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.

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.

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.

Workflow Modeling and Automation

A core feature of Business Process Management is Workflow Automation.  This feature enables companies to describe their business process in a block diagram view, definding the flows, the roles, the activities, and business rules.  And once defined, the Business Process Management (BPM) Platform can automate and execute this workflow, notifying users when they are required to complete a task, providing them the information they need in context to complete the work, reminding them if they are late and keeping them up to date on the overall process status.  Managers can oversee the process in real time and be notified of any delays, audit the history and decisions that were made and ensure that everyone is following the company standard.

An Example Document Workflow

The diagram above represents a document control workflow indicating the path the document followed, colored in green, to completion.

Most of the core processes in Quality Management Systems require workflow.  Document control is an obvious process where there are mutliple people collaborating together on the authoring, reviewing and approving of a document.  Workflow Modeling capability enables you to model your company's document control process, specifying all the roles, steps, rules, approvals, and decisions.  They system will then execute the workflow everytime a new document is created or is selected to be updated.  

One of the key advantages of this capability, as can be seen above, is a realtime view on the status of each document: where is it, who has it, how long has someone been reviewing it, was it approved or rejected, an so on.  A detailed and complete audit trail provides all the historical information necessary to pass any inspection or audit and to meet compliance with all ISO and 21 CFR standards.

In addition, the workflow model is defined by the company to meet their unique process needs. If the process changes, the modeler allows the company to very quickly update the workflow model so that it reflects the new process.  No programming or speciall skill sets are required.  Just an understanding of the company process and simple drag and drop.

Workflow capability is a very powerful feature to have in your QMS system.  Not only will it help you enforce your own unique company process, it also ensures everyone is following the right process, with full auditable history and visibility.

Do you have a Workflow Modeling feature in your QMS? Sign up today for a demo to see the power of Workflow + QMS. 

After the advent of electronic record keeping and digitized business processes, the natural evolution for companies was to support electronic signatures.  The technological requirements to support this feature have been around for some time but the laws and regulations had to catch up.  Today, electronic signatures are very common and legally accepted in numerous industries to meet a wide variety of use cases and regulations. There are also many online signature tools like DocuSign and Adobe Sign (formerly EchoSign) that have become standard for applications in real estate, contracts, and insurance transactions.

Given the flexibility in interpretation of the applicable laws and regulations, there are many ways for business software systems to support electronic signatures.  Here are a few of the requirements you should consider when evaluating software options:

1. Association

Is the electronic signature associated with the specific electronic record or document that is being reviewed?  There has to be a technological and auditable way to link the electronic signature to the record.  This can be accomplished by taking a snapshot of the record when digitally signed and associating that snapshot with the signature.  It can also be accomplished by encoding the signature and other parameters to the specific document, i.e., inside the PDF or Word document itself.

2. Authentication

How do you ensure that the user digitally signing is authenticated? This can be accomplished in a number of ways.  Some systems rely on the user simply being logged in as a form of authentication and when digitally signing, the assumption is that it is the same person.  However, more stringent regulations like the FDA’s 21 CFR Part 11 require more verification that the user digitally signing is the same person and this can be accomplished by requiring the user to enter their password again at the point of digital signature to ensure authentication.  Some systems go further and require that the user maintain two separate signatures, one for the logging into the system and another for signing.

3. Auditability

How do you track and maintain a historical record of the electronic signature? Many systems provide a full historical trail of who signed the document or record and when it was signed.  Given the nature of electronic data and that it can be changed, some go further and track the exact information that was signed off on at the time of signature, so there is an exact record of what exactly was reviewed, even if the data changed later on.

Electronic signatures are critical for meeting compliance and for a comprehensive Quality Management System (QMS), among many others. In the not too distant future, electronic signatures will permeate all aspects of our lives.  I am sure the technology will evolve further and leverage other types of authentication and means of signature that we haven’t conceived of yet.

