Transcript Process Control Audit

Problem Reporting & Resolution
What are the Key Steps of the Problem
Reporting &Resolution Process?
 Step 1- Problem Identification
– Give a detailed description of the problem and its impact

Step 2- Supplier’s Initial Response & Containment
– Actions required to ensure that the customer is protected from receiving
further nonconformances
– Response required within 1 Business Day

Step 3- Delphi Accepts or Rejects Initial Response
– Reply required within 1 Business Day

Step 4- Supplier Determines the Root Cause
– Detailed investigation of what caused the problem. Delphi prescribes 5 why
as the tool to determine root cause

Step 5- Supplier Develops Corrective Action/Solution
– Actions taken to eliminate the root cause
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Problem Reporting & Resolution
What are the Key Steps of the
Problem Resolution Process?

Step 6 - Supplier Implements and Verifies the Corrective Action
– Detail of dates and plans for implementation and verification that the
corrective action is effective
– Supplier Final Response required within 15 calendar days
– Supplier may submit an Extension request
New

Step 7 - Delphi Accepts or Rejects Final Response
– Reply required, including Extension request, within 2 business days
 Step 8 - Supplier Provides Verification Evidence
– Data, gate charts, pareto charts, or others as requested

Step 9 - Delphi Evaluates Verification Evidence
– Accepts or rejects response based on the verification evidence

Step 10- Delphi Closes the PRR

Full PRR cycle within 30 calendar days!!!
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PRR Response Flowchart
Supplier Problem Identified
SQ involvement also
based upon plant requests
Owner(Delphi) Issues PR/R
Major Disruption, Repeats,
Customer Impacted
yes
Start
Involve SQ, PC&L, Other Stakeholders
as appropriate
no
Supplier Initiates Containment &
Provide details
1 business day
Owner Provides feedback to Supplier
Owner Reviews
Supplier’s Response
reject
accept
Supplier’s Final Answer
including 5 Why
1 business days
Extension Request
Owner or SQ Provides
feedback to Supplier
Owner (with SQ for MD,
Repeats, CI) reviews RC,
CA, and Implementation
Plan
Any item
rejected
15 calendar days
2 business days
All
accepted
After Implementation, Supplier will
provide at Delphi’s request 15 days of
Verification evidence
Timing based on
agreed upon
Implementation
Date
reject
Owner reviews
Data
accept
Owner closes PRR
PRR Training
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30 calendar
days
November
6, 2001
PRR Responsiveness
 The new PRR process was designed to reduce the
cycle time from PRR issuance to closure
 The new PRR system (Covisint Problem Solver) will
monitor PRR responsiveness of the Supplier and Delphi
 Supplier response requirements:
– Initial Response - 1 Business Day
– Final Response - 15 Calendar Days
– Extended Request - As approved by Delphi
 Delphi response requirements:
– Supplier’s initial response reply- 1 Business Day
– Supplier’s final response reply - 2 Business Days
– Final Closure - 30 Calendar days if no extension
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Problem Reporting & Resolution
Guidelines for Effective Problem Solving
Become familiar with the situation and the related systems
Provide a sufficient amount of detail
Be clear and to the point
Be sure you eliminate the opportunity for misinterpretation
Documentation!
Communicate, communicate, communicate
Avoid using acronyms (e.g. PCP= Process Control Plan)
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5 Why Analysis
Effective Root Cause Analysis
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5-WHY TRAINING AGENDA
Where
does 5-Why Fit within the PRR
process
Understanding
Quick
5-Why Exercise as a group
Critique
5-
of 5-Why
Sheet
Why Examples
Wrap
Up/Discussion
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5-WHY
Where does it fit within the PRR process?
 After
a supplier has submitted an initial response and
containment plan (Step # 2 in the PRR process), a detailed
investigation is necessary to determine what caused the
problem. Step # 4 (Supplier determines the root cause) requires
a 5-Why analysis to help in identifying the root cause of the
problem.
 Going
back to one of the elements within the Purpose of a
PRR “to facilitate problem resolution”, 5-Why is the prescribed
tool for determining the root cause of the problem to facilitate
problem resolution.
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5-Why Analysis Three Paths
5-Why:
•
Specific problem:
•
•
Problem not detected:
•
•
Why did we have the problem?
Why did the problem reach the Customer?
System failure:
•
Why did our system allow it to occur?
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5-Why Analysis Process
PRACTICAL PROBLEM SOLVING MODEL
5-Why Funnel
G
R
A
S
P
T
H
E
S
I
T
U
A
T
I
O
N
PROBLEM IDENTIFIED
(Large, Vague, Complicated)
Problem Clarified
Basic Cause/Effect Investigation

