Summary: Planning of a Plant Maintenance Shutdown
- Defining risks to your maintenance shutdown
- Including Quality in your shutdown
- Defining the methods of communication
- Managing change
- Writing the Shutdown Plan document
- Scheduling the planning meeting
Building the Plant Maintenance Shutdown, Part 2
You’ll notice that this post starts with Step 7. I covered the first six steps in the previous article, Building the Plant Maintenance Shutdown Plan. See that post for the first six steps.
Once you have put your schedule together, which as you know, will need to have some flexibility, there are other considerations you need to take into account before you launch your shutdown. If you’re not experienced in regulated manufacturing companies or classic project management there may be issues “hiding in the weeds” that can make or break your shutdown.
Some of the most difficult issues to include in your plan are constraints and risks. Let’s take a look at some often overlooked issues in your Plant Maintenance Shutdown Plan, including GMP and cGMP guidelines, communication, risk factors, change management, and the actual writing of the plan.
Step 7: Defining risks to your maintenance shutdown
If you don’t think about risks, your plan is at risk for failure. Every day is filled with risk, and there are plenty of risks to a successful shutdown. Let’s take a look at some of them.
Situation: You have spent months developing a shutdown plan. It includes detailed steps to replace that ancient process controller with a state-of-the-art process controller, that will integrate tablet press and feeder operations. You have spent dozens of man hours on just that part of your shutdown plan, think you’ve covered all the bases. The schedule and budget are wired-in, conforming to your shutdown plan. You’ve got it in the bag. Then, a few days before your shutdown, you find yourself in a meeting with a bunch of higher-ups, real decision makers. The VP of Engineering, after studying your plan, pauses and asks you, “What if the installation and programming technicians flying in from Germany don’t show up on time? It’s happened with these guys before.”
You better have an answer.
What is a risk assessment?
A risk assessment is an examination of the various aspects of your Plant Maintenance Shutdown Plan that could go wrong. Risks that might affect the time, cost, quality, or scope of your activities. For example, weather uncertainty can be a real risk for your re-roofing project. A delay in getting a city permit required for construction activity can knock your plan completely off-track. A backordered part for a critical repair or upgrade can cause delays that cascade down through a list of dependent tasks. A key member of your team might develop a family problem that will affect his or her participation and productivity. And yes, those technicians from Germany might get delayed at a connecting airport and show up 2 days late.
These are all examples of unpredictable events that can crash a shutdown. How do you anticipate these events?
Devote a brainstorming session to risks
Your brainstorming sessions should include one or more sessions devoted to risks. Your team members and other participating stakeholders will have ideas about risks that never occurred to you. Once you’ve documented a long list of potential risks, no matter how far-fetched, you need to assess the likelihood of each potential risk and the possible severity of that risk. Only then can you devise contingency plans for the most likely of those events.
The contingency plan might include “rainy day” money in the budget or a list of alternative vendors for that backordered part. You might need to hire backup temporary contract employees to cover potential staffing issues. Or, you may need to move up the schedule to avoid a potential rain delay for your construction event.
How to build your contingency plan
Once you’ve got your big list of risks, create two columns side-by-side next to the list. In one column, use a number from 1 to 3 to rank the likelihood of that risk happening with 1 being the most likely, and 3 being the least likely. In the next column, put A, B, or C next to each risk to identify the potential severity, with A being the most severe or costly event.
When you’re done, sort the list by likelihood–that is, the numbered column. Anything that’s a “1” will need a contingency plan, no matter which letter is in the second column. If you’re experienced at running shutdowns, you’ll probably just ignore anything that’s a “2” or a “3” but if you have a “2A” or a “3A” you should create some contingency plan, just in case. Yes, a “3” is an unlikely risk, but if it DOES happen, it’s also an “A” so it’ll be a doozy.
You can organize your risks on a spreadsheet with contingency plans and responsible personnel in separate columns, along with your rankings. Attach a printed copy of the spreadsheet to your written shutdown plan, so when that meeting with the VPs happens, you will have the answers.
Click here to download a copy of this spreadsheet.
