Managing product quality risks through the supply chain

Malgas, Yolanda (2003-03)

Thesis (MBA)--Stellenbosch University, 2003.

Thesis

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.

Please refer to this item in SUNScholar by using the following persistent URL: http://hdl.handle.net/10019.1/53493
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