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© 2003 Lowden International
© 2003 Lowden International
Total Quality ManagementTotal Quality ManagementA Management Strategy aimed at Embedding AwarenessA Management Strategy aimed at Embedding Awareness
Dr P Strydom
Technology Office ParkIGH Imuniti HouseCnr Witkoppen and Leeukop StreetsSunninghillJOHANNESBURG
Tel: (011) 803-2481Fax: (011) 803-1900Maxi: 086 123 (RISK) 7475
Dr P Strydom
Technology Office ParkIGH Imuniti HouseCnr Witkoppen and Leeukop StreetsSunninghillJOHANNESBURG
Tel: (011) 803-2481Fax: (011) 803-1900Maxi: 086 123 (RISK) 7475
© 2003 Lowden International
DefinitionDefinition
As defined by ISO:
“TQM is a management approach for an organisation, centered on quality, based on, and the participation of all its members and aiming at long-term success through customer satisfaction, and benefits to all members of the organisation and to society.”
© 2003 Lowden International
Definition cont.Definition cont.
In Japanese, TQM compromises four process steps, namely:
1. Kaizen – Focuses on Continuous Process Improvement, to make processes visible, repeatable and measurable.
2. Atarimae Hinshitsu – Focuses on intangible effects and processes and ways to optimize and reduce their effects
3. Kansei – Examining the way the user applies the product leads to improvement in the product itself.
4. Miryokuteki Hinshitsu – Broadens management concern beyond the immediate product
© 2003 Lowden International
Definition cont.Definition cont.
TQM requires that the company maintain this quality standard in all aspects of its business. This requires ensuring that things are done right the first time and that defects and waste are eliminated from operations.
© 2003 Lowden International
History of QualityHistory of Quality
The first management consultant was an engineer named Frederick W. Taylor, who’s application of science to complex human endeavours was built upon by Walter A Stewart. Edward Deming, a statistician, like Joseph M. Juran, an investigator at the Hawthorne Works experiments recognized that system problems could be addresses through planning, control and improvement. The “Zero-defects’ program was advocated by Philip B. Crosby and all three (Deming, Juran and Crosby) initiated the TQM process.
© 2003 Lowden International
1. Clarify your Concept1. Clarify your Concept
2. Realize your Concept2. Realize your Concept
3. System & Process Management[the Core of TQM Practice]
3. System & Process Management[the Core of TQM Practice]
4. Constant Learning4. Constant Learning
5. Teams and Leaders5. Teams and Leaders
6. Reap the Rewards6. Reap the Rewards
Deming’s Principles of Total Quality Management
(TQM)
Deming’s Principles of Total Quality Management
(TQM)
© 2003 Lowden International
Clarify your ConceptClarify your ConceptDefine your mission/vision/goal – aim for constant improvement in the product or service you offer your clients. You cannot do this without maintaining a high level of motivation and satisfaction in the people that compromise your organisation – consider that an aspect of your goal.
Realize your ConceptRealize your ConceptWith clear vision energetic motivation, make your concept a matter of daily practice:
• Have a long term, not short term profit orientation
• Find, understand (the causes), and root out the 4 detriments (fear, jealousy, anger, revenge)
• Eliminate practices that undermine worker’s self/mutual respect and motivation (production quotas, sloganeering, sexist / racist expressions, favouritism / nepotism)
• Foster all chances for pride of workmanship and sharing in the improvements process.
© 2003 Lowden International
System & Process Management [the Core of TQM Practice]System & Process Management [the Core of TQM Practice]Study and understand in ever greater depth the process of production or service that you are delivering. Deming’s 85/15 rule: 85% of a worker’s effectiveness is determined by the system he works within, only 15% by his own skill. To break down your system into meaningful blocks for analysis, consider your “internal customers’’ of processes.
• Look at inputs from suppliers
• Quantitative analysis of process –Use Plan/Do/Check/Act cycle repeatedly.
• Monitor “outputs” throughout
Constant LearningConstant Learning• Before hiring – rigorous pre-employment screening
• Before working – rigorous pre-work training
• Retrain on the job
• Management must constantly learn from entire team as well as clients and competitors
© 2003 Lowden International
Teams and LeadersTeams and Leaders
All levels of the organisation must be involved, starting with full commitment at the top. Eliminate organisational and physical barriers to teamwork. Eliminate performance ratings. Emphasize stability and constancy of effort – steady small gains rather than disruptive crash programs. Avoid unsettling changes without involving the whole team. Involve suppliers, help them with Quality management. Involve your clients, get their feedback and ideas. Send your staff to both (suppliers and clients) to learn.
Reap the RewardsReap the Rewards
Spread profits to workers as a team (but eliminate merit pay for short term performance). Enlist pride of workers in improving the system; empower people to take charge of work environment, safety issues, etc. Encourage pride of workmanship in delivering the product. Finally: spread what you have learned to the community.
