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Agile Process Teams

Use Cases & Demos


Explore Typical Use Cases by Role

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Incident Management

Use Case: Material Shortage Requiring Secondary Source

Typical User Role: Supplier Relationship Management, Production Planning,  Supply Chain Manager, External Sourcing/Supply and Direct Materials Supply

Situation: A supplier relationship manager or external manufacturing manager learns that a critical item is not going to be available in the expected quantities, forcing the company to source smaller quantities from multiple suppliers. 

Solution: The issue is documented using Agile Process Teams (APT) incident management capability and an initial response is agreed upon. Subsequent changes in batch size and formulation are managed using APT’s change management capabilities. Teams, managers, and executives have access to all incident and change artifacts, and visibility into the resolution of this compounding problem.

Business Value: Because all parties have a common understanding of all the facts, information, and next steps regarding the issue, it is resolved much faster, thus avoiding production and shipment delays. Revenue and time to market goals are met, and costs related to managing the supply disruption are minimized. Over time, understanding the patterns of material shortages allows companies to build resilience and lower safety stocks resulting in increased OTIF, better cash conversion cycle, improved visibility, fewer disruption escalations, and improved supplier performance.

Use Case: Late Shipment

Typical User Role: Supplier Relationship Management, Production Planning, Supply Chain Manager, External Sourcing/Supply and Direct Materials Supply

Situation: A supplier relationship manager monitors on-time delivery of direct materials used in the production process at internal and external manufacturing sites. A supplier needs to push back the delivery date on a line item of a purchase order. 

Solution: As soon as the supplier is aware of the delay, they create an incident in Agile Process Teams (APT) indicating that the line item will be late. Teams on both sides are assigned to determine the best mitigation plan to reduce the potential impact on production. Using APT, they share information on the manufacturer’s supply requirements, the supplier’s capacity, and transportation schedules to reach the best possible outcome.

Business Value: By gaining visibility to a late shipment and proactively managing the situation, the manufacturer minimizes the impact on revenue and customer service levels. Expediting costs are minimized. Over time understanding the patterns of late shipments allows companies to build agility resulting in improvements in OTIF, better cash conversion cycle, increase inventory turns resulting from decreased safety stock, enhanced visibility, up to a 70% reduction in disruption escalations, and improved supplier performance.

Use Case: Packaging Problem (poor quality, wrong artwork, damaged, wrong materials)

Typical User Role: Supplier Relationship Management, Supplier Quality,  External Sourcing/Supply and Direct Materials Supply

Situation: A pharmaceutical company quality control department detects a problem with product labelling and the affected products are placed in quarantine. Such issues can be related to company branding, product strength, or lot and serialization imprint.

Solution: The company creates an incident in Agile Process Teams (APT.) The supplier or CMO gets notification of the issue. The manufacturer’s supplier relationship management team is included in the workflow and works with the supplier to develop a short-term resolution (such as repackaging or scrapping) and a long-term resolution (such as better version controls).

Business Value: Quick resolution of packaging incidents means finished goods shipping delays are minimized. Collaboration across teams means that the most efficient resolution (repackaging versus scrap) can be determined. It is estimated that over 50% of product recalls are related to the labeling or the packaging artwork. Cost avoidance can run into the millions of dollars from more effective packaging quality control and issue resolution. Understanding the patterns of such issues over time enables companies to establish better quality controls resulting in up to 50% improvements in OTIF, better cash conversion cycle, enhanced visibility, up to 70% reduction in disruption escalations, and improved supplier performance.

Use Case: Serialization Issue

Typical User Role: Serialization and Supplier Relationship Management

Situation: A manufacturer’s distribution center (3PL or internal) receives a lot shipment of serialized product from a contract packager (CPO). Approximately 50% of the lot had a discrepancy in which the data encoded in the 2D bar code neither matched the lot number and expiration date in the batch record, nor the lot and date printed in human readable form on the label. This portion of the shipment needs to be sent to a third party repackager for rework, causing additional delay and a shortage of commercial stock. The initial assessment indicates that there are missing recipe management standard operating procedures in the packaging process that are causing sloppiness at the L3 level in managing lot numbers and expiration dates.

Solution: An issue is created in Agile Process Teams (APT) by the distribution center receiving team and shared with the external manufacturing team as well as the CPO team. An initial resolution is that the CPO will assume responsibility for the cost and coordination of the rework and will send a courier to pick up the products. However, this is a chronic recurring problem across multiple products, and the manufacturer invests more time and identifies the root cause. They work with the CPO to take corrective action.

Business Value: By managing this issue in APT, all parties are able to have access to the same information as to who is doing what and what the next steps are to resolve the problem. The manufacturer minimizes the impact on OTIF, protects revenues, and avoids drug shortages that might adversely affect patients. Over time, understanding the patterns of serialization issues enables companies to establish better controls resulting in improved OTIF, better cash conversion cycle, enhanced visibility, reduced disruption escalations, and improved supplier performance.

