Increasingly Complex World Existing Business in-vivo (within living) – imaging radio active pharmaceuticals Recent Acquisitions in-vitro (within glass) – fluids Customer Requirements Traditionally QMS EH&S added
Increasingly Complex World Existing Business independent 9001, 14001, 18001 Recent Acquisitions UK Business part of European wide 9001
Increasingly Complex Siemens World Heavily Regulated Industry UK - Medicines and Healthcare products Regulatory Agency (MHRA) Similar organisations in every country Different requirements GENERAL TERMS – ALL PRODUCTS NEED TO BE APPROVED BEFORE BEING SOLD IN ANY COUNTRY!
Siemens History = Compliance Risk Adverse Country Sold Unapproved Product Internal Regulation “Enhanced” Series of documents Expert audit teams Audit every country Needed to address business acquisitions, existing management systems and recently introduced internal regulations!
Publically Available Specification - PAS 99 Appropriate Management Systems For Healthcare this is: Quality Regulatory Health and Safety Environment Process Business Continuity
Management System – Plan – Do – Check - Act Framework for managing and improving an organization's policies, procedures and processes.
Elements of our IMS R Q H E P B Regulatory Quality H&S Environment Process Business Continuity
Common Requirements Common Requirements = Integrated Management System Common Requirements a) Policy b) Planning c) Implementation and Operation d) Performance Assessment e) Improvement f) Management Review
IMS Manual PAS 99:2006 identifies six requirements common to all systems: a) Policy b) Planning c) Implementation and Operation d) Performance Assessment e) Improvement f) Management Review These are defined in IMS manual.
Policies, Objectives and Programmes Quality Regulatory Affairs Health & Safety Environmental Process Management Business Continuity
Documentation Approach – Black and Blue 2.2 Environmental policy Top management shall define the organization's environmental policy and ensure that, within the defined scope of its environmental management system, it a) is appropriate to the nature, scale and environmental impacts of its activities, products and services, b) includes a commitment to continual improvement and prevention of pollution, c) includes a commitment to comply with applicable legal requirements and with other requirements to which the organization subscribes which relate to its environmental aspects, d) provides the framework for setting and reviewing environmental objectives and targets, e) is documented, implemented and maintained, f) is communicated to all persons working for or on behalf of the organization, and g) is available to the public. Healthcare has developed an environmental policy. It is reviewed on an annual basis and authorized by the Managing Director. It contains the required commitments and it is supported by a number of environmental objectives. These objectives are also reviewed on an annual basis by being presented to the directors of the business for discussion and agreement. This information is recorded within the document 05/01/05/005 Siemens Healthcare - Integrated Management System Policies, Objectives and Programmes It is also deployed via the Healthcare intranet site for employees and on the Healthcare internet site for external use (e.g. members of the public).
Key IMS Processes Management System Manuals for each area of our IMS. Supported by the following key IMS processes. 05/01/05/006 - Document Control 05/01/05/014 - Corrective and Preventative Action 05/01/05/015 - Control of Quality Records 05/01/05/016 - Management Systems Audit and Assessment 05/01/05/017 - Control of non Conforming Product These five key processes deployed across the whole of our IMS
Documentation Approach – Audit and Training New sections added for Audit and Training Rationale: Wanted the arrangements to be thought through at the time of document preparation/maintenance, i.e.: What and how will we audit Who and how will training be delivered
Benefits Challenged The Organisation – New Requirements All management systems “refreshed” Consolidated Approaches Policy Programmes Objectives Management Review
Benefits All management systems looked the same – A FIRST! Defined Ownership No increase in management system headcount – Extra 250 staff and new business activities! Documentation – Requirement plus Healthcare approaches Increased Transparency Facilitated Support – Common Approach
Benefits – External Audits Pas 99 Audits 3 year integrated audit plan Reduced number of audit days despite extra 250 staff despite additional business complexity Auditors that operate across all management systems
EXPERIENCE Healthcare Expert Audits Very forensic Documented Approaches Documented Records Coroner’s Court? Pas 99 Audits 3 year integrated audit plan Integrated Policies, programmes and objectives Updated annually with management review
Achievements? Successful PAS 99 surveillance audits More Challenging Auditors Integrated Approach Appropriate Levels Of Review Successful “Healthcare Expert” audit Global Finalists Siemens QT AWARD
Summary It was time for revolution, not evolution Fresh start Facilitated top down approach