Thesis (MBA)--Stellenbosch University, 2003. / ENGLISH ABSTRACT: With globalisation and the accompanying increase in international trade there
is a great drive towards performing risk assessments on the quality of
products. Such assessments are of particular importance within the food and
drug industry, so much that this approach is also being adapted by the FDA in
their analysis of the quality of products and probable risks to it.
The pharmaceutical industry is heavily regulated to reduce or eliminate the
production and distribution of poor quality products. Pharmaceuticals have to
be of high quality as people's lives depend on it.
Many pharmaceutical companies import raw materials from international
manufacturers or international agents. In most cases the raw material or the
products have to go through a long and complicated supply chain. The more
parties involved in the supply chain, the greater the risk to product quality.
Supply chain partnerships have therefore become critical to manage these
risks to product quality throughout the supply chain.
In order to manage risks to product quality, it has become vital to perform
product quality risk assessments, especially through the supply chain. In this
study the Failure Mode Effect Analysis (FMEA) is used to perform a risk
assessment of risks to product quality throughout the supply chain. To obtain
the criticality of the risks the Failure Mode Effect and Criticality Analysis
(FMCEA) is applied.
Quality improvement systems which contribute towards managing the risks to
product quality are also discussed in this report.
By managing quality risks to pharmaceutical products along with using quality
as a strategy, the pharmaceutical company contributes towards improved
health for patients as well as customer satisfaction, business success and
excellence. / AFRIKAANSE OPSOMMING: Die toepassing van die analise van die risiko op produkte is vinnig besig om te
vermeerder. Die FDA gaan dit toepas in hulle analise van die kwaliteit van
produkte en die risiko wat daarmee gepaard gaan, in die voedsel en medisyne
bedryf.
Die farmaseutiese industrie word baie streng gereguleer om te verhoed dat die
produksie en distribusie van swak kwaliteit produkte ervaar word. Farmaseutiese produkte moet van hoë
gehalte wees, omdat die gesondheid van pasiënte daarvan afhang.
Baie farmaseutiese maatskappye bestel rou materiale van oorsese makelaars
en in baie gevalle moet die rou materiale deur 'n lang en gekompliseerde
voorsieningsketting gaan. Hoe meer agente betrokke is, hoe hoër word die
risiko met respek tot die kwaliteit van die produk. Die voorsieningsketting
speel 'n kritiese rol om te verseker dat risikos beheer kan word, omdat elke
party verantwoordelik is vir die lewering van kwaliteitsprodukkte.
Om te verseker dat risikos beheer word, het dit belangrik geword om risiko
analise te doen op die kwaliteit van produkte, veral wanneer in die
voorsieningsketting. In hierdie studie word die "Failure Mode Effect Analysis
(FMEAJ' gebruik om 'n risiko analise te doen met betrekking tot risikos op 'n
produk se kwaliteit wanneer in die voorsieningsketting. Die "Failure Mode
Effect, and Criticality Analysis (FMECAJ', word ook toegepas om te bereken
hoe krities die risiko is.
Verbeteringstelsels wat bydra tot die beheer en kontrole van risikos vir produk
kwaliteit word ook in hierdie studie bespreek.
Deur die risikos te beheer op die kwaliteit van produkte, dra die farmaseutiese
maatskappy by tot beter gesondheid vir pasiente, en verseker klient
satisfaksie en suksesvolle besigheid.
| Identifer | oai:union.ndltd.org:netd.ac.za/oai:union.ndltd.org:sun/oai:scholar.sun.ac.za:10019.1/53493 |
| Date | 03 1900 |
| Creators | Malgas, Yolanda |
| Contributors | Von Leipzig, K., Stellenbosch University. Faculty of Economic & Management Sciences. Graduate School of Business. |
| Publisher | Stellenbosch : Stellenbosch University |
| Source Sets | South African National ETD Portal |
| Language | en_ZA |
| Detected Language | English |
| Type | Thesis |
| Format | 110 p. : ill. |
| Rights | Stellenbosch University |
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