 4 weeks

COGS Target $4,500 <$6,000

Resources 25 FTEs 15%

3 Year Revenue $78M 20%

Project Cost $8.9M <$10M


Core Team operates according to agreed upon project contract with the PAC.

Core Team and Extended Team


Core Team Lead

Quality Assurance

R&D Manufacturing Product Management

Engineering

Data Integrity

Regulatory

Trade Compliance

Supplier Quality

Hardware Design

Software Design

Research

Verification

Planning

Purchasing

Packaging

EHS

eBusiness

Marketing

Legal

Finance

Engineering

Training

Technical Support

Validation Distribution

Manufacturing

Sales

The Core Team facilitates nimble and quick decisions led and documented by the Core Team Lead.

Project Contract Example (1 of 3)Attribute Phase Review DtC

EstimateSDC Commitment

SMC Commitment

CTC/PRC Commitment

PCC Analysis

COSTS Concept $84K - - - -

Definition 122K (+38K) $71,500 $71.5K $71.5K -

Development TBD $230,863 $230.9K $276K -

Manufacturing TBD $75,625 $75.6K (±14K) $30.3K -

Confirmation TBD - - - -

Sales TBD $9,625 $9,625 (+1K) $1.3K -

Total Cost N/A $387,613 $387.6K $379.3K -

REVENUE Volume @ YR1 1,241 755 755 (-113) 755 (-113) -

YR1 ASP $260 $379 $379 (-$57) $379 (-$57) -

YR1 Margin 70% (±15%) 75.7% 76% (-11%) $75.7% (-11%) -

YR1 Revenue 323K (±195K) $286,145 $286K (-28K) $286K (-28K) -8Design Control Guide



SMC Commitment

CTC/PRC Commitment

PCC Analysis

SCHEDULE DtC 03/20/2012 03/20/2012 03/20/2012 03/20/2012

SDC 11/06/2012 (+12 weeks)

03/5/2013 03/5/2013 03/5/2013

SMC n/a 06/11/2013 08/27/2013 08/20/2013

PRC n/a 10/31/2013 11/5/2013 11/5/2103

PCC n/a - 11/25/2013 11/25/2013

QUALITY CTQ1 Notes 1

CTQ2 Notes 2

CTQ3 Notes 3




SMC Commitment

CTC/PRC Commitment

PCC Analysis

RESOURCES Prog Mgt 0.05 (+0.02) 0.1 (+0.05) 0.1 (+0.05) 0.1 (+0.05) -

Prod Mgt 0.05 (+0.02) 0.1 (+0.05) 0.1 (+0.05) 0.1 (+0.05) -

R&D 0.58 (+0.2) 0.9 (+0.1) 0.9 (+0.1) 0.7 (+0.1) -

Man 0.03 (+0.01) 0.1 (+0.05) 0.1 (+0.05) 0.1 (+0.05) -

Quality 0.01 (+0.01) 0.1 (+0.05) 0.1 (+0.05) 0.1 (+0.05) -

Eng 0.03 (+0.01) 0.1 0.1 0.1 -

Total FTE/mo - 1.3 (+0.3) 1.3 (+0.3) 1.1 (+0.3) -

NPV 5 yr NPV $ - 224,553 224.6K 262.3K -

10yr NPV $ - 818,565 818.6K 912.1K -


PCP Deliverables


Decision to

Investigate

CONCEPT Decision to

Commercialize

DEFINITION Start Development

Checkpoint

DEVELOPMENT Start Manufacturing

Checkpoint

MANUFACTURING Confirmation Test

Checkpoint

CONFIRMATION Product Release

Checkpoint

COMMERCIAL Project Closure

Checkpoint

Program Management Project Charter

Risk Assessment

Intellectual Property

Position

Management Review

Integrated Project Plan &

Integrated Schedule

Product Requirements

Management Review

Management Review Management Review

Management Review

Management Review

Management Review

Product Management Business Plan

Customer Wants

Customer

Requirements

Design Review

Field Test Plan * (Alpha

and Beta)

User Documentation

Plan*

Management Review

Marketing Plan* Field Test Report (s) Marketing Materials

(Web, Hardcopy)

