Among the factors that affect how quickly a business will grow; one of the most important ones is undoubtedly efficiency. For example, there is a clear difference between companies that use paper-based processes and those that are entirely digital. To improve business, you need to have a streamlined process that ensures quality, and that is also easy to use at the same time.

One solution for improving your business process management is undoubtedly using workflows. An effective workflow helps you grow your business by providing the framework through which all tasks are done. Let’s have a look at what right workflow solutions can do for a company and how they are used in quality management systems.

What Is a Workflow?

Simply put, a workflow is the way employees get work done. It’s usually presented as a diagram or checklist containing a series of tasks that need to be completed sequentially. A workflow can be as complicated or as simple as you make it, but its purpose is to make work easier. Once all the tasks are laid out in a visually engaging manner, employees can go through them and check them off one by one.

It also allows managers to oversee the work process in real time. Workflows make it possible for managers to be notified of any delays as well, and with them, it’s easier to ensure every employee is following the company standards of work.

The Impact of Workflow Automation

Businesses that implement workflow automation gain the clear insight into the work process itself. That can have an instant and noticeable impact on the organization’s efficiency. The best part is that once automation is set up and all the roles, approvals, decisions and steps are defined, there’s no need to spend time setting up new workflows each time. In case of the process change, you can update the workflow to reflect the changes with a few clicks.

Business Improvements Brought on by Workflows

The benefits of gaining better insight into your organization’s business process management and making it streamlined are numerous. Employees will work faster as it will be easier to manage the inevitable delays and roadblocks. It’s going to make the collaboration of multiple people on a project much less stressful. All of this directly influences the overall performance of an organization. It also improves your quality management process, as some QMS solutions have automated workflow features.

Benefits of a QMS Solution with Workflow Automation

A QMS solution is a powerful tool since it can ensure business optimization through quality improvements and saving costs. However, an out of the box QMS solution that also incorporates workflow automation in modules such as Doc Control and CAPA can make all the difference when it comes to improving your business’ efficiency. With Intellect’s QMS solution, you don’t have to develop your workflow, although it’s an option — you can use existing ones or customize them.

Visit our website for more information about Intellect’s QMS solutions and how they help you streamline your business management process to improve your business.

For compliance managers in any industry, it’s imperative to provide tools and practices for a company-wide commitment to quality. Whether the industry is construction, government, education, healthcare or manufacturing, there are usually plenty of different compliance regulations to meet.

In that kind of a corporate climate, being as efficient as possible at ensuring compliance can be a significant time-saver. Not only that, but efficiency at implementing some of the necessary compliance solutions can ensure that human error has been reduced to a minimum. And in today’s environment of technological advancement, efficiency is often the synonym for automation.

Automating compliance processes is something any company can benefit from, regardless of the industry. Still, automation is beneficial for those organizations that need to comply with ISO and FDA quality standards. Let’s have a look at three compliance issues that can be solved by automation:

Staying on Track with Quality Objectives

Automation of quality management doesn’t only mean that it will be easier to complete compliance and quality management processes in the technical sense. It also helps everyone in the organization be aware of the organization-wide quality objectives. Losing sight of them makes for inconsistent employee performance, and the organization might fail at building a culture around compliance and quality.

Since quality standards and goals are visible to everyone in an automated system, it makes it easier for the employees to meet them. And, in the case of collaboration with external teams, it ensures that the same quality standards will apply to them.

Corrective And Preventive Actions (CAPA)

CAPA is an integral part of any automated QMS, and it’s crucial to staying within compliance standards. In case of any undesirable events, the CAPA can help identify its cause. After that, it’s only a matter of prevention and coming up with a plan that won’t let it happen again. A procedure that helps set everything back on track is necessary. By having an automated solution that handles it, everyone in the organization will be aware of how best to handle any unwanted situation and resolve it quickly.

Document Control

An automated system creates a centralized hub for all organization-related activity. And when it comes to daily functions of an organization, document control is one of the most critical processes. Without a well-organized document control system, you’re inviting chaos into your organization (and most likely inspection as well.) Since FDA-regulated and ISO-certified companies are required to have a document control system, it’s clear to see how problems in this area can affect the whole company. Keeping up with audits and making sure that all necessary documents are created, stored and shared according to the company’s quality standards helps maintain a team that’s more accountable and informed. Therefore, automating document control can significantly improve an organization, not only with compliance but with the day-to-day operation as well.

