WHAT

Material What are the supplied materials? Do they contribute to the making of nonconforming materials? How do you know the supplied parts are meeting requirements? Process Equipment/Tools How were the equipment/tools selected for the process? Are the equipment/tools for the job adequate and available when needed? How are equipment/tools for the job identified, controlled and maintained? What else needs to be in place prior to commencing the job?

WHO
Directly Involved Parties Who is setting the job up? Who is producing product? Who is determining the (inspection) status of the product? Who is determining the disposition of nonconforming product? Who is the process owner (responsible for managing the process)? Linkages/Interfaces with Other Involved Parties What Support Process personnel are involved? How? What supplier, customer or other external personnel are involved? How? How is competency determined for all parties involved?

OUTPUT INPUT
Identify what the customer wants/needs.

PROCESS
Name/Description List COP or Other Process Title

Identify what the customer gets.

Output Requirements (criteria and records) Input Requirements (specifications) List sources of product requirements (i.e. customer, organization & regulatory requirements documents). How were these requirements collected and reviewed for accuracy and completeness? Steps/Activities List Key Process Steps/Activities What output criteria are used to determine if what should have been produced has been produced? What measures are used to demonstrate or ensure product compliance? (see measures) Consider: - ppm - delivery performance - response time - time for returned product test/analysis - quality cost

MEASURES
Who decides what measures to use to judge this process? What are the metrics used to show if the process is effective? Why were these measures selected? How is data collected? Who does the analysis? How is it reported? How is data used to identify and resolve/prevent problems? What actions are taken based on the data collected? How are actions tracked to assess their impact? Has the corrective action worked?

HOW
Procedures/Control Documents How are the process control conditions defined (i.e. what work instructions, inspection instructions, control plans, procedures governing the control of nonconforming material, etc., exists)? Are they available and used? Where is the control methodology breaking down ? Support Processes What processes/systems are needed to support the work? (i.e. maintenance, housekeeping, logistics, storage, packaging, measuring, data analysis, etc.) Have any nonconforming materials been traced to support processes

WI 8.4-2 Turtle Guide Rev: 0 12/31/2010