Imperative. Tim Mohn Industry Principal Sparta Systems

Transcription

1 Enterprise Level ChangeControl: Control: A Life Science Business Imperative Tim Mohn Industry Principal Sparta Systems

2 Agenda GlobalChange Control: An Overview Benefits and Challenges Change Control as Part of a Quality Management Solution Implementing a Change Control Solution Most Common Areas of User Frustration and How to Avoid Them Questions & Answers

3 Change Control Overview

4 Implementing a Change ControlSolution The most effective automated change control systems comprise the following types of critical functionality: Electronically and securely managing all information in a centralized, scalable, and reliable system eliminates the potential loss of information Centralized management of all change control items eliminates redundant systems and decreases production costs Consistent and harmonized processes and procedures across the organization reduces liability and patient risk Applying the right controls, at the right time, to ensure compliance while also maintaining a culture for innovation

5 High level Change Process Change Request Request Assessment Pre approval Execution Change Management Change request vs. change management Why is the change happening? Who does it impact? What actions are required? Regulatory implications? What approvals are required? Real time status? Post approval

6 Enterprise Change Control: Desired State Hierarchical relationship of one change request and its associated activities Electronic attachment and organization of supporting documentation Logical association of supporting information directly to change request Automated, consistent, and efficient change control process Clear visibility iibilit to all levels l of the organization through centralization of information and dashboards Accommodation of both proactive and reactive change activity Clear Linkage Change Request Electronic attachment Impact Assessment Regulatory Assessment Implementation Activities

7 Benefits and Challenges

8 Business Drivers for Enterprise Change Control Time to market Companies require a consistent mechanism to implement change Supports global supply chain initiatives Enables plant rationalization and supply continuity Supports product enhancements and evolution Supports merger & acquisition (M&A) strategies Provides mechanism to harmonize onto common systems and processes Compliance Significant consequences to non compliance including fines, production stops and even requirements to register new product variations Globalvisibility ofchange is expected

9 What s Slowing Companies Down? Alignment Getting a global company to set aside resources at the same for the same purpose requires executive sponsorship and commitment Efficiencies Local site leadership may bli believe their local lprocess is optimized i for their needs. Why should ldthey give that up? Regulations In some companies, especially those that have grown via M&A, products are regulated differently either based on product type or region. Companies must devise a strategy to hold each product to the appropriate regulation not too little or not enough Perception In many companies change control is seen asnot value add. add This perception must be actively managed during any project Process Reengineering Before investing in an electronic system, the best practice is to use that opportunity to refine your business process. This requires the right team and targeted effort but pays dividends in the longrun. Smart companies know that software alone won t solve their problems

10 Other Common Challenges Existing infrastructure it is often unclear where/how change control fits in with the other applications that are in place

11 Common Systems Impacted by Change Control ERP PLM / Doc Management EQMS

12 ERP PLM/Doc Management EQMS Primary Audience Operations, Supply Chain R&D, New Product Development Manufacturing Quality, Auditors, Complaint Handling Units Processes Inventory management, Design History File (DHF), CAPA, Nonconformances, hold status, Bill of Material Document Management, Bill of Material, Change Order processing Audit, Complaints, Holistic Change Management Core competency Key Value Proposition Inventory management, costing Enable Supply Chain Efficiencies Reusable parts, Revision control/doc management Develop new products faster Flexibility Low Medium High Time to Value High Med Low Workflow management, closed loop processes, configurability Streamline processes and enable continuous improvement, in both processes and products

13 Typical Complaint Process Training Change request Doc Mgt and PLM ECO Change request Complaint Investigation CA CRM Web Service Product investigation Correction Risk assessment Root cause CAPA Field Service CSV Complaint Manually entered Reportability assessment Reportability assessment Regulatory Reportability Assessment Reportability assessment emdr emdv Paper

14 Change Control as Part of a Quality Management Solution

15 EQMS Overview: How It All Fits Together Audit Management Deviations & Incidents Lab Issues Complaint Handling Supplier Quality Management Investigations Adverse Event Reporting Training Management Risk Evaluation Root Cause Analysis CAPA Product Registration Tracking Correspondence Commitments Change Control Batch / IT / Process / Document Material / Equipment Effectivity Analysis

