To ensure proper project recovery for all pharma/biotech projects and with, ultimately, timely delivery of life-saving medicine to the patient, WuXi Biologics project manager Colin Dickie outlines the areas that will be affected and the recovery plan that should be put in place.

During these trying times of self-isolation and uncertainty, our primary concern, naturally enough, is that of our families and loved ones, to ensure that everybody stays safe and healthy. Once that is assured, you look to your working life, the life of your engineering project and the effect that COVID-19 is having on it – both now and in the months and years to come.


All resources will react to this situation in a different way, some will feel okay, some will feel lonely, some will be very worried and a limited amount will thrive, given that they can work at home with no distraction.

The bottom line is, during this time, more than ever, you need to listen to your team and take on board everything they are saying. Talk with them, and ensure that at least once a week they get a call – not necessarily about work – but just to make sure that they are doing okay.

The key to this 'working from home period', is that you catch up on all the document preparation, to ensure, when everybody gets back onsite, you all hit the ground running. People make projects, so they need to be looked after, even more so at the moment.


If your project is still in the design stage, whether that be concept, detailed, Issued for Design (IFD), Issued for Construction (IFC) or as-building, the current situation will be affecting the progressing of the design. The key to ensuring the impact is lessened is down to three major factors: team work, communication and facilitated reviews.

If the client and the design team can forge a 'one team ethic' with design reviews and if the communication paths are open, honest and proactive, then the battle is almost won.

The final cog is the detailed facilitated reviews; if the reviews are carried out in a controlled, logged and open fashion, then hopefully the knock-on effect to design can be kept at a minimum.

Additionally, ensure that all those working from home have correct access to the design model and any software that is required. Lastly, the RFI (Request for Information) register needs to work like clockwork at this time, so ensure that the RFI coordinator has all she/he needs to progress any queries.


The shutdown will affect all schedules throughout the project; construction and CQV (commissioning, qualification, and validation), sometimes with the tail-end work, water batches, engineering batches, or PPQs (process performance qualifications) not moving due to client demands. So the construction and CQV resources need to box clever.

The first step of this is an internal group workshop and brainstorming session to review the singular activities, durations, process links, predecessors, successors and any potential 'work arounds' which could be put in place, particularly for the grey utilities.

Once that is done, the linkage between both construction and CQV schedules can be put back in place, and dates reviewed. People always have a fascination with the 'critical path' – it is massively important but not the be-all and end-all, please also keep an eye on Critical Path 2, 3, 4, which, in most cases, are only days behind and are generally the ones that will catch you.

The other potential time saver in the current environment is looking at a detailed shift pattern – one which will actually work and from which the project will benefit. Don't just do it for the sake of doing it (I’ve seen that before).

Your normal schedule will be built: five days flat shift. You should look at various different scenarios – five days double shift; five days 24 hours; six days; even seven days; but, again, it needs to be done for the right reasons and there is a fine balance between working long hours and burning out the resources.


With the majority if not all fabrication yards closed in Europe, this will have a huge effect on the schedule, particularly if you are in the middle of the construction phase.

A lot of the fabrication yards do have sister or alternative plants in other countries that are back up and running, so this should be considered, as long as the alternative fabricator can ensure the same documentation requirements can be met, along with the usual segregation in place, between carbon and stainless steel, as an example.

Additionally, you would be seriously advised to perform a remote quality assurance (QA) audit on the new fabricator to ensure all correct certification, qualifications and Quality Management Systems (QMS) are in place. If they are, the price is acceptable and the schedule works, then progress

Factory Acceptance Testing (FAT)

Currently, all vendor FATs for the most part have stopped, with certain ones progressing, albeit slowly. This not only affects the FAT schedule, but ultimately the onsite delivery dates, the installation timeframe and the increase in site acceptance durations. 

Most countries are not letting foreigners into their countries, so for the project you could utilise local engineering expertise, to witness testing on behalf of the client. These resources will be trained on the project standard operating procedures and, in effect, represent the client.

This will be costly and the amount of testing you can leverage is questionable, but at least you have the assurance the FAT has been completed and witnessed.

The other avenue to explore is remote FATs, by that I mean using a 'Zoom' type system to play back the FAT to your resources back home. Again the testing leveragability will be called into question and this isn’t ideal.

The worst thing a project can do right now is cancel FATs and just assure that "it's okay, we can test the equipment on site". Don’t ever do this, it will end up costing more money and even more time once the equipment is installed.


