What is required and what tools are available?
Many companies already have a risk based change notification program. The goal of this effort has been to develop a standardized way of making and reviewing risk assessments for change notifications.
For this standardized approach to benefit the industry it is important that participating companies implement elements of the program in a defined manor defined so that companies know when they have implemented the practice. The overall aim has been to make implementation meaningful but not onerous.
There are currently four aspects of the practice that companies are being asked to implement, these are
- Use of the decision tree and supporting principles in categorizing changes
- Use of Single Points of Contact for change notifications (SPOC)
- Commitment to completing the scorecard survey annually to monitor the impact this way of working is having
- Use of the guidelines on data package quality to deliver right first time data packages (once available).
The tools the team have developed are designed to promote critical thinking and better understanding and alignment of risk between biomanufacturers and supply partners within the biopharmaceutical single use industry.
It is not possible to cover every eventuality and technology that may be encountered and consequently several of the tools are not prescriptive. The intention is also for the community to continue to evolve processes and ways of working to achieve the desired state.
Conversely, as this practice is intended to provide a common way of working for the industry, establishing trust in the methodology and in its application across companies is critical. To that end there must be some standardization of approach and implementation across companies for the best practice to be valuable and impactful. The team has looked at each element of the practice and have agreed what constitutes implementation. Once a company has met these conditions, they can consider that element of the practice implemented.
|Item||End User||Supply Partner|
|Decision Tree Implement||What is Implementation for the End User?|
1. Recognition of the BPOG/BPSA Change Notification categorisation
2. Alignment of categorisation (as far as possible)
3. Notify supply base of the recognition of the BPOG/BPSA Change Notification categorisation
• Develop a plan to allow practices and procedures for change notification to recognize the BPOG/BPSA Change Notification categorization, which will require input from Stakeholders
• The Stakeholder Map provides a tool to help identify who within your organization needs to be aware of the BPOG/BPSA Change Notification Best Practices and Decision tree tool
• Review your plan with your BPOG L2 with the aim of securing organizational sponsorship for the plan from your L2 or L1
• For 1 & 2 above: Revision of procedures to document recognition of the BPOG/BPSA Change Notification categorisation and guide practices
• For 3 above: Use the end user letter template and/or new supplier agreements
• Commit to providing feedback to improve the decision tree
|• Use the stakeholder map or other tool to identify who within your organization needs to be engaged with implementation.|
• Get commitment to begin to use the BPOG/BPSA Decision Tree to determine the level of change that you will assign to an SUS change.
• Develop a plan to update any training, procedures and practices to reflect this.
• Review this plan with your L2 and secure organizational sponsorship via your L2 or L1 for the implementation.
• Commit to indicating which level of change you assign to a given change within your notifications.
• Use the supplier template letter (or similar)Inform your customer base that you will be notifying change levels based on the BPOG/BPSA Change Notification Best Practices Paper and decision tree.
• Commit to providing feedback for the improvement of the decision tree.
|Scorecard Implement||• Commit to completing the scorecard survey annually in Q3. Provide output to BPOG for blinding and aggregating into an industry overview.||• Commit to completing the scorecard survey annually in Q3. Provide output to BPOG for blinding and aggregating into an industry overview.|
|SPOC||We encourage the adoption of a single point of contact e-mail address. Further detail Coming Soon||We encourage the adoption of a single point of contact e-mail address. Further detail Coming Soon|
|Data Package Quality||Data package recommendations to be published soon. Actions to implement will be updated once available||Data package recommendations to be published soon. Actions to implement will be updated once available|
Stakeholder Mapping Tools
Workflows around change notification can become complex and involve diverse stakeholders from multiple organizations. Consider a change that arises from a component manufacturer and is being notified by an integrator as shown in figure 1.
This simple case assumes that there is no request for additional information from the biomanufacturer and that the component manufacturer can simply accept any requests for last time buys before the change is initiated which may not always be the case. The key point is that different aspects of a change may be handled by different parts of an organization. Incoming changes may be handled by a different team to outgoing changes, responses to a change from a customer may come from quality functions (accepting the details of the change) and from procurement functions (responding to the customers business continuity needs). These may feedback via quality and/or account management functions at the integrator side.
The team reviewed which functions may need to be considered in implementation of these change notification practices and developed the two documents below. If you are reading this you are likely to be interested in implementing these practices at your organization. Nobody will know your organization as well as you do. You will need to navigate your own organization to implement these practices successfully and bring value to your organization. The tools provided below do illustrate how it may be necessary to consider and engage a broader pool of stakeholders than one might initially consider, they were developed by multiple stakeholders considering the question of who may have a role in this within my organization. They should be used as a pre-populated list of stakeholders for you to consider and challenge your thinking about who needs to be involved/aware of this within your organization. Some stakeholders will be more important to influence than others and you may consider some not necessary within your organization.
