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4 Signs it's Time to Standardize Your Quality Management System

Global organizations are increasingly grasping the power behind data and process streamlining; the benefits will pave the way for growing a culture of quality and compliance. Becoming a mature, global enterprise focused on quality-driven initiatives requires transformations in IT, Validation, and business process functions to create and achieve standardization within the organization. One of the main challenges in adopting a global enterprise quality management system is the complex nature of separate existing tools, applications, and spreadsheets that companies often acquire or create over the years through M&A activity. Within the Quality Management Ecosystem, there is an increasing recommendation to move towards replacing these disparate, disjointed, often paper based or home-grown systems with an upgraded, top of the line, enterprise-level quality management solution. Having to deal with too many systems and platforms create unnecessary complexity. There is a better way: It involves having a strong, well thought out application standardization strategy in place to accomplish a smooth transition to one global platform.

Drivers for Streamlining / Signs that it’s time…

Often, there are indicators and red flags that will point to the need for streamlining, or at least the need to consider whether migrating to one platform may be the right move for your organization. We’ve captured some of the tell-tale signs that merit your attention.

1. Too Many Systems 

This is the obvious one. Over time, the number of systems, spreadsheets, and tools for tracking quality processes within a business tend to grow. Systems are added to fill business requirements and, in many cases, are acquired, such as through M&A activity. As the number of systems grow so does the company’s responsibility to manage them. Operating this way greatly reduces efficiency and incurs additional costs, such as IT staff, infrastructure fees, and even increasing the volume of help desk activity. Streamlining related systems reduces these burdens and facilitates centralization and standardization. Companies can also reduce costs and increase efficiency by consolidating support teams and administration of their applications through the process. Even dealing with other non-quality system departments becomes easier because it's all done in one place. This leads to resource, IT and infrastructure cost savings.

2. Hard to Extract Actionable Analytics

Disparate systems make it much more difficult to perform analytics and business intelligence (BI) right. When you analyze BI on multiple systems that aren't unified, each with their own data elements that don’t match up or are hard to relate to the elements in other systems, getting actionable insights becomes a cumbersome, if not impossible, task. If you’re not getting quality information about your entire landscape, how can you make improvements and grow? With standardization, it's much easier to get clear and actionable information on the Quality Events happening in your organization. Consistent, correct, and actionable reporting through one harmonized reporting platform can be one of the main, and often the most valuable, drivers.

Once a company decides streamlining is right for them, then they can also take advantage of upgrades to their application versions and to the latest reporting and analytics technologies allowing the company to benefit from best-in-breed business intelligence that is accurate, holistic, and scalable.

3. Mistakes Creeping In

Mistakes can be costly. In regulated industries, mistakes can translate into fines and even significant loss. With disparate systems, users may need to learn and use several different systems, user interfaces, etc., increasing the risk of error. Standardizing not only makes users less prone to errors, but can also speed up the rate of user adoption by lowering the amount of training required for users to access the business’s Quality Systems. This process will also reduce the inconsistent, ‘disjointed’ user experience between different sites and provides common standards across the organization in areas such as:

  • System integrations
  • Reporting standards
  • Configuration and data management standards
  • Enhancement release schedules
  • Validation and documentation standards
  • Application maintenance and support efforts
  • User account administration and user management

4. Lengthy Audits

Businesses that operate in regulated industries are audited or inspected regularly to ensure compliance. When audits take a long time to do, it’s a sign that it's time to standardize. In scenarios where the FDA comes in and must inspect numerous systems, it takes longer, costs more money, and introduces more risk of compliance issues due to errors, versus having one system they can easily access and audit.

Recommendation: Plan Your Strategy

Any good standardization project starts with a strong foundation of planning and assessing the overall consolidation strategy. Upfront planning and preparation, including framing the sequence of events, will raise the likelihood of success for your overall streamlining project. During the planning phase, it’s important to focus on assessing each of the disparate “source” systems. In this evaluation, drive towards a deeper understanding of each of the key components and areas of focus that will be impacted and that will need to be mapped as part of the streamlining. A good place to start is by identifying and reviewing the overall system and requirements for the target, or Global Quality System, and mapping each source system to this.

Review the approach to harmonizing and optimizing data fields, selection values or lookup lists, configuration components, and your reporting. Where possible, harmonize data field names, workflow component names and status points, and values for drop down lists between the siloed systems. Create a data dictionary that maps each of the data points and configuration components from the source systems, applications and spreadsheets to the planned “target” global streamlined system. While this process can be tedious and very detailed, it is a crucial step in the streamlining process. Upfront diligence to the mapping and analysis process will lead to effective reporting, searching, and overall quality of the data in the streamlined system.

Equally important is the need to assess the appropriate phases or sequence of events during the streamlining. This will ensure you are planning the re-key efforts that may be required to ensure you minimize business disruption. One possible strategy is to use a phased approach as described below:

  • Phase 1 – Analyze and map systems
  • Phase 2 – Install or upgrade a new Global Consolidated System
  • Phase 3 – Re-key or reconfigure siloed system configuration 
  • Phase 4 – Validate the configuration & development as necessary
  • Phase 5 –Data migration (preferably using validated tools built for facilitating migration for your specific application)
  • Phase 6 – Go live / Cutover your Consolidated System

Migrating and Archiving Data: A Key Consideration

One of the key factors in any standardization process is to evaluate your options and plan for how you will treat data and records in the disparate systems. Plan for a minimum of 50% of the effort in analysis (of the data sources) and design (mapping and transformation rules) activities, before any data migration process development occurs.Ask yourself, will you be migrating historical data and records from the old applications into the newly streamlined system? Or will you be maintaining an archived/view only version of the existing legacy systems for data retention purposes.

Alternatively, consider the need for creating a global archive system as well to create a legacy data and record repository. Keeping a close eye and evaluating the right fit for your organization when it comes to data migration can make or break a project. According to a 2014 Gartner study by Ted Friedman, through 2019, more than 50% of data migration projects will exceed their original budgets and result in some form of business disruption due to flawed execution.Look for a partner that has the tools and experience to make data migration as seamless as possible. Out-of-the-box application migration utilities can often help achieve better results, that are faster and cheaper. They can provide pre-built extraction, conversion and transformation rules leading to cost and time savings for the data migration portion of your projects. Having a solid consultative partner with a proven methodology can help your organization navigate through choppy data migration waters, and lead to a higher probability of overall success in your streamlining strategy.

Last, review and assess your current system pain points. After all, you have an opportunity to ‘right’ the ‘wrong’ in a Global Standardized System so you want to take advantage of understanding gaps and challenges in the old systems, ensuring that you are adhering to best practices for design, process, and functionality, leading to a higher probability of overall success in your streamlining strategy.

When you begin evaluating your systems, look specifically for siloed applications, homegrown excel spreadsheets and systems that cannot scale to an enterprise level. Their presence will indicate it’s time to consider some level of standardization. When you do decide to standardize these applications and tools, careful thought, planning, and a sound data migration strategy are the keys to a successful approach. These fundamentals will allow your organization to streamline its business process, training, and technology while realizing large savings and improving operational performance.

1"Best Practices Mitigate Data Migration Risks and Challenges," 9 December 2014, Ted Friedman, Gartner, Inc.