Process Audit Preparation "Turtle Diagram" Product/Process Design

With Who?

With What?

FMEA Team
Multidisciplinary - APQP Team
Customer contacts
Design suppliers / contractors
Training dept or external

IT hard- & software

Product Design skills
Prototypes - ECR - SCUT
Competitor product analysis
Laboratories - Measuring & Testing equipment
Error proofing technique
Technological awareness

Inputs
Customer requirements
Customer special characteristics
Design input requirements
Avery manufacturing feasibility
Competitor analysis / field data
Acceptance criteria

How?
Design & Process FMEA
Design reviews & records
Product safety & Confidentiality
Change control
Quality planning process
Product approval process
Document & records control
Corrective/ preventive action
Analysis of data & Rejected product test

Process

Outputs

Product / Process design

Verified & validated design, meeting

customer requirements

Design planning
Design activity
Design output

(Support Processes)

What Results?

Sales process
IT processes
Human Resources
Laboratory processes
Warranty process
Communication process
Product approval process
Manufacturing process
Quality support

Design process objectives

Adherence to timing plans
Cost as planned ? & Cost reductions
FMEA Severity/RPN reduction
Targets for quality, life, reliability & durability
Internal audit results
Customer satisfaction
Management Review
P(P)AP approval from customers

How?
Design & Process FMEA
Design reviews & records
Product safety & Confidentiality
Change control
Quality planning process
Product approval process
Document & records control
Corrective/ preventive action
Analysis of data & Rejected product test

(Support Processes)

What Results?

Sales process
IT processes
Human Resources
Laboratory processes
Warranty process
Communication process
Product approval process
Manufacturing process
Quality support

Design process objectives

Adherence to timing plans
Cost as planned ? & Cost reductions
FMEA Severity/RPN reduction
Targets for quality, life, reliability & durability
Internal audit results
Customer satisfaction
Management Review
P(P)AP approval from customers