Gap Analysis of the Change Control Process The History of a Transformed Change Control System

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1 Gap Analysis of the Change Control Process The History of a Transformed Change Control System Juan Alcazar Quality Systems Carolina, PR

2 Content Introduction Gap Analysis Phases to perform a Gap Analysis using Pfizer Carolina as a Case Study

3 Why to Perform a Gap Analysis? "Where are we?" "Where do we want to be?"

4 Why to Perform a Gap Analysis? Identify and address potential performance problems. Identify areas of improvement. Evaluate the impact and risks of current practices.

5 Why to Perform a Gap Analysis? Understand where the system is in terms of : Complying with Procedures Complying with Regulations Complying with Customers needs Company's goals

6 Why to Perform a Gap Analysis? Optimizing Resources System Employees

7 Gap Analysis Gap Analysis is the process to determine where you are in relation to where you want to be. The desired state of performance is compared with the current state of performance.

8 Gap Analysis The desired state of performance will be the goal by which the success of the process will be measured.

9 Gap Analysis Desired - Current = Gap

10 Gap Analysis The information used in the Gap Analysis needs to be measurable. Data for business results, operational metrics needs to be available. During the process new metrics might be needed in order to compare the current and the desired state. These metrics can be used to measure if the new conditions are maintained.

11 I- Preparation Identify and set the goal Comply with Regulatory Agencies Comply with corporate procedures Simplify the process Make the process more robust To improve how to set interdepartmental expectations in terms of change requirements

12 I- Preparation Identify key multi-disciplinary contributors to your process and users to participate of the gap analysis Users Approvers (Supervisors, Area Experts) Contributors Coordinators

13 I- Preparation Take a time to evaluate your process Participants must commit to the exercise A specific percentage of time must be designated for the exercise.

14 I- Preparation Identify the documentation related to the current process Policies Procedures Regulations Flowcharts Metrics

15 Our Transformation Objective, Project Scope, Team Members and Tools were identified. Team s training needs were identified and a plan was developed. Copies of procedures, metrics and other relevant documents were available.

16 II- Dissect the current process Is my current Change Control process working? Map the current Process Compare current process with the procedures and regulations Question the value of every step Eliminate waste Verify system efficiency Identify the key elements of the process and start building on

17 Our Transformation The current process was mapped Completed and ongoing Change Controls were reviewed Forms and Electronic Systems were evaluated Internal and External Audits, Investigations and CAPAS related to Change Control were reviewed

18 Our Transformation Are my forms functional? Simple to complete? Do they include all relevant information needed for decisions? Are my approvals adequate? Do we need more / less signatures? Are the requirements (tasks) appropriate? Is my tracking system working for me? Manual vs. Electronic

19 Our Transformation Is the process linear? Can the procedure be followed? Is the communication between areas effective? Are process controls adequate? How are my metrics? What is my Cycle time? Which tasks are consuming more time? Is the customer satisfied? Are we performing according to the procedures?

20 Our Transformation Gaps were identified The gaps are stated without implying the solution. When identifying the characteristics of the desired state, all ideas were evaluated. A "wish list" of characteristics was created.

21 Our Transformation The gaps were evaluated in meetings with the areas involved in that specific part of the change control process. The gaps were evaluated in terms of the risk and magnitude Compliance Resources Time

22 Our Transformation The Desired Process Improvements were Identified and divided in 3 Categories Operation of the System Management of the System Mindset Changes or capabilities needed The goals were included in a table format stating the current and the proposed states for each specific goal

23 III- Build a new process Verify key elements of the process are accounted for Compliance with regulations and local procedures is maintained Address gaps found Make sure you have the infrastructure and people to operate using the new process

24 Our Transformation The gaps found and recommendations were evaluated Regulations Company procedures Resources All possible solutions for the gaps found were evaluated The Change Control Process was simplified to its core elements.

25 Our Transformation With the core elements as the desired state, the team then started to incorporate the recommendations to improve the process The new process was mapped The improved process was discussed with relevant parties involved Agreement on new process Commitment to be aligned

26 Our Transformation The process was modified based on the feedback obtained Incorporated new process to the Change Control procedures Team agreed on items for future revisions

27 IV- Implementation Mind set renovation Launch new process Patience during training stage System users that participated of the gap analysis can help in the training process Implement tools to track system improvement

28 Our Transformation The team changed the mindset to be aligned with the new process Trainings were offered on subjects such as: Coping with Change Communication The team was prepared to deal with different reactions Users Ourselves

29 Our Transformation Persons involved in the exercise participated of the training sessions The process is explained from another Point of view Represented areas / departments are featured The exercise is not perceived as a Quality Initiative

30 Our Transformation Patience was the key to the successful implementation. The areas accepted and adopted the new process.

31 Our Transformation Metrics were implemented to monitor the process improvements

32 V- Monitoring Review metrics and compare it with previous periods. Listen to the system users. Schedule another system evaluation. Gap Analysis evaluations should be periodic

33 Our Transformation Metrics are prepared and presented to the company's management. All suggestions or complaints are compiled in a list to be evaluated for future Change Control Program revision.

34 Summary Monitor Prepare Implement Dissect Build

35 Our Transformation Process improvements 50% reduction in steps Electronic solution substituted manual forms 75% reduction in processing time 86% reduction in approval time

36 Exercise Examples from FDA web - Warning Letter Observations Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR (a). (FDA 483 item #4) Specifically. Failure to review and evaluate a process and perform revalidations where appropriate when changes or process deviations occur, as required by 21 CFR (c). (FDA 483 item #2) specifically. Failure to establish and maintain procedures to ensure that the device design is correctly translated into production, as required by 21 CFR (h). (FDA 483 item #19) Specifically, your Design Control Procedure (Document No.: DES-500) did not address design transfer.

Profit. Enterprise Risk and Compliance Management. Effective Risk & RCM and Three P s. Ed Sattar, CEO, 360factors inc.

Profit. Enterprise Risk and Compliance Management. Effective Risk & RCM and Three P s. Ed Sattar, CEO, 360factors inc. Enterprise Risk and Compliance Working in Compliance vs. Working On Compliance Ed Sattar, CEO, 360factors inc. Effective Risk & RCM and Three P s Profit Planet People Page 2 1 Outline Regulatory & Operational