Development Technology

Assessment

Design Review

Product Specifications

Trace Matrix

Consolidated Test Plan*

Product Development

Plan*

Design Review

Verification Plan

Verification Protocol

Design Review

Verification Report

Design Freeze

Consolidated Test

Report*

Product Development

Report*

Validation Plan

Validation Protocol

Validation Report

Design Review

Operations Operations Plan* Operations Report*

Design Review

Quality & Regulatory Quality Plan*

Regulatory Plan*

Risk Management Plan*

Clinical Evaluation Test

Plan*

Risk Management

Report*

Clinical Evaluation

Test Report

Certificate of Analysis

Regulatory

Submission

Service & Support Service and Support

Plan*

Types of Design Control Reviews


PHASE REVIEW

The purpose of the Phase Review is for a PAC to determine if the project team has completed the requirements to exit the current phase and its readiness to enter the next Phase. The Phase Review date is requested by the Core Team.

EXCEPTION REVIEW

The purpose of the Exception Review is a structured interaction between a Core Team and the PAC when the contract boundaries are violated or are likely to be violated. The Exception Review date can be requested by either the Core Team or the PAC.

UPDATE REVIEW

The Update Review is a review between a Core Team and a PAC if the 2 parties identify a need to meet even if the project is within the boundaries of the contract. The Update Review is requested either by the Core Team or the PAC.

DESIGN REVIEW

The purpose of the Design Reviews is to review technical details of the program with the Core Team, extended team, and at least one Independent Reviewer. A summary of the Design Review is given at the next Phase Review.

Decision to Investigate (DtI)


R&D and Product Manager Lead Questions:

Customer Need-What is the hypothesized customer need (define the problem)?

Market Drivers-What market space does the customer need fit into?

Business Drivers-Comment on the strategic fit of this customer need.

User Centered Innovation (UCI)-plans to confirm the hypothesized customer need, market size, growth, and share.

Internal Technology- Do existing or potential technologies exist in development that could be applied?

Gap Analysis- What are the gaps between current technologies and the hypothesized customer need?

Baselining-Do baselining plans coincide with the User Centered Innovation Collection? What are the experimental plans & goals proposed between now and DtC/Decision to Commercialize?

Resources- What are the resource needs?

Schedule- What is the integrated schedule?

Decision to Commercialize (DtC)


Core Team Questions:

1. Do we have the resources and skill sets required to execute the proposed solution?

2. How does the plan fit with the business strategy?

3. Does this plan outline sufficient financial return?

4. How are top priority customer needs reflected in the business plan within the proposed technology?

5. Are the underlying product technologies feasible and available to use?

6. What components of the solution have already been commercially developed?

PAC Questions:

1. Is there a strategic, financial, and technical fit?

2. What assumptions drive profitability in the financial model and was finance involved?

3. What customer input do you have that validates the customer requirements driving your financial assumptions?

4. What infrastructure and resources are needed to execute?

5. Does this program still make sense and what is the level of importance?

6. What is the regulatory pathway for this program?

Design Control Purpose and Benefits


Purpose of Design Control:

1. The purpose od the design control subsystem is to control the product design process to assure devices meet user needs, intended uses, and specified requirements.

2. Design Control provides a common based approach to the development process which all products can follow.

Benefits of Design Control:

1. Customer satisfied with product appropriate for its intended use and meeting requirements.

2. Regulatory body satisfied.

3. Product delivered on time and repeat work minimized.

4. Efficient production processes..

5. Design History File can resolve post-launch identified issues.

6. Speedy execution with roles and responsibilities clearly defined.

7. ISO certification maintained.

8. Successful customer audits.

9. Facilitate regulatory approvals.

Quality Management System (QMS)


Change Control

Design Control

Corrective & Preventive

Actions

Material Controls

Facility Controls

Production Controls

Customer Feedback

Design Control is part of the QMS

Design Control Regulatory Standards

RUO Products:

• ISO 9001• ISO 13485

IVD Products:

21 CFR 820 ISO 13485 CE Marked ISO 14971 IEC 62304

A Design History File (eDHF) is created based on the regulatory standards.