Use Case: Updated Supply Plan

Typical User Role: Supply Planner, Commercial Team and Supplier Relationship Management

Situation: A marketing authorization holder (MAH) is bidding on an invitation to tender from the UK’s National Health Service (NHS). The resulting business will increase production for one of their products from 10 to 30 batches per month. The NHS is specifying a 7-day dosage pack instead of the current 28-day pack. The NHS requirements will have an impact on lead times, safety stocks, and pack-out configuration and require close coordination among trading partners to confirm production capacity and material availability.

Solution: The MAH supply planner has created an incident with Agile Process Teams (APT) and invited the team at its contract manufacturer (CMO) to collaborate to confirm capacity, required lead times, materials availability, pack-out configuration changes for the additional batches, and other requirements needed to confidently create a proposal for the NHS. Confirmation information is recorded in the incident history.

Business Value: By documenting all of the steps, questions, clarifications, and commitments, the entire team on both sides has access and visibility into all of the sub-issues, checklists, tasks and challenges necessary to ensure that production schedules can be met as agreed to against this new tender. By collaborating during the tender process, the MAH can create a comprehensive proposal with full confidence that it can deliver on its commitments. Over time, accurate responses to tender requests will likely lead to more orders, improved OTIF, greater market share, and increased revenue.

Use Case: Product Quality Review Document Deviates from Previous Agreed Version

Typical User Role: Quality Assurance and Quality Control

Situation: The quality teams at the marketing authorization holder (MAH) and a direct materials supplier established an annual product quality review (APQR) document process. Upon review of an updated version of the APQR provided by the supplier, the MAH quality team noted that there were several changes to the document that had neither been discussed nor approved by the MAH and were inconsistent with the expected supporting data. Failure to be in specification with the APQR could result in a production stoppage and potential penalties, including an FDA 483.

Solution: Upon discovery of the APQR anomalies, the MAH quality team and the supplier relationship team create an incident with Agile Process Teams (APT) and share it with the supplier, asking for an initial assessment and explanation for the incorrect and missing supporting data. An initial assessment is provided by the supplier, but the MAH requested additional assessment detail as this issue is likely to become a formal corrective and preventive action (CAPA) given the GxP nature of the violation. The APQR is revised and corrected through a structured review process that involves many teams across both the supplier and MAH. 

Business Value: The corrected revision is completed in half the time expected as all parties are synchronized as to next steps, tasks and responsibilities. Quick resolution of quality document issues means products spend less time in quarantine and shipping delays are reduced. Collaborative issue resolution of quality document issues also improves the likelihood of right first-time resolution. Analyzing the patterns of issues over time can uncover opportunities for process improvements that avoid certain types of deviations and result in increased OTIF, better cash conversion cycle, improved visibility, fewer disruption escalations, and improved supplier performance.

Use Case: Production Delay at CMO

Typical User Role: External Manufacturing Operations and Production Planning

Situation: Pharma companies often place multiple orders with the same contract manufacturer (CMO) with no consideration for the CMO’s production capacity or material availability. If the CMO is unable to meet the demand schedule, they require input from external manufacturing operations at the pharma company to prioritize capacity and materials common to multiple orders.

Solution: CMOs can be connected to Agile Process Teams (APT) in order to communicate potential production delays and late shipments as soon as they are aware of a potential problem. Teams on both sides can be assigned to determine the best mitigation plan to minimize the impact on customers. This advanced visibility enables external manufacturing operations to work with the supply chain organization and the CMO to prioritize orders.

Business Value: With more advanced notice to understand potential production bottlenecks, external manufacturing operations has more options for mitigating the impact on customers, including reallocating on-hand inventory, reallocating raw materials, and rescheduling the production backlog. Over time, understanding the patterns of delays and how they affect the supply chain allows companies to refine their supply planning resulting in fewer supply bottlenecks, improved OTIF, better cash conversion cycle, higher inventory turns, enhanced visibility, reduced disruption escalations, and improved process performance.

Use Case: Out of  Specification Process Control

Typical User Role: External Manufacturing Operations and Quality Assurance

Situation: A manufacturing operations team at a virtual biotech company needs careful control over outsourced manufacturing processes to ensure that consistent products are produced in every batch. Due to the complexities of manufacturing biologics, there are hundreds of process control steps and standard operating procedures that need to be followed across the multiple contract manufacturers that each perform a step in a complex manufacturing process. Any deviation from the specified approach will result in an issue and potential change controls for adjustments to pull the process back into specification. Production is stopped until the specification issue can be resolved.

Solution: The process control deviation is documented in Agile Process Teams (APT) and the pharma company and supplier come up with an optimal solution to bring the process back into tolerance. All relevant operations, quality, and commercial teams from both sides have visibility into all the facts and who is taking what action to resolve the problem. Related change controls are managed efficiently in a structured workflow to ensure that production can be restarted.

