Process deviations can be viewed as an opportunity for improvementand further development, or as something negative that delaysproduction. A case study has been conducted at AstraZeneca´s active pharmaceutical ingredient plant (API) specific to the EFA factory.The deviation process has been investigated and evaluated to see how process management can be improved to ensure that benefits and opportunities originating from deviations are taken in account. AstraZeneca is today being led to improve the overall deviationrate, which is controlled through KPI indicators. In addition to the deviation rate EFA also measures the lead time for deviation investigations for minor deviations.The study revolves around four questions, “How is the deviation control process designed?”, “What obstacles are affecting the investigation of deviations?”, “What is the current situation regarding process deviations?”, “How can the number of process deviations be reduced?”A process map was made to visualize the activities in the deviation process based on in house documentation and interviews. Interviews were also held with key employees to find out what cause delays in the investigation of minor deviations. Processdata was analyzed to see the variation in lead time over time, and to visualize the trend of occurred deviations. In addition, the deviation rate was analyzed per product, and cause of deviations was visualized.The results were put in perspective through theories originating from the sphere of process management, quality management anddeviation reduction theory. Evaluation of the deviation process made it clear that the output from the process differs depending on the classification of the deviation. The lower grade classification does not require acorrective action plan, which could lead to a higher occurrencerate. This is indicated in the trend and cause of deviation results.The analysis concludes that there are several aspects that affectthe investigation lead time. For example: delayed team review and more. The analysis continues to discuss how the number of deviations can be reduced by preventive error reduction. The study concludes that EFA should differentiate their processesmeasurements results with regards to the other factories at API, to get closer to the problem. This would ensure a clearer and more precise representation of their current situation. It is recommended that visual tools are implemented so that informationregarding the state of deviations is made more accessible, thus making decision making easier. It is also recommended that thedeviation process is evaluated continuously, and more often, to ensure future improvements.
| Identifer | oai:union.ndltd.org:UPSALLA1/oai:DiVA.org:uu-412465 |
| Date | January 2020 |
| Creators | Zetterström, Linnéa |
| Publisher | Uppsala universitet, Institutionen för samhällsbyggnad och industriell teknik |
| Source Sets | DiVA Archive at Upsalla University |
| Language | Swedish |
| Detected Language | English |
| Type | Student thesis, info:eu-repo/semantics/bachelorThesis, text |
| Format | application/pdf |
| Rights | info:eu-repo/semantics/openAccess |
| Relation | TVE - LKF ; 20 002 |
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