Because organizations have different titles for roles within their company and responsibility may be delegated differently the document is organized by role and department/function rather than job title. For example: Owner of company change management policy, corporate quality rather than VP corporate quality or director corporate quality. The intention is that you will download this document and complete the specific name and function of the person responsible within your organization.
In order to secure implementation it is important to be able to measure the current status and demonstrate success through timely progression towards a desired state. Demonstrating quick wins is essential to securing organizational support for ongoing efforts. This is especially true when attempting to have multiple companies align on a standardized industry way of working.
The team has identified four areas critical to the success of change notification practices. We are asking companies to complete the survey once per year providing feedback of their aggregated experience across their customer/supplier base. Very few companies keep hard metrics on these aspects therefore we are asking for an indication of the companies experience in each area
The intention is that a cross functional team will come together and assess the companies experience over the previous 12 months. In this way bias should be removed by getting different perspectives and discussing/agreeing what the company score is. To support the discussion the team has developed a scorecard framework which provides an opportunity to identify and align on what a particular score means, both within and between companies.
|Categorization and timing||BioPhorum or other industry standards (ASTM, USP, ect) to assign Change Categories. Are not used||We consider that less than 25% of changes are categorized correctly according to the industry standard||We consider that 25-50% of changes are categorized correctly categorized correctly according to the industry standard||We consider that 50-75% of changes are categorized correctly categorized correctly according to the industry standard||We consider that 75-90% are categorized correctly categorized correctly according to the industry standard||We consider that >90% are categorized correctly according to the industry standard|
|Change description effectiveness (and anticipated EU Impact assessment (IA)||A description of the change is not provided or the description provided does not allow an EU IA. There may be a significant amount of follow-ups required to obtain proper descriptions||Less than 25% of the time, a change description is provided that will allow the EU to complete the right first time (RFT) IA. There may be a significant amount of follow-ups required to obtain proper descriptions.||25-50% of the time, a change description is provided that will allow the EU to complete the RFT IA. There may be a major amount of follow-ups required to obtain proper descriptions||50-75% of the time, a change description is provided that will allow the EU to complete the RFT IA. There may be a minor amount of follow-ups required to obtain proper descriptions||At least 75-90% of the time, a change description is provided that will allow the EU to complete the RFT IA||The change description provides sufficient information to allow the EU to complete the RFT IA >90% of the time|
|Data package quality||Data packages are not sent with the change notification, and data is not available||Data package is provided however with significant gaps and rework is required, impacting significantly timelines for implementation||Data package is provided with major gaps and rework is required, impacting timelines for implementation||Data package is provided with minor gaps that are easily addressed without impact to timelines for implementation||Data is available with no gaps, however it is not always sent along with the notification and must be requested||Data is always available, with no gaps, and sent along with the notification (right first time)|
|Workflow/communication effectiveness||Pre-notification is not provided (when needed). The quality and timing of the notification is not acceptable|
Timelines for change implementation are not acceptable most of the time
SPOCs, are not used and there is no opportunity for bidirectional feedback
|Pre-notification (when applicable) & notification is provided less than 25 of the time, with sufficient time to properly implement|
Implementation timelines are acceptable less than 25% of the time
SPOCs are not used, but there is opportunity for timely and effective bidirectional feedback <25% of the time
|Pre-notification (when applicable) & notification is provided 25-50% of the time, with sufficient time to properly implement|
Implementation timelines are acceptable 25% of the time or more
SPOCs are used and there is opportunity for effective bidirectional feedback 25- 50% of the time
|Pre-notification (when applicable) & notification is provided 50-75% of the time, with sufficient time to properly implement|
Implementation timelines are acceptable 50% of the time or more
SPOCs are used and there is opportunity for timely and effective bidirectional feedback with 50-75% of the time
|Pre-notification (when applicable) & notification is provided 75-90% of the time, with sufficient time to properly implement|
Implementation timelines are acceptable 75% of the time or more
We use SPOC's and have timely and effective bidirectional feedback with <75 -90% of the time.
|Pre-notification (when applicable) & notification is provided at least 90% of the time, with sufficient time to properly implement.|
Implementation timelines are acceptable 90% of the time or more
We use SPOC's and have timely and effective bidirectional feedback with >90% of the time
A PDF Version of the industry scorecard is available for download here.
Communications letter templates
One of the key aspects identified as part of the proposal for change notification best practices is good, clear and timely communication. Each company must take responsibility for communication around individual changes following its own practices and policies. However, the team did agree that for the sake of clarity it would be good for each organization that has implemented key aspects of these best practices to communicate this to their customers and/or suppliers. The templates provided below are provided for use in communicating engagement with an aspect of the practice and can be modified as necessary for your use.