C
A
U
S
E
I
N
V
E
S
T
I
G
A
T
I
O
N
Area of Cause Located
Where in the process
is the problem occurring?
Point of Cause
(PoC)
“Go See” the problem.
Why? 1
Cause
Why? 2
Cause
Why? 3
Cause
Why? 4
Cause
Why? 5
5-Why Analysis
Investigation of Root Cause
Why did we have
the problem?
Why did it get
to the customer?
Why did our
“system” fail?

Root Cause

Corrective Action

Lessons Learned
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5-Why Analysis Chart
Corrective Action
with Responsibility
Date
Define Problem
Use this path for
the specific
nonconformance
being investigated
A
Root Causes
WHY?
Use this path to
investigate why the
problem was not
detected.
WHY?
WHY?
B
WHY?
WHY?
A
Use this path to
investigate the
systemic root cause
WHY?
WHY?
C
Ref. No. (Spill, PR/R…)
WHY?
WHY?
B
Date of Spill
WHY?
Customer
Product / Process
WHY?
Delphi Location
Content Latest Rev Date
WHY?
C
Problem Resolution Complete
Lessons Learned:
PRR Training
Communicate to Customer Date:
Process Change Break Point Date:
Implement System Change Date:
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Generic Information for 5-Why Example: Regular
Cola Soft Drink vs. Diet Cola
Quick 5-Why Exercise as a group
•The plant received a PR/R from a customer. (We use 5-Why Analysis to
answer every PR/R.)
•The PR/R states that the customer received “Regular Cola in the right container
(same for both products) with the Diet Cola label”. The order called for Regular
Cola.
•The plant has two identical lines that are capable of running either of our two
products. The lines are located immediately beside each other. The only
differences in the products are the syrup and the labels.
•The plant runs both lines 24 hours per day. There are three shifts that run 7:00
a.m. to 3:00 p.m., 3:00 p.m. to 11:00 p.m., and 11:00 p.m. to 7:00 a.m.
•The date code indicates that the defective product was manufactured at 3:03 p.m.
•Defective product has been contained and sorted.
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Bottling Process Flow for 5-Why
B
O
T
T
L
I
N
G
BOTTLES
WATER
SYRUP
LIDS
INSPECT
LABELS
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5-Why Analysis Cola Example Chart
Corrective Action
with Responsibility
Define Problem
Use this path for
the specific
nonconformance
being investigated
Regular Cola with Diet
Cola Label.
A
Root Causes
Wrong Label.
WHY?
Changeover
Use this path to
investigate why the
problem was not
detected.
WHY?
Not following
procedure.
WHY?
B
No formalized
procedure.
Operator not certified.
WHY?
WHY?
Expected to be
covered with "on-thejob" training.
No formal certification
procedure.
Use this path to
investigate the
systemic root cause
A
WHY?
Budgetary constrains.
WHY?
Operator dependent
process; no
supervision.
C
WHY?
WHY?
Relying of operator to
follow up procedure.
Ref. No. (Spill, PR/R…)
B
WHY?
No formal process of
monitoring adherence
to procedure.
Date of Spill
WHY?
Failure not included in
original PFMEA.
Product / Process
Delphi Location
Content Latest Rev Date
WHY?
C
Problem Resolution Complete
Lessons Learned:
PRR Training
Communicate to Delphi Date:
Process Change Break Point Date:
Implement System Change Date:
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Date
5 Why Critique Sheet
A.) Don’t jump to conclusions!; B.) Be absolutely objective. C.) Don’t assume the answer is obvious.
D.) If you are not thoroughly familiar with the process yourself, assemble a cross-functional team to
complete the analysis.

General Guidelines:

Step 1: Problem Statement
Is the analysis being reported on the problem as the Customer sees it?

