© 2003 Lowden International - the dpsa Strydom.pdf© 2003 Lowden International Definition As...


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


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.”


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


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.


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.


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)


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.


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


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


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


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



The Approval for Release System exists to support

Patient safety

Regulatory compliance

Approval


Making Medicines

Changes in Scale

Review of Analytical Test Results

Review of Production Documents

Management of Deviations

Batch Supporting SystemsBatch Supporting SystemsBatch Supporting Systems



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


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


Approval


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


Quality Control Strategy

General Quality Systems

Training System

Documentation Control System

Document Management System

Validation System

General Quality SystemsGeneral Quality SystemsGeneral Quality Systems


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.


Approval


Test results






Evolution of the general quality systemsEvolution of the general quality systems


Inter-relationship between Systems

Stability System

Complaints Analysis and follow-up

Product Surveillance SystemsProduct Surveillance SystemsProduct Surveillance Systems


Approval


Test results



Product Surveillance Systems




Product Stability Complaints


A building needs a good foundation …


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


Qualified Person Development

Quality Policies

Senior Management Systems for Senior Management Systems for Supporting Quality Cont.Supporting Quality Cont.


Approval


Test results



Quality PoliciesQuality Policies

Senior Management Systems for Supporting Quality

RecallSystemRecallSystem

QualityReviewSystem

QualityReviewSystem

QualityImprovement

System

QualityImprovement

System

ProcessesDefinitionSystem

ProcessesDefinitionSystem

PersonnelQualitySystem

PersonnelQualitySystem

QPDevelopment

System

QPDevelopment

System




Product Surveillance Systems

Product Stability Complaints



1. Poorly designed quality systems

2. Senior management support is absolutely critical

1. Poorly designed quality systems

2. Senior management support is absolutely critical


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


Remember Remember ……

If you put the Best People into a Bad System

The System will eventually defeat them …

Every Time!


On a lighter note- Quality Motor -Wise


And the response


Copycats


Superior Quality Rules

© 2003 Lowden International - the dpsa Strydom.pdf© 2003 Lowden International Definition As...

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