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BPA and CPO Project Status

BPA and CPO Project Status. April 15, 2010. Project Budget vs Actual. Project Plan. Accomplishments. BPA Project 1 Items Accomplished This Week: Continued gathering SOP documents from supply chain, packaging, manufacturing, global supply, and engineering quality.

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BPA and CPO Project Status

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  1. BPA and CPO Project Status April 15, 2010

  2. Project Budget vs Actual

  3. Project Plan

  4. Accomplishments • BPA Project 1 • Items Accomplished This Week: • Continued gathering SOP documents from supply chain, packaging, manufacturing, global supply, and engineering quality. • Attended strip manufacturing tour. • Created detail flow of non-conformance product handling process. • Facilitated non-conformance As-Is process review and captured issue, gaps and risks. • Created and delivered executive status presentation. • Reviewed Witney Quality and Operations org charts and scheduled conference calls. • Items for Next Week: • Complete Non-Conformance process narrative and recommendations. • Complete process flows for majority of areas. • Complete document gathering. • Create Document Control project definition and approach overview for DVP review. • Issues and Concerns: • If we start the Document Control project in the next week or so, we will either need to extend the length of the BPA project another 4 weeks or bring in an additional resource to either backfill for John or Dave on the BPA project or assign to the Document Control project. Brining in an additional resource will allow the Document Control project to start soon and keep the BPA project on course. Let’s discuss next week. • Should we include Internal Audit, Management Review, and Validations in the BPA scope? • We’re still waiting on MS Project and Visio for our Abbott laptops. We’re using 2 laptops each in the meantime.

  5. Accomplishments • CPO Project 3 • Items Accomplished This Week: • Conducted meetings with: • Kelly Cotoni (US Customer Service) to review/revise the next-level process flow for Customer Services • Clay Geran to explore past projects to enhance the complaints handling process • David Azamey & Mauricio Alberto (Complaint Investigations Group) to review/revise the next level process flows for Phase I and Phase II investigations • Peter Blackman to continue dialogue about the overall process and differences between the UK and US operations • Continue to update flow charts and narratives for the major steps within the overall process. • Toured strip manufacturing facility with Jason Jower. • Items for Next Week: • Conduct meetings with: • Devin Dirstine to review/revise the next-level process flow for Complaint Evaluation. • Tara Miller to review/revise the next-level process flow for Complaint Closure • Suzanna Ward to review/revise the next-level process flows for Product Impact Evaluations (as they relate to Complaints Management) • JoseeFauteux to review existing, approved Quality Plans • Set telephone meetings with UK product investigation group • Set telephone meetings with Asia/Pacific and Europe Customer Service to review their processes in relation to registering complaints and in communicating with the various country units • Continue to update flow charts and narratives for the process • Issues and Concerns: • None

  6. Status BPA Interview Matrix

  7. Status CPO Interview Matrix

  8. Scope update In Scope Out of Scope? – (Need to discuss) Validations, Internal Audit, Management Review

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