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System QSB First Step Fast Response PDF
System QSB First Step Fast Response PDF
Standardized Work
(Institutionalized)
Corrective Action
Corrective Action
Lessons Learned
Layered Process
Proof/Detection
Next
Implemented
Overall Status
Containment
Date (of
PFMEA / CP
Date Closed
Root Cause
Owner
Operator
Analysis
Updated
Verified
Report
Audits
Error
Issue Issue Date out to
Number Description Opened Unit I.D. # Owner Staff)
Material
Y 1 1/10/2005 333933 McGrath 4/29/2005 G G G G G G Y G Y Open
Contam inated
• External Concerns:
– Customer concerns (PRR’s, Liaison Issues, Customer Calls, Warranty)
– Supplier concerns (Suppliers should be notified in advance when they
are to report out at the meeting).
• Internal Concerns:
– Verification Station Findings
– Layered Process Audit Systemic issues
– Line stops and Teardown issues
– Other internal Quality concerns (Dock Audits, containment activity)
– Error Proof device failures
Each issue documented & reviewed at the meeting to provide structure for the
report out
properly status each item Target Timing, Status, & Date Green
24 H 7D 14 D 34 D 35 D 40 D
Containment - Breakpoint
Error Proof/Detection
Exit criteria shall be established for
Lessons Learned
Corrective Action
Corrective Action
(Institutionalized)
Implemented
each key step in the problem solving
Instructions
Validated
process.
Standard
Discrepancy
Actual
TIME
Need to determine
• Whether other areas or customers are impacted by the problem and to what
extent.
Cause Effect
Identify similar products and processes which potentially have or may produce the
same failure mode.
Implement the solution across the organization.
Update remaining necessary documentation:
– PFMEA
– Control Plan
– Error Proofing Verification
– Standardized Work
– Operator Instructions