February 22, 2012

Circle of Compliance Part IV: Improve

Sal Lucido, VP Enterprise Solutions, AssurX

In Part I, Part II and Part III of this series we discussed the benefits of using a closed-loop process for managing regulatory compliance (pictured below). We discussed how setting up Key Performance Indicators (KPIs) that monitor performance to goals is a good way to Check that processes are working properly thus reducing the need to perform manual audits of a given operation. We also looked at how to collect and process problem information ensures that the right information is collected, the problem is contained and that the root cause is identified. This sets us up for the next step, which is to fix the problem by executing a Corrective Preventive Action (CAPA) project.

The primary goal of this step is to implement changes that correct (corrective action) the problems and prevent recurrence (preventive action). This is where we get our payoff; this is where we ‘close’ the loop. Remember the overall goal is to systematically and continuously improve regulatory compliance. The inputs we will need to execute the CAPA project are show in Figure 1 (below).

Corrective Action Inputs

Problem Scope: Determine the boundaries of the problem we are trying to solve. Trending helps determine the scope. If the scope is too narrow the project will not address all of the future potential issues. If the scope is too broad the project may be too time consuming and expensive.

Root Cause(s): In the previous step we determined the root cause or causes. Check that the corrective actions taken in the project address all of the causes.

Project Schedule: Determine how long this project is expected to take or how long you want to allow it to take. Time is money. This will guide your resource loading decisions.

Project Costs: Determine the overall project budget. Include all labor and material costs.

Determining the Root Cause or Causes is a crucial part of the process. Here are two effective methods for making this determination. The Eight Discipline workflow shown in Figure 2 is optimized for larger, multi-member team projects.

8 Discipline Workflow

8 Discipline Workflow

The Five Why Methodology shown in Figure 3 is an effective technique for separating symptoms from causes. The example in the diagram illustrates this process.

5 Why Methodology Principle: Five or more iterations of asking why is generally sufficient to get to a root cause.

Once you have all of this information you can execute the CAPA project. The CAPA project outputs are shown in Figure 4.

Corrective Action Outputs

Action Items: Define and assign each task that needs to be completed. Unassigned tasks never get done.

Due Dates: Refer to your project schedule and consider the order of action item execution to set target due dates for each task. With team projects have each member report progress to due dates. Missing due dates is a symptom of a problem with the project (not enough resources, unclear tasks, etc.). Address these to keep the project on schedule and budget.

Document Changes: If you don’t change the ‘process’ and/or ‘product’, which are documented in your ‘procedures’ and/or ‘specifications’ – then you are not improving your operations. Remember what Einstein said: “Insanity is defined as doing the same thing over and over again and expecting different results.

Notification and Training: If a tree falls in the forest and no one is around to hear it, does it make a sound? The same can be asked of CAPA projects. If process and products are change and no one is notified or trained on these changes, did we make an improvement? I know the answer to the second question, no.

Verification: Check to make sure the project solved the problem. This step usually takes place sometime after the project is completed. Set up the verification criteria and date before closing the project.

And there you have it – we have closed the loop. We have defined how a closed loop process defined by what I call the “Circle of Compliance” is used to automate a process that continuously “pulls” the operations toward meeting regulations. By replacing a manual ‘audit’ and ‘check’ routine with this process your company saves time and money while improving its ability to comply with industry regulations. This is the definition of a win-win situation.

Sal Lucido is Vice President, Enterprise Solutions at AssurX, Inc. You can follow him athttp://twitter.com/ComplianceTips

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Savvy Compliance Strategy Part III: How to Track Problems

Sal Lucido, VP Enterprise Solutions, AssurX

Sal Lucido, VP Enterprise Solutions, AssurX

In previous series of articles Part I and Part II, we discussed the benefits of using a closed-loop process for managing regulatory compliance (pictured below). I also showed how setting up Key Performance Indicators (KPIs) that monitor performance to goals is a good way to Check that processes are working properly, thus reducing the need to perform manual audits of a given operation.

The Circle of Compliance

The Circle of Compliance

Let’s now take a closer look at the Track Problems step. The primary goal of this step is to collect and analyze data related to operational problems. This is a vital prerequisite for the next step in the process: Improve. Remember our overall goal is to systematically and continuously improve regulatory compliance. So let’s first take a look at collecting data.

