Process Audit Preparation "Turtle Diagram" Product/Process Design
With What?
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
With Who?
Process
Product / Process design
Design planning
Design activity
Design output
(Support Processes)
Sales process
IT processes
Human Resources
Laboratory processes
Warranty process Targets for quality, life, reliability & durability
Communication process
Product approval process
Manufacturing process
Quality support
FMEA Team
Multidisciplinary - APQP Team
Customer contacts
Design suppliers / contractors
Training dept or external
Outputs
Verified & validated design, meeting
customer requirements
What Results?
Design process objectives
Adherence to timing plans
Cost as planned ? & Cost reductions
FMEA Severity/RPN reduction
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 Design process objectives
IT processes Adherence to timing plans
Human Resources Cost as planned ? & Cost reductions
Laboratory processes FMEA Severity/RPN reduction
Warranty process Targets for quality, life, reliability & durability
Communication process Internal audit results
Product approval process Customer satisfaction
Manufacturing process Management Review
Quality support P(P)AP approval from customers