Turnover Packages for cGMP Projects - Why They Don't Get Enough Respect and How Much it Can Cost You - Part 1

Turnover packages or TOPs as they are known in the cGMP (current Good Manufacturing Practice) world are a critical part of any construction project. They are important because they document in PAINFUL detail every element of a validated system or space from the paint and flooring to the air systems and piping. They are required for FDA regulated systems and spaces and can be required for a facility owner to produce on demand during an FDA inspection. They must be complete and accurate without exception, so why is it that we give them so little respect in the construction and engineering arenas? It is invariably a deadly and costly mistake not to give the TOP process the respect it deserves.  

1. Administrative misconception - Part of the problem is that they look a lot like an administrative function, often confused with Operation and Maintenance Manuals (O&Ms) by less experienced contractors – after all, all you do is pull together some documents, right? I once had an inexperienced project manager say to me “it's no big deal, I'll have my wife assemble them in the basement on the weekends”. Back in the day they took the form of dozens of 4” binders packed with paper. These days they are an electronic file structure with strict controls for file naming conventions and review processes. The qualifications for the persons responsible for TOP assembly, verification and submittal go far beyond administrative. There are many kinds of documents; the parties need to know what the documents are, what they look like, what information they need to contain, and verify what was provided is complete and accurate.  
2. Timing misconception – they are not due until after the work is complete, sometimes as late as substantial completion, so we don't need to worry about them until then, right? Sorry, no. How TOPs are assembled and timed are critical to project success. This must be worked out many months in advance, and once determined cannot easily be changed without cost and schedule impacts to the project. Waiting too long to make these decisions also result in cost and schedule risk to your company and your project, not to mention a lot of stress on the project team. I have seen poor TOP planning add months of schedule and hundreds of thousands of cost to a project. 
3. Construction is the end misconception – inexperienced contractors do not understand that the TOP is the beginning of a process not the end. An accepted TOP is the first step in a CQV process that is beyond the installing contractor's scope, but completely dependent on it. I am going to say that again – completely dependent on it. Commissioning, Qualification and Validation (CQV) starts when the TOP is complete and accepted. This process can take many months after the TOP is accepted and is required for the Owner to use the facility as intended. There is a whole schedule after construction that must take place for the facility to produce usable, saleable product and meet the FDA requirements for a cGMP facility. For a TOP to be accepted, all required documents must be present, assembled and labeled properly, complete, reviewed, and each document accepted. 
4. Decision maker misconception – who is involved in making the decisions around what and when TOPs are required. Not having the right people in the right roles at the table during this decision-making process can have negative impacts. Personnel who have ultimate responsibility for TOPs from the General Contractor, Mechanical, Electrical, Instrumentation and controls (I&C) and other trade contractors, as well as facility engineering, owner's representatives, and CQV personnel are critical to the process. Excluding key people can result in complete invalidation of months of work – this is not an uncommon event, and the team must start over again under extreme time pressure.  
5. Organizational misconception – how TOPs are organized is critical to the success of the project, but there is no one way to do this. The decision makers will have to agree on this early in the process. TOPs are often organized by system such as WFI, nitrogen, compressed air, CIP, etc. but are sometimes required to be organized by room, area or to include only the scope of a shutdown to expedite getting systems or spaces back online after a shutdown. How they will be organized must be determined early and cannot be changed without substantial impacts.  
6. Typical misconception – There is no such thing as a typical TOP. No typical index or guideline can be provided to a contractor to guide them. I once had a contractor ask me to provide them a specification that outlined detailed TOP requirements for the project – I wish I could.  Every single one is completely unique dependent on: 
   1. The systems, equipment, and finishes in a given TOP boundary. 
   2. Classification of the space.
   3. CQV requirements in the Validation Master Plan (VMP). 
   4. Which systems / equipment are validated in a facility.  
   5. Validation boundaries of each piece of equipment / system. 
   6. How liberal or conservative the Owner’s decision makers are.  

Determining exactly what is required for each TOP takes experience and attention from people with the appropriate background, roles, experience, and information.  

7. On the job misconception – many contractors go into a cGMP project with the idea that the PEs, PMs, or admin staff on the project will learn “on the job" without prior experience. By prior experience I mean prior cGMP experience, not just construction experience, cGMP work is unlike anything else in the industry.  It seems like it would work like many other things in the industry, but I caution you about disrespecting the TOP. There is not one thing listed above that is appropriate to delegate to an inexperienced person without appropriate experienced supervision and participation. This is one of the most common mistakes I see, and it will cost you big. By the time you realize how much trouble you are in, you are in so deep you just must fight your way out. The cost? 

1. Tens of thousands to hundreds of thousands of dollars in labor.

2. Loss of trust with your client.

3. Leaving a project with a negative impression.

4. Team member burnout and mistrust. 

5. Schedule impacts, potentially resulting in liquidated damages.  

On my first cGMP I was provided a whole team of experienced PMs and PEs to provide me information, guidance, answer my questions and keep me from making big mistakes. That is how you mitigate risk and train your people to do things right, putting your company's best foot forward.  

It was harder and more complex than I could have ever imagined, and I am yet to find the words to adequately explain the experience to someone who has never been through it. Once you have been through it beginning to end, you get it. It's an experience like nothing else in the industry. Not other life sciences, not hospital work even OSHPD, not semi-conductor work.   

More complicated than you imagined? Yes.  

Takes more experience than you thought? You bet. 

Presents more risk than you thought? Absolutely.  

In part 2 of this blog we will discuss mitigating risk for TOPs.  

Need training for your staff on TOPs? YSPE can provide that for you. Contact us at [email protected]  

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