Collecting data about operational problems sounds like an easy task, but it turns out to be anything but. First of all, there is a cultural stigma associated with anything that is labeled as a problem. This is because, where there is a problem, there is blame. And where there is blame, there are consequences. Given the fact that we are talking about consequences associated with someone’s livelihood, this is not something to take lightly. Therefore it is important to set a “tone from the top” that let’s employees know that the data will be used to improve operational processes and not punish employees. It is also helpful to ask employees to suggest improvement ideas. I’ve even seen some companies acknowledge and reward employees for suggestions that result in positive actions.  These are all good ways to encourage problem reporting. You want to tip the scale in favor of logging problems as shown in the illustration.

Logging Problems

Logging Problems

The next question is, “What data should we be collecting?” Let me start by pointing out that some data is better than no data. Waiting to create the perfect system will result in the loss of valuable information that could have alerted you to looming problems. So at the very least, start collecting data any way that you can.

I have seen hundreds of problem tracking forms spanning many processes and many industries. I’ve created product issue forms, process problem forms, out of spec forms, suggestions forms for industries regulated by the FDA, NERC and the SEC. I’ve summarized four design tips in the next illustration.

The Four S's: Problem Tracking Form Design Tips

The Four S's: Problem Tracking Form Design Tips

Now that you are collecting problem data, what should you do with that data? The high level steps for processing issues are: Identification, Investigation, Immediate Actions, Analysis and Planning for Further Action.

Problem Processing Flowchart

Problem Processing Flowchart

This is a summary of what each of these steps involves:

Identify: Collect problem data from all sources. Route these to someone that can determine immediate actions and investigate the problem.

Investigate: Look into the problem beyond the initial problem report. Look for trends from other sources (employees, vendors, customer) and from similar product and problems.

Immediate Actions: This step may be performed in parallel with or before the Investigate step. Determine if there are any immediate actions that need to be taken to contain the problem. While you are looking for root causes you don’t want the problem to grow or continue to do damage.

Root Cause Analysis: This is different from the initial investigate step in that you now are trying to determine what actually caused the problem. During the investigation you may determine that the problem was a result of operator error. But the root cause analysis may reveal that the operating procedure is unclear and is in fact the root cause of the problem.

Plans for Further Action: Once you have established the root cause you can take actions to Improve operations. In this step you would plan out what those improvement actions will entail, who will implement them, and how long they will take to enact. Typically this Corrective Action project requires management approval to allocate the required resources.

One benefit of this process is that a single Corrective Action project can address multiple problems. See the following illustration.

Investigation Funnel

Investigation Funnel

The next step is to Improve operations through implementing the corrective action project. We will take look at that step in the next article.

Read Part IV.

Sal Lucido is Vice President, Enterprise Solutions at AssurX, Inc. You can follow him at http://twitter.com/ComplianceTips

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Savvy Compliance Strategy Part II – Checking Compliance

 

Sal Lucido, VP Enterprise Solutions, AssurX

Sal Lucido, VP Enterprise Solutions, AssurX

In Part I, we took a high-level look at a process for automating regulatory compliance management. The closed-loop process starts with Documenting your processes followed by Monitoring or Checking that your processes are being followed. Next you provide a means of Logging or Tracking any problems that may arise and then take actions to Improve. This improvement should then result in a revision to the Documented process followed by notifying or training those affected by the process improvement.  This closed-loop process, which I call the Circle of Compliance, should be used to automate the process of complying with regulatory standards.

 

The Circle of Compliance

The Circle of Compliance

 

Now lets take a closer look at the Check step. The goal of this step is to eliminate the need to manually audit a process in order to determine its effectiveness. One way to do this is by defining a Key Performance Indicator (KPI). That’s a measure of performance that is used to help an organization monitor progress to goals. For example, a company may decide to improve responsiveness by reducing the number of late tasks. A company might also set a goal for reducing violations or incidents to improve conformance to regulations or standards. You can see an example dashboard showing these two KPI’s in the diagram shown below.

Key Performance Indicators for monitoring late tasks and monthly incidents. Traffic Light indicators provide a method for quickly showing progress to goals

Key Performance Indicators for monitoring late tasks and monthly incidents. Traffic Light indicators provide a method for quickly showing progress to goals

Key Performance Indicators for monitoring late tasks and monthly incidents. Traffic Light indicators provide a method for quickly showing progress to goals.