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Design Control Deliverables Comprising eDHFDesign & Development Planning

Design Input Design Output

Design Reviews

Risk Management

Design Verification

Design Validation

Design Transfer

Design Changes

eDHF Index & PAC Review Records

Integrated Plan & Schedule

Customer Requirements

Product Specifications

Definition Phase Review

Risk Management Plan

Design Verification Plan

Design Validation Plan

Operation sReport

References to Design Change Records

eDHF

Product Development Plan

Product Requirements

Traceability Matrix

CR Review Risk Management Report

Design Verification Protocol

Design Validation Protocol

Product Development Report

Document Approval matrix

PAC Review Records

Operations Plan PR Review Hazard Analysis Template

Design Verification Report

Design Validation Report

Consolidated Test Report

Regulatory Plan Development Phase Review

dFMEA Field Test Plan

Quality Plan Design Verification Review

pFMEA Field test Report

Service & Support Plan

Manufacturing Readiness Review

Software Hazard Analysis

Clinical Evaluation Test Plan

Consolidated Test Plan

Manufacturing Validation Review

Clinical Evaluation Test Report

Design Control Guide 18

Design Control Procedures

Guidance Documents Procedures

Risk Management Procedures

Business Plan Integrated Project Plan and Schedule

Product Risk Management

Risk Management

Marketing and Launch Planning

Design Reviews Design Transfer Product Risk Management

Pre-Launch & Launch

Traceability Matrix Software Development Lifecycle

Hazard Analysis Work Instruction

Field Test Sites Product Approval Committee (PAC) Reviews

Electronic Design History File (eDHF)

Design/Use/Process FMEA

Design Verification & Validation

Customer Requirements, product Requirements, & product Specifications

Roles & Responsibilities

Product Commercialization Process

Product Risk Management


Content of eDHF Deliverables (1 of 3) INTEGRATED PROJECT PLAN:

Activities & Tasks Planned PCP Phases

Planned PCP Deliverables

Identify all planned exceptions and deviations

Interfaces Key meetings and attendees

Points of contact between various groups

Resources Core Team and key extended team members

Major equipment/materials needed for the development effort

SCHEDULE: Only high level project milestones and decision points to avoid constant updating of the plan.

Field Test Plan: The plan must identify the scope and purpose of testing, how the information will be used, and identify the customers and sites.

USER DOCUMENT PLAN: A plan for all the labeling material needed (user’s manual, product insert)

PRODUCT SPECIFICATIONS: Translation of the Product Requirements into end device; describes how the product satisfies the design input requirements in the Product Requirements.

TRACE MATRIX: The tractability from CR to PR to PS with a reference to the Verification & Validation reports and any Risk Mitigations.


eDHF Documents Content (2 of 3)

CONSOLIDATED TEST PLAN: This plan includes all planned evaluation activities; when testing will occur; who is responsible for testing; the scope of the testing; and it may consider verification testing, validation testing, stability testing, EMC/Electrical Safety testing, reliability testing, Shiping testing, Field Testing, and Clinical Testing.

PRODUCT DEVELOPMENT PLAN:

Planned Design Characterization and optimization activities;

Planned Design Reviews and their Scope

Key Development Extended Team members and their responsibilities

High level development milestones

Planned development iterations

If multi-sites are participating, what is expected form each site

Major equipment and materials needed for the development effort

PRODUCT DEVELOPMENT REPORT: captures results of the design characterization and optimization activities

OPERATIONS PLAN: Where will the product be made; Who are the critical suppliers; Who will create the DMR; How many will be built; How many will be built; How will the product be qualified; What are the dependencies; What information does Operations need from R&D or a successful transfer; How will the product be scaled up.

QUALITY PLAN: What Quality System will be followed; How will suppliers be qualified; Development team training plan;Quality metrics; Quality sustaining activities.


eDHF Documents Content (3 of 3)

PRODUCT SPECIFICATION (PS):

Consumables: Formulation; Chemical Properties; Kit configuration; Volumes

Instruments: Optical Properties; Electrical properties; Material Properties

Software: Screen Layout; Navigation; Algorithms

Design Inputs and Outputs


CR PR PS DMR

Triple Constraint of Quality Resources


Cost

Scope

Time

Verificaton Deliverable Requirements

Verification Test Plan

Traceability Matrix

Verification Protocol

Verification Report

Traceability Matrix


Verification vs. Validation


Verification Validation

Verify detailed requirements and specifications Validate use needs and intended use

Acceptance criteria found in PRs and PSs Acceptance criteria found in CRs

Production intent design: Design frozen and documented

Production intent design: DMR complete

Units do not have to be built by production Units built by production using final process

Verificaton: A detailed examination of aspects of a design at various stages in the development.