Step 2: Three Paths (Dimensional, Detection, Systemic)
-Are there any leaps in logic?
-Is this as far as the Whys lead? Can you still ask one, two, three more why’s)?
-Is there a true cause-and-effect path from beginning to end of each path? Is there statistical data/evidence to prove it? ---Can the
problem be turned off and on?
-Does the path make sense when read in reverse from cause to cause? (e.g.—We did this, so this happened, so this happened, and so
on, which resulted in the original problem.)
-Do the why’s go back to the actual error?
-Does the systemic path tie back to management systems/issues?
-Does the dimensional path ties back to issues such as design, operational, tier-n management, etc…?
-Does the detection path ties back to issues such as protect the customer, control plans, etc…?

Step 3: Corrective Actions
-Does each corrective action address the root cause from a path?
-Is there a separate corrective action for each root cause? If not, does it make sense that the corrective action applies to more than one
root cause?
-Is each corrective action possible to implement?
-Are there corrective actions that affect the Customer or require customer approval? How will they be communicated to the
Customer?
-Is there evidence and documentation to support the validity of the corrective actions?
-Are the corrective actions irreversible? If not, are there corrective actions in place that address containment?
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5 Why Critique Sheet (cont)

Step 4: Lessons Learned
-How could this problem have been foreseen?
-How will this information be implemented:
a.) on the line or in the plant?
b.) at the point of detection?
c.) cross-functionally at the Supplier?
d.) other product/plants?
-Are there lessons learned for the Customer?