Let’s take a closer look at this KPI dashboard. Both measurements are listed: Late Projects and Monthly Incidents. Notice that the date the measurement was made along with the actual performance data are displayed. We can see that for the month of May there were two late projects and five incidents. Then on the right we see a trend arrow (more on this below) and a traffic light, which give us a quick indication of performance to goal. Green is good and red is bad. Of course in order to set the traffic light to the correct state (green, yellow or red) we need some goals.

For example if there are less than two late projects each month the light will be green. If there are between two and four late projects we would consider that a yellow light (or caution). And if there were more than four late projects in a given month we would set the light to red.

When implemented properly, KPI’s monitor performance over a given time period (day, week, month, etc.) and provide a visual indication (traffic light, flag, etc.) of performance to goal. So let’s dig a bit deeper to better understand how to do it right.

Since a KPI measures performance over a given time period there must be historical data, trends and state changes. Let’s start with historical data. By clicking on the KPI dashboard we can see past measurements (shown below).

A report of historical KPI data shows an improving trend. An email is automatically sent in May when the light changes state.

A report of historical KPI data shows an improving trend. An email is automatically sent in May when the light changes state.

A report of historical KPI data shows an improving trend. An email is automatically sent in May when the light changes state.

We can see from the historical data that the trend is moving from bad to good and that in May there was a state change to red and yellow respectively. This system is set up to automatically send an email to the KPI Owner whenever there is a state change.

Emails are automatically sent when the light changes state. This shows a notification indicated that a things are getting worse given the light changed from green to yellow.

Emails are automatically sent when the light changes state. This shows a notification indicated that a things are getting worse given the light changed from green to yellow.

Emails are automatically sent when the light changes state. This shows a notification indicated that things are getting worse given the light changed from green to yellow.

Also if you look back at the KPI Dashboard you see the Trend arrow is green and down. Down indicates that we have fewer late projects than in the previous reporting period. The arrow is green, which indicates that this is a ‘good’ or desirable trend.

In summary, setting up Key Performance Indicators that monitor your performance to goals is a good way to ‘Check’ that your processes are working properly. It also eliminates the need to perform manual audits of
a given operation reducing labor costs. The next step in this closed-loop process is ‘Tracking Problems’.

Next time: We’ll take an in depth look at the ‘Tracking Problems’ step.

Read Read Part IIII and IV.

Sal Lucido is Vice President, Enterprise Solutions at AssurX, Inc. You can follow him at http://twitter.com/ComplianceTips

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Savvy Compliance Strategy Can Ease GMP, Electric Reliability Regulatory Challenges

Sal Lucido, VP Enterprise Solutions, AssurX

Sal Lucido, VP Enterprise Solutions, AssurX

The primary function of the compliance department is to ensure that the company complies with all of the applicable regulations, rules, and laws. Regardless of industry (life science, energy and utilities, financial services, etc.) this is a universal charter.

As someone who serves customers across many heavily regulated industries, I think I’ve got a unique perspective — and I’d like to share some of what I’ve learned along the way in the hopes that it helps you in some small way .

One particularly useful tool I see used across all industries is what I call the ‘Circle of Compliance’. Before I explain this concept, let’s take a deeper look at the job of the compliance department.

As I’ve already mentioned, the compliance department is put in charge of ensuring that all applicable compliance requirements are met. For example U.S. medical device companies must comply with the FDA’s Good Manufacturing Practices (GMP). Regulation 21 CFR Part 820.90 states that each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. So the compliance department must determine if their company follows this process.

This is not so different from a U.S. power company that owns transmission lines. They must comply with Reliability Standard FAC-003 that mandates a clearance be maintained between transmission lines and vegetation. It also requires the company to report any vegetation related outages. These are different industries and different regulators (FDA, NERC), but each has the same fundamental task.

So how does the compliance department go about ensuring these regulations are met? Typically they audit the company for compliance. If there is a gap between the requirement and current practice, they work with the appropriate departments to close the gap. Take a look at this illustration for a visual representation of this ‘push’ exercise.

