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Selecting,
Implementing
and Using FDA
Compliance
Software Solutions
The Life Sciences Guidebook
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
2 |
Table of Contents
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
1 | Getting on the Quality Management Software Soapbox
Introduction: Why do We need QMS?
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
2 | Getting on the Quality Management Software Soapbox
Introduction: Why do We need QMS?
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
3 | Getting on the Quality Management Software Soapbox
Introduction: Why do We need QMS?
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
4 | 8 Simple Rules for Selecting a Quality Management Software System
Getting Started on Your Journey
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
5 | 8 Simple Rules for Selecting a QMS System
Getting Started on Your Journey
false scalability promises—some systems will claim scalability, 8. Time to Value—Implementation and Deployment: You’ve
but have no real experience in the matter. A scalable system covered your needs in terms of the solution and it has all the
must obviously be technically capable of handling the load of bells and whistles your company needs—now what? The solution
additional users, but that is only half of the picture. The scalability needs to be implemented. This is where, many times, software
of administration is equally important and can be much more selections fail. In fact, in a recent study of over 9,000 software
expensive to fix later if not considered up-front. implementations, 71% of them either failed or were late or over
budget. Many of these projects cited the implementation project
Look for customer references that have scaled the system to a level as a major reason for failure. It is critically important that the
that is equal to your business, specifically in the ability to delegate software vendor be able to demonstrate their capability to not
administration to different levels in the organization, across the only deliver the solution to you on time and on budget, but do so
entire enterprise. Truly scalable systems include location-based in a fashion that lets you use the system as you intend to use it—
administration that extends beyond simply managing different user with all your configurations and best practices built in.
groups, to enabling location-specific configurations and dynamic
filtering of location-specific data. Look for a solution that has a proven implementation method that
involves the requirements gathering, the side-by-side collaboration
6. Tying Systems Together through Integration: Operational with their folks and your team, and sticks to an agreed upon project
areas no longer live in silos when it comes to business systems. scope. Furthermore, get your requirements finalized up front—
Whether they are Production, Financial, or Quality systems, adding new features and functions mid-stream often delays projects
the ability to interact, collaborate, and coordinate across the as more time is added to the project to meet these new “last minute”
business is key to uncovering any gaps in processes, and creates entries. Finally, make sure all the stakeholders in your organization
visibility from one operational area to the next. It is of paramount have had their opportunity to contribute to the requirements
importance to be able to integrate your systems. phase. This will ensure that all parties are satisfied before the
implementation begins.
When looking to select a system, keep in mind the integration
options available within the solution. Avoid solutions that claim These 8 rules of engagement when selecting a software solution
integration, but will only do basic integration “lookups.” While this is (which can really be applied to any enterprise solution, not just
powerful and eliminates some degree of double-entry of data, true Quality or EHS), can have a tremendous impact on how you approach
integration will not only pull data in from production systems, but your software purchases in the future.
will also push data back to those systems, such as nonconformance
issues, overall cost of Quality activities and more.
When selecting a software system, take into account the end user’s
experience. Make sure the software can easily be configured to help
the end user—whether it is familiar forms and layouts, even colors
that match the corporate look. If you are replacing an existing system,
see if you can match the new system’s look and feel, even the form
layouts to the old system. This can make the transition much easier,
and make the end users more productive right from the start.
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
6 | Look Under the Surface: 4 Things to Ask a Compliance Software Vendor
Getting Started on Your Journey
In this day and age, very rarely do people buy anything without doing software sale draws so much focus, that the service element
their research. This rings true when it comes to the buying process becomes an afterthought. Look for a vendor that has a proven
for enterprise software systems. In many ways, the buyer has so many track record of implementing their solutions successfully, and
tools available to research vendors and understand the pros and make sure to spend some time reviewing their strategy. Proper
cons, we see a much more informed and educated enterprise buyer. implementations, whether large or small, should incorporate
Web-based research will give you some of the key areas to rate a some element of project management that involves both parties.
vendor on, such as: The best way to find out if the implementation methods are
“proven” is to look for proof from existing customers.
