Striving for Operational Excellence is nothing new to both leaders and followers in the food industry. Still, given the industry’s unique characteristics, finding a way to accomplish it can be a difficult feat for a company.

Any food industry enterprise often finds itself at the mercy of global commodity markets. Once you account for other difficulties such as high demand variability and low margins, it becomes clear why achieving Operational Excellence is a challenge. However, there are ways to ensure both quality and Operational Excellence in the food industry. Here are the things you should keep in mind:

Optimizing Your Manufacturing Process

You can’t achieve Operational Excellence without having a firm hold on your manufacturing process, and that starts with controlling your data. The only way to optimize the process is through data collection and analysis — the more automated this process is, the better. To this end, do away with paper-based systems and digitize them instead. You’ll feel the positive impact of this change throughout your entire organization. There are plenty of benefits to enjoy, from making it easier to demonstrate compliance with quality standards, to being able to trace your metrics a lot more reliably.

Keeping Up with Compliance Standards

With digitizing your enterprise comes the ability to track your implementation of compliance standards. It is important because it gives you some useful insights into how you can improve the quality of your products. It’s always better to address compliance standards early on, instead of running afoul of them and having to correct course. It keeps customers happy and prevents possible financial consequences.

Becoming Able to Save the Day

In case of an unwanted event related to non-conformance to compliance standards, you need to be able to react quickly. