Philips MR Product Development Launch and Maintenance BJP-030000

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Product Development Launch an

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Document ID: BJP-030000

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Contents

1. Purpose..........................................................................................................................................3
2. Scope..............................................................................................................................................3
3. References......................................................................................................................................3
4. Terms & Abbreviations...................................................................................................................3
5. Roles and Responsibilities..............................................................................................................4
6. PDLM Process.................................................................................................................................5
6.1. General process flow.............................................................................................................5
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6.2. Incorporating the Philips V-model.........................................................................................6

6.3. Applicability to Design control...............................................................................................6
6.4. Program Control....................................................................................................................7
6.5. Process Description................................................................................................................8
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1. Purpose
The purpose of this overall procedure is to define the set of interrelated processes and gates that
comply with the relevant standards and regulations for the development, launch and maintenance
of new/derived products (PDLM).

2. Scope
The scope of this procedure is the development, launch and maintenance of new/derived products
in the BU MR. Deviations from phase deliverables may occur depending on the type or scope of the
Project. When agreed upon by the Project core Team, those deviations shall be captured in the
Project management plan [PM].

3. References
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Ref Document id Title document

[DUBN] BJP-030001 Develop user and business needs and concepts
[FHLR] BJP-030002 Finalize High Level Requirements Designs and Plans
[DetD] BJP-030003 Detail Designs
[PrepM] BJP-030004 Prepare Markets
[InteP] BJP-030005 Integrate Product
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[VerD] BJP-030006 Verify Designs

[ValD] BJP-030007 Validate and Release Designs
[PrepL] BJP-030008 Prepare Launch
[MonL] BJP-030009 Monitor Launch
[DCP] QJP-031000 Design Control Procedure
[PM] QJP-031001 Design and Development planning procedure
[GMR] BJP-030030 Gate and Milestone Review Procedure
[ISC] BJP-030035 Integrated Supply chain readiness procedure

4. Terms & Abbreviations

Terms and Abbreviations Explanation
PDLM Product Development, Maintenance and Launch

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5. Roles and Responsibilities

Role Responsibilities
Executing the project charter and managing the cross functional
project according the PDLM Process and Philips (Generic) Project
Project Management
Management Process.
Managing project risks and stakeholders.
Defines and executes on the value proposition.
Defines user Needs (incl. claims).
Product Marketing
Updates the business case.
Defines integrated marketing brief and Marcom material.
Market Business Provides Market input and needs into the project.
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Marketing Management Prepares Market for launch.

(a.k.a. Field Marketing) Ensures initial customer order intake takes place.

Provides user knowledge and executes validation (incl. clinical trials)

against user needs.
Application
Defines learning material (Directions for Use / Instructions for Use,
etc.) .
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Defines and creates the Experience design of the product and/or

DE Designer service bringing in different disciplines/competences from the Philips
design function.
Establishes the business needs and product requirements.
Development
Develops the product, performs safety risk assessment and verifies the
Engineering
product against the product requirements.
Ensures the use of applicable regulations and standards and supports
product approbation and country clearances.
Regulatory Operations Supports the project team in interpreting the applicable standards and
to translate the applicable standards into User Needs, Business Needs
and product requirements.
QR Product Quality Ensures planning of all quality assurance activities.
Engineering
Ensures the product can be serviced during the life time of the
Customer Service
product.
Supply Chain manager Defines and creates the supply chain set-up.
(SCM) Translates customer orders to volume planning and ships products.
Manages end to end in-house and out-sourced industrialization
Product Industrialization
activities. Accountable for both in-house and out-sourced
Project Manager
manufacturing designs.
Defines and creates the in-house manufacturing designs, executes
Product Industrialization
engineering and pilot runs for in-house manufacturing and qualifies
Engineer
and releases the in-house Manufacturing processes.
Supplier Quality Engineer APQP execution lead.
Coordinates supplier involvement and supplier selection together with
Procurement Engineering commodity management based on a project sourcing plan.
Leads design for excellence activities.

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6. PDLM Process
6.1. General process flow
The process flow below provides a high level overview of the project phases, gates and
milestones in PDLM.
 Each project phase includes a set of defined deliverables designed to establish the desired
level of management control. The end of a program phase is marked by an ISC pre-gate
review, milestone review and gate, in order to determine whether the program can continue
into its next phase.
 Design Control activities will be executed according to [DCP].
 The phases and milestones as described in this procedure do not mandate a serial
development process nor does it discourage parallel or concurrent activities.
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A Milestone is a significant point or event in a project that marks a formal review/consensus that the
project has or has not complied with all requirements and deliverables for the phase under review.

A Gate is a significant point or event in a project that marks a formal decision on continuation of the
project (Go, Recycle, Hold, Kill) by the Project Core Team, based on project results and business
judgement. Each Gate is preceded by a Milestone and Integrated Supply Chain (ISC) pre-gate review
[ISC]. The integrated Supply Chain (ISC) pre-gate review checks the performance of the project in the
current PDLM phase by monitoring the ISC KPIs associated with this phase. The milestone review
with the same name, checks completeness of the deliverables in accordance with the Gate and
Milestone Review process [GMR].

Note: Detailed description of the activities per PDLM phase can be found in Table 1 of Chapter 6.5

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6.2. Incorporating the Philips V-model

The Philips V-model is used to describe and trace PDLM deliverables at the level of business,
product, subsystems and components. The V-model is mapped on the phases of PDLM as depicted in
the figure below.
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Disclaimer: This picture above contains both Design Control and Business relevant elements. The
V- model relevant for a QMS perspective (DHF) is captured in the Design Control Process (V- model
according to Design Control [DCP].

6.3. Applicability to Design control

The picture below describes the relation between PDLM phases and the design control process.
Details about design control can be found in the design controls procedure [DCP]. The required
activities for design controls are included in the PDLM process and captured within the PDLM Master
List (which includes the DHF and DMR index). By executing the tasks of the PDLM process (and the
general enabling processes Project Management, Change Management and Risk management) and
by capturing the process output will result in compliancy with medical regulations.

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Disclaimer: This picture above illustrates a high level mapping between PDLM phases and Design
Control phases. The activities can start and end earlier or later than depicted above.

6.4. Program Control

All PDLM activities are carried out in compliance with the applicable Quality System Regulations as
defined in the Quality Manual. To ensure top level control of all PDLM programs the following rules
shall always be applied.
 (Product) Configuration management will be planned and coordinated by the program team.
 All documents that are identified as deliverables of each PDLM Phase shall be put under formal
change control.

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6.5. Process Description

The items in the process flow in Section [6.1] are described in Table 1.
Activity Description
Project Initiated The project team is installed and has a clear understanding of the
project charter and related program information. The project team is
(gate PI) prepared and committed to start. The project KPIs (including O2C KPIs
are reviewed, approved and included in the project charter).
Develop user and Develop cross functionally the integrated and balanced set of business
business needs and and user needs, create the concepts to meet these needs and check
concepts. whether these are in line with the value proposition.
See [DUBN]
Concepts and initial VPA: Value Proposition Agreed
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product requirements
Gate: The formal decision has been taken by the Sponsor on
(gate VPA) continuation of the project, based on the project results and business
judgment.

Milestone: The integrated and balanced set of business and user

needs have been defined. The integrated concepts (e.g. product
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concept, experience design direction, supply chain concept and

manufacturing concept) have been chosen. The initial project
management plan has been defined.

The value proposition can be met.

Note: Design Control has started.
Finalize high level Translate the user and business needs into requirements for product,
requirements, design and service, manufacturing, service operations, supply chain and
plans marketing. Create architectures and finalize high level designs. Define
and plan the activities to develop and launch the new product.
See [FHLR]
High level product design PDC: Product Design Committed
and plans
Gate: The formal decision has been taken by the Sponsor on
(gate PDC) continuation of the project, based on the project results and business
judgment.

Milestone: The requirements for product, service, manufacturing,

service operation, supply chain and marketing are defined. The high
level technical designs are finalized, cross functionally balanced and
checked on cost and quality aspects. The high risk items have been
mitigated.
All plans (e.g. verification, validation, launch, service) are in place.
Detail designs Create detailed designs for product, service, manufacturing, service
See [DetD] operations and supply chain.
Prepare markets Refine and localize the market offer in terms of timing, pricing,
marketing and training material.