Market expertise
Features and utilities 2. Customer Satisfaction: Today’s enterprise software buyer
will no doubt ask for references. Most vendors will gladly turn
Broad company overview
you towards their go-to reference or load you up with case
Pricing and support structure studies. And most buyers will discuss the cursory questions—
Breadth of applications offered “What do you like about the software,” and “does the software
meet your needs,” etc. When doing your reference call, it’s also
All these things can be commonly found after some basic research,
a good practice to delve into some more intangible questions.
and a few discovery demonstrations. However, we still see cases
Remember, enterprise software is not only an investment in
where a company has selected a vendor, and that vendor continues
a solution; it can be an investment in the people within the
to fail on their delivery of the solution. You would think that these
company. Questions like “What do you think of your account
failures would be picked up on during their extensive, informed
manager or service manager,” or “Do they respond to your needs
research, but there is more to a company than the above bullet
at this company,” or even“ What is their user conference like” will
points. Below are some additional considerations to be aware of
give you a deeper insight into how this company operates. These
when selecting an enterprise vendor—those that go beyond pricing,
types of questions (which may seem silly at first) add dimension
features, and tools.
to the vendor, and also give you an indication of the health and
1. Implementation Track Record: One of the primary reasons longevity of the company. You want to invest with a company
software implementations fail is a lack of communication and that will be around for as long as you continue to work with
project management within the implementation team. To put it them.
more simply, the project scope goes over time and over budget.
Often (and especially in the Compliance software market), the
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
7 | Look Under the Surface: 4 Things to Ask a Compliance Software Vendor
Getting Started on Your Journey
3. Financial Well-Being: As stated above, you are investing in an 4. Proof of Concepts and Workshops: If you get to a point where
enterprise solution and the company behind it—it’s critically two vendors are equally adept, then it might be time to suggest
important that you feel comfortable about the company’s a workshop or proof of concept. These are typically 1-2 day
financial well-being as well as their product offering. In this day engagements with the vendor whereby you give them a simple
and age, software companies are being bought and sold, and set of requirements, and ask them to implement it on a small
a company’s control is sometimes in the hands of a venture scale. It’s like a “test-drive” of the system on your terms and
capitalist rather than a software architect. In some cases, the using your processes. What makes it powerful is that you can get
software vendor is a minority shareholder in their own company. a glimpse of how your future relationship with the vendor will
Venture capital investment, loans and lines of credit to keep be, and how they work when implementing your solution. These
operations going—truth is, a software vendor may have more workshops can be time-consuming (and occasionally a pay-for
debt than equity. Don’t hesitate to get financial information from exercise), so reserve this for special circumstances.
the vendor.
In our world where we have all the information at our fingertips,
Now many may not be apt to opening their books for you, and that’s it’s sometimes easy to say we know everything. But there are still
fine—there are a few ways to get an accurate financial picture: those data points that are not publicly known, and getting the right
answers can make a big difference in your decision. So it’s important
a. Search the Web for Investment News: Vendors may not to do your research and come to the table prepared, but don’t
actively promote when they are bought or invested in, but be afraid to ask for more information on your enterprise software
the investors love to talk up their portfolio. Look for press solution.
releases from investors on your vendor, and read carefully
on whether the investment firm is providing capital, or
actually purchasing the vendor.
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
8 | Build vs. Buy: Best-Practice QMS Solution over Custom Development
Tips for Implementation Success
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
9 | Build vs. Buy: Best-Practice QMS Solution over Custom Development
Tips for Implementation Success
The root of all these challenges lies in the ability of the project to
be defined properly. With custom developed solutions, the project
scope encounters obstacles not foreseen at the outset of the
project, and it is extremely difficult to estimate the time and expense
associated with a major development project. This is primarily due
to development of new features not inherent within an existing
application or customer developed application, which creates a
tendency to change and modify the scope “on the fly.” The result,
according to the Standish Group, estimates that 52.7% of all custom
application projects cost 189% of the original estimate provided.