Relying on the Compliance Department to close compliance gaps is a time consuming, never-ending job…

Relying on the Compliance Department to close compliance gaps is a time consuming, never-ending job…

You can see from the illustration that this is a manual task. The problem is that it is a time consuming, never-ending job. As soon as the compliance department shifts their attention to another area of the company, compliance gaps can (and usually do) reappear. This is then addressed with ‘periodic’ audits. What we end up with is an endless and expensive merry-go-round of audits and fixes.

The solution? Set up a process that continuously ‘pulls’ the operations towards the regulations. I’ve illustrated this type of system below.

…it is better to implement processes that automatically and continuously close compliance gaps.

…it is better to implement processes that automatically and continuously close compliance gaps.

You can see the advantage of this system from the illustration. It does not require the constant and repeated attention of the compliance department.

So what is this process? I call it the ‘Circle of Compliance’ as illustrated below.

The Circle of Compliance

The Circle of Compliance

In a nutshell, this is a closed-loop corrective/preventive action process. While you might recognize the process as it relates to quality systems, you may not have considered its application to the job of regulatory compliance.

This is how the process works: Let’s look at the U.S. power company that must ensure that trees are kept away from transmission lines. Of course the compliance group would first check to make sure the vegetation inspection and removal procedure is ‘Documented’ adequately.

Next the compliance group would see if there is a ‘system’ in place for monitoring that the process remains effective. This is the ‘Check’ part of the process. Also they would ensure that there is a process for documenting problems such as vegetation related outages. Most compliance departments do a good job of auditing these two steps, but it is crucial that the next two steps are completed.

Any and all problems with the vegetation monitoring system must be ‘Tracked’. This means they must be documented in a system that links directly to the next step: Improve. All problems must be looked at to determine how the problem occurred and how the system can be ‘Improved’ to prevent reoccurrence. This improvement must then result in a change to the ‘Documented’ process followed by retraining of the workforce to the new process.

If implemented properly this closed-loop ‘Circle of Compliance’ will save the company time and money while improving its ability to comply with industry regulations.

Next time: I’ll explore each of these steps (Document, Check, Track and Improve) in more detail.

Read Part II, III and IV.

Sal Lucido is Vice President, Enterprise Solutions at AssurX, Inc. You can follow him at http://twitter.com/ComplianceTips

 

 

 

 

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Risk Management Matures Beyond the Spreadsheet

RiskMgmt150Risk management is one of those terms that is often used a bit too loosely, warns AssurX’s Sal Lucido. “People say ‘risk management’ but it can mean very different things to people working at different parts of a company.”

For example, the finance and accounting department focuses on documenting and managing risks associated with business financial transactions and reporting as governed by Sarbanes-Oxley (SOX). The information technology group (IT) focuses on cyber security risks, which involves processes such as identity and access management, threat and vulnerability management, and configuration control. The regulatory compliance group is concerned with meeting government regulations, laws and standards applicable to their industry. For example medical device companies must meet regulations imposed by the FDA regarding such activities as quality and incident management. Energy companies must abide by national and state mandated regulations established by NERC, FERC and their respective regions. Noncompliance can lead to fines that sometimes total in the millions.

Across these industries “the Federal Government is actively auditing and levying large fines for those companies found to be out of compliance. The bar is being set higher each year and the penalties are becoming more severe.”

“Having a risk management system that is managed on paper and spreadsheets is just not going to cut it anymore.”

Sal has helped dozens of regulated companies in industries ranging from utilities to medical device manufacturers to better manage their corporate risk data and processes. And he’s observed that they have a lot in common when it comes to handling risk management. Based on his years of experience with many different firms working to address risk, he has some valuable observations and advice.

Across the board, “what we’ve been finding is that information associated with risk management is rarely made available to the departments that need access to it. For example, if the audit department had access to the identified risks and their risk levels, they could use this information to plan their audit activities aiming audits at those that pose the greatest liability to the company. ”

Companies are now looking for tools that “allow for secure collaboration” so that the risk information and data is readily available for all those who need to access it.

”Because each of these departments already have their own processes” companies are looking for applications that allow each group to maintain their own forms and workflows. “It’s critical to have an application that provides processes unique to each group while harmonizing the underlying data” so that each group can access what it needs, when it needs it.

