Competency Flashcards
(18 cards)
What are some examples of options for ambitious for patients?
Pink C951
Cobo bulk not crimped
Batch release spreadsheet
Item code WOW
Give a summary of questions examples and their response for Ambitious for Patients
Having the courage to prioritise an activity that others deem is the least important thing/Prioritise something more important than other work
-Pink C951
Doing things faster
-New item code WOW
Decision under pressure /decision with a positive impact
-Cobo bulk not crimped
Ambitious for Patients: Give the STAR response for - Prioritise something more important than other work
Situation: Filtering C951 water from the cleaning reconciliation at the end of Cabotegravir Milling and the filter immediately turned pink. This indicates there’s something wrong with the mill seal - this issue had been seen before.
Task: I escalated all information and the Ops manager implied it was added to an ongoing DE - it was not. So the task was to advocate for the DE.
Action: I had a meeting with quality, MSAT and ops managers to put forward/present the case it needed to be a DE as this happened on 6 batches with a linking factor of increased batch size. The Ops manager didn’t see this as important at the time to investigate as it was ‘insignificant colour change’ as the plate had no growth and OTC was satisfactory.
Result: I presented my findings and along with MSAT support from other data got the DE, meaning the final 6 150 L batch campaign was investigated. This resulted in engineering changes to the mill seal - ensuring integrity. This hasn’t happened again since Dec 2023 during this campaign.
Reflection: Even though it wasn’t seen as important I had the courage to speak up and advocate for the DE. Taking this forward into meetings with RMQC, I’ve spoken up about sampling raw materials that is always seen as unimportant for their team, however, leads to delays and tight deadlines due to growth times for the test. As a result I’m looking into improving this communication to ensure the importance of the early sampling doesn’t hold up production.
Ambitious for Patients: Give the STAR response for - Doing things faster / identified an opportunity to improve a process
Situation: Item codes for Sterile products have never been communicated to Micro prior to samples coming down to be tested. Even though, the item code has to be added to a document to ensure it is okay to test (quality and safety perspective - covered under the PQS).
Task: to ensure this process ran more efficiently and allowed testing to move faster on the day (not doing checks within a few hours), I decided I wanted Micro to receive these codes prior to coming down on a product.
Action: I lead multiple meetings cross-functionally with many departments giving their input on what stage we should receive the codes. Working mainly with the lifecycle team.
Result: I got a task added into the lifecycle’s team PL for when they make a new code (buffer/manufacture/fill). As a result I have been able to perform the necessary checks for the item code and add new code into the testing document prior to products coming down. Which has saved time and therefore allowed the flow of bioburden testing to run faster, as well as prevented potential deviations as we cannot test a product until the item code is checked and verified.
Reflection: How I’ve taken this forward is realising communication and cross functional work is essential to making a process work - as often other’s don’t know something is an issue until highlighted. Therefore, as rounding up bioburden samples on a Friday was such an issue - I gemba’d the process with Analytical to find the rate limiting step and set up teams chats with production to ensure easier communication between the departments. This has allowed our samples to be tracked and more easily retrieved especially with shift changeover (as all shifts are included within these chats).
Ambitious for Patients: Give the STAR response for - Decision (either under pressure or with positive outcome)
OR
Worked with different departments to achieve a common goal?
Situation: Opened a bulk bioburden bag and found the end tube that was attached to the line was not crimped off - exposing the product to the air. This is a quality and potential safety risk. This product was the final fill batch for it’s PQ.
Task: I need to minimise the contamination of the sample as is and escalate this issue to the necessary people.
Action: First for the product, handled with gloves and I bagged it in an irradiated bag and washed it into a UDAF cabinet in an attempt to minimise further contamination. It was early in the morning (TM/senior not in) so escalated to ops manager who came round and to confirm I’d acted correctly. I then got in touch with Production ops managers, QA NPI, OQ and MSAT - and wrote a statement for the rapid response team including the times of the sample being exposed.
Result: The test came off as nil cfu and I recommended it go for OTC which was also satis. The PQ was completed and this initiated a new procedure across Steriles to clamp the tubing if the crimp was unsuccessful.
Reflection: what went well was I acted quickly to get the product under laminar flow to reduce contamination risks. Also learnt, the current method for something isn’t always the best, as the manual crimp could fail leading to a new way of working to ensure quality and safety. This thinking lead me to creating a syringe manipulation video, with cross-collaborative input to find the best/safest way to re-sheath a needle when necessary - as the old way wasn’t necessarily the best.
What are some examples of options for accountable for impact?
Sterile item code
Late bulk - teams chats
Batch release spreadsheet
Filtration video / CWS video
Leading entire project solo on placement
Give a summary of questions examples and their response for Accountable for Impact?