Step 5: Overall
-Do there seem to be big holes where ideas, causes,
corrective actions, or lessons learned are being avoided?
-Where things are missed or not documented?
-Do the corrective actions address what are the actions the supplier owns?
-How many iterations has the supplier gone through so far in preparing
this 5-why (It doesn’t happen on the first try!)
-Who prepared the 5-why?
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Generic Information for 5-Why Real Example:
‘O” Ring Seal
•The plant received a PR/R from a customer. (We use 5-Why Analysis to answer
every PR/R.)
•The PR/R states that the customer received “Mixed/Foreign Material in
Shipment”.
•The supplied part is an “O” Ring seal for oil filters.
•A cutting operation produces the part to specified size. As the raw material
(cylindrical component) goes through the cutting operation, the irregular end-cuts
are removed from the station.
Cutting Station
Mat’l Flow
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5-Why Analysis: “O” Ring Example, Initial Response.
Corrective Action
with Responsibility
Date
Define Problem
Use this path for
the specific
nonconformance
being investigated
End-cuts mixed with
good parts.
Root Causes
End-cut misloaded on
to "good" exit
conveyor.
A
1. 100 % visual containment before
packing.
12/01/00
2. Dock audit each lot.
12/01/00
3. Posted quality alert at cutting station.
12/01/00
B
1. Posted quality alerts at cutting and
packing operations.
12/01/00
WHY?
End-cut not properly
removed from cut
station.
Use this path to
investigate why the
problem was not
detected.
WHY?
Operator failed to
remove.
WHY?
Operators not able to
detect.
Operator mistake.
WHY?
Use this path to
investigate the
systemic root cause
2. Modified operator instructions to
include the quality alerts.
WHY?
Parts not 100%
inspected
(2 PPM issue).
12/01/00
A
WHY?
Audit and SPC.
WHY?
Mixed end-cuts not
identified in PFMEA.
Produce millions of
"O" rings per year.
WHY?
Low frequency
problem (2PPM).
Ref. No. (Spill, PR/R…)
C
1. Added "improper end-cut removal" to
the PFMEA.
WHY?
12/01/00
B
WHY?
12340000
Date of Spill
WHY?
11/30/00
Product / Process
"o" ring seal
Delphi Location
Content Latest Rev Date
Flint, MI.
Problem Resolution Complete
C
Communicate to Delphi Date:
Lessons Learned: PFMEA(S) TO INCLUDE END CUT REMOVAL.
PRR Training
WHY?
11/28/00 Process Change Break Point Date:
Implement System Change Date:
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5-Why Analysis: “O” Ring Example, Initial Response Path A
Define the Problem
End-cuts mixed with
good parts.
Corrective Actions
Use this path for the
A
specific nonconformance
1. 100 % visual containment
being investigated.
before packing.
End-cuts misloaded
2. Dock audit each lot.
on “good” exit
3. Posted quality alert at
conveyor.
cutting station.
End-cuts not properly
removed from cut
station.
Root Cause
Operator failed to
remove.
Operator mistake.
•Problem definition, is it as the customer sees it?
- customer stated “mixed/foreign material in shipment.”
•Is the 5 Why response acceptable?
- Process of removing end-cut is operator dependent, yet no actions taken for error-proofing this area.
•Is this as far as the Why’s lead? Is the last statement within each path the root-cause?
•Does the analysis tell the entire story?
- Low frequency/intermittent problem, though no actions identified to address issue from ever re-occurring.
Actions still dependent upon “the hope” that an operator finds the problem.
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5-Why Analysis: “O” Ring Example, Initial Response Path B
Define the Problem
End-cuts mixed with
good parts.
Corrective Actions
Use this path to
B
investigate why the
1. Posted quality alert at
problem was not detected.
cutting and packing stations
Operators not able
2. Modified operator instructions
to detect.
to include the quality alerts.
Parts not 100 %
inspected.
(2 PPM issue).
Root Cause
Audit and SPC.
Produce millions
of “O” rings per
year.
•Problem definition, is it as the customer sees it?
- customer stated “mixed/foreign material in shipment.”
•Is the 5 Why response acceptable?
- Process of removing end-cut is operator dependent, yet no actions taken for error-proofing this area.
•Is this as far as the Why’s lead? Is the last statement within each path the root-cause?
•Does the analysis tell the entire story?
- Low frequency/intermittent problem, though no actions identified to address issue from ever re-occurring.
Actions still dependent upon “the hope” that an operator finds the problem.
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5-Why Analysis: “O” Ring Example, Initial Response Path C
Define the Problem
End-cuts mixed with
good parts.
Corrective Actions
Use this path to
C
investigate the
1. Added “improper end-cut
systemic root cause.
Mixed end-cuts not
removal” to PFMEA.
Root Cause
identified in
PFMEA.
Low frequency
problem (2PPM).
•Problem definition, is it as the customer sees it?
- customer stated “mixed/foreign material in shipment.”
•Is the 5 Why response acceptable?
- Process of removing end-cut is operator dependent, yet no actions taken for error-proofing this area.
•Is this as far as the Why’s lead? Is the last statement within each path the root-cause?
•Does the analysis tell the entire story?
- Low frequency/intermittent problem, though no actions identified to address issue from ever re-occurring.
Actions still dependent upon “the hope” that an operator finds the problem.
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5-Why Analysis: “O” Ring Example, Final Response.
Corrective Action
with Responsibility
Date
Define Problem
Use this path for
the specific
nonconformance
being investigated
Mixed/foreign material.
Root Causes
End-cut misloaded on
to "good" exit
conveyor.
A
1. 100 % visual containment before
packing.
12/01/00
2. Dock audit each lot.
12/01/00
3. Posted quality alert at cutting station.
12/01/00
4. Add closed end-cut chute with parts
pass sensors to single proper end-cut
removal, cutting station stops if not.
12/08/00
5. Added lock box to hold end-cuts.
12/08/00
6. End-cuts made larger than "good" Orings; no pass bar installed on exit
conveyor to stop any end-cuts.
12/08/00
B
12/08/00
WHY?
End-cut not properly
removed from cut
station.
WHY?
Use this path to
investigate why the
problem was not
detected.
Operator failed to
remove.
WHY?
Use SPC and audits.
Problem is 2 PPM.
Operator mistake.
WHY?
No error
prevention/detection
inplace.
WHY?
A
WHY?
Few customer
complaints.
2. Added verification of error detection
methods to Process Control Plan
(PCP), Set-up, and Preventive
Maintenance (PM) instructions.
Not
Considered.
WHY?
Operator dependent
process (end-cut
removal) not
addressed with error
prevention.
C
WHY?
WHY?
Mixed end-cuts not
considered in PFMEA.
Ref. No. (Spill, PR/R…)
12/08/00
WHY?
Assumed 2 PPM is
good enough.
Use this path to
investigate the
systemic root cause
1. Added end-cut mishandling to
PFMEA.
1. Process design standard now
includes end-cut handling best practice.
2. APQP process to identify and
address all customer quality issues and
process causes.
WHY?
Occasional mixed
end-cuts had not been
a noteworthy problem.
12340000
12/08/00
B
Date of Spill
WHY?
11/30/00
Product / Process
"O" ring seal
Delphi Location
Content Latest Rev Date
WHY?
Flint, MI.
Problem Resolution Complete
C
Communicate to Delphi Date:
11/28/00 Process Change Break Point Date:
Implement System Change Date:
Lessons Learned: 1.) Operator dependent process must be supported by error prevention methods. 2.) PFMEA must include all process failure modes and associated causes.
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