Dashboards and Metrics in CATSWebThe other trend we are seeing is that companies are looking to move beyond just documenting risks and listing mitigation efforts. They are looking for enterprise applications that can manage the associated business processes. For example, risk assessment and mitigation efforts are tasks that need to be assigned to individuals or teams, with due dates and status updates. In order to ensure projects stay on track there is a need for escalation functionality that automatically emails the appropriate personnel when tasks become due and go late. These activities also have associated workflows and approval routings that need to be managed via software. Of course this type functionality goes well beyond the capabilities of simple risk tracking software and spreadsheets.

The other need we are seeing is related to reports and dashboards. Department and process managers are looking for reports that show risk levels, heat maps, late reports and so forth. The executive staff is looking for enterprise dashboards that report on the state of compliance throughout the organization using easy to read traffic light and gauge or thermometer formats.

Finally the solution should also be flexible enough to integrate with data and systems that are already being used within the company. For example, if a system is already being used to document the status of key risk indicators (KRI’s) such as violations or incidents, “that data should be reported within (and accessible from) the risk management system.”

In conclusion, managing risk across the corporation means something different to each department yet it requires the entire organization to work together. It involves documenting and sharing risk data across the enterprise, managing workflows and tasks, while handling escalation and reporting. Yes, risk management has matured beyond the spreadsheet.

Sal Lucido is VP of Enterprise Solutions at AssurX, Inc.

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NERC Comments to NIST Stress Importance of Coordinated Standards

electricitylightbulbIn comments filed last month, the North American Electric Reliability Corporation (NERC) told the National Institute of Standards and Technology (NIST) that it should focus hard on coordination of standards as it works on its Proposed Framework for Smart Grid Interoperability Standards.

NERC simultaneously stressed the differences between the three types of proposed standards: Interoperability Standards, System Security Standards and Reliability Standards – and the ultimate need for streamlined, real coordination between the different standards.

“Although the voluntary Interoperabilty Standards proposed by NIST are designed to achieve a different purpose from the NERC mandatory Reliability Standards, it is critical to the continued reliability of the bulk power system that the two bodies of standards be compatible and complementary,” the Nov. 9th comment noted.

NERC also stressed the importance of cyber security to smart grid technologies and encouraged NIST to integrate adequate cyber security protection, at all levels (device, application, network and system) in the development of its Interoperabilty Standards.

While NERC CIP Reliability Standards provide for the reliable and safe operation of the bulk power system by preventing the unauthorized cyber and physical access to critical assets and critical cyber assets, NERC commented, there is a need to develop additional cyber security protection for distribution facilities in the development of Smart Grid Interoperability Standards to address, for example, security aspects of interoperability at the distribution level.

http://www.nerc.com/files/FinalNERCCommentsNIST_Smart_Grid_Framework_Document.pdf

Click here for more information about NERC Electric Reliability Compliance Solutions

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AssurX's 2009 Electric Reliability Special Interest Group a Great Success!

bluebulbThe 2009 Annual AssurX Electric Reliability Special Interest Group Meeting was a great success. This year we met in Denver on June 9-10, 2009 and kicked the event off with a networking reception that mixed business and great conversations. During the conference sessions, we discussed the latest product upgrades for CATSWeb ER, which makes it easier to import new and revised NERC Standards and RSAWs.

In our open forum we learned about how everyone is using the product to manage compliance to the NERC Standards and much more. Presentations on CIP Compliance, Compliance Framework and a customer presentation were loaded with important, useful information. I want to thank RRI Energy for a very informative presentation on their NERC compliance process: recurring evidentiary documentation/
gap analysis process
.

I also want to thank our customers and partners who participated in this great event. We look forward to the next one!

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Track Progress to Goals with CATSWeb Measurements Feature

greenllightThe CATSWeb Measurements feature makes it easy to track performance to goals, monitor trends and automatically send performance-based alerts. Measurements can be added to executive and corporate dashboards to provide important, easy to read, quality metrics information. Not only does this give you feedback about your performance to goal and trends, it also allows you to focus your resources on the areas of the business that need attention. Detailed information can be easily accessed by clicking on the metric of interest. All this is done within CATSWeb without relying on any third party tools or add-ons.

Because most of us don’t have time to look at these dashboards every day, alerts may be configured to automatically send E-mail notifications when the metrics change. Measurements can link to any data source such as internal system data like queries and filters, and with all system reports and graphs in CATSWeb – the source data can even be ‘external’  – such as from ERP and HR systems – or other Oracle and Microsoft databases.