Today’s business revolves around complex rules and regulations. To ignore any of them is a fatal mistake, but to comply most efficiently, you need a staunch ally. An automated compliance solution that can meet your company’s unique needs could be the difference between success and failure.

With Intellect’s QMS solution, you don’t have to develop your workflow unless you want to customize the existing ones. It works out of the box and makes sure you have an easy time automating your organization’s quality management and compliance processes.

All companies, regardless of industry, are responsible for ensuring that their policies and processes are designed to comply with applicable laws and regulations. Because of the complexities of regulations and requirements, many companies struggle to secure compliance.

Companies who compliment their efforts with technology have found that staying compliant has become far less challenging. In the past, businesses had no choice but to rely on Excel sheets and Word docs to keep track of all their people and processes. It meant exchanging numerous emails and risking communications getting lost. Innovative software means the end to duplicate reporting and copying data repeatedly.

These centralized technology tools meant having confidence in your compliance and meeting regulatory requirements. Compliance workflow automation gives you the ability to audit multiple tasks into one process and schedule these processes to run on a regular basis automatically.

While the technology has been revolutionary, it still doesn’t relieve compliance teams of monitoring people, processes, and anyone else who must meet compliance obligations.

One of the crucial steps to ensuring compliance is streamlining workflows to ensure that only employees who should have access to specific data have relevant access. The purpose of a workflow is to divide processes into smaller steps which are passed to different people with the company.

Because of the multiple exchange of hands in documents, there could be numerous submissions for review and need for amendments. All the necessary steps should be taken into account and control processes must be enforced, and verification of information should be ensured.

Here are some tips track and monitor workflows to ensure that they achieve compliance, and nothing is overlooked or goes missing:

1. Identify Legal Obligations

What are all the compliance obligations and how do they impact your business? Once you have identified what these are, interpret them into specific compliance requirement statements.

Each of these requirements should be organized according to underlying regulations and codes along with common requirements such as policy development and monitoring requirements.

2. List All Parties Subject to Audits

List everyone who will be held responsible for meeting compliance obligations; this includes people, vendors, 3rd parties, sites, and processes. Because this will likely be a comprehensive list, be sure to organize them in department folders.

3. Evaluate Level of Risk

It’s impossible to monitor every aspect of your business at all times; instead of attempting to do so, focus your attention on where risk is highest. Identify who you would consider as compliance risks to your business based on criteria that evaluate the levels of risk.

4. Determine of Level of Attention

Set up your system to conduct audits regularly. Audit frequency should be established based on the level of risk. For obvious reasons, high-risk people, processes, and parties should be audited more frequently than those that are considered as low-level risks.

While the right software can help you achieve workflow compliance, the reality is that your employees are the risk that you will have the least control over. To become fully compliant, it’s important to not only streamline your processes and systems but also regularly review your people.

We had the pleasure to work with one of the largest food safety and quality services providers in the world. The company is known for working with clients as a trusted partner to promote public health through analysis, consulting, auditing, training, contract research, and sensory analysis services, through a network of global laboratories.

The Challenge

The multilingual global company needed a way to address and improve non-conformance response, customer complaint response, and compliance which included approvals, and documentation with Oracle CRM. The solution has to be multilingual to accommodate all their labs worldwide.

The company needed an effective solution to capture, track and maintain accurate, auditable non-conformance records through a centralized database. They wanted to streamline the process for identifying, evaluating, reviewing, and handling nonconforming parts, materials, and products and view any aspect of their workflow for complete transparency and reporting.

They also wanted to streamline customer complaints management to improve product quality and safety, decreases audit time, lower risk, and ensure FDA and ISO compliance.

The Solution

To address non-conformance, the company used Intellect’s NCM solution to create, track, and maintain accurate, auditable conformance records to ensure compliance with all management records. The “Quality Tools” app for non-conformance, customer complaints and corrective and preventive actions (CAPA) was configured to meet their exact business processes in 3 months. Employees are now assigned and notified of follow-up tasks to ensure accountability, automated email notifications and reminders.

