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Select Design Situation: Lower Design Requirement (LDR) Only
Upper Design Requirement (UDR) Only
LDR & UDR
Estimated Sample Mean
Test Sample Mean:
Estimated Sample Standard Deviation
Test Sample Std. Dev.:
Lower Design Requirement
LDR:
Upper Design Requirement
UDR:
Minimum number of independent, random, and representative samples to be included in the test/inspection.
alpha = Probability that the Defined Proportion of Coverage is Not Covered.
Proportion Covered = Minimum Proportion of Performance Distribution to be Covered by Tolerance Interval.
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Analysis for Design Verification
Design verification involves the generation objective evidence to support the conclusion that the design is capable of meeting the requirements of its engineering input acceptance criteria - defined by the lower design requirement (LDR), the Upper Design Requirement (UDR), or both. Design verification is required by 21 CFR 820.30 (f), 21 CFR 820.250 (a) and (b) | ISO 13485 Sections 7.3.5, 8.1, 8.2.4.1, and 8.4 | ISO 9001-2013 Sections 7.3, 8.1, and 8.4 |
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Analysis for Process Validation: Process Capability Process validation involves the generation objective evidence to support the conclusion that the process is capable of repeatedly producing product that meets the requirements of the design specifications. Let it be assumed that in order to be deemed capable, a process must demonstrate a CpK that accepted by company policy. Process validation is required by 21 CFR 820.75, 21 CFR 820.250 (a) and (b) | ISO 13485 Sections 7.5.2, 8.1, 8.2.4.1, and 8.4 | ISO 9001-2013 Sections 7.5.2, 8.1, and 8.4 |
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