It is surprising how many companies today are solving their need to customize their Quality Management Software by modifying source code.  It is understandable why a company may want to customize a software to meet its unique business and quality processes.  However, software platforms have evolved so much that there shouldn't be a need to change or add code to the vendor platform.  Not only does this require expensive development skills and expertise, it also means that the company can no longer receive vendor upgrades to their platforms as they have branched out with their own custom solutions.

Intellect has built a full Quality Management suite on our award winning Business Process Management (BPM) platform, Intellect Accelerate, to solve this problem and provide many additional benefits.

1. Below are just 5 of the many benefits of working with Intellect:

1. 1. BPM Platform with No Coding Required

2. BPM platforms are designed to enable companies to automate any business process. In addition, they are designed to enable constant changes to those processes. However, the process of automating a business process on a BPM platform does not require programming.  It is a drag and drop environment designed for business analysts and process owners. It enables them to control and make all the changes they want. They don’t have to rely on the vendor.

4. 2. QMS Suite with Incredible Flexibility

5. Intellect Accelerate is available with an out of the box QMS solution that includes all the core modules like Nonconformance Management (NCM), Corrective and Preventive Actions (CAPA), Document Control, Change Management, Audit, Training, Supplier Management and Risk Management.  But being built on a BPM platform means every one of these processes can be modified by the company to fit their unique needs and process requirements.  Companies can add, remove or modify data fields, change business rules, change the workflow model, create custom reports and dashboards, modify security settings and on and on.  All this can be performed quickly and through simple drag and drop, without programming or modifying source code.

6. 3. Automate Much More Than Just QMS

7. With Intellect Accelerate, you are not limited to just the QMS processes.  The platform enables automation of any business process.  This means you can expand and automate other processes like Customer Complaints and Returns, Project Management, Time Tracking, Expense Reporting, Capital Expenditures, HR onboarding, Employee Lifecycle Management, Inventory, Asset Tracking, Bug Tracking, Issue Management, Incident Reporting, Work Management and many others.

8. 4. Always Access the Latest Release

9. Despite all the configuration changes you make to the processes or additional processes you automate, you can always upgrade to the latest release, and get the latest platform tools, enhancements and bug fixes. You are not stuck with an outdated custom solution that can no longer benefit from vendor innovations because you have modified source code.  BPM is designed with the expectation that each company will configure its own unique processes and make changes to them.

10. 5. Advanced Workflow

11. BPM includes a core feature which is critical for compliance and audits – workflow management.  With workflow, you can model your process flows, assign roles and requirements, and easily track each process with status indicators, reminders, notification, escalations, reports and full audit trails. In addition, you can easily modify the workflow as your process changes and evolves over time.

12. The days of customizing source code to modify quality processes to fit a company's needs are numbered.  Sign up today for a demo to see how easy it is to use and modify the quality processes built on Intellect Accelerate.

Managing NonConformance (NCM) is an integral part of an organization’s continual improvement plan. Intellect’s QMS Platform enables organizations to capture, track and maintain accurate, auditable nonconformance records through a centralized database to have transparency for departments, sites, or locations. This allows organizations the ability to exceed audit, nonconformance, and corrective and preventive action requirements of common standards including ISO 9001, ISO 14001 and OHSAS 18001.

Complaints Management software is needed for customer retention, compliance with industry regulations and avoidance of potential product liability lawsuits. Quality, compliance, safety, efficiency, and costs are impacted in addition to poor communication without a proper QMS in place. Intellect QMS includes change management, automation, version control, and workflows to communicate, acknowledge, and then implement any requirements.

Change Management software is imperative for closed-loop quality and requires automation, version control, and workflows. Intellect QMS integrates with any enterprise system, so full transparency is included in the change management process. The submission of change requests and control plan revisions can be included at any point in production.

