Research On Material Supplier Quality Management For Product P In GZL Company

The paper is focused on the improvement of raw material supplier quality management relevant to product P in GZL company,which is a chemical API manufacturer regulated by GMP regulations,with reference on supply chain quality management theory,GMP and procedure analyse methodology.Based on the collection of the raw material quality complaints related to product P occurred within 2016~2017,the raw material quality issues are classified by using Pareto methodology.It is revealed that the major raw material quality issues are abnormal analytical result(50%),foreign matter contamination(23%)and weight error(20%).Furthermore,the major raw material issues are analyzed extendedly considering the raw material categories defined in supplier management procedure,which are critical raw materials and commodities.It is found that most of the major raw material issues are related to commodities.Then,the root cause of major raw material issues are investigated by 5 Whys methodology.It is disclosed that the cause of abnormal analytical result complaints is that current supplier management procedure doesn't require a comparison of analytical results and test methods between supplier and GZL company during supplier qualification,even without pre-shipment sample test for commodities.The cause of foreign matter contamination and weight error is that current supplier management procedure doesn't require a on-site audit for solid commodities.Correspondingly,the improvements of supplier management procedure are defined: add a procedure to verify new suppliers' test results(pre-shipment sample testing and evaluation),add the requirement of solid commodities on-site audit into supplier qualification management procedure.And,the feasibility of the defined improvement actions are fully evaluated with procedure analytical mothodology,they are fully feasible.With the support of GZL company management team and suppliers' co-ordination,the number and severity of raw material quality complaint occurred in 2018 are obviously lower than previous years,the company management team and clients are very satisfied about the actions taken in GZL company.There should be some reference value about the problem analysis thinking and the improvement actions for the raw material supplier management in chemical API manufacturers.