Medical Device Validation (DQ/IQ/OQ/PQ)
Medical Device Validation plays a key part in medical device manufacturing, and is equally key here at Empire Precision.
The 10 Steps to DQ IQ OQ PQ Medical Validation in Injection Molding
At Empire, there are 10 steps to a complete Medical Plastic Part / Assembly Validation. These 10 steps are broken down into checklists to verify all substeps are getting properly completed. The completed DQ-IQ-OQ-PQ package is then approved by the Customer. In some cases, Customers have their own Validation package, in which case we will submit their package along with ours.
DQ is "Design Qualification", Empire steps 1 and 2.
Step 1: Part Design - refers to things like Nominal walls, Corner Radii, Proper Draft Angles, Projection vs. Nominal Wall, Depressions / Features (Weld Lines, Core Pins, Proper Draft), Advanced Items, Gate Location, Ejector Style, Parting Lines, Direction for flash (At Core Pins, Tool shut-off areas), CTF Dimensions, etc.
Step 2: Mold Design and Build - CAD Model, Design Creation, Designing for Scientific Molding, Ejector Style, Parting Lines, Direction for flash (At Core Pins, Tool shut-off areas), CTF Dimensions, etc.
IQ is "Installation Qualification", Empire steps 3 and 4.
Step 3: Mold Inspection - refers to things like Markings (Asset tagging, engraving, cavity numbering, etc), Cavity / Core Surface and component Quality (Free of undercuts, pitting, blemishes, nicks, chipped edges Slides have positive locks, stops, grease, function easily, clear part, etc), Mold Base (Fits in press, KO rods, pry bar slots, mold plate chamfer, Correct wiring & functionality for hot runners/sprues, etc)
Step 4: Molding Machine and Auxiliary Equipment - refers to things like Selecting proper specification for molding machine, Select appropriate auxiliary equipment (Blenders, Dryers, Water Units, Process Monitoring, etc), Analyze and/or establish preventative maintenance requirements, Establish process monitoring parameters (Times, Temperatures, Pressures, Cushion, etc).
OQ is "Operational Qualification", Empire steps 5, 6, 7, and 8.
Step 5: Mold Installation and Dry Cycle - refers to things like Documented production folder (Process setup sheet, water diagram, temperature and flow rates, hot runner connections, etc), Mold installation (Location, level, ejector rods, etc), Mold Dry Cycle (Verify mechanical actions and slides), Verify there are no fundamental flaws (Mold build, mold design, cooling channels etc)
Step 6: Scientific Molding Principles - refers to things like Initial Process determination, Establish first shots, Rheology Study, Mold cavity balance, Pack pressure latitude, Gate seal, Cool time optimization, Designed Experiments, etc.
Step 7: Steel Safe Adjustments - refers to things like Optimal Process Setup (As a result of step 6), Achieve steady state, Run parts for quality submission, Submit to quality for 100% and Capability Study, Evaluate inspection reports, Make steel modifications from inspection analysis, etc.
Step 8: Verification Run - refers to things like Set back to optimized process (As a result of step 6) Achieve steady state, Run parts for quality submission, Submit to quality for 100% and CAP Study, and Evaluate inspection reports (Are parts good? If yes continue, otherwise back to tool room). Run OQ which is testing the limits of the process to in turn test the limits of the part specification, Send OQ parts to customer for approval of ALL parts, etc.
PQ is "Production Qualification", Empire steps 9 and 10.
Step 9: Extended Acceptance Run - refers to things like Documenting production folder, Determining (with help of Customer) the required length of run (in hours) needed for PQ (This is typically 4 to 24 hours), Set to Optimal Process, and start the production run. This is treated as a standard production run. The idea is to run this production the same way it always runs, let the production floor do their thing! It should not be treated as a special run. All inspection is done according to procedures, and collect enough data to develop Capability Studies on all CTF’s Submit parts for Customer Approval, with all supporting data required.
Step 10: Approvals - refers to things like parts passing first article inspection, parts pass visual and functional testing, Mold achieves a minimum Cpk or better on all CTF dimensions, Mold is running at or faster than the quoted cycle time, Steel inspection dimensions received & in specification, Spare component steel within range of steel measurements in the mold, Production Folder is complete, Customer Approval is received
Validation Checklists
Where do we use Validation Checklists? On Medical devices and parts (old and new), new build tooling, and Transfer Tooling. There are over 200 check boxes on Empire Precision’s DQ/IQ/OQ/PQ checklist. The completed checklist is part of APQP (Advance Product Quality Planning).