Business Value: By providing visibility for all parties involved in the process control deviation, everyone knows what to do, who is responsible, and which team members have the next step in the resolution process. With a structured process for resolving the out of spec issue and the corresponding change controls, production can be restarted quickly, avoiding shortages and cost overruns and ensuring that high value batches continue to reach patients. Revenues are protected and expenses related to the out of spec issue are minimized. Over time this approach enables robust root cause analysis so that process improvements can be made and batch yields can be improved. The result is improved OTIF, better cash conversion cycle, higher inventory turns, enhanced visibility, reduced disruption escalations, and improved process performance.

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Change Management

Use Case: Material Shortage Requiring Secondary Source and Change Controls

Typical User Role: Supplier Relationship Management, Production Planning, Supply Chain Manager, External Sourcing/Supply, Direct Materials Supply

Situation: A supplier relationship manager or external manufacturing manager learns that an API is not going to be available in the expected quantities, forcing the company to source smaller quantities of the API from multiple suppliers. 

Solution: After the issue is addressed using Agile Process Teams (APT) incident management capability and an initial response is agreed upon, the resulting changes in batch size, formulation, and delivery dates are managed using APT’s change management capabilities. Quality, commercial, supply, and manufacturing operations teams are involved and have access to all change artifacts. The change controls are approved, allowing the modified API production process to proceed.

Business Value: Because all parties have a common understanding of all the facts, information, and next steps regarding the change controls related to the API shortage, the changes are fully documented and approved much faster, thus avoiding production and shipment delays. Revenue and time to market goals are met, and costs related to managing the supply disruption are minimized. Over time, an understanding of the patterns of material shortages allows companies to build resilience and lower safety stocks resulting in increased OTIF, better cash conversion cycle, improved visibility, fewer disruption escalations, and improved supplier performance.

Use Case: Material Change from Sub Supplier

Typical User Role: Supplier Relationship Management, Supplier Quality, Supply Chain Manager, External Sourcing/Supply and Direct Materials Supply

Situation: A pharma company’s supplier relationship manager works with their counterparts at internal and external sites, managing routine and unplanned change controls. Quality, commercial, supply, and manufacturing operations teams may all be involved, depending on the nature of the change. A supplier of prefilled syringes is having trouble procuring syringe needles and plans to switch to a new sub-supplier. This will have an impact on three different products at two sites.

Solution: The supplier submits a change request using Agile Process Teams (APT), so the pharma company can evaluate the impact of the change, assess the new sub-supplier, and perform an audit of their facilities. With APT, everyone involved across three tiers of the supply chain can go to one place to view all supporting information, such as an assessment of the change impact, the previous audit of the sub-supplier, and other pertinent information. And to coordinate the activities of the many people involved from three different companies, APT provides a structure for planning each step in the process. 

Business Value: By accelerating the review and approval of change controls, companies can more confidently maintain the continuity of supply, safeguard product integrity, and deliver on customer service commitments. They also gain the flexibility to make such changes more often when warranted by business conditions.

Use Case: Process Control Change

Typical User Role: Supplier Relationship Management, Supplier Quality, Supply Chain Manager, External Sourcing/Supply and Direct Materials Supply

Situation: A biopharma company’s external manufacturing manager works with their counterparts at contract manufacturers (CMOs), managing planned and unplanned change controls. A CMO is planning on using a new type of fermentation tank to increase the yield of one of the biopharma company’s products. 

Solution: The biopharma company and its CMO use Agile Process Teams (APT) to collaborate on the review and approval of the CMO’s change request. Because the new fermentation tank represents a significant change to the production process, multiple experts are invited from both companies to carefully participate in the request process and review technical documentation and pilot production data. All information is centrally managed, and a project plan with due dates and accountability is established to complete the review. The change is approved, and the new tank goes into production ahead of schedule, increasing yield as planned.

Business Value: By accelerating the review and approval of change controls, companies can more quickly put process changes into effect, accelerating the time to value associated with lower costs, increased yields, and other benefits resulting from process improvements.

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Quality Review

Use Case: Batch Record Review

Typical User Role: Supplier Quality and Quality Control

Situation: A pharmaceutical company needs to approve the batch record for each batch of products from its suppliers and contract manufacturers (CMOs) before a production batch can be released for shipment. The approval of such batch records may require extensive review and discussion between the two parties. 

Solution: Instead of circulating the document by email and relying on email and phone to discuss the document, the supplier submits the batch record to Agile Process Teams (APT). APT provides a secure workspace to collaborate on the review and facilitates a structured process for completing the process quickly and efficiently. Users gain real-time visibility into review status, anomalies needing attention, and audit trails. Supply chain and commercial teams have full visibility to the status of each batch. Note that APT facilitates the review process, but the manufacturer can use their existing quality management system (QMS) to create the quality document.

Business Value: The use of APT accelerates the batch record review process because all the necessary information is in one place and a structured process is established with accountability and deadlines. There’s no more time wasted fumbling through emails for the latest document version and trying to match lot numbers. The end result is improved OTIF, reduced inventory levels, and better cash conversion cycle. Companies also benefit from an improved and better documented quality process.

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