cGMP Turnover Packages (TOPs) - Part 2 Mitigating Risk

In part 1 of this blog we discussed how TOPs get less attention than they deserve, and how and why that presents a serious cost and schedule risk for Owners and Contractors.

So how do you mitigate this risk of weeks to months of schedule slippage and tens to hundreds of thousands of dollars in cost?

Define your project – defining how the project will be delivered is the crucial first step. Assembling the right people in the right roles, with the right experience during the planning stages of the project is not only appropriate but it is critical to the success of this process. Understanding how the project will be delivered is crucial in this early stage.

1. Will the project be delivered in phases?
2. Are there tie ins to an existing facility? When do they need to happen?
3. Are shutdowns to existing operations required?
4. Is there a specific shutdown window that needs to be planned for?
5. Will the project be delivered by system, area, or some other method?
6. Does the client require some equipment or systems to be delivered earlier than others?

Often a combination of the above is required to meet the client's needs and expectations for expedient project delivery. These days with speed to market, it is rare that we are permitted to deliver an entire facility all at once at the end of construction. Often there is owner furnished equipment that has it’s own schedule for delivery, SAT and CQV that is outside the contractor’s control, but the contractors are required to meet the Owner’s schedule for connections and utilities.

Plan your work and work your plan - It is NEVER too soon to start planning for TOPs.  Dedicated staff for the TOP effort from the beginning may sound like overkill, but you truly cannot over plan this activity. Here are just a few of the additional items that need to be discussed and decided:

1. Where will the team file their electronic documents?
2. What is the naming convention for files?
3. Who (by name) from each team will be doing the work?
4. How many people from each team will be needed?
5. What are the responsibilities for each role?
6. Are the parties appropriately trained and qualified?
7. How will the TOPs be organized?
8. How many TOPs will there be?
9. How will the TOPs be named?
10. When is each TOP due?
11. Are TOPs in the project schedule?
12. Who is defining the boundaries for each TOP?
13. Who will provide quality checks of the TOPs?
14. Has adequate time been allowed for revisions?
15. How will document revisions be tracked?
16. How will CQV or review team be notified that something is available for their review?
17. How will acceptance of a document or TOP be confirmed?
18. How will revision management be handled and tracked?
19. Who is responsible for review of each TOP before submission?
20. How will deadlines be managed?
21. How is Mechanically Complete defined?
22. What are the implications of a late or unacceptable TOP?
23. Are all team members including all field staff GDP (good documentation practices) trained?
24. Who is providing GDP training on an ongoing basis for team members?
25. Are specifications drafted in a way to support TOPs? Items such as weld log requirements, 3rd party verification, receipt verification, ISO requirements, etc. called out?
26. Is clean build specification issued?
27. What systems require ISOs?
28. What information is required on ISOs? Is it adequate to meet the requirements of CQV?
29. Are there different levels of IOS? If so, what is the difference?
30. Have the URS’ been drafted? Do they match the specifications?
31. What documents from the construction team can be leveraged?
32. Are wet signatures required on any of the test or inspection documents?

These are just some of the questions that need to be answered before this process can be started. Once these decisions have been made and the team embarks on this journey, not much can be changed without substantial impact to cost, schedule, and team morale. It can take months and many meetings to discuss and make decisions on all the necessary key points.

Training and supervision – for team members that do not have cGMP TOP specific experience is essential. Training on TOP requirements, documents (identification, reading and interpretation). Refreshers are appropriate for anyone that does not work with TOP documents regularly. Supervision must come from an experienced team member. This role is often contracted out if the resource does not exist internally.

Communication – Team communication early and often with all members that are working on TOPs, Owner, and CQV team are essential to maintain continuity and adjust to the changing needs of the project over time.

Indexes – Establishing final indexes as early as possible, ideally before finalizing trade contracts. How many TOPs there are and how they are organized can have a substantial impact on cost. Establishing at least an outline of this for key trades can help manage cost and schedule impacts. Plan for the worst and work towards better.

Schedule – Assign order and dates to each TOP and make sure they appear in the schedule. Additionally, incorporate the Owner Furnished Equipment (OFE) deliveries, Site Acceptance Tests (SAT’s) and their utility requirements into the master project schedule.

Mechanically Complete – an agreed upon definition is required early and listed as a predecessor to the TOP completion in the project schedule.

ISO requirements – defining which systems are put on isometrics and what the requirements are for the ISOs are critical for cost and schedule. I have worked on projects where every system including drains and vents had full iso documentation and inspection, and I have worked on projects where very little was required. The VMP (validation master plan) and the CQV strategy play heavily in determining what is required. This can vary greatly from owner to owner and site to site, and can present one of the greatest risks to cost and schedule if not made clear early in the process. Contractors have no control over this decision making, it’s 100% the owner’s call. If you are a GC or process contractor, you need to insist on defining this up front to manage project risk.

Inspection requirements – there are many kinds of inspections that can happen on a cGMP project, this blog addresses 3^rd party process inspections. Your 3^rd party inspector can provide a wide range of services from receiving inspections (MTR’s, surface finish, ovality, wall thickness, etc.) to field inspections (welds, weld logs, hangers, slope, etc.) on various process and process utility systems. It is imperative that the scope of this work be defined in detail early in the project. Determining which systems get what level of scrutiny by service and material type. This is more complicated than it sounds – systems can have more than one material type, some material types can be placed in multiple systems. It is essential that we control, mark, and segregate the materials so we are certain of what materials get placed in critical systems.

While the process is somewhat the same for all projects, each project, facility and team is unique, so there is no one answer for every project.

If this sounds like a lot of moving parts and somewhat complicated, it is! Experienced professionals leading the way on your TOP journey is essential to your success in meeting budget and schedule.

Need training for your staff on TOPs? We’ve got you! Contact us at [email protected]

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