January 31, 2012

IT Deviations: Tool for Improving Overall Performance

Posted in IT tagged , , , , , at 7:36 AM by Solutions2Projects, LLC

I am a firm believer in documenting deviations from performance expectations for IT systems.  This includes functional and procedural errors, both system and human.  Documenting deviations provides data for better management and control over IT systems.   The process for capturing and managing IT deviations should be simple to be most effective as we know most IT folks do not like cumbersome documentation tasks especially if they think they will be penalized as part of the process (which should not be the case, ever!). 

 A basic deviation has the following elements:

  • Deviation description
  • Date(s) of occurrence
  • Categorization for tracking purposes (planned, unplanned)
  • How it was discovered and by whom
  • Investigation into source of deviation
  • Recommended resolution or actions to be taken
  • Approvals of investigation and recommended resolution
  • Documented action taken to resolve issue
  • Approval of action taken

 Deviation examples include:

  • Backup failures
  • Failure to follow documented procedures
  • Unexpected system behaviors
  • Unplanned outages

By tracking and trending the deviations, you can see if there are recurring issues and answer the following questions to improve data integrity and reliability. 

  • Is additional training required?
  • Should work instructions be developed or be more detailed? 
  • Is there a technical issue that needs to be addressed due to a repeated failure? 
  • Is there a configuration issue that needs to be addressed?
  • Should the issues be addressed with a vendor? 
  • Does the system need to be replaced?

 IT personnel and business system owners gain visibility into issues and can track patterns if deviations are documented.  It is too easy to forget when something happened (let alone if it happened at all) and how it was resolved.  We have too much to keep track of these days.  Deviations are often seen as something that is bad rather than as a useful tool to gather information to improve overall performance.  For those of us in IT that like data, deviations should be seen as an effective tool to gather data to improve overall system performance.

January 30, 2012

IT Policies to Establish Control

Posted in IT tagged , , , , , at 7:33 AM by Solutions2Projects, LLC

When we at Solutions2Projects are brought into a biotech or medical device company to work for the first time, it is usually to provide selection or implementation services for the first big IT project.  The companies are usually positioning themselves for an IPO and need greater control over their financial transactions or are preparing for commercialization and therefore need a system for inventory management or manufacturing.  In both cases, the companies need policies and procedures for managing these systems once in place. 

 Over the years we have identified the following as the minimum policies that need to be in place once the system is released into production.  If the system is a GxP system and is being validated, the policies are verified as part of the validation process. 

  • Change control / change management
  • Operation and maintenance
  • Security
  • Passwords
  • Backup and restoration
  • Deviation management

 Having these policies in place (and adhering to them) provides IT personnel, affected system users, and business owners with a foundation for control.  For GxP systems, FDA has been known to hand out 483’s for GxP systems that were not controlled from inception.  Think about it.  If you are basing a submission on data from a system that was not under control from inception, how can you demonstrate data integrity and data reliability?  Getting the systems under control from the beginning reduces the system and data integrity risks. 

 Of course, the policies need to be followed.  There’s no point in creating policies and ignoring them.  IT needs to embrace these policies to be successful.  Getting IT involved in the generation and release of these policies increases the likelihood of adoption and success. And the policies need to be in a centralized location for all affected personnel to access (not just IT).  This is generally handled by Quality Assurance (QA) as they are used to document management.  If a training program is in place for GxP documents, these should be incorporated into the training program as well.  

 For each system, there will be procedures to define how the policy requirements are met.  A few examples include

  • the periodic review of users and access
  • instructions for performing test restorations and verifications
  • periodic maintenance activities for the system (technical, application)
  • periodic review of failed logins

 Each system will require different instructions for accessing the data or performing the tasks.  The procedures or work instructions allow the IT personnel to focus on the data or value-added activity and not struggle with how to get the data or perform the task.  This is especially true for activities that are performed infrequently, like annual restoration tests. 

 The policies and procedures can be expanded on over time.  Initially, enough details need to be included to meet compliance requirements and provide affected personnel with guidance to achieve the desired level of control. 

 I understand that ‘control’ is a four letter word to a lot of IT folks.  But, control reduces risk and increases data integrity and reliability, which is what IT is tasked with ensuring.  Compliance (SOX, GxP) mandates establishing control over these systems, and policies and procedures are one of the tools companies can use to satisfy the requirement.

January 26, 2012

Change of Scene

Posted in Project Management tagged , , , at 7:45 AM by Solutions2Projects, LLC

A change of scene offers us the opportunity to look at things from a different perspective which allows us to see what we may not have noticed before.  Seeing it differently can offer up new opportunities or solutions or even eliminate roadblocks or obstacles.  It can also help us to appreciate our original scene. 

 A change of scene requires us to get our of our comfort zone.

