Root Cause Basics
NONCONFORMITY
RCA TOOLS
CORRECTIVE ACTION
QMS DOCUMENTATION
100

A problem that does not fulfill a requirement.

Nonconformity

100

Which type of nonconformity is an isolated failure that is not systemic?

Minor Nonconformity

100

This tool organizes possible causes into categories such as Man, Machine, Method, Material, and Environment.

Cause-and-Effect (Fishbone) Diagram

100

This action eliminates the immediate problem.

Correction

100

ISO 9001 now uses this term instead of "documents" and "records."

Documented Information

200

According to RCA principles, we should focus on improving this rather than blaming individuals.

The system or process

200

A complete breakdown of a management system requirement is considered what?

Major Nonconformity

200

This questioning technique repeatedly asks the same question to uncover deeper causes.

Five Whys

200

This action prevents the problem from happening again.

Corrective Action

200

Evidence that activities were performed is called:


 Retained Documented Information

300

This represents the visible part of a problem.

Symptom

300

A KPI target was not achieved. This is an example of what source of nonconformity?

Process Nonconformity

300

After identifying possible causes, this table is used to confirm which causes are actually valid.

Validation Table

300

Which tool is commonly used to compare several corrective action alternatives using weighted criteria?

Decision Matrix

300

Which document describes the specified way of performing a process?

Procedure

400

A recurring problem usually indicates this has not been properly identified.

Root Cause

400

A finding that is close to becoming a nonconformity but may not require RCA.

Audit Observation

400

In a Fishbone Diagram, which category would "SOP does not require verification" most likely belong to?

Method

400

Which analysis identifies forces that support and resist a proposed change?

Force Field Analysis

400

Which support document gives detailed instructions for performing one specific task?

Work Instruction

500

According to the training, a good root cause must be something management can ________.

Control or influence

500

This type of finding identifies practices that could be improved even if requirements are currently met.

Opportunity for Improvement (OFI)  

500

True or False:

Every possible cause identified in a Fishbone Diagram automatically becomes a root cause.

False

500

Before implementing a corrective action, what should always be confirmed?

That the true root cause has been verified

500

When a controlled document is revised, what should happen to the previous version?

It should be retrieved or marked obsolete according to document control procedures.

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