Case Studies I

Summary

Barely keeping up with market supply, the test strip assembly machine had to move and be qualified in the new facility over a 3 day holiday weekend, 4 weeks away. Similar efforts required 6 months in this organization. By moving all non-essential work off of the assembly machine move and qualification critical path, and by having an operational and production qualification dry run the weekend before the move, the project team accomplished the move and qualifications in just 26 hours!

Problem

1. Projects don’t go as planned

2. Large, complex manufacturing equipment, that was market supply bottleneck, needed to move to a new manufacturing facility

3. Only 72 hours, over a holiday weekend, had been allotted for uninstalling the equipment, moving, reinstalling and qualifying the assembly machine, to ensure continuous market supply. Previously, a similar project required six months minimum within this organization.

4. The project manager would be gone during the move, due to previous commitments. They reluctantly agreed to the project dates, having been persuaded by their friends, the operations and engineering directors, that any project team coached by the project manager would do fine in their absence.

5. The two technical leads for the move and validation project thought that a whole day for detailed project planning was a waste of time; when there was so little time to prepare for the move. There were only four weeks before the holiday weekend when the assembly machine move would occur.

6. Technical issues were encountered when trying to validate the assembly machine procedure which would be used for production qualification, PQ, following the move.

   a. It took weeks to resolve the issues and get the updated procedure approved through document control

7. There was a product error marking system on the assembly machine, and the team had to validate that all of the marked product included all of the defective product all of the time

8. During the assembly machine move, the team discovered that equipment wouldn’t fit through the door of the building that it was currently housed in.

9. During the assembly machine installation, the electrician didn’t show up when they were needed, and the team discovered that they didn’t have the electrician’s contact information

Solution

1. Determined that the assembly machine move and qualification would take place around the clock, to maximize the amount of time available for the project team to accomplish their mission

2. Provided a project coordinator, so there would be a single point of project management contact during the move and qualification

3. Persuaded the two reluctant technical project leads to attend an all-day Critical Path Management™ services project planning session, which is much more detailed than normal project planning.

   a. The two technical leads were stunned to find out that the procedure for the assembly machine PQ was brand new and unvalidated, therefore not ready for use.

   b. If the technical project leads had insisted on proceeding with the assembly machine move and qualification without Critical Path Management™ services project planning, they would have ruined the project’s 72 hour, holiday weekend timeline because the PQ procedure qualification turned out to be on the project critical path.

4. The team moved all the project work effort possible off of the move critical path, so that only the essential work had to be done in the 72 hour move window. Flexible ducting and conduit were installed for utilities; connections were pre-wired so that installation could proceed as quickly as possible. All protocols, procedures and reports were written such that data could simply be dropped in during the qualifications.

5. It was a difficult process to overcome the issues with the procedure for the assembly machine production qualification, and took weeks to resolve. So there was almost no time to get the modified procedure through document control and approved before it had to be used in the dry run.

6. The weekend before the move, the team conducted a dry run to iron out any difficulties they ran into. They didn’t do the actual move or the installation qualification, IQ. The team performed the operational qualification, OQ, and the PQ using the newly validated procedure. A roll of laminated test strip material was produced, 50 meters in length that was marked for defects.

   a. The team spent 5 hours measuring defect marked areas vs. defects and then figuring out how they could use the data, along with the machine’s defect-marking logic, to demonstrate that defective areas would always be marked defective no matter what. It was a fairly complex problem, but they were able to prove categorically that defects would always be part of a marked defective area.

7. When the assembly machine couldn’t fit through the double doors of the building it was moving from, the facilities department removed the door jamb to enlarge the opening enough so that the assembly machine could pass through.

8. The project coordinator contacted the electrician’s boss to get their contact information. The project coordinator called the electrician, and they were onsite in less than an hour.

Description

The test strip production was barely keeping up with market supply, but the manufacturing equipment needed to move to the new facility. When the project manager joined the cross-functional assembly machine move and validation project team, four weeks before the target move dates, they replaced one of the technical leads as project manager. The project had already taken the better part of a year, and had to be complete within 5 weeks. When technical leads are asked to manage their projects too; both roles are rarely done well. Usually, it’s the project management role that suffers, because it’s not their area of expertise. For the assembly machine move, the project manager quickly started aligning the project team with the Critical Path Management™ services introduction presentation that outlines expected team culture, norms, and behaviors. CPM uses many tools to constantly reinforce the expected culture, norms, and behaviors to ensure conformance, which is why so many CPM projects yield high performance teams.