Validation: A cumulative summation of all efforts to assure the design will conform with user needs and Intended use, given expected variations in components, materials, manufacturing processes, and the use environment.

Validation Deliverable Requirements

Validation PlanTraceability

MatrixValidation Protocol

Validation Report

Traceability Matrix


Design ReviewA Design Review is a systematic assessment by experts of a specific design to:

Ensure that requirements have been captured correctly;

Identify and resolve technical issues;

Examine alternative designs and provide recommendations;

Provide feedback to designers on existing or potential problems;

Ensure the design is able to meet requirements, specifications, and standards;

Ensure the design has been transferred correctly;

Confirm the activity or phase has been completed in an acceptable manner and the next activity or phase can begin.


Design Review Occurrences


CR & PR Review Product Development Review

Design Verification Review

Design Validation Review

Manufacturing Readiness Review

Are Product Requirements Clear

Are design decisions likely to meet the product requirements

What issues did verification uncover

What issues were found during he Design Validation

Does manufacturing have all the information they need to start pilot production

Are there any conflicts in the requirements

What design alternatives have been considered

How will issues be resolved

How will issues be resolved

Have all the PS items been transferred to the DMR

Have tradeoffs been resolved

How can the design be improved

Is the product designed to be manufacturable, reliable, and serviceable

What issues have been found from preliminary testing

Are test procedures known and adequate

Design Review Record for eDHF

Type of Design Review

Date

Participants and their roles including an Independent Reviewer, Moderator, and Meeting Minute Keeper

Identification of Issues

Action Taken until the design addresses the design criteria

Issues Resolved

Signatures

Design Review Record with closure of action items are placed in DHF


Design Transfer

Ensure the device design is correctly translated into production specifications

Link between the design team and manufacturing

Ensures items in the PS have been implemented in the DMR

The design team reviews, approves, and issues product related documents

Manufacturing:

Reviews, develops, & issues supplemental process related procedures

Validates the manufacturing process and reduces variation

Produces the product


Process ValidationValidation

Process

Validation Plan (VP)

Equipment Qualification

Performance Qualification

(PQ)

Operational Qualification

(OQ)

Installation Qualification

(IQ)

Process Validation

Test Method Validation


Process Validation means establishing by objective evidence a process consistently produces a result or product meeting its predetermined specifications.

Validation Protocol Scope

Identify Requirement Number

Acceptance/Passing Criteria

Sampling Plan

Templates

Operating Conditions

Test Method Validation

Equipment Qualification

Statistical Analysis

Training Requirements

Methods to document any deviation form the plan and who would need to approve the deviation


Validation Report Materials and Methods

Summary of deviations and their impact

Identification of the design

Configuration of the design

Equipment

Dates of validation of activity

Traceability and manufacturing records (Device History Record)

Training documents

All paper and electronically generated result information

Statistical analysis

Do results meet pre-determined acceptance criteria

Storage of raw data

Conclusion and recommendations


Change Control Formal process in which changes to equipment, system, procedures, processes proposed by

staff planning them.

Changes justified and documented

All design changes verified and validation.

Reviewed by qualified representatives

Specified reviewer determines verification or validation requirement

Changes communicate through training

With Class III (PMA) devices, after initial FDA approval and launch most changes require a Regualtory Submission and approval before implementation.


Design History File Design History File (DHF)/electronicDHF (eDHF) contains the evidence Design Controls

were implanted

Documents in the DHF must be approved

Approval order is important:

Plans approved prior to activities occurring

Design Inputs approved before Design Outputs

Inputs and Outputs approved before verification

Test plans approved prior to initiation of testing

Deliverables approved in the phase required by the PCP and the Integrated Project Plan and Schedule