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
10 | Build vs. Buy: Best-Practice QMS Solution over Custom Development
Tips for Implementation Success
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
11 | Avoid Scope Creep in Enterprise Software Implementation
Tips for Implementation Success
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
12 | Avoid Scope Creep in Enterprise Software Implementation
Tips for Implementation Success
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
13 | Why Marketing is Important for Your Quality Management System
Tips for Implementation Success
If I were to give you $1000 to switch to my car brand, you are The Launch Party: This does not need to be a hip-hop rave, nor
certainly more likely. Or, if I associate my energy drink with your does it need to be a black-tie gala. Everyone still has to work
favorite sport, then you might feel compelled to drink my highlighter- —a simple gathering with catered lunch is more than enough. In
colored, sugar-filled beverage. I’m talking about marketing—the one the case of the EPIC launch, the customer ordered lunch for the
thing that we are exposed to every day. Believe it or not, consumers team, had a sign made up and a cake with the EPIC logo on it.
today encounter from 3,500 to 5,000 marketing messages per day— Never underestimate the power of free food. They sat...they ate...
so we are no stranger to “the pitch.” they saw the new system.
Perhaps one of the biggest obstacles in user adoption of a new QMS Incentives and Raffles: If you have some extra slush money,
System is getting people excited about it. But part of user adoption maybe you want to invest in a few promotional items or a raffle
and acceptance is inspiring people to use it. It’s one thing to have for the launch. You can even ask the software vendor for a few
to use the system, but it’s a completely different thing to want to of their incentive items for the launch—they would be more than
use the system. Here are just a few techniques in how to effectively willing to help out. Everyone loves gifts, and if you associate gifts
incorporate a little marketing into your Enterprise QMS or EHS and rewards with your new system, it becomes a pleasurable
rollout: experience for the users. “Remember the EPIC launch? Yeah, they
gave out food, free stuff, and raffles—it was great. What a great
1. Give it a Good Name: More often than not, the software system!”
vendor’s name sticks with the company, but there is rarely a
clause in the agreement that says you can’t rename it. So why 4. Keep the Dialogue Going: Every system launch goes through it’s
not give it a name that will resonate with your company? One “honeymoon period” when everyone is buzzing about the system.
company wanted to eliminate the “Quality” from its QMS so The key is to keep it in people’s minds, after the honeymoon is
that employees outside of the Quality department would be over. Email newsletters are a big help here—create a monthly
interested. So they renamed the software, Enterprise Processes newsletter to let your company know what is going on in the
for Integrated Compliance—“EPIC.” Now that’s a cool name. system. This can be company wide or just in your area. Let them
Another company didn’t even try the acronym route, they just know how many CAPAs were processed, how the system has
named it “Turbo.” Now, who wouldn’t want to work in “Turbo” all improved Quality, or where to find the new Document Control
day? A good name goes a long way. module you installed. Communication helps to keep your system
at the forefront of their minds.
2. Dress it Up: Most software solutions are flexible and
configurable enough to change not only the business processes With just a little bit of marketing, you can turn an ordinary Quality
and workflows around the tool, but also change the look and Management System rollout into something special for your team.
feel. Take advantage of this flexibility and brand your solution to They worked very hard to get the system up and running—why not
match your company’s colors, logos, and corporate look. People a little notoriety and fun in return? You’ll find that you not only have
love to feel at home with a new solution, and having the same rewarded your employees for the effort, but you’ve also inspired
“decor” helps to ease the transition. people to adapt and use your new system.
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
14 | The Importance of Risk in the Complex Quality Lifecycle
Risk Management in QMS
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
15 | Risk Assessment: Creating a Risk Matrix
Risk Management in QMS
How do you define risk? It’s not as easy as you may think. Companies
spend plenty of time and money coming up with a scheme on
how to calculate risk for their organization. Risk is defined as the
“systematic application of policies, procedures, and practices to the
tasks of analyzing, evaluating, and controlling risk.” All this really
means is that we put tools in place to help us look for risks, assess
those risks, and then take action on the risk. The trick here is finding
the risk, isn’t it? How do we find the risk?
Now you can go off and start using it, right? Well...you need to “vet
the matrix”—put it through real-world historical examples and see
if the risk matrix comes up with the correct risk based on historical
events. You may need to “tweak” the matrix based on the vetting
process. Hard mathematics will not properly assess the risk without a
little real-world honing. Once you’ve fine-tuned the matrix, you can
start utilizing it in your Compliance system.
