Professional Documents
Culture Documents
Gideon Roth
V.P. Quality & Regulatory
Cabiran (1991) Ltd
Background
Product Development
Process
APQP phases
1 - Planning D 5 - Production
A
E
4 - Product Process
2 - Product Design & Development B
Validation
Product Development
Process
4 - Product Process
2 - Product Design & Development
Validation
4 - Product Process
2 - Product Design & Development
Validation
4 - Product Process
2 - Product Design & Development
Validation
Product Development
Process
APQP phases
1 - Planning 5 - Production
4 - Product Process
2 - Product Design & Development
Validation
APQP milestones
Phase 1 Planning: Activities
2
Procurement?
Are applicable regulatory requirements available? Evidence
Are customer requirements available including:
Project milestones and product delivery date
The
3 Projected volumes
Project lifecycle
Product and process assumptions
Marking following
Are all internal data to build product performance
expectations available including:
• Historical problems internal and external
• Warranty
slides
4
• Reliability requirements
• Quality requirements
• Technical Requriements
show the
Have lesson learned been conducted including:
• Best Practices
• Project management
principle of
5 • Quality issues
• Product design guidelines
• Process design guidelines
the SCMH
Is the company strategy available including:
• Business plan
checklists.
6 • Marketing strategy
• Industrial strategy Questions
• Technical strategy
Have the resulting project/product requirements
been referenced/recorded into a repository,
Each
7 including supporting data?
Data is made available to be used by the project
team?
phase has
it’s own
Is there a process to keep formal requirements
8 document up-to-date?
Has (Have) any potential risk(s) not highlighted by
9 previous question been identified? If no, describe
10
this risks?
Rating checklists
11
X 25% N/A Deliverable RYG Rating
IP 50%
Red: Some questions have a negative answer and no recovery plan is in place or the plans
25% - Action Identified 50% - Owner Identified identified will have an impact in program timing. Support is required. When an item is
Status (%): 75% R
75% - Action in Progress 100% - Action Closed highlighted Red an assessment on the impact to the WP timing needs to be provided.
100% Y Yellow: Some questions have a negative answer but a recovery plan is in place which will
G prevent impact
Green: All on timing
questions have a positive answer (Y) and are ongoing normal program development
Phase 1 Planning: Checklist
example – questions section
Table 1
Question
Was a a cross-functional team used to gather
project inputs including the following as applicable:
Y*
The questions are used to evaluate the quality of
the deliverable attached to the element.
Program Management, Quality, Design Engineering,
Manufacturing Engineering, Marketing and Sales,
Procurement?
Are applicable regulatory requirements available?
Red: Some questions have a negative answer and no recovery plan is in place or the plans
R identified will have an impact in program timing. Support is required. When an item is
highlighted Red an assessment on the impact to the WP timing needs to be provided.
Y Yellow: Some questions have a negative answer but a recovery plan is in place which will
G prevent impact
Green: All on timing
questions have a positive answer (Y) and are ongoing normal program development
Phase 1 Planning: Checklist
example table 2
Product Development
Process
APQP phases
1 - Planning 5 - Production
4 - Product Process
2 - Product Design & Development
Validation
APQP milestones
Phase 2 Product Design and
Development
• The purpose of this phase is to ensure design
features and characteristics are formalized and ready for
process design and development.
• During this process the intended production phases and
potential supplier used to realize the product are identified.
• During this phase the organization shall identify &review the
production process design input requirements, including:
– Product design records.
– Targets for productivity, process capability, quality, and cost.
– Customers and regulatory requirements, including customer demand
rate.
– Lessons learned.
Phase 2 Product Design and
Development: Activities
The phase includes the following:
• Turning product specifications into robust product definition
– Design risk analysis
– Design for Manufacture and Assembly (DFMA)
– Design for Maintenance, Repair, and Overhaul (DFMRO)
– Identification of product KCs
– Product error proofing
• Create BOM
• Conduct design reviews
• Validate and verify product design
• Conduct design record review at production
sources to evaluate manufacturing feasibility
Phase 2 Product Design and
Development: Deliverables
Product Development
Process
APQP milestones
APQP phases
1 - Planning 5 - Production
4 - Product Process
2 - Product Design & Development
Validation
Product Development
Process
APQP phases
1 - Planning APQP milestones 5 - Production
4 - Product Process
2 - Product Design & Development
Validation
Product Development
Process
APQP milestones
APQP phases
1 - Planning 5 - Production
4 - Product Process
2 - Product Design & Development
Validation
• Quality indices [e.g., CpK, Parts Per Million (PPM), rejection rates]
• Key Performance Indicators (KPIs) reflecting product quality and
reliability
• Evidence that project targets have been met
• On-time Delivery (OTD) and capacity KPIs
• OTD and capacity improvement plan
• MRO KPIs and plan(s) to reach the established targets
• Project closure recommendations
• Continuous improvement actions
• Lessons learned
• Updated design risk analysis, PFMEA, and control plans
Phase 5 On-going Production, Use, &
Post-Delivery Service: Outputs
Project closure
Personal view and experience
Inspection
IF NOT OK GO TO
move
store
Description
parts.
self inspection
The form had 4 symbols:
manufacture
RECEIVING look at control
Inspection
0 MATERIALS FROM step AA11 plan "Reaction
STORAGE plan" step 0
move
store
Circle – Manufacturing
Arrow – Move
Triangle – Storage
look at control
FMEA
Responsible / date
Current detection
Potential Causes
Potential failure
Actions done
Class
OCC
RPN
SEV
Occ
Sev
Det
Det
Wax certificated are
DELIVERY OF Supplier sends
Part failure 6 Human error 2 Visual Visual 8 96 checked prior to QA 6 1 2
WRONG WAX TYPE COT
shipment
FMEA
Responsible / date
Current detection
Potential Causes
Potential failure
Actions done
Class
OCC
RPN
SEV
Occ
Sev
Det
Det
Wax certificated are
DELIVERY OF Supplier sends
Part failure 6 Human error 2 Visual Visual 8 96 checked prior to QA 6 1 2
WRONG WAX TYPE COT
shipment
Control plan
Control method/instructions
Method and equipment
Requirements
Reaction plan
Frequency
KPC
KCC
Last phase was to assign a control plan for each of the >96
risks.
This tool exposed Cabiran in a structured process
to identify risks unknown or assumed to be not important.
Personal view and experience
Summary:
1. Cabiran does not design and therefore could perform only
APQP’s phase 3 and on.
2. The process helped focusing on risks and preventive
action that improved the process
3. The FMEA is a living document and should be maintained
constantly
4. Failure rate and scrap were reduced, supply improved and
process is more efficient.
Thank you