Step 8: Including Quality in your shutdown
Quality in a Plant Maintenance Shutdown can have a huge impact on every aspect of your planning.
Situation: Your team’s Plant Maintenance Shutdown is well on its way. Your Facilities maintenance and Metrology teams have done the bi-annual replacement of all of the class 100 clean room HEPA filters. Your team ordered the HEPA filters 6 months ago and received them in-house last month. You have dialed in the smoke and flow rate tests and are ready sign off the work order. Your Quality team goes through test results and the HEPA datasheets and notices a flow rating discrepancy between the replacement HEPA filters from the already room-validated HEPA filters you just replaced. Ugh….what’s next?
The risk of excluding Quality
I have seen entire shutdown processes come to a screeching halt and others extended for weeks beyond the scheduled time, because nobody got Quality on board during planning. Your Quality department has to be part of the conversation from the very early stages of planning, right through to the end. Get them on your team and develop a good relationship with them. The Quality team can be a huge asset. Some subjects for discussion when talking with your Quality team representatives might be:
- What does Quality consider to be successful project deliverables?
- How are they going to measure the results?
- Who will measure the results and when?
- What testing requirements will there be?
- How will Quality problems be remedied?
- What are the GMP and cGMP regulations that will affect this shutdown’s activities?
- What are the documentation requirements?
- What role will Quality play in the plant restart?
Since we’re at it, how about documentation?
Documentation is a subject I want to address here because it is of particular interest in a planned shutdown for a regulated company such as pharmaceutical or food manufacturers. These types of companies run on paperwork and paper trails. Documentation is critical to Quality planning for a Planned Maintenance Shutdown. Some of the documents that might come into play in your shutdown for Quality purposes might be, but are not limited to, the following:
- Work orders
- Various permits
- Calibration certifications
- Quality documents
- Materials certifications
- Technical data reports
- Training records
So, make sure these documents are up-to-date, that you have access to them, and that your personnel are trained in all required documentation.
Step 9: Defining the methods of communication
One of the most frequent causes of all project failures is poor communication. The project failure rates that I have seen due to poor communication range from 33-55%, depending on who’s statistics you are reading.
Situation: Your Plant Maintenance Shutdown is well on its way, with all of the appropriate team members and stakeholders in your update meeting. The VP of Quality makes an unexpected visit and begins listening quietly to the proceedings. When the discussion comes around to her side of the table, the VP begins speaking about the method of re-validation that has been agreed to and why some aspects of it don’t quite make sense to her. She wonders aloud why she wasn’t brought into the discussion earlier…and on and on. Not only has the lack of communication blown up your meeting, but because Engineering, Metrology, Validation, and Quality hadn’t communicated effectively, your entire schedule might be at risk, as well.
Don’t lose the personal touch
With an almost infinite choice of impersonal communication methods and media available today, it is critical that you don’t lose the personal touch with your team members and stakeholders. You, as the Project Manager, are the linchpin to the communication chain for your shutdown. With any project, your choices of timing, content, and methods of communication are critical to the success of your project.
Find out how each person wants to hear from you
Given all of various elements to a maintenance shutdown, many different people have varied expectations when it comes to communicating. So, I suggest you sit down with each stakeholder and team member to discuss how, when, and what information will be communicated. How does each person want to communicate:
- in meetings
- in one-on-one sessions
- by way of reports
- over email
- over Jabber or IM
- by tele-conferencing or video conferencing over Skype
You should get agreement from each team member and stakeholder, make note of each person’s preference and stick to it.
