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Product liability
Robert C. Menson, PhD
Use of a Product, Process or Service in accordance with the specifications, instructions and information provided by the manufacturer
Systems for the analysis and control of manufacturing processes based on timely measurement during procession of critical quality parameter and performance attributes of raw and in-process materials and processes, to assure acceptable end-product quality at the completion of the process.
Assessm ent
Risk Analysis
Risk Evaluation
Risk Control
Post-Production Information
5
Management
Risk Matrix PHA= Preliminary Hazard Analysis FTA=Fault Tree Analysis FME(C)A=Failure Mode Effects (Criticality) Analysis HAZOP=Hazard Operability Analysis HACCP=Hazard Analysis and Critical Control Point
6
FMEA Model
POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS
X-Ray ZM Device Subsystem Component ____________________ Process FMEA Number Page of Prepared By FMEA Date (Orig.) Responsibility (rev.) Core Team: _______________________________________________________________________________________________
Device/ Function
Current Controls
R P N
Recommended Responsibility Action Results Action(s) and Target Actions R Complete Date Taken S O D P N
1) Light Failure
2 3 4 24 1 1 2 1 1 4 2 4
2) Alignment Failure
3 Wrong Field Defined Causing Repeat xrays and additional setup time 3
b) Mirror moved
4 60
HAZOP Model
Design Statement
Activity Transfer Material Powder Destination Hopper
HAZOP
Transfer
No Valve closed Line blocked Pump broken Pump fast
Material
Tank empty
Destination
Valve closed Hopper full
More
Other than
Robert C. Menson, PhD
HACCP
Biological Hazards Chemical Hazards Physical Hazards Prerequisite Quality System Program Traditionally GMPs
Requires
10
1. Risk Assessment
2. ECP Analysis
11
Severity (S)
Occurrence (O)
Detection (D)
12
Evaluation Rules
Concept of ECP:
A process that is in control ( i.e. does not produce significant defects) but is very difficult to verify by testing. The corollary is a process with a "high" level of defects that can be detected before shipment to the end user.
No
Det<5
Yes Assign ECP to Reduced Parameter Assign ECP to Detection (Either at that point or downstream) Assign ECP to Process
END
14
No
Det<5
Yes Assign ECP to Reduced Parameter Assign ECP to Detection (Either at that point or downstream) Assign ECP to Process
END
15
No
Det<5
Yes Assign ECP to Reduced Parameter Assign ECP to Detection (Either at that point or downstream) Assign ECP to Process
END
16
No
Det<5
Yes Assign ECP to Reduced Parameter Assign ECP to Detection (Either at that point or downstream) Assign ECP to Process
END
17
Potential Cause
LIMS not referencing new #, ManMan only references old # causing incorrect CofA
Existing controls
Detection Method
Stability
Visual check of CofA with LIMS and ManMan(produc tion) WFI System Validation, SOP (equipment, preventive maintenance, manual cleaning, manufacturing, training, USP / EP water environmental, procedures) test,
4.1
Collect Water @ 126 drop / WFI System (Processing High Count/ obj tank #1,2,3) organism Collect Water @ 126 drop / WFI System (Processing tank #1,2,3) Collect Water @ 126 drop / WFI System (Processing tank #1,2,3)
10
4.2
None
10
10
4.3
Training, SOP
10
10
18
10
YES
Potential Cause
Equipment (7)
4.1
high count WFI System count/obj. P-F7010 <25/250mL / no Failure organism Specific Batch objectionables Record
sampling milliflex sensor II QCP-017 (equip) QG-I5034 vitek DLSA1030 report 49 micro Training hood 409164 cal HVA-0101-SP Procedure incubator 68955-1 cal SPT-0595-QC 020912 / pH meter 45057 calibration Daily records
19
Equipment (7)
4.1
high count WFI System count/obj. P-F7010 <25/250mL / no Failure organism Specific Batch objectionables Record
sampling milliflex sensor II QCP-017 (equip) QG-I5034 vitek DLSA1030 report 49 micro Training hood 409164 cal HVA-0101-SP Procedure incubator 68955-1 cal SPT-0595-QC 020912 / pH meter 45057 calibration Daily records
Prerequisites Respon Completion Reference Required or sibility Date Document Prerequisite (5) (6) (7) to (4)
QCP-017
20
Prerequisites Respon Completion Reference Required or sibility Date Document Prerequisite (5) (6) (7) to (4)
QCP-017
21