CAPA (Corrective and Preventive Action) and product registration tracking are standard features to allow implementation of corrective and preventive actions. This will meet compliance with industry regulations including GMP, ISO 9001 and 14001, TSCA, REACH, etc. CAPA process workflows provide a controlled environment and reduce the risk of repeat issues by ensuring that defined CAPA solutions and processes are met.

Document Control/management organizes all documents into a centralized database with approval workflows and audit trails. This eliminates document redundancy, reduces the risk of manufacturing products with out of date SOPs, and creates efficiency in organizing documents.

Supplier Quality Management manages the process of qualifying, selecting, and monitoring suppliers and supply chain partners. Other requirements are supplier qualification workflows and tracking systems for supplier non-conformances and CAPA. Intellect QMS offers the flexibility and configurability to adapt to company specific business processes, requirements and needs. This allows organizations to define, track, manage, and report actions.

Audit Software reduces risk by enforcing consistent and harmonized processes while securely managing all information in a centralized system. In addition, it facilitates compliance with global government regulations and industry standards providing management the data needed to evaluate audit system effectiveness. It also provides auditors authoring tools required in the field.

Employee Training Software creates a single interface to develop and manage training initiatives organizationally. This allows enterprises to maintain a complete inventory of employee education levels, job descriptions and certification records. This will maximize the effectiveness of developing employee skills internally. Intellect QMS keeps employee certifications up-to-date as a full employee life-cycle enterprise management system.

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

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

In talking to many customers that are researching a business process management or workflow management solution, I’ve compiled a list in no particular order, of top preferences. I have set price aside as there are vast differences in cost for off-the-shelf solutions and dedicated platforms and SaaS products. Below, I have listed the top 6 requests that most organizations will discuss early on when researching new products.

UI Design. Some people just call this the “skin.” It’s the look and feel of the product and its your first reaction to the quality and user friendliness of a PaaS or a workflow solution. If it looks too old or outdated, it will work for some companies, but for others, it will not even be considered.  Adoption is proven higher with better looking UI’s as they are more enjoyable on a subconscious level to work with. Colors, simple navigation, charts and graphs, reminders, company logos and other choices are all key in decision making.

A Flexible Platform. For most companies, a platform is needed that will be flexible and have many uses. Certainly some organizations will choose a product that has one specific function, but that will only suffice for a year or two until additional inefficiencies are discovered in multiple workflows. A platform that can bridge departments and connect with legacy applications is required for most mid-market and large companies. It also needs to pass the IT depts. scrutiny while being simple enough for business analysts to configure and for end users to use.

Mobile and Cloud Based. Most mid-market and large organizations are moving to cloud based architecture and look for mobile availability. Cloud application users have little to no maintenance and can allow access to anyone that has user rights.  Mobile apps are the standard now and many mid-market companies have CRM’s and external apps that allow easy access to clients. This is very popular in banking and retail businesses. Eventually most businesses will have some cloud-based solutions and mobile availability. 

Ability to Grow with Organization. Because all businesses expect to grow, a platform is needed that can scale at the same rate.  There are many functions, added tasks, departments and staff that will increase the load that is required of a workflow automation platform. The ability to make changes without the use of programmers or coding is a deciding factor for many.  Intellect’s Accelerate Platform with its no-code drag and drop technology is an example of a PaaS that can grow to any size.  

Speed in Delivery. Most businesses need to get up and running quickly. Nobody wants to spend months configuring, building, integrating and implementing. The reality is most of these tasks take time and it can be 3 to 6 months. With no programming and a team of business analysts configuring workflow apps, launching can happen in under 2 months. If the apps are built by Intellect’s Professional Services team, launching can happen sooner.  

Excellent Customer Service. This is a popular request for many companies. Its important that the platform vendor chosen is available and ready to help in all phases of designing, testing, integration and launch. After the product is launched, its also important to have a customer service team that is available to fix any bugs or problems. A PaaS provider that works with you for the complete lifecycle of the application will be a critical part of the success of the 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