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
16 | Risk Assessment: Creating a Risk Matrix
Risk Management in QMS
Risk Assessments and risk matrices are wonderful tools to help guide Risk helps to ensure that not only is the CAPA effective, but it’s
decision-making in an organization, but they are not meant to be within the risk limits of your organization’s compliance standards.
stand-alone tools. They help to provide a guide for Risk Assessment,
using quantitative and repeatable metrics to ensure a consistent CAPA is an effective and essential tool but, like many processes, can
method of determining risk. Most best-in-class organizations will be blocked up if you are too reactive to events. In order to streamline
assemble a “risk team” to go over adverse events and determine your CAPA process, it is important to look at adverse events and filter
the risk. It’s up to the team to decide how an event will be handled, them to properly determine how critical they are.
and what the true risk is. Risk matrices are the keys to unlocking
quantitative risk-based processes, but the people are the drivers of
the system.
1. Not every event needs to be a CAPA: Yes, it’s true—if you can
immediately correct an event, then correct it. Not every event
needs to be opened up as a Corrective Action, only those that are
systemic issues and pose a critical impact on the business.
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
17 | Using Complaint Handling Software to Improve Quality
Regulatory Matters—FDA Compliance in Quality Management
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
18 | 3 Reasons to Adopt Automated Validation in Quality Management Systems
Regulatory Matters—FDA Compliance in Quality Management
3. Cost savings: You may say “cost is not the issue when it comes to
validation. The cost of liability outweighs the cost of validation.”
Customers often say those exact words, and they are right—to a
point. If automated validation produces the same exact results as
a manual validation project, but does so in 20% of the time, then
wouldn’t it make sense to choose the cost-effective option? We
had a customer take the exact same workflow and do it once using
manual validation, then again using automated validation. The
result was exactly the same, only the automated tool took a few
hours. The manual team was still working 3 days later...
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
19 | 3 Reasons to Adopt Automated Validation in Quality Management Systems
Regulatory Matters—FDA Compliance in Quality Management
So, with the right amount of assurance and knowledge, you can learn
to reap the benefits of stepping up to the next level.
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
20 | GMP Compliance that Spans Enterprises: Supply Chain Compliance
Regulatory Matters—FDA Compliance in Quality Management
With all the compliance initiatives to increase visibility into the supply Knowing “Too Much”: Sometimes, ignorance is bliss—even in
chain, and the stringent regulations that companies must adhere to, this world we live in today. Some companies do not want this
it would make sense to provide a system that spans enterprises in level of visibility and/or control. This may be due to “plausible
addition to divisions. Here’s why: deniability,” liability issues, or it could just be that they don’t
have the bandwidth to engage the contract manufacturers at this
1. Visibility: Having a contract manufacturer work in your QMS level. But think of this—if there is a serious event related to your
provides you with the real-time visibility into their own Quality product as a brand owner, who is liable for the repercussions? The
operations. With this level of visibility, you can maintain control answer is the brand owner, not the contract manufacturer. So the
over the state of Quality outside of your four walls. pain of knowing too much may bite back at you in the long-run.
2. Real-time Collaboration Cuts Cycle Time: If there is a defect or The world is smaller, and more and more companies are collaborating
noncompliance, then the collaboration to resolve the issue can on new levels. We all are engaging in business. The key to success,
happen much more quickly. Unlike in current disparate systems, especially in the regulated environment, is incorporating more layers
you do not have the “lag time” while the supplier works on their of visibility into the various areas that help to make your products. This
end to resolve the issue. Quality and compliance events now not only includes standardized compliance between divisions but also
become a collaborative effort, all working toward the same goal standardization across enterprises.
and cutting the overall cycle time.
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
21 | Using Quality Management Software Tools to Manage Recalls
Regulatory Matters—FDA Compliance in Quality Management
1. Submit Recall Information to the FDA: Once it’s determined that QMS Solution—Document Control: Having the required
a product or device warrants a recall, the process must be swiftly documentation such as notification letter templates, website
put into action. The FDA must receive all information related to the templates, press release templates, work instructions, and similar
product such as the name and information of the recalling firm, records is key to providing a quick response to a recall. Using a
name of manufacturer, as well as the reason for the recall including revision controlled Document Control system, organizations can
a description of exactly how the product is defective, how this has ensure that the necessary documentation is available within the
affected the safety of the product, and the date the issue occurred. system and is accurate and controlled, and ensures management
An FDA Health Hazard Evaluation (HHE) form, which shows the of the creation, approval, distribution, and archiving of these
organization’s assessment of the health risk, must be completed controlled documents.