As discussed in the schedule section above, the closure of any site is going to affect construction massively and the schedule, but it’s all about how the construction personnel react to this. Yes, there will be delays, but look at the delay as a challenge and perform detailed reviews on how you can get that time back.

An example of this would be the mechanical completion walk-downs. Traditionally if you were performing walks (W1/W2/W3), then cut the walks to one and ensure that the system is truly ready for construction and CQV inspection.

Review shift patterns, and review the trades' locations. Do all the electricians and pipefitters need to be in one area at one time? Do the ducting resources need to go on night shift to ensure an increase in their weekly meterage?

With the delays we will have, the working relationship between construction and CQV becomes even more important. There is no 'them and us', there is one team to deliver a facility at mechanical completion and ultimately installation operation qualification (IOQ) summary report approval.

Commissioning and Qualification 

Generally with 'normal' project delays, the commissioning and qualification (C&Q) timeframe is compressed due to later mechanical completion being delivered and the end date for the client not moving. It is nothing unusual; this situation is, however, a once-off.

So, C&Q will utilise this time to improve on documentation preparation, whether that be for FAT protocols, Quality Risk Assessments (QRA), Requirement Trace Matrices (RTM), Installation and Operational Commissioning (IOC) templates and or test scripts, the point being, now they have the time to solely concentrate on the documents with no distractions, hence saving time as the project moves on.

Equally, and like our construction counterparts, we will review shift patterns, test requirements, work arounds and timing of testing, i.e. running a long operational type test on a night shift to ensure that when the day shift starts the long, complex operational type testing is completed, documented and approved.

If the project were to go to shift, another 'lessons learned' would be to have a quality assurance engineer on each shift to ensure the executed documentation is approved there and then and not stuck in a folder for two months. The QA engineer should be out on the floor with the C&Q team and be an integral member – this can make or break the C&Q testing period.


In our case, commissioning and Qualification consumables, prior to the shutdown we noticed two factors that had changed: the delivery time of the consumables and also the cost of same.

Some 'off the shelf' items were now going to be four to five weeks and with a 10-15% increase on price. The key here is to ensure the consumables, where possible, are ordered up front and early. Even if the orders haven’t been placed now, make sure it is done soon; you don’t want to be left ready to start up and have no consumables.

Lessons learned would be to employ a resource that solely takes charge of the coordination, ordering and management of all consumables with the group.

Site Leadership Team (SLT)

A project always needs a strong and honest SLT, even more so during these trying times – it can make or break a project. Many resources will look to the SLT for guidance, advice and 'the latest updates'. If this is done properly, then respect is gained across the board, and that respect flows both ways.

Particularly at this time, all SLT updates should be clear, concise, upfront and honest, always giving the resources the correct and latest information, and if done correctly, some laughs added in also. I have seen projects (absolutely not my current one) where this has not been the case and the outcomes are never good.

Risk Register (RR)

Projects always have an RR, but I think it’s very important to keep a separate Risk Register, relating just to the effect and risk COVID-19 is having on the project. This should be kept to ensure the risks are managed, but when we all return to normality you will have a separate record and traceability on why, when and how decisions were made and the agreed path that was taken.

A proper scoring system should be deployed for the risks, and should cover probability, schedule delays and cost knock-ons. By doing this, you will have a proper risk scoring mechanism.

Return back to site 

This will be probably one of the most important things you do, the initial reaction is 'get all resources back onsite ASAP'. This cannot be done, given the nature of the virus.

The return back to site needs to be carried out in a controlled and steady manner, not just letting all resources back through the gate on day one.

If you have a site capacity of, say 1,500 resources, a weekly increase of 300 to 350 per week would make sense, with shift patterns being looked at to ensure minimal contact with other resources and everybody keeping to government regulations for distance separation.

By progressing in this manner, you will ensure the wellbeing of the resources and also the progression of the site project works.

Author: Colin Eric Dickie has 30 years of project experience, and is the CQV project manager currently working for WuXi on its Dundalk biologics project. He has extensive project experience within the biotech and pharmaceutical industries, installing a one-team ethic. Proficiently implementing industry standards/regulations/procedures, including ASTM E2500, GAMP5, 21CFR 210/211, 21CFR Part 11. Specialties include commissioning, qualification, validation; ASTM E2500; Verification; Project Management; Schedule creation and management; QA/QC; Pharma and Biotech Processes; Design Coordination; Construction Management; and Communication from board level to shop floor.