In addition, Intellect managed their customer complaints by tracking the intake of customer complaints through investigations and CAPAs which enables continued improvement. The easy-to-use solution works on any device. Record incidents were centralized to facilitate investigations, report results better, and close cases. With Intellect’s Complaints Management, they improved communications with customers by acknowledging, tracking, and implementing any requirements that resulted in improved product quality and reduction in product recalls, ensuring compliance.

The solution met their multilingual requirements and was available to users in 8 languages, English, French, Spanish, Italian, Polish, Portuguese, Turkish and Mandarin.

The Results

The results were improved visibility to common issues for better resolution. Response time to customers on issues was improved. Internal audit tracking was overhauled resulting in reduced audits by 25%. ROI was achieved in less than 6 months. Overall, shared knowledge across the company was increased which ultimately provided considerable annual savings.

Managing workflow in any business or industry can be like trying to tame an octopus with its many tentacles, especially in today’s tech-centric production lines. However, effective workflow management and planning can do more than lead to efficiency and cost savings. It can also increase the success of data gathering and analysis in across the board quality management systems including CAPA and Document Control.

By keeping the right people in the loop and informed though a transition to digital workflow, your management team can improve information sharing and communication. Effective workflow management stems from a variety of practices and technological inclusions that replace older practices not designed to keep up with today’s rapidly changing business environments.

Get Back On Track Quickly

No business functions without quality and improvement. Systems like CAPA and Document Control benefit from improved workflow because information is disseminated, returned, and processed more quickly and accurately. When CAPA practices detect a regulatory anomaly on a pharmaceutical or medical device production line, efficient workflow enables a rapid correction to ensure a near instantaneous return to compliance.

Efficient workflow management reduces communication discrepancies and lags that may lead to production disruptions. When companies increase the reliability of delivered information and corrective planning and action, they reduce down time and the traditional non-digital evaluation period between a business process interruption and return to service.

Communicate Effectively with Team Members

One obstacle facing production businesses, especially those operating in remote and multiple sites, is ensuring that all team members have the latest and most accurate information regarding a company goal, directive, case management, or other time-sensitive communication. Information delivery provides feedback that leads to productivity, solutions, and drives quality control and customer satisfaction. A lack of shared information results in policy and procedural breakdowns that impair quality output and other business processes.

With employees working off-site, separate from management and quality control teams, the simultaneous delivery of information and management decisions ensures that your entire team functions as a unit. Some examples of synchronized information delivery accomplished through increased workflow management include:

• Regulatory issues and updates
• Workload assignments
• Customer feedback
• Task notices and deadlines adjustments

When every member of your team receives the same information, it eliminates the occasional system-wide hiccups that interrupt quality management, production, and output. Synchronized digital delivery eliminates the redundancy of paper copies and the need to file documents at a number of locations and offices when a single cloud-based alternative serves multiple recipients.

Keep Teams on the Same Digital Page

When a business relies on compliance and regulatory issues — such as FDA directives codified at the ubiquitous 21 CFR — every member of the quality control team needs the same up-to-date information at their fingertips. Communication among management personnel relies on integrated and autonomous workflow that includes delivery to key personnel who are aware of assigned tasks and problem solving procedures.

Effective business process management demands on-the-fly delivery, communication, and tasking. When a quality issue arises, you cannot afford to have team members thumbing through outdated manuals and regulations or not knowing their position in the QMS flow.

For businesses focused on strict regulatory compliance to critical standards, workflow management assures heightened responsiveness and effective quality performance. Eliminate lag times, outdated documents, and interactive missteps with an out-of-the-box QMS solution that incorporates workflow in both CAPA and Document Control modules. Should you wish to develop your workflow by customizing these modules or creating new ones, this is an ideal solution for your business.

In my previous post, “Workflow Automation Can Be Scary!”, I outlined how workflow automation can be scary to many employees, as it creates uncertainty, introduces transparency and takes away control.  In this post, I will explain three well established strategies that will help address each of these concerns. 

