The document discusses managing non-conformities through effective corrective and preventive action. It defines problems, non-conformities, sources of quality problems, and the difference between symptoms and causes. It then defines corrective action as action taken after a non-conformity to address the root cause, while preventive action is proactive in identifying potential issues. Effective corrective and preventive action requires understanding systems, variation, theory, tools like the PDSA cycle and 5 Whys, and applying a problem-solving process.
2. PROBLEMS AND NON-CONFORMITIES
A problem is an undesirable deviation from an expected desirable outcome
A non-conformity is a non-fulfillment of a stated requirement(s)
A non-conformity is a problem
SOURCES OF QUALITY PROBLEMS
Customer or employee complaints and satisfaction data
Products noncoformances
Management review
Process measurement e.g EQA
Supplier problem
Internal and external quality audits
3. SYMPTOMS OR CAUSE?
SYMPTOMS; ANY CIRCUMSTANCES, EVENT OR CONDITION THAT ACCOMPANIES
SOMETHING OR INDICATES ITS EXISTENCE
CAUSE; A SITUATION THAT PRODUCES AN EFFECT
4. CORRECTIVE PREVENTIVE ACTION
DEFINITION
CORRECTIVE ACTION: ITS AN ACTION TAKEN AFTER A NON-CONFORMITY HAS
OCCURRED TO REMOVE THE ROOT CAUSE OFTHE NON-CONFORMANCE AND
PREVENTS IT FROM REQURRING FOREVER
PREVENTIVE ACTION: A PROACTIVE PROCESS OF IDENTIFYING POTENTIAL NCs
ANDF TAKING ACTION BEFORE NON-CONFORMITY OCCURES TO PREVENT IT
FROM EVER OCCURING
IMMEDIATE ACTION: ACTION TAKEN AT THE TIME OF THE NONCONFORMITY TO
MITIGATE ITS IMMEDIATE EFFECT
5. REQUIREMENT OF CORRECTIVE AND
PREVENTIVE ACTION
CORRECTIVE ACTION: SHALL BE APPROPRIATE TO THE EFFECT OF THE NONCOFORMITY
REVIEWING NONCONFORMITIES
DETERMINE THE ROOT CAUSES
EVALUATING THE NEED TO CORRECTIVE ACTION TO ENSURE THE NONCONFORMITIES DO NO RECUR
DETERMINING AND IMPLEMENTING CORRECTIVE ACTION NEEDED
RECORDING THE RESULTS OF CORRECTIVE ACTION
REVIEWING THE EFFECTIVENESS OF THE CORRECTIVE ACTION TAKEN
PREVENTIVE ACTION: SHALL BE APPROPRIATE TO THE EFFECT OF THE NONCOFORMITY
REVIEWING NONCONFORMITIES
REVIEW LABORATORY DATA AND INFORMATION TO DETERMINE WHERE POTENTIAL NCs EXIST
DETERMINING THE ROOT CAUSES OF POTENTIOAL NCs
6. CONTINUATION
EVALUATING THE NEED FOR PREVENTIVE ACTION TO PREVENT OCCURRENCE OF NCs
DETERMINING AND IMPLEMENTING PREVENTIVE ACTION NEEDED
RECORDING THE RESULTS OF PREVENTIVE ACTION TAKEN
REVIEWING THE EFFECTIVENESS OF THE PREVETIVE ACTION
7. SYSTEM (WHAT IS A SYSTEM)
AN INTERCONNECTED COMPLEX OF FUNCTIONALLY RELATED COMPONENTS
THAT WORK TOGETHER TO TRY TO ACCOMPLISH THE AIM OF THE SYSTEM (BY
DR DEMING)
8. UNDERSTANTING HOIW TO EFFECTIVELY IMPLEMENTING A
CORRECT OR PREVENTIVE ACTION DEPENDS ON
UNDERSTANDING THE FOLLOWING
UNDERSTANDING VARIATION
COMMON CAUSE VARIATION; PROBLEMS BUILT INTO THE SYSTEM E.G
MISTAKES
SPECIAL CAUSE VARIATION: UNIQUE EVENTS THAT IS OUTSIDE THE SYSTEM
E.G NATURAL DISASTERS
THE BEST WAY TO DEAL WITH THESE IS TO CONTROL COMMON CAUSE VARIATION
AND ELIMINATE SPECIAL CAUSE VARIATION. DISTINGUISHING THE DIFFERENCE
BETWEEN THE VARIATION IS KEY.