Common communication methods
Some common methods follow with commentary on pros and cons:
- Preferred means of communication
- Best way to read person’s response
- Can ask for clarification on the spot
Meetings and teleconferencing suggestions:
- Set Time Limits
- Schedule recurring meetings in advance
- Meet with team regularly but not too often
- Have a purpose for each meeting
- Create an agenda with team input
- Distribute agenda beforehand
- Stick to agenda
- Let people know their responsibilities in advance
- Bring the right people together
- Assign a note-taker or secretary
- Chair and lead the meeting with a set of rules
- Assign deliverables with time limits for all work assignments that result from meetings
- Document and publish meeting minutes
- One of the least preferred methods but sometimes necessary
- Keep them short and to the point
- Write them only as needed
- Use as necessary but don’t overuse
- Meaning, context, tone of voice often misunderstood or misconstrued
- Realize that emails in today’s business world often go unread
At the risk of repeating myself, communication is THE linchpin to your Plant Maintenance Shutdown scenario. Communication with determine either success or failure. You have to get this right and make sure you, as the project leader or manager, are in control of the rules of engagement.
Step 10: Managing Change
Change is an inevitable component of a Maintenance Plant Shutdown and managing it should be factored into your planning. Change is a fact in every project and you should prepare for it in advance.
Situation: The shutdown plan has been agreed to and signed-off on by all concerned. Three days into the installation of the new state-of-the-art controls for tableting line, the controls engineer and maintenance supervisor (after consulting with Engineering) decide to install the upgrade to the maintenance diagnostic software module, requiring 10 new sensors, extra calibration procedures, and some minor programming. You, the project manager, don’t discover what’s going on until the installation is about half complete. Of course, you’ve been wondering why the installation is falling behind schedule. Then Validation calls and asks how they should validate the new software addition. Oops. That could set the shutdown back a day or two. Best of all, your boss calls you into his office to wave an invoice in your face and ask how you thought you could authorize $4,500 for the new module and $15,000 for software integration.
Get your change control systems in place
This stuff happens all the time in shutdowns. You had better have:
- mechanisms in place for change requests
- a designated body authorized to review proposed changes
- a documentation paper trail
The simplest reason for these measures is to provide a little CYA. Because you and I both know that what too often happens is, some authority figure comes along after you’re midway through implementing a change and asks “Why are you doing it this way?”
You should definitely consider making change control a formalized process. The generally accepted process consists of a change request form, a Change Request Board (CRB), which is a group of people, including SMEs and decision makers, that reviews and approves changes to the plan, and a Change Control log where you document the proposed and actual changes to the plan. You don’t have to overdo it here. What you don’t need is a huge monolithic obstructionist entity that will waste a lot of time and words.
If you are forced to work with HAL
Many large companies put complicated and expensive document management and control systems in place and expect you to use them. Remember HAL from the film 2001: A Space Odyssey? HAL the computer simply didn’t want his human Dave to screw up the mission and so put all types of obstructions in his path. Although HAL’s digital heart was in the right place, he had incomplete data, and Dave had to find a way to circumvent HAL to survive and complete the mission. Fortunately, because HAL’s heart was in the right place, Dave easily located and disabled it.
Use ’em if you got ’em
Don’t get me wrong, these systems can be useful if they are implemented and customized to your specifications. But more often than not, I’ve seen these systems suffer from data rot, simply because they were so hard to use that the people on the ground simply reverted to a simpler data collection tool–either a spreadsheet, or a paper notebook. If you are required to use an automated system, do the best you can to make it work for you by customizing forms and workflow, if possible. And remember, more detail is always better.
Shutdowns are short in duration, and you don’t have time to mull over the minutia of every little change. Just work it out with your stakeholders, including Quality, and set some realistic criteria for change review and acceptance.
Step 11: Writing the plan document
You and your team have planned your annual Plant Maintenance Shutdown, but you haven’t written it down in a cohesive plan because you have never had to do so in the past. You and your management team are carrying the plan around in your heads.
Situation: You’re faced with a conflict of priorities: which budget does the Quality-mandated clean room modification and re-validation come from? You have several choices: the Engineering budget, the Operations budget, the Quality budget, or the Validation budget. You remember holding meetings about this issue, so why is this a problem now?
It is a problem now–which by the way is probably the worst possible time for the issue to arise–because people have short memories and conflicting agendas. It is a bottleneck now, because you have no written agreement to call on to make the case one way or another. Unfortunately, that agreement floats around in various people’s heads and each person imagines or remembers a different agreement.
