QIAstat Large Scale Ramp Up Copy

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Extracorporeal Membrane Oxygenation (ECMO) by Jared Bienstock, MS, CCP, LP, CES-A Copyright © 2021 (All Rights Reserved)

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COMPARATIVE/SUPERLATIVE

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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Insufficient or outdated process risk documentation...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