WITHOUT KNOWLEDGE OF VARIATION ACTION MAY BE TAKEN WITH BEST
INTENTIONS, BUT ACTUALLY MAKING THINGS WORSE
9. THEORY OF KNOWLEDGE
TEACHES US THAT A STATEMENT ; CONVEYS KNOWLEDGE, PREDICTS THE
FUTURE OUTCOME, WITH THE RISK OF BEING WRONG, AND THAT IT FITS
WITHOUT FAILURE OBSERVATION OF THE PAST.
Rational prediction require theory and builds knowledge through systematic
revision and extension of theory based on comparison of prediction with
observation
Again without theory, there is nothing revise. Without theory experience has
no meaning. No questions to ask without theory.
10. PDSA CYCLE
Plan; plan a change in a process aimed at continuous improvement
Do; Carry out the change
Study; study the results to determine if the change improved the process
Act; if appropriate, adopt the change
11. PROBLEM SOLVING PROCESS
5 STEP PROBLEMS SOLVING PROCESS
1 DESCRIBE THE PROBLEM
2 INVESTIGATE THE CAUSE
3 SELECT AND TEST SOLUTIONS
4 IMPLEMENT THE SOLUTIONS
5 VERIFY AND MONITOR THE SOLUTIONS
PROBLEMS CAN BE SOLVED USING THE TRIAGE APPROACH, ESPEACIALLY WHEN
THEY ARE TOO MANY. IT IS NOT PRACTICAL TO INVESTIGATE EVERY PROBLEM
CRITERIA MUST BE SET, FOR PRIORITIZING PROBLEMS FOR FULL INVESTIGATION
12. PROBLEM SOLVING TOOLS
THE BASIC PROBLEM SOLVING TOOLS
BRAINSTORMING
BRAIN WRITING
5 WHYs
CAUSE AND EFFECT DIAGRAM
CHECK SHEET
PARETO DIAGRAM
RUN CHART
13. THE EFFECTIVESS OF PROBLEM SOLVING
TOOLS DEPENDS ON KNOWLEDGE OF WHEN TO
USE THE TOOLS
BRAINSTORMING
WHEN IT IS IMPORTANT TO GO BEYOND THE OBVIOUS
WHEN IT IS IMPORTANT TO ENSURE THAT ALL IDEAS ARE DISCUSSED
BRAIN WRITING
WHEN ISSUES ARE TOO DIFFICULT OR EMMOTIONAL FOR PEOPLE TO VERBALLY
EXCHANGE IDEAS
WHEN AVOIDING GROUP THINK
WHEN SESSIONS ARE DOMINATED BY A FEW MEMBERS
14. CONTINUATION
5 WHYs
WHEN THERE IS NEED TO LOOK FOR THE ROOT CAUSE
WHEN THE CONTRIBUTING CAUSES ARE CONFUSING
WHEN A VISUAL TOOL IS NEEDED TO EXPLAIN THE CAUSES TO OTHERS
RUN CHART
WHEN SHOWING THE EVOLUTION OF A SITUATION OVER TIME
PARETO DIAGRAM
WHEN TRYING TO FOCUS ON THE MOST SIGNIFICANT PROBLEMS OR CAUSE
15. 4W/2H/1C
PROBLEMS FORMULA
WHAT; WAS AFFECTED
WHERE; DID THE PROBLEM TAKE PLACE
WHEN; WAS THE PROBLEM DISCOVERED
WHO; DISCOVERED THE PROBLEM
HOW MUCH; WAS AFFETED
HOW OFTEN; HAS THE PROBLEM OCCURED