Over the objections of the two technical leads, who felt that planning for 8 hours was excessive, the project manager held a day long project planning session. Critical Path Management™ services planning is much more detailed than traditional waterfall planning. The granularity is such that every task has a task owner. It doesn’t necessarily mean that the task owner will do all the work on the task, but they’ll be responsible and accountable for the task; at any given time during the project, the task owner will know the task status. The assembly machine validation consisted of the IQ/OQ/PQ. During the planning, the two technical leads were shocked to find out that the procedure intended for the assembly machine PQ was new and unvalidated, therefore, not ready for use. Validating the procedure became part of the project plan. The team’s primary strategy was moving all of the possible work effort off of the actual 72 hour move critical path: Flexible ducting and conduit would be installed for utilities; connections would be pre-wired so that installation could proceed as quickly as possible. All protocols, procedures and reports would be written such that data could simply be dropped in during the qualifications. In the end, the planning session took six hours.

During the procedure validation, technical issues were encountered that took weeks to resolve. There was barely enough time to get the revised procedure through document control and approved cross-functionally before it had to be used. If the team had discovered the unvalidated nature of the PQ procedure any later, the holiday weekend move window would have been missed. Detailed planning always pays off because the devil is in the details.

The weekend before the move, the team conducted a dry run to iron out any difficulties they ran into. They didn’t do the actual move or the IQ. The team performed the OQ and the PQ using the newly validated procedure. A 50 meter roll of laminated test strip material was produced and marked for defects. The team spent 5 hours measuring marked defective areas vs. defective areas and then figuring out how they could use the data, along with the machine’s defect-marking logic, to demonstrate that defective areas would always be marked defective no matter what. It was a fairly complex problem, but they were able to prove that defects would always be marked. During the week before the move all vendors (electricians, HVAC, plumbers, etc.) were confirmed to be on call 24 hours a day for the holiday weekend assembly machine move. All move documentation was finalized, ready to be populated with qualification data. 

The actual move began Friday evening at 5 PM. The assembly machine uninstallation proceeded smoothly. However, when the time came to move the machine out of the building, it wouldn’t fit through the double doors. It was a surprise, because the route had been given an all clear by the facilities manager. He rectified the situation by having the door jamb removed so that the assembly machine could fit through. The machine got into the new facility without a problem. When it came time to install it, the electrician didn’t show up as scheduled. The project coordinator discovered that the team didn’t have the electrician’s contact information, so they called the electrician’s boss in the middle of the night to get their phone number. After being contacted, the electrician was onsite in less than an hour. After that the IQ went smoothly, as did the OQ. The PQ ran smoothly on the assembly machine. The team measured the marked defective areas vs. the actual defective areas and did the calculations that they had figured out the weekend before. One of the technical leads observed that it was a good thing that they had done the dry run to figure out how to qualify the defect marking system, because they never could have done it with their lack of sleep during the actual move. The data from the qualifications was added to the qualification reports and the team completed the assembly machine move and qualifications in 26 hours!

Summary

The project scope was neuromodulation system clinical trials, with implant, modified controller, and extensive legacy design control, for an early October de novo 510k submission; it was March. The technical lead was the project manager; rarely can someone do both jobs well, and it’s usually the project management that suffers. The Neuromodulation project kept slipping. The timeline for a key controller feature slipped so much that it was out of scope. So, the CEO brought in InSync Solutions LLC to do Critical Path Management™ services to turn the project around.

The CPM project manager started with the CPM project initiation presentation which establishes the norms for team behaviors and culture, as well as the CPM tools for reinforcing these traits. It also introduced the C³ Model, Communication, Cooperation, and Coordination, along the project critical path. Following the C³ Model is how compliant project execution excellence was achieved. Detailed  Critical Path Management™ services planning was conducted, which is considerably more  detailed than waterfall planning. There was continuous use and reinforcement of the CPM open and transparent team culture; this ensures that issues are immediately brought to the surface. The Neuromodulation project members evolved into a high performance team.

