Site Quality Metrics OTC perspective. Veronica Cruz, PhD Executive VP/COO. May 13, 2014 Quality Session 3

Transcription

1 1 Site Quality Metrics perspective Veronica Cruz, PhD Executive VP/COO May 13, 2014 Quality Session 3 2 1

2 Quality Management System A comprehensive Quality Management System. Establishes controls that allow delivery of product that meets the needs of customers, consumers, regulatory bodies and internal standards. Utilizes metrics to effectively monitor, track and trend system, process and product performance to identify and correct areas that could potentially compromise product quality in a timely manner. Enables an environment of continuous improvement. 3 Effective Monitor, Track and Trend Rx vs. Expectations related to product quality are the same for Rx and However uniqueness and context between Rx and must be recognized and considered: High volume, multiple formula variations Broad spectrum of patients/consumers Product readily accessible Broad spectrum of products: dose limiting vs. non dose limiting Rx Lower volume, fewer formula variations and packaging presentations Targeted spectrum of patients Controlled access 4 2

3 Effective Monitor, Track and Trend Product Quality Development CTQ s Commercial Production In process data Release testing metrics Enviro. Monitoring trends Market surveillance Customer complaints Exp. Dating Stability program Product reviews 5 Effective Monitor, Track and Trend Product Quality Site Performance Development Commercial Production Market surveillance Incoming materials Manufacturing Packaging QC testing CTQ s In process data Release testing metrics Enviro. Monitoring trends Customer complaints Exp. Dating Stability program Product reviews Supplier metrics Shop floor metrics Lab metrics 6 3

4 Effective Monitor, Track and Trend Product Quality Site Performance Development Commercial Production Market surveillance Incoming materials Manufacturing Packaging QC testing CTQ s In process data Release testing metrics Enviro. Monitoring trends Customer complaints Exp. Dating Stability program Product reviews Quality Systems Supplier metrics Shop floor metrics Lab metrics Operational efficiencies RFT, Waste, Cycle times Capital investments, Infrastructure Product Life Cycle Management Change Control, Training Non Conformances, PM s Continuous Improvement 7 Effective Monitor, Track and Trend Product Quality Site Performance Development Commercial Production Market surveillance Incoming materials Manufacturing Packaging QC testing CTQ s In process data Release testing metrics Enviro. Monitoring trends Customer complaints Exp. Dating Stability program Product reviews Quality Systems Supplier metrics Shop floor metrics Lab metrics Operational efficiencies RFT, Waste, Cycle times Capital investments, Infrastructure Product Life Cycle Management Change Control, Training Non Conformances, PM s Continuous Improvement Communities of Practice/Quality Councils GOVERNANCE Executive Management Reviews 8 4

5 Effective Monitor, Track and Trend Metrics- are used as performance indicators, with a goal to assess quality of the product and state of control of the production sites. As such, individual data points are rarely the target of performance monitoring, Monitor trends/signals (vs. judge individual data points) Monitor overall timeliness AND effectiveness of system performance 9 EXAMPLES OF KEY QUALITY METRICS Product Quality metrics Site Performance metrics 10 5

6 What Customer complaints Signal detection PRODUCT QUALITY METRICS Adherence to complaints investigation cycletime Why An indicator of Product s ability to satisfy customer s need Defects going undetected at time of release Defects created after release Timely reporting to BOH Timely reaction to confirmed product quality issues Potentially higher number of complaints as compared to Rx Higher product volumes Broader customer spectrum Product access at store shelves and multiple users at home Seasonal effects Therefore, monitoring trends and signals could be more meaningful to asses product quality. 11 PRODUCT QUALITY METRICS What Confirmed OOS Why An indicator of Critical to quality attributes or parameters not in control Typically have longer validated manufacturing campaigns, so one event can potentially impact a campaign of multiple lots To avoid misleading interpretation of metrics need to take into consideration total # of lots in review period and impact of campaigning 12 6

7 SITE PERFORMANCE METRICS What Why QC Laboratories QC data used for product release decisions Minimum oversight of testing activities labs are high volume as compared to Rx labs. Monitoring percentage or trends could be more meaningful when comparing intra and inter site performance or when comparing Rx vs. lab performance 13 SITE PERFORMANCE METRICS What Right First Time (RFT) Why Indicator of operational excellence an potential systemic issues Need to have understanding of the volumes and contributors for non RFT to reach meaningful conclusions on the metrics. vs. Rx longer manufacturing campaigns can compromise multiple lots in a RFT metric. RFT does not typically indicate acceptability of a lot. Often has more impact on business efficiency (continuous improvement) than risk to consumer. 14 7

8 Inter Intra Site Monitoring Performance Indicator RFT batches (%) Green 90% Yellow 90 80% Red 80% Past due CAPA Green CAPA past due 30 days Yellow Past due CAPA days Red Past due CAPA 90 days Site 1 Site 2 Site 3 Site 4 Site 5 85% 100% 95% 100% 85% Metric 3 Medium High Low Low Low Metric 4 Acceptable Marginal Acceptable Acceptable Acceptable Metric 5 100% 20% 95% 98% 93% 15 Summary To Effectively Monitor Product Quality and Site Performance Have consideration for type of product Rx vs Trends and signals are sometimes more meaningful than individual data points Efficiency metrics are important but if considered in isolation they can be deceiving Details behind the numbers are important to assure assertive conclusions related to state of control 16 8

9 Thank you Q&A 17 9