GMP Compliance Basis Blog

you can’t afford it…

We were discussing a new project the other day…a retro-fit required to address on-going production issues…sounds typical right?  the interesting part was the background…

In order to increase production capacity, the first train was “duplicated”…except for a couple of changes…most likely caused when someone suggested some “Value Engineering” ideas…a change to the pipe spec on a feed line, and a reduction in the physical size of the unit being driven by pipe slope…considered individually, both ideas sound like they could be justified…

let’s look at the impact, with some hypothetical numbers….yours may vary…

Original cost savings……….                                          ($100,000)

Original Engineering costs to review cost savings………..  $20,000

New retrofit project costs………                                   $2,500,000

New engineering fee……….                                            $250,000

Production losses (over 5 years)……….                        $2,500,000

Total Savings……..                                                         Priceless

No one wants to actually look at situations like this, it would be political suicide on the operations side…

The lesson?…beware of false economies…

Engineering is the process of making decisions, documenting what you have done, and putting it behind you in order to move on to the next issue…

GMP engineering is performing the same process while in a “state of control”…

I had a brief conversation with some folks from LS Planning last week at the ISPE Meeting…

I asked them how they convinced their clients buy into the idea of strategic planning…

They indicated that there was a cost associated with planning, and that it was more cost effective than not planning…

The “Cost of Acting versus Re-acting”…

Some people might want to perform a cost comparison to prove this point…

I think it’s more important that you just believe it…

What are Service Provider’s looking for?

A reasonable business relationship

• Contractual terms
• Profit Margin
• Risk Profile

A realistic business model

• Sustainable success
• Stable workload

Talented personnel with relevant industry experience

Operating Companies often lack proper personnel “mix”…

• Quality
• Quantity
• Experience
• Qualifications

Operating Companies may lack process expertise…

• Process Technology
• Process Design
• Process HVAC
• Process Architecture

Operating Companies may lack project execution expertise…

• Planning
• Management
• Engineering Procurement
• Construction Management

It’s yours…

Generate it the way you want, gather it, format it, verify it the way you want…

You know where you’re trying to go…let your information help you.

It is, after all, yours…

In honor of the game tonight (Eagles…)…

I heard someone say the following (approximately) during a football post-game interview…

“You don’t put your entire playbook in your gameplan…”

Think about that one in terms of your project execution planning.  Just because you know how to do a project three different ways doesn’t mean you should try them all…espacially at the same time.

Each project should have a specific gameplan…

Link to the Project Management Issues Page

Why do a formal design review?

Its too late when the project is finished to say:

“We didn’t know that this is what was on the drawings…”

- the drawings were reviewed 3 times…how does stuff like this get missed?

try a formal “Enhanced Design Review”- if nothing else, you will have documents covering what got reviewed…the formal review process will bring things to light, what decisions were made and why…and also get this information out to all parties, even after the the fact, the documents can be issued to answer the questions that always seem to come up after the fact.  It also helps to get everyone to buy into the progress of the project to date, and maybe even take some responsibility for the decisions being made.

Consultants look at engineering as a series of decisions to be made…evaluate the situation, make the best decision you can, put it behind you, and move on to the next one…the process builds on the preceding decisions… 

Clients also view engineering as a series of decisions…except they expect every decision to be “perfect”…and are willing to re-visit a decision time and again to evaluate…the process does not build as quickly… 

Consultants understand the concept that endlessly re-visiting certain decisions can’t really justify the possibilities of delays and wasted efforts…but, ultimately, the Client needs to wind up with what they want… 

Clients feel the effort is justified, and may be willing to endure the delays and re-work associated with this approach…I also wonder if they are aware of the delays… 

I think this represents two sides of a “Cost- Benefit” evaluation…   

Client project teams seem to try to avoid making a decision, such as defining requirements, or spend too much time developing “consensus” among the project participants… 

Outsiders could attribute this to client organizations being “risk-averse”… 

The schedule gets pushed to the breaking point…when the project starts, the schedule is already impossible, decisions haven’t been taken, project scope is in flux, the budget may be poorly defined… 

Suddenly, the project has assumed risks that were never anticipated… 

Is it really possible that these risks are the result of risk-averse behavior?…   

One of the biggest hurdles in the “integrated execution” model is establishing a relationship between the design effort and the other critical documents…to often critical efforts like the Validation Master wind up in it’s own silo with a separate schedule, scope, and focus… 

Once this gap is created, it can be very difficult to re-establish the “integrated” effort we may be looking for… 

I have been considering project execution models and have identified 3 or 4 prototypes… 

Classic 

Fast-track 

Flash-track/ Hyper-track 

I haven’t decided if the last two are just different names for the same thing… 

These various models have implications to how the project will be conducted 

Will link to the graphics when I get them done and posted…     

I was talking to Chad the other day, and, as usual, he had lots of good ideas going…

Among other things, he mentioned a “GMP Toolbox”…he did follow up by saying that having the tools is not enough if you don’t know how to use them correctly…we all have some basic tools in the basement, but how many of us can build furniture?

So what would be in a GMP Toolbox?

What would be in a Project Manager’s Toolbox?

Bob Yerby once said “Don’t tell me about ‘Lessons Learned’…I’m only interested in ‘Lessons Implemented’…”

Why are we always “learning” the same lessons…

Some of this keeps coming up…I wonder why we have to keep explaning the same stuff to Clients over and over…

Risk is $$$…

No other way to put it…

They may talk about risk…in terms like “we will proactively manage risk”…”, or ”all projects have to accept some level of risk…”, or “that’s part of our risk evaluation and mitigation procedure…”, or ”we’re prepared to accept that level of risk…”

But at the end of the day, or the end of the project more likely, risk equals dollars…

Suddenly, when it has a price tag associated with it, the buzzwords don’t cut it anymore…when reminded of the previous, possibly bold, statements, you may here things like “that isn’t what I meant…”, or “we meant some risk, not this much…”

So remember…risk is money, plain and simple…

Project Management is often considered a Level of Effort activity…

x hours a week for the duration of the project…with a list of activities and some deliverables…meetings, reports, lists, managing the flow of infromation, admistrative tasks, and so on…

Don’t forget the “Other” list…over and above the typical list of tasks…
all of the one-off special requests and issues that come during the project…
the Client needs help with this…the Client has a question about that…how do you want handle this issue?…what are we gonna do about that issue?

These tasks aren’t full-time, are not deliverables per say, but are sometimes the most important tasks you have as a PM when you consider providing the level of quality service this industry requires…

Architects seem to generate most of their information themselves…

Beyond the project program, they are in control of their destiny from an information standpoint…

Engineering is extremely information-driven, with a direct cause and effect relationship between information and the ability to complete engineering calculation and design efforts.

It also seems very alien to the engineering mindset to generate information based on assumptions to be verified.

Conclusion: engineering progress will be directly related to the infromation flow on a project…

The flow of information…

Who needs it? What do they need? When do they need it? What do they do with it? Where does it come from? Where does it go? How does it get updated?

An essential part of Project Management (PM) is an detailed understanding of how infromation is being handled on your project…

If you do nothing else, get everyone on your project team the infromation they need