and sent to the FDA. The company must also include the volume
3. Evaluate the Recall: Once the public has been notified and the
of product that was produced. They will need to submit the
recall has been initiated, the organization must then conduct
quantity and dates of distribution and the amount of product that
a recall evaluation to check its effectiveness. This will enable
is on hold due to the recall. They will then need to submit the
the organization to benchmark its effectiveness and assess the
distribution pattern and inform the FDA of the number of direct
progress of the ongoing recall. During this stage, recall status
accounts that they deal with in order to retrieve all products back
reports must be created; these status reports should consist of
from facilities and consumers.
the date each customer was notified, the number of customers
A recall plan must also be established at this point if the organization who were notified, the number of customers who responded, the
does not already have one in place. A recall plan is an important part quantity of product that was accounted for or returned, as well as
of an efficient Recall Management system. Every organization should the details of the effectiveness check.
have a plan in place in the event of a recall and should conduct drills
Once the root cause of the recall is discovered, this information
or “mock recalls” on their plan to guarantee its effectiveness. This helps
should be sent to the local FDA District Recall Manager, along with
to ensure that in the event of a recall, all of the necessary steps are
any corrective actions that have been established at this point.
executed thoroughly and correctly, the first time. The recall plan covers
Termination of the recall is the final step and can be started once it’s
everything from the submission of information to the FDA and how
determined that all parties involved have been notified, and all traces
the public will be notified to the evaluation of the recall. It is essentially
of the product have been recovered. Before the FDA will consider
the company’s “map” of the recall process, telling them exactly which
termination, a final status report should also be sent to the local FDA
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
22 | Using Quality Management Software Tools to Manage Recalls
Regulatory Matters—FDA Compliance in Quality Management
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
23 | The Bill of Compliance in Quality Management: The Quality Hub Concept
Regulatory Matters—FDA Compliance in Quality Management
“The BOC, like a bill of materials or bill of process, provides a persistent While these concepts are a fairly recent perspective on our way of
structure (a metadata definition) that defines bindings for master thinking about Quality, many organizations are already employing
and operational data elements (these could be stipulated regulatory these methods in some form or another. Quality by Design, Supplier
documents, Material Safety Data Sheets [MSDSs], assay results, Quality, and even EHS activities are being tied to Quality Management
raw material specifications and training certifications) required to Systems, and as more and more systems begin to integrate with
demonstrate product and process compliance for material sources Quality, the closer we are approaching to a true Quality Hub. As you
and destinations by region, industry or even customer,” says Simon begin to evaluate your business systems and explore your options
Jacobsen of Gartner Research in report “EQM Hubs Unite Quality for improving your compliance visibility, look to Quality to provide
Management IT Systems Across the Value Chain, ”published on March you with the Hub that will house a Bill of Compliance. This level of
29, 2012. Simon goes on to say that “...the EQM hub provides the compliance has proven effective for many organizations in leading
master data management processes needed to maintain the BOC over the charge to put Quality and Compliance at the forefront of the
its life cycle, and provides a single version of the truth with respect to operation.
compliance requirements for all other enterprise systems involved in
conversion processes.”
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
24 | The Hitchhiker’s Guide to Quality Management Software
Final Thoughts: Fun Takes on QMS Software
1. Don’t Panic: I think this phrase should precede every software 5. Reporting on Life, the Universe and Everything: OK, maybe not
discussion, let alone Quality Management Systems. Too often, everything, but without a solid reporting system the data becomes
people get caught up in the hoopla of system analysis, RFPs, hidden. Part of any QMS solution is having a comprehensive
and overreaching functionality. While these are all great things business intelligence component that will provide you with the
to have in the QMS process, there should be a core element ability to see trends in your Quality data. Understanding trends
at the forefront–“What is my business need, and how can the within the system can help to foster change within your processes,
system meet my needs.” Don’t overthink the project; too often continual improvement, and more efficiencies in your Quality
solution selection initiatives become overburdened by too many operation. Look for a solution with a built-in and centralized
requirements, and you lose focus. The key is to have a clear goal in reporting system that rolls up data across all modules and facilities.
your project and, if the system is robust enough, it will grow with
The Guide Says: Reporting tools are a key component to the
your needs.
