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The Record Behind the Decision / Unit 2
Lesson 3 · Judgment · Week 3
What do the results show?
Which statements in a release recommendation are measurements, and which are conclusions that need a basis on the record?
Start with the question
Every result on a release testing summary is within limit. The recommendation says the batch is consistent. Which of those words are measurements, and which carry the decision?
By the end of this lesson you should be able to:
- Sort the statements in a release recommendation into observations and conclusions.
- Name the assumption that sits between a passing result and a conclusion about the process.
- Recognize when a conclusion has no basis on the record.
- Write the observation, the conclusion and the assumption between them in three sentences.
Read
Read the article this lesson is built on (about 7 minutes): A Passing Result Is Not the Release Decision.
Watch
Transcript
A passing result answers the question the test was asked. It does not answer the question the release decision asks.
Picture a release recommendation for a synthetic batch. Every result is within limit. The unspecified impurity reads 0.09 percent against a limit of 0.10. The three batches before it read 0.04, 0.06 and 0.07. The recommendation says the batch is consistent, and that the increase is normal variation.
Sort the statements. The impurity result is a measurement. The comparison to the limit is a measurement. The last four values in order are a measurement. That the process is consistent, that the rise is normal variation, and that the batch is suitable for release are conclusions.
A conclusion is not wrong because it is a conclusion. It needs a basis on the record. The step between the number and the conclusion is the one nobody writes down, because everyone in the room made it the same way, instantly.
So write three sentences before you sign. The observation. The conclusion. And the assumption between them: here, that the rise is variation and not drift, and what evidence is on file for it.
When that evidence is on file, the conclusion has a basis. When it is not, the record should say it is not established.
Make the review answer four questions. What did each result measure? What did the conclusion claim beyond the results? What did it assume? And what is on file for each assumption?
Check what you took from it
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Apply it
Take one release recommendation you have read, or imagine one. Write three sentences before you sign:
- The observation: what the results measured.
- The conclusion: what the recommendation claims beyond them.
- The assumption between them, and the evidence on file for it.
Next: What else could explain the result?, where you work through a synthetic release case and make the judgments yourself.
If you want to go further
These already exist on this site. You do not need them to continue the lessons.
Check a batch release decision against what the results do and do not show.
$59Follow an out-of-specification investigation from first result to conclusion.
$149