Suspected object
Pack PK-071
ON HOLD
NON-CONFORMANCE CONTROL
Anomalies are not the real risk—
losing boundaries, evidence, and closure criteria
is the risk
Identify, isolate, disposition, verify, correct, and prevent recurrence. Lock the impact scope at the first moment of an anomaly, freeze logistics and digital workflows together, retain non-overwritable failure evidence, and close only with authorized decisions and verification.
Risk control before disposal; evidence before closure.
HOLD
Isolating
Isolating
Spatial Impact Map
2025-06-18 10:24
Materials
Module
Rack
System
FAT
Shipment
1
2
3
4
5
X
SHIPMENT BLOCKED
Object
PK-071
Affected
1 Pack
Downstream
0
Today's mass trigger
1
Key NCR open
0
Average block time
11 min
Overdue CR / CAPA
0
Evidence chain integrity rate
100%
Unauthorized downstream exposure
0
01 We'll lock the border and discuss the disposal.
The module to which it belongs
Module M-24-11
FROZEN
Distribute Rack
Rack R-12
BLOCKED
SYSTEM ASSEMBLY
System SYS-03
DENIED
FAT Test
Factory Test
NO EXPOSURE
Delivery
Shipment
RELEASE BLOCKED
WMS inventory
Frozen
MES Status
On Hold
Worksheets/plugins
No Slip
System distribution
Allocation Denied
Delivery plan
Shipment Blocked
Downstream exposure.
0
Suspected object:
The anomaly first freezes the minimum identifiable object PK-071 and prohibits movement until its scope is confirmed.
02 Physical isolation and digital freezing take effect simultaneously.
HOLD
Isolating
Isolating
!
Object ID
PK-071
Status
On Hold
Associated posts
CELL-07
Impact Time
2025-05-18 10:22
MES Freeze
Worksheet Execution
Block
Downstream collar.
Block
Workspace flow
Block
Process crossing.
Block
WMS Freeze
Inventory status
Freeze
Library request
Block
Turn Library
Block
Autoallocation
Block
Mass Lock
Inspection records
Association
NCR number
Generated
Scope of impact
Freezed
Responsible persons
Confirmed
03 An unsatisfactory record must return to the subject, scope, evidence and responsibility
Object & Record
Object Type
Pack
Object ID
PK-071
Serial number
SN310810071
First date
2025-05-04
Location
CELL-07
Test Results
Feature
Frozen pressure
Actual
1.42 kPa
Criteria for determination
≤1.00 kPa
Decision
NG
Coldboard interface
O-Ring Seal
Pressure test point
Serial number/ ID
Test Method
Methodology
Air leak test.
Method Number
WI-QA-CP-014
Equipment
DP-1000
Instrument Status
The calibration works.
Uncertainty
±0.05 kPa
Responsibility and scope
Found someone.
Quality tester
Responsible party
Manufacturing works
Scope of impact
Module / Rack / System
Evidence number
EVD-250518-071
CUR
Original Curve
RAW
Original Data
LOG
Equipment records
IMG
Defective photos
VID
Test Video
WI
Operational guidance
CAL
Calibration records
04 Case presentation: TC-DEMO-NR-2608-0059
Organisation
Object
Pack PK-071
Abnormal description
Frozen pressure deviation
Check Features
Frozen pressure
Actual value
1.42 kPa
Criteria for determination
≤1.00 kPa
Initial results
NG
Disposal status
Pack isolation
Time of discovery
2025-05-18 10:18
Pressure - Time Curve
Test and Validation
Appearance
Gas supply system
Pressure measurement 1.42
Data acquisition interface
05 MRB disposal is not a list of options, but a decision-making mandate Field
| Disposal results | Conditions of application | Risk level | Authorized role | Decision-making in this case |
|---|---|---|---|---|
| Give and take. | Non-security key, client approval | Low | MRB Chair + Customer | Not used |
| Return to work | Recoverable to original technical requirements | Low | MRB Chair | Adopt |
| Maintenance | Deviation from original design but controlled risk | Medium | MRB Chair + Engineering | Not used |
| Return goods | Vendor / Not suitable for internal repairs | Medium | Supply chain manager | Not used |
| End of life | Security is critical and unrecoverable. | High | MRB Chair | Permission granted |
• Security requirements must not be circumvented by “conditions for release” “concessional acceptance”.
