PET Course KFSH&RC Shoaib (2) total quality management

1. Total Quality Management
“Training Course on PET Radiopharmaceuticals:
Production, Quality and Clinical Aspects”
21 – 24 May 2017
Cyclotron & Radiopharmaceuticals Department
King Faisal Specialist Hospital & Research Centre
M. Shoaib Shawoo, M.Sc., CMQ/OE

2. Quality Assurance Functions
Other Quality Assurance responsibilities include:
 assurance of process controls;
 documents management and change control;
 customer satisfaction monitoring;
 data analysis and performance monitoring;
 self-inspection / internal audits;
 liaison with regulatory and certification bodies ;
 root cause analysis and corrective actions
 continuing education and training;
 risk assessment and control;
 continual improvement

3. Qualification of Equipment
Critical Process Equipment:
 Dose Calibrators
 Laminar Flow Hoods
 Dispensers
 Balances
 Clean Room
 Hot Cells
 Sterilizers
 Ovens
Critical QC Testing Equipment:
 Dose Calibrators
 Multi Channel Analyzers (MCAs)
 Pipettes
 Gas Chromatograph (GC)
 High Performance Liquid
Chromatograph (HPLC)
 Osmometer

4. Qualification of Equipment
A list of due equipment is
provided to concerned
Section Head
QA maintains database
of Calibration, Validation
and Maintenance of all
Critical Process and QC
Equipment
Concerned Section staff
performs the required
action
Qualification test report and
accompanying data are
forwarded to QA
QA updates equipment
database accordingly;
hard copies of records
are archived
QA prepares labels and affixes on
the Equipment; “Out of Calibration”
equipment are marked as such and
not allowed to be used in
Production or QC

5. Document Change Control
Document is signed by person
preparing the document and the
Section Head, and is forwarded
to QA for review
Concerned Section staff prepares or
revises the document (SOP, Form,
Production Batch Record, QC Test
Record, Raw Material Records, etc.)
QA approves the document and
approves it; Revision Number is
issued
QA stores the document
soft copy in the relevant
folder as well as in a
Backup Folder
QA ensures that previous revision
is not accessible anymore.
QA reviews the document and sends it
back the concerned section if any
changes are required
QA updates the Document’s
historical record with regards to
Revision Number, Date Prepared
and Date Effective
QA allows “read only”
access of the document to
the concerned Section(s)
Document Change Form is initiated; QA
“cancels” the previous revision of the
document and archives it in a Historical
folder.
QA issues hard copies
(if document is SOP)
at points-of-use

6. Control of Documented Information
Batch Record, Test Records and Data are compiled and stored by QA
Older Batch Records are sent to Office Services Department for long-term
storage
Original Standard Operating Procedures are owned by QA
Records generated, such as calibration of equipment, are also maintained
by QA
Certain Records are maintained at points-of-use, such as:
 Cleaning Records;
 Daily Equipment Check Records;
 Pressure Differentials Records;
 Cyclotron Run Sheets, etc.

7. Customer Satisfaction Monitoring
Customer Complaints:
 Review and Analysis of Complaint;
 Planning of Corrective Action;
 Response to Customer
Customer Surveys:
 Sending out Questionnaire;
 Receiving and reviewing the responses;
 Planning of actions based on responses
 Responding to customers
Analysis of production / delivery data

8. Analysis of Data
Requirements for customer satisfaction:
 Product of desired quality;
 Product in desired quantity;
 Product on time
To ensure that these customer requirements are consistently met, QA:
 Maintains a database of all generated process and test data;
 Performs various kinds of trending analysis;
 Extracts meaningful information from these stored data, such as:
Cyclotron uptime;
Activity Produced;
Stability of process and test equipment;
Any “downward” trends
 Devises Corrective / Preventive Action plans based on these trends

9. Analysis of Data – Product Delivery

10. Analysis of Data – Trending of Incidents

11. Inspection
Internal:
 Periodic Internal Audits;
 Spot checks;
 Management Review Meetings
External:
 Periodic Audits by Certification Body (ISO 9001 QMS);
 Periodic Inspections by Regulatory Body (SFDA);

12. Root Cause Analysis and Corrective Actions
Based on root cause findings, a
report is generated and action is
planned; responsibilities are
assigned with deadlines.
QA provides Non-
Conformity Report to
concerned Section Head
Completed report is
forwarded to QA
QA follows up with the
Section Head regarding the
implementation of corrective
action and its effectiveness.
If Corrective Action is found
to be effective, the
report is “closed”. If gaps are
present, new CA is planned;
cycle is repeated.
Non-conformity is reviewed
and analyzed by the
concerned Section staff;
root cause is determined

13. Risk Management
Identification of potential risks
Assessment of the criticality of the risk
 Simple Risk Assessment
 Failure Mode and Effects Analysis (FMEA)
Planning for eliminating or reducing the negative effect of the risk
Devising objectives; assigning responsibilities with deadlines
Finding opportunity for improvement through elimination or reduction of
risk

14. Continual Improvement
Promoting the culture of continual improvement
Improvement of product characteristics
Improvement of process performance
No process is ever perfect – there is always room for improvement!
Improvement Tools:
 Kai-Zen (Good Change)
 PDCA (Plan-Do-Check-Act)
End result – Customer Satisfaction!