 Yesterday I was forced out of my (latest) normal routine of writing some blogs and doing some online marketing from the comfort of my couch, with my dog cramping my laptop, after the kids have left for school (much like I am doing today).  From the comfort of my living room, I have found myself staring outside at the birds and squirrels, listening to the dog snore, without writing a word for a period of time.  It’s been comfortable but not always productive.

 But yesterday I had to leave the house for an hour before an appointment and I went to a local coffee shop.  I got more than a buzz from the super caffeinated Mexican coffee.  I ran into a friend and had a discussion that gave me the inspiration for yesterday’s blog.  The writing flowed so easily, I finished it in less than 15 minutes (and not because of the caffeine).  

 All it took was leaving a comfortable spot and moving to a different one to get an idea that would not have surfaced if I hadn’t moved. 

 This is one of the things I like best about consulting.  While I’ve enjoyed the comfort of working with a particular client on and off for over six years (with other clients at the same time and in between), I’ve also enjoyed the challenges associated with starting new projects at new client sites.  I can take what I’ve learned at one client and apply it at another client (both what works and what doesn’t work).  It also forces me to be flexible as all companies have different cultures, processes and people that require different approaches.  I can refine my processes or try a new approach at a new client without them knowing that I am trying something new.  I might get resistance at an existing client.   

 I am in between projects right now and this too is a change of scene for me.  My workaholic / jam packed schedule routine is thrown off and there are days that I have no scheduled appointments.  Talk about uncomfortable!  What I have been given during this time is the opportunity to stand back and evaluate what works and doesn’t work in my life, both professionally and personally.  It is a welcome and unwelcome gift that I do not want to squander as I can establish some new and healthier habits and practices that will make me a more effective consultant and a happier person. 

 I’ve already started asking myself some questions about what I want to be doing differently, what I want to do more of, and what things could look like if I change things up a bit.  I don’t have any answers yet but without the change in scene, I wouldn’t even have the opportunity to ask them.

January 25, 2012

Staying Connected

Posted in Project Management tagged , , , , at 7:41 AM by Solutions2Projects, LLC

During a project it is very easy for me to focus on the tasks and forget about focusing on the people (other than to make sure they know what tasks they are to be working on).  I assume that everyone is working toward the same endpoint and that completing tasks is the most important thing.  I have to remind myself that part of my job is to stay connected with the people and make sure they are feeling the love.  It is easier to stay connected than to have to reconnect after a period of neglect. 

 This means getting up, walking around, getting on the phone, and giving team members and stakeholders personal attention.  In a formal team setting, they don’t always want to openly discuss issues related or unrelated to the project that could indirectly or directly impact the project.  Taking the time to give them an opportunity to feel heard is vital to the success of the project. 

 Sometimes the information or feedback is difficult to hear (which may be why I sometimes avoid it) but to be effective, I need to set aside my personal insecurities and do what’s right for the team members, stakeholders, project, and client.  I often learn things that may not be pertinent at the time but can be useful later or when pieced together with other pieces of information, begin to form the answer to a problem we might be encountering or better yet, provide us with an opportunity that wouldn’t otherwise be made obvious to me. 

 This is helpful personally as well.  While at a coffee shop this morning, I bumped into a friend I hadn’t seen in a while.  She’s on a board with my husband and mentioned a meeting tonight that I wasn’t aware of.  This prompted me to text my husband to confirm that I need to be in home with the kids.  The bonus here was that I got to reconnect with a friend and, as an extrovert, replenish some energy that’s been lacking a bit lately.  She also shared with me some information about some mutual friends and community projects that I am storing for future reference (all of it good).  I had to look away from my computer long enough to have the chat but it was worth it. 

 As a goal oriented person it is so very easy to focus on ticking things off the to-do list leaving others to their own devices.  This also leaves others to their own agendas which may not match up with the goals and objectives for the project.  Making the communication a to-do list item (a high priority one at that) is critical for project managers.  The people are the keys to the success of the project regardless of the number of tasks completed and staying connected keeps the people connected to project.

January 24, 2012

The Perfect Project Plan

Posted in Project Management tagged , , , at 7:33 AM by Solutions2Projects, LLC

The perfect project plan is perfectly accurate for a nanosecond before it is no longer accurate.  The hours of discussions and effort to create tasks and dependencies, assign resources, add durations, and determine the overall timeline are not completely wasted.  The effort of bringing everyone together to understand the overall objectives and subsequent details is priceless.  The perfect project plan provides a framework for the overall project. It takes into account past experience, expectations, and reality and combined together is a guidance document for the overall project. 