How have you built/contributed to impact your teams success
-Late bulk - teams chats
-Sterile item code
Give an example of when you have listened and actively sort out feedback to improve
-Batch release spreadsheet (VW)
-Late bulk – teams chats (bulks ops meeting with Rachel)
Something about holding yourself accountable / communicating a complex idea
-Filtration video / CWS video
Accountable for impact: Give the STAR response for - How I’ve built / contributed to impact teams success
Situation: Bioburden testing has to be completed within 24 hours, therefore when production manufacture on Friday these samples have to be tested on the same day as we don’t work Saturday. Therefore all samples need to be rounded up – ensuring I know what goes on in each area at all times.
Task: I wanted to improve this day as when I started it relied on calling all areas, to which many didn’t pick up or know the answer. I also wanted to understand where the bottle necks and rate limiting factors holding up the sample were to minimise these.
Action: I gemba’d the process, following the sample to Analytical to understand how long it took their tests to be complete (as mepo/beli require 3 tests before manufacture can be completed). I also set about talking to each FLL, complying all the required managers, movers, ops etc… to include in teams chats in order to improve the communication between all parties.
Result: Understanding Analytical’s role allowed us to calculate timings based on when they received or sent their sample. The team’s chats have made a vast improvement in how we communicate with production. Ensuring all shifts are included – allows communication with the area regardless of who is in. Late bulk was previously going past 5 pm (we work days), the samples are now consistently coming at around 2pm (as long as manufacture finishes). The awareness for the ops to understand this has to be brought to us in a more timely fashion has saved a lot of time.
Reflection: I’ve taken this forward by working with cross-functional teams on implementing a task for Micro in the lifecycle team’s PL when creating new Sterile item codes. By working with other areas to understand a process, and see the part that Micro play in that role allowed me to figure out where in the process we needed to be notified there were new testing item codes put into place.
Accountable for impact: Give the STAR response for - Give an example of when you have listened and actively sort out feedback
Situation: The water in L-block is normally thermally sanitised, but this mechanism broke – leading to the water being chemically sanitised. As this wasn’t a validated procedure, all water used to manufacture media – that was then used in microbiological testing was to be held and only manually released by a manager once the report for chemically sanitising the water was approved. My manager wrote a method statement for this but her feedback was she was unhappy about how long it was going to take her to release all the samples at the end (entire day).
Task: I decided that releasing all the batches I test for bioburden over 3-4 weeks (100 samples) - would take a very long time, if they weren’t all recorded and stated whether implicated media was used.
Action: I created a spreadsheet documenting all information required from the product and batch tested to whether implicated media was used all with references in LIFT.
Result: As a result the batches not implicated could be released by the manager before the report was issued as and when they had time. Meaning the feedback of not wanting to waste an entire day releasing samples as only the manager could do this (following the method statement), I created a system to allow her the ability to save time and minimise the amount of batches held.
Reflection: taking forward the idea that when I see a problem I should listen to feedback and actively seek to fix it. When the new PPM board came in the feedback from our team was it was stilted and not currently working for us. So I decided to go and Gemba another more established tier 1 board. I gemba’d chemistry’s as they had been using it for 2 months longer than we had. This lead to an update to our own board, making it more obvious what the questions were asking and allowed us to engage with it better to pull out problems.
Accountable for impact: Give the STAR response for -
Something about holding yourself accountable
OR
Communicating a complex idea
Situation: From bioburden testing the department were seeing a lot of spreading growth on the filters but it was found to be operator induced. This was due to the way of working, in which the tweezers were run along the filter to prevent bubbles.
Task: The way of working had to be changed for a CAPA, and I believed the best way to ensure everyone performed the task the same way and correctly was to create a video.
Action: I created a video demonstrating how to successfully perform a filtration, and the correct technique for laying the filter on media without spreading any colonies that may grow.
Result: the video entered MyLearning and all relevant SOPs, and we haven’t had a single case of spreading growth attributed to operator induced technique since. The training video is also due to go into the Micro QP training in 2025.
Reflection: Taking this forward I have since made a video to standardise the cleaning technique for cleaning a CWS in micro. This has aligned closer with the MHRA cleaning standards and has ensured everyone in the department is cleaning the same way.
Accountable for impact: Give the STAR response for -
Describe a project or initiative for which you were responsible
Situation: On my placement year, I was put in charge of a project – therefore given the role of a manger, due to headcount and staffing resource issues. The project was for a new mAb that was undergoing initial differing conditions in mammalian cell culture.
Task: I was tasked with performing the ProA titre on UPLC to analyse the protein concentration, which was required for the next stage in downstream processing. I also had to coordinate, deliveries between sites, have meetings to acquire all technical information (standard, EHS ratings, calculate extinction coefficient from the DNA sequence).
Action: I led this project, coordinated between all departments and other sites, as well actually performing the wet work and analysis in empower.
