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Learning Cafe Investigation
Transcript of Learning Cafe Investigation
•Review training records
•Review Device History Records (SFP, production logs, etc.)
•Review equipment maintenance and calibration records
•Review trends associated with events
•Review test data
•Review remainder of the batch or statistical sample of the batch to determine the scope
•If further issues found within the batch, review previous and in-process batches
•Review work instructions / SOPs
•Attempt to duplicate condition
•Review the process
•Review the risk documents Investigation Scope -Actions Taken to verify scope: in-process assessments, records review, interviews, etc.
-For product related NCEPs: Product spec non-conformance, quantity of product affected.
Hint! Is / Is not chart can be used to determine the scope Investigation Conclusion -Confirmation of actions taken to verify scope: in-process assessments, records review, interviews, etc.
-Confirmation of Data Sources reviewed
-Confirmation of Impact on product, on process, on function.
-Any additional containment action
-Investigation conclusion based on supportive evidence.
-Assignable cause Investigation Documentation Sources of data reviewed: DHRs, training records, interviews, calibration & maintenance records.
Impact to product form, fit or function: document how the product is affected by the non-conformance
Result of testing performed including any statistical analysis.
Hint! Use charts and graphical tools as possible
Overall conclusions: Make "data driven" decisions as possible.
Quality Notification: QN is required in Coyol for impacted product / raw material.
Quality Incident information: Include rationale for QI determination. If the event is not classified as Quality Incident a Rationale shall be included.
Hint! There is a template for Investigation attached to PDM Doc 90123526 Investigation Process Objective: Confirm the non-conformance, verify the scope and collect data to support actions and decisions in response to an event.
Input: Preliminary investigation details identifying the scope and type of issue, product risk documentation (ex. FMEA) and severity.
Analyze / Execute: Analyze issue types and associated risk to determine the type of action warranted in response to the event (ex. correction and / or escalation to corrective/ preventive actions)
Output: Documented objective evidence to support rationale for decisions and traceability to further actions. General Writing Tips 1. Make "Data Driven" Decisions as possible
2. Do not state your opinion in the investigation
3. Keep it simple: use short sentences and punctuation to keep ideas clear and simple. Introduce a single idea, concept or action per sentence.
4. Avoid over-capitalization. It can be tempting to capitalize particular words in a sentence just because they seem important, but this looks untidy and makes it hard to maintain consistency in a long document. Practice vs Procedure NCEPs Several NCEPs are closed using Assignable Cause: "Procedure not followed / Step omitted"...
If this is your case, please review attachment 1 of 90123526.
This is a guidance on how to confirm if the correct assignable cause is "Procedure not followed / Step omitted" or if there is another one more appropriate.
Additional Writing Tips 1. Avoid using aggressive descriptions:
(-) Hit return to reboot the system
(+) Press return to reboot the system
2. Use third person:
(-) You should run the installation script
(+) Run the installation script
3. Do not use exclamation marks Spanish - English false friends and other pitfalls 1. Dudas / Doubts: "Doubt" in english usually has a quite negative meaning. A better translation is "questions".
2. His / hers: In English, only people have a gender. Things are always neutral and take the possessive pronoun "its".
3. Avoid using names of people, addresses and other information that are not common in the English language.
4. Review / Revision:
To "review" means to read/study/see, or to evaluate something (e.g., to review a document by reading it)
To "revise" means to change something (e.g., you might revise a document after reviewing it). Questions?