 Resources and availability change.  New information is obtained.  External and internal pressures adjust priorities.  These are all elements that contribute to the immediate obsolescence of a project plan.  As effective project managers, it is our job to take this data into account to reassess and rework the plan and the plan details.  This does not mean modifying the MS Project Plan (my tool of choice) every time there is a new piece of information.  It means communicating revised priorities and tasks and expectations to project team members and stakeholders.  Experienced project managers are constantly adjusting the pieces in the project picture to achieve the overall objectives and communicating to keep the project team members moving toward the finish line.

 I use a status report to communicate tasks on a weekly basis.  It includes the barriers or red flags, work for the week with assigned resources, completed tasks, resource availability, and a high level weekly calendar.  During the status meetings we walk through each section to confirm team members are aware of what tasks should be worked on that week.  We also discuss the completed items, albeit briefly, to give a sense of accomplishment.  I like to go over the weekly calendar to reinforce what is coming up to reduce the number of surprises.  We never look at the project plan as I believe that it is a project manager’s tool.  It is available to team members but generally, no one else actually wants to look at it. 

 The perfect project plan is a project manager’s tool designed with the intention that it will be modified throughout the project.  Resources, durations, end dates, and dependencies can be adjusted to give the project manager a revised sense of what is important on a weekly basis.  In other words, the perfect project plan is flexibly designed to be modified and perfected throughout the life of the project.

January 23, 2012

Lightening the Load

Posted in General tagged , at 7:26 AM by Solutions2Projects, LLC

I love beginnings.  It can be the beginning of the year, project, friendship, journal or blank page.  Every beginning allows me to start over and do something better than the last time.  At the beginning, life is uncluttered. At the beginning, I am filled with hope and optimism and I love that feeling. 

 Since it is the beginning of a new year I felt compelled to start afresh with a modified attitude toward things, people and habits that don’t add value in my life.  This year it is all about lightening the load. 

 This year will be the year I

  • learn how to say ‘no’ to things that do not contribute to my overall goals and objectives
  • stop wishing for things that will never be,  accept them for situations as they are, or take action to turn them into what I want them to be
  • streamline processes
  • eliminate material objects that are taking up space and weighing me down
  • focus on the little things that add pleasure to my life

 These apply both personally and professionally and will be the focus of the year.  It will be hard as the newness of the beginning transitions into the day to day reality of applying my new mantra.  It is time to eliminate the toxic thoughts, people, and things in my life. Change is hard.  Acceptance is hard.  But it will be worth it. 

 With each new beginning there will be an end.  And with each end there will be a loss which must be acknowledged to be able to move forward effectively.  For the most part I look forward to saying ‘good riddance’ to the outdated, unused, unnecessary, and unhealthy and ‘welcome’ to the light, positive, fruitful, and beneficial.  We can all benefit from throwing off the extra baggage and lightening the load.

January 20, 2012

In Between Days

Posted in Project Management at 7:10 AM by Solutions2Projects, LLC

Over the last week or so, I’ve had a lot of trouble getting motivated to do anything that requires more than two hours of my attention (maybe even an hour).  I thought it might be the weather or being out of a regular routine or post holiday blues.  And then it hit me…this happens after every project I finish (I just wrapped up at Alexza) or after a major goal is accomplished (like the half marathon).  It’s what I’ve dubbed the ‘post project letdown’.

 It’s a very frustrating period for me as I pride myself on accomplishing a lot in a very short period of time.  As a goal oriented person, the more I can check off a list the better I feel.  But it’s during this time that what motivates me normally is what I most abhor.  I can’t even schedule coffee or lunch with a friend while I am in this phase.  And of course it causes my world to be completely off kilter. 

 I used to fight and resist this as there was always another project demanding my attention and there was no time to rest.  Every task took a lot of effort and in the end, resulted in some level of burnout. 

 Now, once I realize what is going on (yes, it can take over a week), I allow myself the time to decompress and replenish my energy stores.  This time, I am blogging, cooking, running, networking, playing poker with the kids, spontaneously spending time with friends, and resisting the urge to feel overwhelmed by the personal project list that grew while I was focused on a client project.  This is no mean feat and a gift that I try to grant myself until I am out of the dip. 

 In a few days, my energy stores will be replenished and I can go back to conquering the world.  Until then, each morning you can find me on my couch, in my pajamas, drinking cappuccinos, listening to French Café Radio on Pandora and focusing my short attention on sharing my wisdom and realizations on Solutions2Projects blog entries.  It’s not a bad way to get back to my ‘normal’ when I am feeling a bit ‘in between’.

January 19, 2012

Carrot or Stick

Posted in Project Management tagged , , , , at 7:43 AM by Solutions2Projects, LLC

What is the best way to motivate project team members?  The short answer is that it depends.  It depends on the individual and as project managers it is incumbent upon us to find out what works for each person and tailor for each. 