QMS; they help to provide visibility into the data, uncover trends
The Guide Says: Build out a comprehensive project, but start with and foster organizational change.
your high level goals and work down from there.
As we hurdle through the universe on this mostly harmless planet,
2. Less is More (more or less): Simply put, keep it simple. Don’t Quality matters to us all (no matter how much we resist). Systems
outthink yourself on your processes. Find a solution that can scale are in place to help ensure that Quality is met, and software helps
to meet your growing needs, and have the technology to grow to streamline the system. There are many ways to look at selecting a
with you, but when you set out on the implementation, start with a software solution and this is probably the strangest one you’ll read, but
few processes. Get your feet wet and then jump off the deep end; the core message is the same—focus on your business needs, find a
you’ll find that a little familiarity will go a long way. solution that will adapt and grow to your needs, and select only those
solutions that will complement your business.
The Guide Says: Build an implementation project that will start
simple, but be able to scale big as you develop the solution.
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
www.etq.com 800.354.4476 info@etq.com
25 | What Star Wars Can Learn from Quality Management Software
Final Thoughts: Fun Takes on QMS Software
Perhaps if The Empire implemented a Quality-based Project 4. Nonconformance, Audits and Corrective and Preventive
Management System, they would be able to clearly define the roles Action: Let’s stay on this, then. Obviously, we know that the Death
involved in the project, assign tasks to those roles, and manage Star had a defect. It was only in the final hour did The Empire
the project from an aggregate level. Workflows keep the project realize the danger, and by that point it was too late. If they had a
deliverables on track, and perhaps this level of visibility would enable Quality system in place, they would have found this flaw, whether
them to maintain control, without having to resort to the Dark Side as through regular space Audits (or at the very least an Audit through
their only means of clairvoyance. tremors in the Force), or a Nonconformance when the defect was
installed, and issued a Corrective Action to fix the problem. Clearly,
1. Document Management: Let’s be honest—even The Empire Quality took a backseat to their overconfidence, and ultimately
could’ve used a strong Document Management System. Given the resulting in, well…you know the rest.
sheer size of the Death Star with the thousands of “employees”
that worked there, there would have been tens of thousands of 5. Management Review and Reporting: As I said before, the
records that would need to be controlled—work instructions, job primary project managers used fear as their primary motivator,
descriptions, procedures, floor plans, and the like. You would think and seldom relied on the data to help them with Quality. In the
that with this “technological terror” The Empire constructed, there movie, you see the officers of the Death Star sitting in a conference
would be a secure Document Management System in place. room, and not one of them produced a report—if they had a
robust reporting system that collected Quality data from all areas
Then how did a small droid like R2-D2 plug into the network and of the Death Star, and rolled this data up to help determine the
download the Death Star plans like it was a space walk in the park? top risks and top Quality issues, then maybe that meeting would
My guess is that The Empire, in all its glory, was using a file system to have gone differently. Perhaps if that poor guy had shown Darth
store documents. If The Empire would have used a Document Control Vader his latest Quality Report, he wouldn’t have gotten the old
system like those in a QMS, access to these specifically sensitive “force choke” from the Dark Lord of The Sith. Having a top-level
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
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26 | What Star Wars Can Learn from Quality Management Software
Final Thoughts: Fun Takes on QMS Software
6. Risk Assessment: I think that perhaps The Empire took many risks
when going about this whole Death Star thing. Did Tarkin assess
the risk of testing the Death Star on Leia’s home world? Did Darth
Vader assess the risk of letting the Rebels escape with the Death
Star plans? Did they assess the risk when they underestimated the
rebel’s chances of destroying the Death Star? In any system, it’s
important to incorporate risk into the processes, whether Quality
or similar system. If The Empire would have perhaps weighed the
severity and likelihood of the risks associated with their actions,
perhaps we would have seen a different outcome of the story. Risk
Assessment, especially in a QMS, allows managers to filter out
critical events, and make better decisions on how to handle them,
and then ultimately mitigate the risk of recurrence.
The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions
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www.etq.com 800.354.4476
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