You must write it down
This is one of the big reasons why, when planning a shutdown, you need to put a little extra work into writing and publishing a physical document. A documented plan severely cuts down on these types of conflicts and misunderstandings..
Depending on your company or industry, requirements for a plan can vary widely, from a memo to a full-scale project plan document. All too often, there is no documented plan at all. This is a mistake, in my opinion. I would suggest that, at a minimum, you write down a plan that includes the sections we have covered in this series of posts, and then add more as needed in your particular situation. Yes, it is a lot of work, but putting in that time and effort ahead of time will save you headache and misery once you start the actual shutdown. There are more benefits to writing a detailed plan that I can’t list them all here. However, some of those benefits might include:
- A contract between the company, stakeholders and the project team
- A reality check on the proposed tasks to be don
- A measurement standard of work to be performed
- A full map to execute your shutdown
- A set of “rules of engagement” for your shutdown
- A set of definitions and limits on the agreed-upon work
Additionally, a written plan demonstrates your leadership skills: “If you can explain it and write it down, then you probably know what you are doing.” And don’t forget, it looks great on your resume.
Sections or documents to include in your maintenance shutdown plan
There are many free templates out there that you can use to write your plan. But if you have followed the guidelines in these articles, most of the content is already at hand. It just remains for you to put it all together in a format that makes sense. As a recap, here’s a short list of topics to include in your plan:
- Shutdown Management Approach—A list of employees, consultants, and vendors who will be managing and participating in this shutdown and any constraints that apply
- Scope—Tasks to be done, responsible resources, and definitions of successful deliverables for each task
- Milestones—Dates on which interim or full tasks need to be accomplished as a measurable “go-forward” to the next step
- Work Breakdown Structure—Detailed list of projects, tasks, and subtasks and their dependencies
- Cost Management Plan—A plan that describes how costs will be tracked and reported, including the Cost Baseline, which describes based budgeted costs of all planned activities in this specific Plant Shutdown
- Communication Plan—A plan describing how and when you will share information with team members, stakeholders, and management
- Schedule Management Plan—A plan for managing work schedules for both inside and outside resources
- Quality Plan—A plan describing how Quality will measure deliverables and what resources, time, or communications Quality will need from you and your team
- Risk Management Plan—A plan covering anything that can go wrong and how you plan to deal with risks
- Staffing Plan—A basic list or calendar of staffing resources and timelines–can be combined with Schedule Management
Step 12: Scheduling planning meetings to get your plan approved
When all is said and done, you still need to find out if your Maintenance Shutdown project plan is approved or rejected. You’ll need your stakeholders to sign-off on the plan, the budget, risks, everything. If you’ve followed my recommendations, you will have had numerous meetings over the last few weeks or months, hammering out details, getting a handle on schedules, resources, costs, and scope . You and your planning team should know your plan by heart. Nevertheless, expect some pointed questions and discussions at this meeting. I’ve never seen a plan get a rubber stamp at one of these approval meetings.
Don’t forget to show your work
Make sure you have copies of all of your supporting materials and attachments to backup your assumptions. Nobody is going to ask you to show all of your calculations but be prepared to explain how you arrived at your assumptions, the data you use to support your assumptions, and your estimates of time and money:
- What documents did you use in your research?
- Who did you talk to?
- How did you arrive at certain assumptions?
- Did you get anybody else to confirm the validity of your assumptions?
Other people may not always agree with your conclusions or your findings, but if you did your homework and can explain your reasoning, you will find these meetings often go much more smoothly.
Laying the groundwork pays off
Also, if you have met and negotiated with all of the stakeholders, individually and in groups, by the time you get to this meeting, you’ll already understand most of the potential objections and questions that will come up. I hope you understand by now that you should have prepared solid answers for these potential objections and questions.
Like I said, others may disagree with you, and that’s OK. They may give you valuable information, show you a point-of-view you hadn’t considered, and uncover gaps in your initial estimates. But even with disagreement, if you show that you’ve done the work to prepare for the planning process and the shutdown, you’ll cross a huge hurdle: gaining the confidence of your stakeholders.
Reprinted by permission from the author.