To get enough patients through clinical trial primary endpoint in time for the de novo 510k submission was quite a challenge. The clinical manager and a clinical consultant were the only resources for visiting clinical sites. All the patients’ visits had to be scheduled at the beginning of their visit windows and visit scheduling covered the summer months too, so vacation schedules were a complicating factor. With just two people for clinical site visits, in order to maximize the number of patients that completed the study, the clinical study resources had to travel to sites Monday – Friday for 16 weeks straight. However, the clinical trial results were through statistical analysis just in time for inclusion in the de novo 510k submission.

The team accelerated the critical path of the key controller feature using Critical Path Management™ services and the Critical Path Method techniques of scheduling tasks in parallel, and adding critical path resources. These efforts, along with the high performance team productivity, brought the controller key feature back in scope. 

Full verification and validation testing was done on the Neuromodulation system: modified controller and implant. All legacy and current design control documentation was completed and a notified body auditor complimented the Neuromodulation project design control implementation. The de novo 510k was submitted on schedule, the first week of October. 

Summary

Senior management wasn’t aligned on transitioning their market leading, flagship, blood glucose test strip to global plasma calibration, yet they agreed to do this because the test strip had a persistent low bias and global plasma calibration was, on average, 12 mg/dl higher than whole blood calibration, making the low bias less noticeable. Reflecting the lack of senior management alignment, the plasma calibration team was unsupportive of the project until the project manager applied the Critical Path Management™ services element of a transparent and open team culture. This uncovered the prevailing sentiment that plasma calibration was only suitable for certain markets; it was desperately needed in Canada, but not in the US consumer and hospital markets. So the team put together a modified project scope, whereby plasma calibration would be introduced in the global markets that wanted it, and pitched the modified scope to the management board. The board agreed with the modified scope with a Canadian launch in June; it was January. The also noted that cross border test strip confusion issues could occur, so the plasma and whole blood test strips must be visually distinguishable. This would be validated in clinical trials. Once the strip was visually differentiated, and the calibration methodology was developed, clinical trials began. The clinical trial results failed with a low bias to reference test strips. A task force was formed with the plasma calibration project manager as the task force leader. After a few weeks the task force discovered a constant, inherent manufacturing variability that had caused the low bias. Resolving the variability was a long term effort, so the task force introduced sub-lotting within a 5 mg/dl response window increasing accuracy by 60%. Clinical trials were repeated and passed. The plasma calibrated test strip launched in Canada in June, and was rolled out to the other global markets that wanted it.

Problem

1) Projects don’t go as planned.

2) Senior management wasn’t aligned on the need for global plasma calibration, yet a persistent low bias in their flagship blood glucose test strip product convinced the management board to approve global plasma calibration. Since, on average, plasma was a 12 mg/dl higher response than whole blood, it would make the low bias less obvious.

3) The Canada franchise was getting hammered in the marketplace because they lacked plasma calibration. They needed the plasma calibrated strips by June to meet their annual sales targets. It was January, and the project required clinical trials, which were time-consuming.

4) Most of the team members disagreed with the decision to do a global transition to plasma calibrated test strips; they felt that some markets were better off with whole blood calibration, and they weren’t willing project participants.

5) A test strip product performance problem was discovered during the plasma calibration clinical trials. The product performance problem had to be resolved before clinical trials could be repeated.

Solution

1) The project manager used the Critical Path Management™ element featuring a transparent and open team culture to identify the undercurrent of dissent about global plasma calibration, which reflected the lack of senior management alignment on the issue. The US consumer and hospital marketing groups made a compelling business case against plasma calibration for the US markets.

2) The team approached senior management with a proposed change in project scope to better fit the company’s global market needs: Launch Plasma Calibration on a market by market basis rather than globally. Management's agreement to the change in scope, with a regulatory caveat, ended the conflict/politics over the project, and the project team aligned on the modified scope.

3) Leveraging Critical Path Management™ services scheduling tools, the project manager split up the project into 11 sub teams (Clinicals, Packaging and Labeling, Calibration, etc.) to ensure focus on the key project milestones. Detailed sub-project schedules were created with task durations determined by task owners. This is another key element of CPM; it ensures task owner buy-in to the schedule, which is vital to project success. Critical Path Management™ services was used to manage the project sub-teams, to ensure not only that the project timeline wouldn’t slip, but to gain critical path time for when it was needed, e.g. to repeat clinical trials.

