Attend any supply chain security conference or discussion group these days and a common topic you’ll hear will involve photo libraries as a tool for verifying the authenticity of raw material receipts.

The drivers for such programs are simple: incidents of melamine and glycerin demonstrate that the opportunity for economically motivated adulteration is real and globalization is leading to an increased complexity within our supply chains.  No single activity will protect a company from all the risks presented; the key is to line up multiple measures to cover the gaps allowed by each.  The use of a photo library where multiple eyes are on each incoming container looking for expected packaging configurations, approved tamper evidence seals, specific labeling, and other unique identifiers can be an important component of your overall security program.

Why Use a Photo Library?

The goal of an incoming raw material photo library is to have an early detection system that is quick, easy, and effective for identifying tampering or adulteration of incoming materials as early as possible.  Whether your company is a single facility startup or a multi-national firm with manufacturing locations around the world, following the basic principal of ‘Keep it Simple’ will allow you to meet this goal and maintain a successful photo library program. 

Planning Your Program

As you begin to plan your program, remember that perfection is the enemy of good and its pursuit has destroyed many valuable initiatives.  Start by gathering the stakeholders involved with raw material procurement, receipt, and quality management.  In the first meeting it will be easy to get derailed by concerns around what value this adds, potential scope, compliance concerns, time, resources, and what will be done if something is seen.  To keep the team focused, come prepared with some draft operating principles separating out immediate and long term goals then include a discussion outline of the expected concerns.

Example initial operating principals:

• Develop a reference library that focuses on pattern recognition, executed through visual cues by the warehouse receiving worker
• Perform at every receipt to add security, but not used as lot release criteria.  If variant found, indentify and enter existing exception processes  
• Deployed via local mechanism
• Managed as a pilot and kept simple

And potentially the long term goals:

• Central library with visual standard per SKU, with version control
• Vendor verified content (label, tamper evidence approach, CoA)
• Developed requirements for creating material photos, updating the library, and outlining the inspection process
• Tie photo management into Quality Agreements and ensure they are covered by Supplier Change Notices

Follow these with discussion topics:

• Why are we here?
• Scope Definition
• Compliance
• Time and Resources
• What if we find something
   

Considerations for your first stakeholder meeting:

Why are we here and what value will this bring? The "why" should be a simple sell to any group concerned about product and patient safety.  Consider typical supply chains that use repackagers, distributors, and warehouses.  Add the potential value of the materials ordered.  Then consider it just takes one disgruntled employee at any of these steps to open the door to potential economically motivated adulteration.  The value lies in the implementation.  If kept simple, implementation can be done quickly and easily with minimal overhead.  Even if nothing is ever found, you’ll find value in the process.

What about scope?  The specific risks at every company are different and should consider what materials are used, where they are sourced from, how they are procured, and how they arrive at your location.  If your materials and supply chains haven’t been mapped to provide risk differentiation, consider starting with your excipients or materials procured through distributors.  Getting your feet wet with a small material set will allow you to gain experience without impacted operations and cycle times.  Once experience is gained in a process, expanding it to other tested materials or including photos in existing inspection profiles is a smaller and easier step to complete.  (continued)

Building Your Library

Once a team is assembled and in agreement that a photo library project should move forward with a defined scope, the next steps are to begin obtaining photos to build material specific pages, define how they will be used during material receipts, and how the project will be tracked and managed.  Ideally a conversation with each of your suppliers would lead them to sending authenticated photos of their materials.  When this isn’t possible, an alternate approach is having your raw material experts take photos of inventoried items or even beginning the photo gathering with subsequent receipts.  A decision will need to be made between the use of a paper based or electronic system depending on your specific situation.  Either can be applied successfully and the approach documented in your CAPA.  With either medium consider building your photo page (think collage) using a consistent format and size.  Within the photos themselves call out key attributes that staff should look for such as specific tamper evidence seals, water marks, and custom or unique labels.

Making it Work

Next, outline operating instructions for the process.   Capture revision 1 of these in the CAPA as well and update it based on feedback from the inspection teams.  Example directions are provided below:

• At the beginning of each day, note the planned receipts and identify if a photo page is available for receipt inspection.  (You may also want to build into the process a notification to your ‘photographer’ if the receipt is an opportunity gather new or updated photos)
• Prior to receipt obtain the photo page for the material (Here you may also want to build in a process to have the program owner participate in the initial receipt process)
• As appropriate and identified in each photo page, review supplier labels, packaging configuration, and tamper evidence seals for consistency of key indicators, colors, and patterns identified
• Follow local procedures for any concerns or issues seen, including the local program owner when available
• Provide feedback to site program owner regarding excessive time spent doing photo verification, any triage activities required, as well as recommendations for changes to the reference photos or inspection process

Compliance:  At every conference or discussion about photo libraries, concerns are raised on how regulatory agencies will react if they see photos being used during material receipts.  The key message to convey here is that the photo library is being applied to provide an additional layer of security without removing anything from the existing processes.  Operators will need something to guide their work however so consider opening a CAPA to describe the project as a continuous improvement effort.  Capture the scope of the work, any directions to be given to operators performing inspections, and where photos can be accessed within this document.  Additionally, describe that the first rounds of photo pages used to compare against incoming receipts are drafts and will be updated as you gain experience with which photos and layouts add value for you.  This gives you the flexibility to learn as you go and quickly adjust without restrictions of change control or validation while you are still trying to fine tune the overall process. 

Time and Resources: When kept simple and folded into existing practices the impact of photo inspections will be smaller than you expect.  When implementing our program we intended to perform time studies around the additional time to perform the photo inspection and quickly found that it took more time to manage the study than complete the work.  At each site implementation teams opted out of the time study on day 2 and just reported out ‘minimal impact’.  The drivers for the minimal time investment is that staffs performing receipt inspections are already looking carefully at each for catalog numbers, material numbers, and secure seals.  What the library does is provides them a reference point of what things should look like and key indicators of authenticity.  It plants images in their mind to help outliers stand out.  A few seconds to familiarize themselves with these details was all it took. 

Consider managing some items consistent across materials at the supplier rather than material level so if a watermark is updated you don’t have to update dozens of individual pages.  Treat each on a case by case basis.  Some you may want to partner with your supplier to understand and control, where others may not provide the additional security you are looking for and could be removed from your photos.  In the early stages you want flexibility to make these changes without excessive administrative burdens.

Your company may be surprised with what you find even outside of unique identifiers.  Inspectors at our company even noticed and elevated variances seen in the words “For Laboratory, Research, or Manufacturing Use” within the photo below to triage teams.

As you gain experience with the photo library begin to revise or draft new procedures around how to build and approve photos, maintain a library, and perform the receipt inspections.  As your company may have new material requirements into the future, develop these procedures allowing new photo pages to be verified and updated against actual receipts prior to any approve or version controls.  For multi-site implementations consider creating a high level standard to govern the program while allowing each location to incorporate the ‘how to’ into site specific documents.  The pilot phase gives a great opportunity to test the draft process in live situations and make on the spot updates.  Capture any updates to the process in the CAPA so a clean record of where you are in the process is available to all stakeholders.

Implementing Your Program