QIAstat Large Scale Ramp Up
Material Availability
Internal Processes
Set up training for new processes
New types of materials were not available because we didn't initiate efforts soon enough to assure stock
Investigate storage issues for each scenario... which may impact capital budget
Did not have critical materials in stock
Capacity is limited or too much inventory... forecast is wrong. Unable to meet Max or oversupplied for Min scenario
Raw material were not ordered in time causing delays
Unable to stage materials due to space constraints or resource constraints... causing delays
3 lines sharing the same materials have large impact on raw materials and supplies in general
Not all material is covered in BOM (e.g., mfg consumption mtl.) Address planning for non-MRP items
Confirm that Procurement has initiated required activities
Critical Issues
Suppliers
Services were not capable or were not as flexible as we needed
Time for qualification reviews were not sufficient to ensure quality of documents etc.
Suppliers need raw material that was not available caused delays... made it difficult to set up QIAGEN equipment properly
ACTION: Set up new suppliers (at least 1 is known) now
Single sourcing put materials and services at risk
Manufacturing
Quality issues related for plastic parts (QC steps not observed) caused higher scrap rates, line stops
Too low OEB caused output issues and demand not fulfilled
Insufficient or outdated process risk documentation... there was not enough revision work done
Overall line TAK time was low impacting output
Tools wear out.. feeding, caused delays in schedule
Machines could not be installed on time
Processes were not reliable causing high scrap and impacting output
LSL project did not cover all production processes caused lower OEE and ultimately output
Delayed or failed process validation prevented product output
Functional
Incorrect master data was maintained impacting capacity planning and related items
Ongoing product changes impacted the project timeline
Processes and training were not set up in time causing delays
Contamination
Contamination related to automation actuators caused delays and Quality issues
Improper or difficult cleaning procedures (related to machine design)... contamination of product and excess scrap rate
Mfg lines had issues with product contamination
Contamination of raw material caused delays
Need a regular meeting/ communications between LCM with stakeholders. Focus on this.
Communicate clear definitions via documentation
This is hard to answer at this time... no one knows what compliant manufacturing
Critical Items
Specifications
Machines
Machines were not specified correctly or missing causing delays
Subtopic
Product
Incorrect or Imprecise specifications for the product
Communicate this risk to the team and raise awareness of the issue
Investigate tolerances/specs on production line windows... consider larger windows. (Product Development issue - at least addressed for future projects)
Update requirements document for any mfg. line. A document exists but is outdated, incorrect, insufficient. Make it editable across sites.
Critical dimensions of plastic parts are not defined causing delays
Materials
Specifications gap or technology gap caused delays and Quality OEE
Enterprise
There is no overall Project Manager for the program which caused issues across the project... no harmonization
Address 'handoffs' when responsibilities change
Address expectations on who is responsible for what across team and stakeholders
Define who is doing what to address many of the identified concerns
Hire a program level PM... this also addresses contamination issues
Incorrect business case from not available or miscalculation caused... budget issues and capacity issue
Structural changes in the organization (responsibilities, interfaces, org changes) impacted the team and stakeholders
Internal talent left the company in multiple departments leaving a skill gaps
No budget available to address increased costs
COVID restrictions impacted team performance (e.g., travel restrictions)
Changes in scope increased costs and went over initial budget
Expectations about flexibility of development, capacity development... caused communication and expectation failures (caused bottlenecks)
People were not brought on board with the right skills
Identify critical roles that need to be addressed
Address both hiring and training issues
Link this issue with Project Manager responsibility
Create clear resource plan for the whole project, not just GxP requirements
Critical Issue:
Commercial Market
We focused on machine availability, but market demands needed things like flexibility that were not addressed during development
We have other production lines that are flexible... Define long term plan for the capacity of each line (including others) and related hiring plan that could address flexibility
Project agreement/communication needs to clarify the flexibility requirements