4)  Application of the Critical Path Management™ services  plus the C³ Model: Communication, Cooperation, and Coordination along the project critical path helped the Plasma Calibration team evolve into a high performance team that was incredibly productive during the six-month project; they produced 50% more project work effort than an average team. This was essential for project success.

5) When clinical trials failed with an unacceptably low bias, a task force was formed to resolve the product performance issue.

i) The solution to product performance issue improved test strip accuracy. 

6) The new plasma calibration methodology improved the accuracy of calibration code assignment, and was adopted for all test strip products within the company.

7) Canada launched plasma calibrated test strips on schedule in June with 60% improved accuracy.
 

Description

What else could possibly go wrong? No one wanted to be on the Plasma Calibration project team except the project manager. It was January, the June deadline was aggressive because time-consuming clinical trials were required for the plasma calibration project. Then, when both of these hurdles were cleared, the clinical trial results failed in March for the plasma calibrated test strips, which had a low bias compared to the reference test strips. The test strip product performance issue had to be resolved, and clinical trials successfully repeated to launch the plasma calibrated test strips. How could the project team possibly deliver the plasma calibrated test strips for Canada by June? 

Facing a team of 26 reluctant participants, the project manager used a transparent and open team culture, which is a key CPM element, to expose the undercurrent of dissent within the project team. Most of the team didn’t support global plasma calibration and weren’t going to cooperate in making it happen. Investigation by the project manager uncovered the lack of alignment for global plasma calibration. The US Consumer and Hospital Marketing team members made a compelling business case for the flagship test strips to remain whole blood calibrated for US markets. So the Plasma Calibration team developed an alternative project scope that they felt was a better fit for the company based on global market needs: the company would transition their number one global test strip to plasma calibration on a market by market basis. The management board approved the modified project scope noting that there was a cross-border regulatory challenge with the new approach. Customers had to be able to visually identify a plasma calibrated strip as different from a whole blood calibrated strip, so there wouldn't be any confusion with the test results since plasma calibration is, on average, 12 mg/dl higher than whole blood.  Also, the the highest priority market was Canada; they needed the plasma calibrated strips by 3rd quarter or their annual sales would miss forecast. The change in project scope aligned the Plasma Calibration team.

The project was divided into eleven sub teams (Clinicals, Packaging & Labeling, Calibration, etc.), in order to provide focus for key project efforts, and each sub team had a Critical Path Management™ services schedule, which is more detailed than typical schedules. CPM services' schedules highlight critical path and near critical path tasks and responsibilities. The team started implementing the project using Critical Path Management™ services' tools like focus on critical path, and they began practicing the C³ Model: Communication, Cooperation, and Coordination along the project critical path. These project management elements, unique to CPM, helped the Plasma Calibration team evolve into a high performance team that was 50% more productive compared to normal project teams.

For visual differentiation between the plasma and whole blood calibrated test strips, marketing decided to print on the plasma calibrated strips, repeating hands with index fingers pointing at the blood sample hole. Clinical trials would assess the efficacy of this visual differentiation between plasma and whole blood calibrated test strips. The high performance nature of the Plasma Calibration project team was crucial for project success. The time saved from the critical path acceleration the team had achieved was needed because Plasma Calibration Clinical trials failed with an unacceptably low bias to reference test strips in mid-March. The performance issue also affected the company's flagship test strips.

A high priority, cross functional task force was immediately formed to resolve the flagship test strip performance issue, with the Plasma Calibration project manager as the task force lead. Within a few weeks, the task force discovered a consistent variability pattern in test strip manufacturing that was lowering the test strip response within a lot, causing inaccurate results. The intrinsic variability of the manufacturing system required a long term solution. In the meantime, the task force opted to sub-lot the test strips, by grouping together test strips with similar blood glucose response, within 5 mg/dl of each other. This enabled better calibration code assignment, and greater test strip accuracy in use.

The team then developed a superior method for assigning a more accurate calibration code; this calibration methodology was adopted across all blood glucose test strips at the company. The net result was a 60% improvement in test strip accuracy by minimizing the manufacturing system variability via sub-lotting and using a better calibration code assignment methodology. Plasma Calibration clinical trials were repeated at the beginning of May and the results were good. The plasma calibration test strips launched in Canada in June, and were rolled out to the rest of the global markets that wanted them in a timely fashion.