​The EBR Implementation Guide: Part 1 – ​Tips on Scoping the Initial EBR deployment

There are several ways to cut and phase the introduction of EBR that should be considered early on in any implementation: 

1. Start with a smaller  solution footprint 

It is usually best to deploy and first use EBR for a specific Operation(s), or for a specific product. For example, this could be all products for a final packaging process, or selected products on a single line, the target being to reduce the time and effort required to get up and running, the benefit being this should result in: 

1. 1. Less master data and recipe elements to define  
   2. Less number of users to train 
   3. Less change management  
   4. Less user hardware such as tablets and barcode scanners 

2. Focus on known quality or compliance problems

Identifying and assessing existing issues in a GxP context where an EBR can help can be a great starting point for the project. As you are building in significant quality benefit from the first phase. These can come from a multitude of areas and should be identified specifically for your company.    

An example could be audit observations on the accuracy and timeliness of data recording on paper inside sterile areas, or discrepancies in the weighing quantity of raw material items.  

Applying EBR as a point solution and part of Corrective and Preventative Actions has the advantage of providing a very clear scope to control the project around, with a clear definition of project success. Once completed, evidence of the benefits will automatically build by using the EBR, providing clear justification in your business case to expand to other areas. 

3. Capture performance data 

Often, we think of EBR as only the Batch Record. However, there is highly valuable information within the production record that is non-GxP, and if extracted and analysed will add significant benefits for other processes.  

One example is in production planning. In the paper world, measurements of operation yield, start, and stop times are not real-time or necessarily precise.  

This means you’re planning team is hamstrung effectively by being in the dark, and unable to react effectively in order to update schedules in an effective way for the overall business process.  

By implementing EBR to collect such non-GxP performance data in real-time, you have the option to start with only a simple data set, which immediately demonstrates a real gain in value to the business. Further data points can later be added, with GxP data and the subsequent validation requirements being phased in over time.

4. Capture quality data 

In the same way as above for performance data, we may first want to focus on only collecting In-Process Control (IPC) information and/or Critical Process Parameters. In typical production sites much of the paper created for batch recording is for IPC, creating an obvious and risky source for human error.  

EBR can be used to quickly record and control these quality measures at the point of entry, we can then track and monitor values throughout a batch, and further over multiple batches. Such use of a ‘lite EBR’ can help to speed up Annual Product Quality Review processes and act as a better source of data for trend analysis to support your continuous improvement objectives. 

If such data is used only for trending and is not replacing GxP records then it also may be possible to reduce validation efforts.

5. Capture original reasoning why to implement EBR. They can QUICKLY get lost! 

From experience assessing many production sites still largely on paper, it can quickly become hard to ‘see the forest through all the low-hanging fruit on the tree’s’! Once you start looking, so many opportunities for improvement become clear, and as good as these ideas may be, it’s vital not to let your project lose its focus and highly valuable (and hard to recreate) early momentum. Often it pays to question what problems we’re going to solve at the beginning, and capture these as objectives in a project charter, that can be used to hold everyone on the same direction:

1.Think about what is the context of EBR in relevance to the overall company / factory improvement initiatives? 

2. Are we trying to improve Assurance, Performance or gain a new Capability? (or all three?!) 

3.What current and real-life issues in the facility contribute most to the overall challenges? and what is the improvement potential? 

4.Which EBR benefits and functions map to these initiatives and improvement areas? For example, we might highlight solely improving cycle time through faster batch review as our project success criteria, this will help to focus and control the scope of the project 

5.Finally, which of the above approaches to scope the EBR by (operation, product or data) can be used to get a deployment done as fast and as easy as possible, whilst meeting our targeted benefits?