1. Listening is key to managing the fear of uncertainty

Management has to invest the time to listen to everyone’s concerns.  Often times, the concerned employees just want to be heard, understood and feel like their concerns were taken seriously.  This can also provide key information that will be helpful in the design and implementation of the process.  It may be that adding a certain report or business rule is all it takes to alleviate some of the concerns, and it may also improve the workflow process when automated.  In addition, by listening, management can uncover and address some of the hidden concerns which may be less about the automation itself, and more about the reasons for it, i.e. will they lose their jobs. It is amazing how many problems can be avoided by simply listening.

2. Communicating the benefits is key to addressing the concerns around transparency

Transparency can stir fears in employees that they are distrusted and will be monitored by management after the automation.  It’s very important to address this by highlighting the many major benefits that transparency and visibility  provide to all employees in the process, not just to the organization. Some of these major benefits include: 

Saving time: Rather than employees spending their time chasing people and paper forms or searching through emails to get status information, a well implemented workflow automation project will provide key dashboards and reports that let everyone know the status of each process.

Providing peace of mind: A typical workflow system will send alerts and reminders to each person when their part is due.  This streamlines the workflow and increases peace of mind when running these processes.  The employee is no longer concerned that they may have forgotten to complete a task as the workflow platform keeps them alerted throughout.

Reducing frustration: Often times, the processes that are being automated are causing a lot of frustrations to many people.  Automation will improve their work life quality, and eliminate wasted time and rework due to mistakes.

Increasing productivity:  The goal for automation is to free up employees’ time to focus on higher value work rather than shuffling paper or manual processes that don’t add value.  They are able to be more innovative and produce more with less manual effort.

By communicating often and clearly the benefits of transparency and visibility from workflow automation, fear and distrust can be turned into anticipation and excitement.

3. Turn process owners into change agents to address fears around loss of control

Process owners can provide a lot of critical insight into the culture, uniqueness of the processes and skillset of the employees who will need to change.  Their resistance to change can be reduced greatly by listening to them, valuing their input and experience, and leaning on them early on in the implementation and even in the platform selection process.  They can provide valuable information that can influence the selection of the workflow solution as well as the design and architecture of the implementation.  By involving the process owners in the design process, their fear and uncertainty turns to pride and security, as they become the thought leaders, owners of the new automated process and designers of the system.  They will then turn into champions and change agents in the organization, helping with training and adoption of the system.

In conclusion, cultural resistance is one of the biggest obstacles to a successful workflow automation project.  Organizations who address this obstacle early on and directly with the strategies listed in this article will improve greatly their chances of project success. A well implemented and adopted workflow automation project will quickly become a success story given all the benefits and time savings it provides for everyone.  Within a few weeks of launch, most people will find it hard to imagine, or even remember, that they were running the process any other way.

If you’d like to learn more and create a Proof of Concept app with Intellect, click here for a free trial. http://www.intellect.com/free-trial

Many business are considering a workflow management system for their internal processes. The paperwork and emails are no longer manageable and with compliance and competitors to deal with, organizations are at a critical mass point in time, having to automate business processes. So the research begins on Google, and the amount of products is overwhelming. There are enterprise solutions, custom built apps, off-the-shelf software, and just about anything in between. But what is best, and what provides the most effective cost savings?

For the Fortune 500, most go with an enterprise solution that is built to spec. For mid-market organizations there are more choices. Many use off-the-shelf solutions for different departments. Some use custom built solutions and others like to configure drag and drop solutions themselves. This is a cost effective choice, as it doesn’t require programming. The key is to find out what the use-case is, determine if will it need to be changed or evolve with the business in the future, and what level of customization is needed for the software to be effective. This is probably the most confusing part of choosing a software provider for workflow management, forms automation, or document management. In considering budget and pricing off-the-shelf is cheaper, but will that translate to cost savings in the future?

Off-the-shelf software is a great choice as an immediate fix that will probably do 75% of what is needed.  But this is merely a Band-Aid in many cases as the 25% that remains will need to be customized for the organization to realize the full potential of the process. Spending a small percentage more on a drag and drop platform that users can configure themselves is a better choice, if there is staff on hand that has the time to build. The benefit here is that the workflow can be configured to the organizations exact specs because the specs are best known by the staff that will configure. And with this intimate knowledge of the internal process, evolution is possible and greater efficiencies are created. There are similarities on every organizational workflow, but as a rule no two are alike.