16 Change Control as Part of a QMS Change control is logicallycorrelatedcorrelated to multiple elements of a company s overall quality system including CAPA, deviations, audits and batch control. Organizations with best in class quality systems processes are including global change control as fully integrated element of their enterprise quality management systems (EQMS)

17 Implementing a Change Control Solution

18 Implementation Methodology Strong executive sponsorship is a critical pre requisite to initiating a deployment Scope must be clearly identified and documented to serve as a baseline to prevent creep Project team resource needs and timelines need to be clearly l communicated and agreed upon in advance of project start Prototype reviews during design/build are critical to insure requirements are metand gain buy in from project team 6 Stage Implementation Methodology 1 Analyze requirements Design/build Test Validate Train Go live/support

19 Initial Discovery Evaluation of existing processes Documentation of as is process Collect all plant and site level SOP s Document site specific processes based on the SOP s Prepare and distribute questionnaires to help learn more about local process Summarize all findings, including major differences Identification of challenges, issues, risks of the overall process as well as impacted functions Evaluation of IT landscape Identify all systems, including interfaces, used by the impacted departments Identify a state of infrastructure to support a global system Master data analysis Identify source(s) of master data Define strategy for to be model

20 Process Harmonization Input From Key Stakeholders Across geographies and functions (QA, RA, Validation & Tech Services etc.) To be Process Definition Identify major changes and areas for improvement Process mapping, including control points Tradeoffs from current state? Leverage Executive Champion Nearly all projects include resource efficiencies, although sometimes there is also a shift of work from group A to B which champion can help manage Initial Face to Face Workshop Alleviates interpretation issues Builds relationships across team Subsequent activities are then easier to conduct remotely

21 Implementing a Change Control Solution Automation Automation of required impact assessments based on the change type, impact, and other criteria improves the impact assessment process Automated notifications for departments and sites when problems occur increases visibility and reduces product impact Automated workflow and parallel review and approval processes improves efficiency and reduces change control closure time Automated and enforced specific actions help comply with ISO and other industry regulations

22 Integration Sophisticated ERP Direct master data validation ERP Batch in ERP Release Fully automated placement of hold notices in ERP by EQMS Fully automated disposition iti updates from EQMS Master Data Integration User Entered Product Information Validated Data SOA Place Hold Affected Batches Disposition Updated Disposition Updated Release process with clear, inherent visibility into quality issues Initiated Change Initiated Change Completed Change

23 Integration EDMS Basic Access to controlled documentation in EDMS from the change management system Seamless no additional authentication Advanced Change management workflow > document lifecycle interaction Two way visibility to status

24 After Go live: Most Common Challenges and How to Avoid Them

25 Traditional View: Two MostCommon Challenges Training Communication

26 Symptoms I don t understand how to use the system I have more work than before Feeling that the team overpromised and under delivered It takes me longer today that it ever did These are all symptoms of needs for incremental training and communication. However, y p g, organizational Change Management takes time and every business process change sees some level of this

27 Other Common Scenario Processes are optimized for quality department and don t necessarily include tangible enhancements for others Change control examples: Product Registration tracking is Regulatory s job any easier with your new process? Why not? Annual ProductReviews again, isregulatory s s jobanyeasier? How do we avoid these scenarios? Proper planning up front to ensure needs of different groups are understood, prioritized, and address.

28 SIPOC Suppliers Inputs Process Outputs Customers Process flow

29 SIPOC Example Suppliers Inputs Process Outputs t Customers Car Car owner Filter manufacturer Engine oil supplier Car Filter Engine Oil Oil Change Dirty filter Used oil Empty filter box Empty oil containers Car owner Trash disposal company Oil recycling company

30 SIPOC Exercise: Change Control Suppliers Inputs Process Outputs Customers Quality Change request Change control Updated SOP Operations

31 Conclusions

32 Conclusions When implementedand managedsuccessfully, electronic change control can be a competitive advantage to differentiate a company from their competition by enabling improved cycle time and time to market, supporting global supply chain initiatives, enhanced product quality, and the flexibility to adapt to changing regulations.

33 Questions & Answers