Lowden InternationalQuality Consulting for the Pharmaceutical World
Quality Consulting for the Pharmaceutical World
The 7 Pillars ModelThe 7 Pillars Model
The Basis of a Continuous Quality Improvement Culture
© 2003 Lowden International
Making MedicinesMaking MedicinesHas always involved considerations of:
• Patient Safety
• Compliance with Regulatory Requirements
• Even when medicines were made by hand, by an apothecary
Because Medicines are different from normal articles of commerce
We tolerate a percentage of defective products in other items
• But not in medicines
Society has higher expectations of quality for medicines
• Because we consume them when we are sick
© 2003 Lowden International
Approval for Release SystemApproval for Release System
From ancient times until relatively recently medicines were made manually
The apothecary had to have a release system
• A final check that all is well
– The correct ingredients were used
– The identity and amounts of ingredients match what was intended
– In the formulary
– On the prescription
© 2003 Lowden International
The 7 Pillars ModelThe 7 Pillars Model
The Approval for Release System exists to support
Patient safety
Regulatory compliance
Approval
© 2003 Lowden International
Making Medicines
Changes in Scale
Review of Analytical Test Results
Review of Production Documents
Management of Deviations
Batch Supporting SystemsBatch Supporting SystemsBatch Supporting Systems
© 2003 Lowden International
The 7 Pillars ModelThe 7 Pillars Model
Evolution of batch specific systemsTo support the Approval Process
Evolution of batch specific systemsTo support the Approval Process
Approval
Sampling DeviationsProductiondocuments
Test results
Batch Specific Systems
© 2003 Lowden International
Processes and Systems
The Environment can have a major impact on product quality
Testing Systems for the starting/raw materials
Testing Systems for packaging materials
Batch Independent SystemsBatch Independent SystemsBatch Independent Systems
© 2003 Lowden International
Approval
Sampling DeviationsProductiondocuments
Test results
Batch Independent Systems
environment materials components
The 7 Pillars ModelThe 7 Pillars ModelBatch Specific Systems
Evolution of Batch Independent systemsEvolution of Batch Independent systems
© 2003 Lowden International
Quality Control Strategy
General Quality Systems
Training System
Documentation Control System
Document Management System
Validation System
General Quality SystemsGeneral Quality SystemsGeneral Quality Systems
© 2003 Lowden International
Change Control (Change Management)
Change Management System
Maintenance System
Control (Management) of Purchasing
Purchasing Management System
Self Inspection
General Quality Systems Cont.General Quality Systems Cont.General Quality Systems Cont.
© 2003 Lowden International
Approval
Sampling DeviationsProductiondocuments
Test results
environment materials components
The 7 Pillars ModelThe 7 Pillars Model
General Quality Systems
Batch Independent Systems
Batch Specific Systems
Evolution of the general quality systemsEvolution of the general quality systems
© 2003 Lowden International
Inter-relationship between Systems
Stability System
Complaints Analysis and follow-up
Product Surveillance SystemsProduct Surveillance SystemsProduct Surveillance Systems
© 2003 Lowden International
Approval
Sampling DeviationsProductiondocuments
Test results
environment materials components
The 7 Pillars ModelThe 7 Pillars Model
Product Surveillance Systems
General Quality Systems
Batch Independent Systems
Batch Specific Systems
Product Stability Complaints
© 2003 Lowden International
A building needs a good foundation …
© 2003 Lowden International
Senior Management Systems for supporting quality
Recall System
Quality Performance Review
Quality Improvement System
Processes Definition
Personnel Quality System
Senior Management Systems for Senior Management Systems for Supporting QualitySupporting Quality
© 2003 Lowden International
Qualified Person Development
Quality Policies
Senior Management Systems for Senior Management Systems for Supporting Quality Cont.Supporting Quality Cont.
© 2003 Lowden International
Approval
Sampling DeviationsProductiondocuments
Test results
environment materials components
The 7 Pillars ModelThe 7 Pillars Model
Quality PoliciesQuality Policies
Senior Management Systems for Supporting Quality
RecallSystemRecallSystem
QualityReviewSystem
QualityReviewSystem
QualityImprovement
System
QualityImprovement
System
ProcessesDefinitionSystem
ProcessesDefinitionSystem
PersonnelQualitySystem
PersonnelQualitySystem
QPDevelopment
System
QPDevelopment
System
General Quality Systems
Batch Independent Systems
Batch Specific Systems
Product Surveillance Systems
Product Stability Complaints
© 2003 Lowden International
The 7 Pillars ModelThe 7 Pillars Model
1. Poorly designed quality systems
2. Senior management support is absolutely critical
1. Poorly designed quality systems
2. Senior management support is absolutely critical
© 2003 Lowden International
The 7 Pillars ModelThe 7 Pillars ModelCan be applied to:
Manufacturing and packaging of:
• pharmaceuticals and other regulated medical products• active pharmaceutical ingredients• clinical trial supplies
Laboratories
Development
Warehousing
Distribution
Logistics
© 2003 Lowden International
Remember Remember ……
If you put the Best People into a Bad System
The System will eventually defeat them …
Every Time!
© 2003 Lowden International
On a lighter note- Quality Motor -Wise
© 2003 Lowden International
And the response
© 2003 Lowden International
Copycats
© 2003 Lowden International
Superior Quality Rules