It’s easy to set up a measurement:

  1. From the Manage page, click on Measurements and choose “Add” (or copy an existing one)
  2. Enter your company goals
  3. Then add the measurement to a Dashboard
measurements1

Example of CATSWeb Measurements showing status of late actions in various departments

The CATSWeb Measurements Feature provides an easy way to track progress to goals and alert you when thresholds are crossed. This helps your company to:

  • Achieve its corporate goals
  • Broaden visibility regarding those goals
  • Reduce cycle times
  • And ensure that tasks get completed on time

Let us know what corporate goals you are tracking (or would like to track) and how you are using the Measurements Feature in CATSWeb.

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Time to Shift Some Priorities When Tackling NERC Requirements

electricitylightbulbBased on the latest information from NERC, the Critical Infrastructure Protection Standards, CIP-002 thru CIP-009 reach the Auditably Compliant stage on July 1st, 2009. Up until now most of us have been focusing on the Sabotage Reporting Standard, CIP-001. Most of the violations associated with CIP-001 are a result of not having an established contact with the FBI for sabotage reporting or for deficiencies in the procedures or training related to sabotage reporting. Given that CIP-001 is only one standard and is fairly simplistic as compared to the other eight standards we all assume that a lot more effort will be required for compliance.  We also assume there will be significantly more violations and significantly higher fines associated with CIP-002 thru CIP-009.

Given companies have limited resources and time it may be helpful to look at what is ‘common’ amongst these standards as they relate to processes and workflows. One process that repeatedly shows up in the requirements are reviews or assessments.  For example, CIP-006 Requirement 1.9 says that companies need to establish a process for ensuring that the physical security plan is reviewed at least annually. CIP-009 Requirement 1 says that companies should perform a review of their recovery plans for Critical Cyber Assets annually. While each of these processes must be tailored to meet their specific requirements, there are many common elements that can be leveraged to save time. For example a typical ‘review’ process includes the following steps:

  • Initiate the review
  • Perform the review and document any recommendations for change
  • Approve the determination and recommendations
  • Implement all approved changes
  • Request approval that that changes were implemented and close the review
  • Schedule the next review based on the required period

Once you have agreed on a general workflow you can then customize the process to meet specific needs. For example, determine who should be approving recommend changes and closure for the specific processes being implemented. So prior to developing your workflows read through the entire set of CIP Standards and look for repeated processes. It may help you to save time and money. Let me know what processes you have found in the CIP Standards that may be repeated.

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NERC Standards Management: Beyond the Spreadsheet

ElectricitySunsetBlue150As we all know on August 8, 2005, President Bush signed into law the Energy Policy Act of 2005, which authorized the creation of an electric reliability organization (ERO) with the statutory authority to enforce compliance with reliability standards among all market participants.  The electric industry has had to adjust to the change from a voluntary system of compliance to a mandatory system of reliability standards compliance.  In order to deal with this situation most organizations decided to use their favorite weapon – the spreadsheet. It was a great choice given there was a lot of information that needed to be organized in a very short period of time, including: standards, requirements, entities, measures, subject matter experts, applicable procedures, evidence of compliance and the list goes on.

However, once these spreadsheets were filled up with reams of data on dozens of interconnected worksheets, problems began to surface:

  • Complexity: Documenting the relationships of each applicable requirement to applicable procedure, compliance rationale for each of the registered entities within the organization quickly becomes a rat’s nest of intertwined data.
  • Maintenance: As new and revised standards are released just managing changes to these spreadsheets becomes more then a full-time job.
  • Doesn’t Manage Tasks: Analysis of compliance to requirements usually requires assigning tasks, which implies management of assignees, due dates along with documenting the task and the outcome.
  • Silos of Information: Spreadsheets by their vary nature are typically owned by one person and are located on that individual’s computer. After a while most companies learn that there is more than one spreadsheet. In fact several people in various parts of the organization are maintaining this information with overlapping data and most of the time without knowledge of each other.

This is when it makes sense to use a corporate-wide compliance management system that can deal with the complexity of the data, can be easily maintained with new and revised standards and manage task assignments, due dates (with automatic email reminders) and associated procedures and evidence.

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