Quality Assurance and Regulatory process for Orthopedics

Abstract

The present study is based on application of tools for quality assurance, validation and regulatory processes. The tools used are Trackwise: Complaint Handling System, SPS (SGTC Partnership Score) and GPRD (Global Product Registration database). These tools have been developed for effective handling, monitoring and registering Joint Replacement products manufactured by Stryker Corporation, a multinational firm with headquarters at Kalamazoo, Michigan (USA) Here, Trackwise Complaint Handling System is the depository for all complaints and related documentation. Product complaints are managed by different roles within complaint handling team i.e CIC (Complaint Intake Centre), CMC(Complaint Management Centre) and PAC(Product Assessment Centre).This project deals with CIC(Complaint Intake Centre) and CMC(Complaint Management Centre). SPS stands for SGTC Partnership Score. It is a feedback Management tool that is used to gauge the strength of customer relationships. It has a scale range of 1-5, 1 being the lowest and 5 being the highest score. Additionally, customers can also provide their comments along with the score. Based on score, customers are categorized into promoters (>3), Passives (=3) and detractors (<3). SPS score is calculated using the below mentioned formula: SPS Score = %Promoters - %Detractors GPRD stands for Global Product Registration Database. It is a system used by Stryker to request and exchange regulatory documentation between design division RA and distribution division RA for registration purposes. The study involved hundred case studies for complaint handling (Annexure I), SPS validation and two GPRD requests. The validation of SPS tool was done successfully by preparing list of users along with the expected responses. Then the survey was initiated to all the users mentioned in the list. Users were instructed to fill the responses as per the sheet and then cross verifying the responses and thus validating the tool (Annexure II) GPRD request 1 is from Latin America region and it is initiated for risk management documents like FMEA risk analysis of simplex with tobramycin and also its biocompatibility reports (Annexure III) GPRD request 2 is from Canada region and it is initiated for retrieval of 210 labels for different part numbers