1. John Cover, CQA (ASQ), CTBS Director, Quality Assurance Science Care American Association of Tissue Banks Quality Assurance Workshop X November 12 th , 2008 Quality Program Overview Elements, Effectiveness and Examples

13. Quality Program Overview AATB Quality Assurance Workshop X John Cover “ Our plans miscarry because they have no aim. When a man does not know what harbor he is heading for, no wind is the right wind.” - Seneca (4BC-AD65)

14. Quality Program Elements Quality Program Overview AATB Quality Assurance Workshop X John Cover Mission & Goals Mission & Goals “ Quality will be a focus in the organization’s strategic planning and in its mission statement.” 2 “ Develop and monitor the quality mission and policy and ensure alignment with he organization’s broader mission.” 2 The Quality Mission Statement should never deviate from the organization’s mission statement, but it should enhance it from a quality perspective and with a customer focus.

15. Quality Program Elements Quality Program Overview AATB Quality Assurance Workshop X John Cover Quality Policy Quality Policy Mission & Goals “ A quality policy is a formalized document created to communicate the overall intentions and directions of the organization s they related to quality.” 2 “ The quality policy should summarize the organization’s view on the definition of quality, the importance of quality, quality competitiveness, customer relations, internal customers, workforce involvement, quality improvement, planning...” 2

16. Quality Program Elements Quality Program Overview AATB Quality Assurance Workshop X John Cover Quality Plan Quality Plan “ The Quality Plan is a document, or documents, that specify quality standards, practices, resources, specifications and the sequence of activities relevant to a particular product, service, project or contract.” 2 Mission & Goals Quality Policy Components: Objectives to be obtained Allocation of responsibilities Specific documents, standards, practices, etc. Testing, Inspection, audit programs, examination Change Management / Achievement Measures 2

17. Quality Program Elements Quality Program Overview AATB Quality Assurance Workshop X John Cover Quality Plan Mission & Goals Quality Program Components Quality Program Components Quality Policy Complaint Mgmt. Quality Control Dev. Mgmt. (CAPA) Equipment Procedures / SOPM Enviro. Monitoring Audit Program Reagents / Supplies Track & Trend Storage Validation Facility Controls Change Mgmt. Records / Review Personnel In-Process Controls Training & Education Competency

18. Quality Program Examples Quality Program Overview AATB Quality Assurance Workshop X John Cover Quality Plan Mission & Goals Quality Program Components Quality Policy (Company Mission Statement). In order to maintain the highest quality standards for those to which we serve, we commit ourselves to the following: Quality Standards To establish industry leading quality standards to control, monitor and continuously improve the quality levels of our services. Customer Satisfaction To focus on critical key measures which have a direct impact on internal and external customer satisfaction and continuous improvement toward understanding the voice of the customer.

22. Quality Program Examples Quality Program Overview AATB Quality Assurance Workshop X John Cover Quality Plan Mission & Goals Quality Program Components Quality Policy Independence The Quality Assurance Department is an independent quality advocate and regulatory adherence monitor for the Company and its affiliated operational entities. All Quality Assurance functions are independent of operational functions. Oversight over Operational functions resides with the Executive Management, while the oversight over Quality Assurance functions resides with the Program Director. Quality Assurance has a direct reporting relationship to the Program Director. Quality Assurance has an information relationship to Executive management, the responsible head for each satellite facility, management at all levels, and all Company staff.

23. Quality Program Examples Quality Program Overview AATB Quality Assurance Workshop X John Cover Quality Plan Mission & Goals Quality Program Components Quality Policy Authority The Quality Assurance Department authority is given by the Program Director. In the Program Director’s absence, the authority is given by the Executive Management. This authority extends to all Quality Assurance activities. Activities include: audit authority, quality improvement documentation approval authority, RCA and CA/PA approval authority, and production control authority. At any time, a member of Quality Assurance has the authority to temporally suspend any/all operational function(s), at any time, if necessary to minimize potential safety risks and/or ensure compliance with subscribed accreditation standards.

24. Quality Program Examples Quality Program Overview AATB Quality Assurance Workshop X John Cover Quality Plan Mission & Goals Quality Program Components Quality Policy In order to further the Company’s Mission, a Quality Plan has been implemented that will focus on the implementation and maintenance of the following Quality Program key functional elements: Quality Improvement Program: The Company will adhere to a strict program for measuring and improving process performance through identification, root cause evaluation, and problems will be documented, tracked and/or trended to ensure continuous quality improvement. Quality Improvement Process: The Quality Improvement Process will provide a mechanism to detect, correct and document problems or to improve a process. By accurately and systematically documenting expected or unexpected events, The company will be able to monitor all regulated processes to reveal weak points, focus on continuous improvement, and ultimately create robust systems, processes and procedures required to fulfill our mission. .

25. Quality Program Examples Quality Program Overview AATB Quality Assurance Workshop X John Cover Quality Plan Mission & Goals Quality Program Components Quality Policy Root Cause Analysis Process : The Root Cause Analysis Process will ensure that problems detected are comprehensively analyzed to determine the deep underlying cause(s) of a process or system problem and the associated contributing factors. Corrective Action Process: An effective Corrective Action Process will enable the Company to precisely and systematically develop and implement solutions that target each identified root cause and contributing factor to a process or system problem. This will ensure that identified problems are effectively corrected to prevent reoccurrence. Tracking and Trending: Tracking and Trending of problems detected by the Quality Improvement Process allows for the effective monitoring of Company’s critical control points in its processes and systems. This will ensure that all processes and systems remain in a steady state of control. .

27. Quality Program Examples Quality Program Overview AATB Quality Assurance Workshop X John Cover Quality Plan Mission & Goals Quality Program Components Quality Policy Audit Schedule: All predetermined audits will be scheduled in advance and will follow a 12 month (annual) cycle. Annual Operational-Process-System (OPS) audits and bi-annual record audits for all departments will form the backbone of the audit program. Ancillary systems will be audited annually as per the pre-determined audit schedule. Audit Process: All Quality Assurance Audit functions will be based on the American Society for Quality (ASQ) Quality Auditor Body of Knowledge and follow all applicable AATB and NYDOH guidelines for quality audits. Pre-established and approved audit work-tools will be used within the agreed scope of the audit. The auditor and auditee will subscribe to accepted auditing standards for the Audit Preparation phase, Audit Performance phase, and Audit Closure phase of the company’s audit program. .

30. Quality Program Examples Quality Program Overview AATB Quality Assurance Workshop X John Cover Quality Plan Mission & Goals Quality Program Components Quality Policy Specific Procedure Sets for: Complaint Mgmt. Quality Control Dev. Mgmt. (CAPA) Equipment Procedures / SOPM Enviro. Monitoring Audit Program Reagents / Supplies Track & Trend Storage Validation Facility Controls Change Mgmt. Records / Review Personnel In-Process Controls Training & Education Competency