Quality Risk Questions For Batch Decisions
Use quality-risk questions to make batch decisions more scientific and proportionate.
Production says, "It passed final spec, so there is no quality risk." Use when one passing result is being treated as complete evidence. Your line The passing result matters. The risk question is whether this process signal could affect a quality attribute that the final test does not detect well. Arguing "spec versus no spec" instead of naming detectability. It respects the data while opening the detectability question. Release pressure Which question is stronger for a deviation? Compare Risk questions should make the uncertainty visible enough to reduce it. The three core risk-assessment questions What might go wrong? How likely…
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