Probably the quickest solution would be a custom built platform configured by experts in the industry. Intellect’s Accelerate Platform and Professional Services Team can build very complex systems in a short amount of time. The cost is certainly more than an off-the-shelf product, or even and drag and drop solution, but the speed in delivery is often the deciding factor.  Most systems can be built, tested and launched in less than 60 days and changes are made as the organization evolves and grows. With these modern systems, expect them to be mobile ready, cloud based, and user friendly with an immediately recognized time savings. ROI’s are often realized within 6 months to 1 year.

In conclusion, when researching a workflow management system here’s a rule of thumb; off-the-shelf is an affordable quick fix, drag and drop is fully customizable and a bit pricier, and custom built is the best choice for speed, accuracy and delivery. If one considers the full life cycle of a custom built solution, the cost and time savings and efficiencies gained will outweigh any other product.

If you’d like to learn more and create a Proof of Concept app with Intellect, click here for a free trial. http://www.intellect.com/free-trial

Many companies are using business process management platforms to automate internal workflows that streamline their processes, increase regulatory compliance and digitize forms. From a business perspective, automation saves money and time, reduces training costs and lead times, and ensures a consistent experience for customers and employees.  This should be common sense for everyone in the organization, however, for many employees, workflow automation means change, and change can be very scary. 

Companies develop their culture and processes over many years and they become ingrained in people, policies and habits.  Thus, changing culture and processes is one of the most difficult challenges to overcome, especially when transitioning from manual processes to automated ones.  Most employees are afraid of change for three main reasons: Workflow automation brings uncertainty, creates transparency, and takes away control.

Workflow automation creates uncertainty:

Change always creates uncertainty in companies, and especially when the change is due to automation.  Is the automation intended to replace jobs with the software?  Or perhaps the automation is intended to cut costs and therefore it’s an indication that the company may be facing financial difficulties.  Could that mean layoffs are next?  This real concern causes employees to feel uncertain about their jobs and livelihood.  As it is often said, people are creatures of habit, and the status quo always feels safer, easier and better.

Workflow automation introduces transparency:

Most of the time, manual processes run slowly, not due to the process steps, but due to the friction involved in the workflow steps passing from person to person or from entering data multiple times in different systems.  That creates delays.  Some delays are unintentional (i.e. “the email went to my spam”, or “the file was under a pile of papers on my desk”, or “I had to rekey the data 3 times”), while others can be intentional (i.e. “I am going to wait on processing this so that I don’t get assigned too many”).  In any case, transparency eliminates all of the delays.  When a workflow is automated, everyone can see where the process is at, how long it has been with someone and when they were notified. In addition, real time reports can compare how long steps take to complete based on role or function. These benefits eliminate the ability for someone to hide behind excuses for not completing their job.  In addition, there is no need to re-enter data in different systems as the workflow can be integrated and send the data automatically which eliminates human error.  Transparency can make some employees nervous as they can no longer hide behind and blame the inefficiencies of a manual process.  Everything is visible and transparent.

Workflow automation takes away control:

Many long term employees at companies develop institutional knowledge over time, and when a process is manual, their input and knowledge is critical to ensuring the successful completion of the workflow.  Some people feel a sense of entitlement, power and security, if they are the only ones who understand the process and can ensure it is executed correctly.  As such, they feel they are in control over situations or can exert control when needed, given they are the experts and no one can challenge them and everyone needs their help.  When automation is introduced however, the goal is to codify the institutional knowledge into the system process rules, templates and workflow.  Those who felt safe in their positions due to the knowledge that only they possessed, now face the reality that they will no longer be needed to run the process.   Automation takes control away from an individual as the process becomes institutionalized in the platform and it guides everyone on how to complete it successfully.

In a follow up post, we will discuss and share best practices and strategies that will help overcome these fears and increase substantially the adoption of workflow automation. If you’d like to learn more and create a Proof of Concept app with Intellect, click here for a free trial. http://www.intellect.com/free-trial