Return:
By returning to the original design and technical requirements, O-Ring was replaced in this case and the test was retested as originally tested.
06 Case presentation supported by evidence
5-Why Analysis
1
Why did the stress test fail?
There was a leak in the O-Ring seal.
There was a leak in the O-Ring seal.
2
Why is O-Ring sealed?
After the assembly, there was a local squeeze in O-Ring.
After the assembly, there was a local squeeze in O-Ring.
3
Why is there a local squeeze?
• Lack of stable positioning structures for the clothing.
• Lack of stable positioning structures for the clothing.
4
Why aren't the costumes located?
PFMEA did not identify the risk of the assembly.
PFMEA did not identify the risk of the assembly.
5
Why is PFMEA not identified?
• New process experience did not feed back into the design rules.
• New process experience did not feed back into the design rules.
Fish bone map
Evidence and authentication
Quantum system analysis MSCA
Interface surface check
Old O-Ring
New O-Ring Authentication
07 Correcting completion does not mean closure
Corrected Validation
Initial results
1.42 kPa
Repeated results
0.42 kPa
PASS . Meet ≤1.0 kPa
CAPA-0026 Measures to prevent recurrence
1
Modify O-Ring assembly SOP and positioning requirements.
2
Adding error-proof locator.
3
Update PFMEA and Control Plan.
4
100% visual confirmation after additional assembly.
5
34 Pack sample validation completed for new fit.
Planned completion: 2025-05-22
Error prevention and closing confirmed.
Validation results:
PASS
Impact review: Completed
MRB approves: Completed
NCR close: Approved
Other Organiser 2025-05-23 18:45
Impact review: Completed
MRB approves: Completed
NCR close: Approved
Other Organiser 2025-05-23 18:45
08 From single point correction to systematic relapse prevention
CP
Control Plan
Update Control Plan
PF
PFMEA
Supplementary expire mode
WI
Operational guidance
assembly request update
JIG
Faultproof.
Add positioning structure
TR
Training
Re-certification of personnel
SPC
Process monitoring
Add trend surveillance
AUD
Level review
Continuous inspection of execution
Sample validation (new bug-proof assembly)
34 Packs
Unqualified
0
NCR Status
CLOSED
TC-NCR-2608-0059
2025-05-26 11:20
2025-05-26 11:20
09 Overview of abnormal governance (other cases)
Status: Closed
Status: Closed
Status: Closed
Status: Closed
Status: Closed
NCR-0047:
The material inspection found local cracks in the busbar, batches were isolated and returned to the supplier and updated the supplier control plan.
10 Closing requires evidence bags and access clearances.
Close Conditions
✓
NCR records are complete and immutable.
✓
MRB decision-making is mandated.
✓
CAPA has been implemented and validated.
✓
The impact range has been re-scanned.
✓
The subject of correction has already passed.
✓
Prevention measures are already in the system.
✓
No downstream exposure or recovery has been completed.
✓
All evidence is auditable.
Close the evidence bag
ISO 9001 NCR records
• Unqualified controls and corrective measures
8D / RCA report
:: Analysis of root and systemic causes
MSC / calibration of evidence
:: Measuring effectiveness
PFMEA / Control Plan
Risk and process control updates
Return/ Maintenance records
:: Evidence of the disposition of the object
Repeat raw data
• PASS is not an oral conclusion
Impact range scan
:: Identification of non-exposure
CAPA validity validation
:: Preventing the recurrence of similar problems
Competence and review
| Role | Responsibility | Close Permissions |
|---|---|---|
| Inspector | Checkout / Original Record | None |
| Quality Engineer | NCR analysis | Recommendations |
| Manufacturing Eng. | Correct implementation | None |
| MRB Chair | Decision-making on disposal | Approved disposal |
| Quality Manager | Final review | NCR Closed |