Tuesday, September 20, 2022

Test case examples from my V&V webinars:

IQ:


Activity Completed       Signed/Dated (or N/A’d)

        01. Utilities: 

o   Power Hooked Up Properly       _____________________
o   UPS required/added       _____________________
o   Air Hooked Up Properly       _____________________
o   Surge Tanks required/added       _____________________
o   Water Hooked Up Properly       _____________________
o   Incoming Air Filtered       _____________________
               o   Incoming Water Treated/Filtered   ___________________
o   Exhaust Air/Oil Controlled             _____________________
o   Spent Water Controlled       _____________________

       02. Equipment/Tool/Fixture Number Assigned/Affixed       _____________________

03. Instruments Calibrated or NCI Tagged       _____________________

04. Safety/OSHA Requirements Addressed       _____________________

    05.   Documentation (Dwgs, Software...) Received       _____________________

06. Floor/Area Layout Approved       _____________________

07. Environmental Testing Completed/Acceptable       _____________________

           08.    SOP’s Written/Approved                 _____________________

09. Meets QS Regulation requirements       _____________________

           10.   PM Program/Spare Parts       _____________________

11. Process Control Required/Addressed       _____________________

Comments: __________________________________________________________________ 


OQ:

Verify proper blow molder heating, shot injection / size (no short shots), “preforms”:

Verification Element

Expected Outcome

Observed Outcome

Heater elements inj. barrel; screw cycle / operation.

Screw / injection cycle.

 

“Preforms” properly configured; no molding anomalies / non conformances.

 

“Preform” ejections.

Resin achieves proper melt.

 

Proper shot size.

 

“Preforms” / cap interface to spec.  No short shots, splay, black specs, thin walls, et al.

 

“Preforms” ejected properly and without damage.

 

Tested by:  ___________________     Date:  ______________

                                     Verified by:  __________________     Date:  ______________


PQs (3 or more):


Similar to the above but the test case "elements" are replaced with repetitive samples (e.g., 10, 30 125, or ...).

-- jel@jelincoln.com


























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