Result: I completed all work required for the milestone, ensuring the downstream timeline stayed on track and reported all results after analysing the chromatograms in a reduced amount of time.
Reflection: I asked for help, acknowledging the project couldn’t have a lead but I had never assumed the role of a manager. However, I was declined a lead due to staffing shortage. I learnt from this I’m very adaptable to a new role and saw these challenges as opportunities to learn. I brought this attitude into my new role in Micro when I started, ensuring that every issue that arose from production – was a challenge to be met.
What are some examples of options for do the right thing?
Pink C951
Sample delivery to Wilton
Give a summary of questions examples and their response for Do the right thing?
To speak up, when under pressure not to
-Sample delivery to Wilton
Tell me about a time when you noticed a potential issue with the quality or standards in a process, product, or service.
-Pink C951
Do the right thing: Give the STAR response for - To speak up, when under pressure not to
Situation: Asked to perform analysis at another site as the CE machine was undergoing maintenance, this work was time critical and needed to be performed immediately
Task: Due to short notice, I was asked to transport mAb samples myself in the car as I drove there - by my lead.
Action: I expressed how this was the wrong thing to do and went to the head of the department who told me it was fine and gave me a lunch box as a sample carrier. I expressed again this was the wrong thing to do, so arranged the delivery which would arrive on Tuesday - losing a day of work.
Result: the result of speaking up under pressure meant, I had lost a day to do this critical work - however, I was able to run two CE machines at once instead of one and utilised the Andrew alliance+ (HTP technique) to do manual and automated sample prep at the same time. I was able to get all work done with high quality results for the milestone - without compromising my integrity and illegally transporting samples.
Reflection: I was able to learn a new high-throughput technique, which allowed me to become a HTP champion attending more meetings/training for further development. It also allowed me to become a integral member in the department for sample delivery. As I performed all the required paperwork correctly and efficiently - I was then tasked with shipping samples to North Carolina in the US - involving more complicated paperwork. So as a result of speaking up under pressure, I did the right thing and learnt two new skills - developing myself further.
What are some examples of options for data analytics?
Bulks data analysis
VDmax email notifications - Power Automate
Give a summary of questions examples and their response for Data analytics?
When have you used data analytics to improve a process
-Bulks data analytics
Then one about: current tools
-VDmax email notifications - Power Automate
Data Analytics: Give the STAR response for - when have you used data analytics to improve a process
Situation: Realised as a department we weren’t tracking any data relating to bioburden testing
Task: I decided to start recording every bioburden test I performed, documenting the day/week/month, the area.
Action: I compiled all this data within Excel over the course of 2024 - creating 6 graph visuals for ease of distribution of the information in presentations and to begin to see trends within the data
Result: As a result I deduced which days were busiest-to-quietest (Monday being the least busy and Friday the busiest), which months had downward trends of amount of testing and upwards trends, realising that 45% of all testing came from IVM2.
All of this resulted in understanding headcount and resourcing better
This allowed me to identify days bioburden testing needed more resource available.
Due to understanding the best time to train new operators was during IVM2 shutdown and outside the Summer months - this has allowed me to train two new operators in 3 different bioburden testing techniques
Reflection: Upon reflection of this it allowed me to look at the operation of bioburden testing as a whole, leading to me creating an OJT for bioburden testing - which amalgamates three techniques instead of being split on a separate GUI. This will allow for more availability in resourcing and easier training with all resources available in one place.
Data Analytics: Give the STAR response for - something about how you’ve used a current tool?
Situation: Cabo is irradiated of site, and on the day of irradiation I perform a VDmax test, to prove the level of irradiation would kill the amount of bioburden present at the time. As it has to be done on the same day we rely on being told when the batch is irradiated. Often the manually updated logistics spreadsheet would be incorrect resulting in a deviation
Task: I wanted to eliminate the human error involved with this spreadsheet, and wanted to use data analytical tools to accomplish this.
Action: I requested access to the Sterigenics portal that said at which stage the batch was up to (received, in-prep, in-process, post-process), I allowed email notifications to be sent to myself so I could see in real time where the batch was up to. However, I would need all bioburden testers to have access to this so I set up a Power Automate workflow that used the subject line to filter which emails I receive to automatically be forwarded to a group bioburden mailbox.
Result: As a result, whether I was on holiday/testing (not on my laptop), every operator who needed to know could be updated on which batch and it’s progress in being irradiated. This allowed a prompt to logistics if no notifications had be received, preventing unnecessary testing or micro missing a batch (preventing deviations) - as the data comes directly from Sterigenics.
Reflection: Upon reflection I have started to look into how I can populate an excel table with timestamp information from these emails - so they could be checked as a group in tier 1, for an ease of collecting data - again without manual input.