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See [PrepM] Finalize the long term volume planning per market.
Detail product design PLC: Product Launch Committed

(gate PLC) Gate: The formal decision has been taken by the Sponsor on
continuation of the project, based on the project results and business
judgment.

Milestone: Detailed designs (e.g. product, tooling, equipment) are

finished and are ready for ordering and installation.
Product launch dates are committed to the markets (Philips internal)
Integrate product Realize manufacturing equipment and service delivery means, and
perform engineering runs. Verify components and subsystems and
See [InteP] integrate product.
Product verification plan SVER: Start Verification
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(gate SVER) Gate: The formal decision has been taken by the Sponsor on
continuation of the project, based on the project results and business
judgment.

Milestone: Components and subsystems are integrated and verified.

The product, manufacturing, service operations and service are ready
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to be verified.
Verify designs Perform manufacturing pilot run and service verification run. Verify
product, manufacturing process, service operations process and
See [VerD] service.
Verified product SVAL: Start of Validation

(gate SVAL) Gate: The formal decision has been taken by the Sponsor on
continuation of the project, based on the project results and business
judgment.

Milestone: The product, manufacturing, service operations and service

are verified against the requirements.
Validate and release Perform manufacturing pilot run and service validation run. Validate
designs product, manufacturing process and service operation process.
See [ValD]
*Obtain regulatory approval / Prepare regulatory submission and
release supply chain.
Launch materials RFA: Released for Acquisition

(gate RFA) Gate: The formal decision has been taken by the Sponsor on
continuation of the project, based on the project results and business
judgment.

Milestone: Sales people are trained and allowed to make quotations

for end customers in specific market(s) which have received the
necessary regulatory approvals.
Risks are acceptable to start acquisition before Release for Delivery.

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Supply chain released Supply Chain Released

(gate SR) Gate: The formal decision has been taken by the Sponsor on
continuation of the project, based on the project results and business
judgment.

Milestone: The product has been validated against the user needs. The
manufacturing process and service operation process are proven to be
scalable and repeatable with managed output quality.
The supply chain is fully released and ready to take customer orders.
Manufacturing of launch volumes can start.
Prepare Launch Start manufacturing and service delivery and release for delivery
(Note, this phase is a.k.a.
Release for Delivery)
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See [PrepL]
Released Product for RFD: Released for Delivery
shipment to customers
Gate: The formal decision has been taken by the Sponsor on
(gate RFD) continuation of the project, based on the project results and business
judgment.
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Milestone: Launch volumes are available and the Market Introduction

is on schedule to achieve the intended Launch Date. Service
organization is ready.
Products can be handed-over to customers in markets that have been
released.
Monitor launch Monitor product quality, volume manufacturing and delivery of
service. Improve product, manufacturing and service up to agreed
See [MonL] targets in the charter. Transfer maintenance to the "Launch to End of
Life team ". Perform a cross functional evaluation and document
learnings.
Launched product PC: Project Closed

(Project Closed) Gate: The formal decision has been taken by the Sponsor on closing
the project, based on the project results and business judgment.

Milestone: The project targets have been met. The project evaluation
is done. The project team formally closes the project.

Table 1: Process Description of PDLM

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Revision History

Training Level
Rev Description 0/1/2/3 (see QJP- Author Date
080001)
01 Initial Version for PDLM 2 Arjan Simonetti 23-Nov-2017
02 Clerical change in the Figure in section 6.3 0 Arjan Simonetti 12-Dec-2017
Include PDLM 9.6 requirements. Clerical 0
updated roles & responsibilities of Product
Industrialization (PI) Project Manager and PI
03 Arjan Simonetti 17-Jun-2019
Engineer for BU-MR. Added Reference to ISC
pre-gate review alongside milestone and
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gate reviews.
04 Included a reference to ISC procedure. 0 Arjan Simonetti 12-Sept-2019
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Owner

Process Owner Project Management

QA Approver Head of Q&R MR

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