 We must get to know the team members and understand what makes them tick.  This takes time that may not appear to be a value-add at the beginning, but it is certainly an investment for later in the project when things really need to get done.  Finding the lever that will get each person moving in the right direction toward the collective goal, helps to eliminate some of the bumps on the road to project success.

 This also means that incentives and rewards need to be built into the project and project budget.  While it would be nice to assume that project team members are intrinsically motivated to do the ‘right thing’, the ‘right thing’ is different for each person and doesn’t necessarily align with the project goals. 

The team can be rewarded or recognized collectively but individual agendas need to be identified in order to increase the likelihood for success. The rewards do not need to be costly and they sometimes don’t cost anything.  For some, recognition is the best reward. Others require cash.  And others, flexibility to work on project tasks at 2 AM. 

Think about what motivates you.  What does it take to get you motivated especially when you’ve been assigned to a project that takes you out of your normal routine and comfort zone.    What would motivate you to work more effectively?  What information or tools do you need or want?  What rewards do you like?  Are you motivated by fear or money or recognition?   

The first step is recognizing that getting your team members motivated to work effectively towards the project goals and objectives cannot be achieved with a one-size-fits-all approach.  The most important and hardest step is taking the time to find the lever that will make each team member a more productive member of the team but it’s worth the effort.

January 18, 2012

Outsourcing to Save Our Sanity

Posted in Project Management tagged , , , , , , at 7:27 AM by Solutions2Projects, LLC

Recently I realized that I will not be the one to teach my children how to drive.  I realized this when my 10 year old was driving the golf cart while we played golf the other day.  It was quite stressful and we were only going 5 miles per hour and no other carts or pedestrians were in sight to run into or over.  Apparently my husband had already given thought to this and was in total agreement.  We have both realized that some things are better left to professionals to save our sanity, increase likelihood of success and reduce likelihood of bloodshed.   

 This got me thinking about my clients and the essential skill sets they need to have on site in their staff versus those that are needed on a periodic basis.  Most of my clients are only able to cover the basics like helpdesk, network, and if they are lucky, database.  Once enterprise or business specific systems are in place, a business analyst is pretty critical.  But IT project management?  The expertise is only really necessary when they are implementing a new system or upgrading and existing one.  This is a function that can be outsourced to experienced professionals. 

 When hiring an external IT project manager for a small company (less than 300 people) in the life sciences industry, compliance experience is key.  Without this experience, the projects can be seriously under planned as validation may not be considered.  Validation is a process that begins at the beginning with requirements definition and vendor selection and goes through system retirement.  Validation is not just documented testing and can add significant time to a project depending on system complexity and risk assessment. 

 Another key element is experience working in small organizations where a project manager has to get his or her hands dirty.  We don’t have the luxury of simply leading and guiding others as resources are generally limited and timelines short.  Therefore, IT project managers in this segment need to step in and act as business analysts, validation resources, and trainers in some cases. 

 Outsourcing IT project management makes sense as projects, by their very definition, have a defined beginning and end.  Once the project is over, it can be closed out and transitioned to on site personnel for ongoing support and your company does not need to retain additional headcount when the project is over.  If done properly, the project-specific knowledge gained by the IT project manager during the project, is transferred to the on site support personnel before the project is closed out. 

 As for drivers’ education, oursourcing makes sense for us personally.  Hopefully the training will be a short-term project beginning with a spin around the block with everyone coming back alive with no bloodshed and ending with a driver’s license.  At this point, as with system projects, once the project ends, or in case of my kids with their driver’s licenses, the real fun and headaches truly begin.

January 17, 2012

Change is Hard

Posted in Project Management tagged , , at 7:30 AM by Solutions2Projects, LLC

My dad often said that if it weren’t for the clients and employees, his job would be perfect.  The same could be held true with regards to project management.  The system implementation from a technical perspective isn’t hard; it’s managing the people and expectations that is most difficult. 

 We all know change is hard.  We also know it is necessary to grow and move forward.  Why do some of us resist it even when we know intellectually it is good for us?

 I know that from my project experience employees are afraid.  In their minds are a series of questions, especially if they haven’t gone through the process before.  Will I still have a job?  Will I be able to do my job?  What if someone finds out I don’t know what I am doing?  What if someone wants more from me than I can do or that I want to do?  I am comfortable with my discomfort; why do I need to change anything?

 I find that getting affected people (team members, employees, stakeholders) to talk about these issues (externalize rather than internalize) acts as a release valve and reduces the fright associated with the unknown.  We also discuss the benefits associated with the change and acknowledge the discomfort associated with the uncertainty.  This doesn’t happen just once and is an ongoing process throughout the project and through the adoption phase after Go Live.  If users don’t use the system and continue to follow old practices, the implementation cannot be considered a success.

 As project managers we are always managing…people, tasks, expectations, constraints.  How we help the people in the organization adjust to the change is a major factor in determining the success of the project.

Next page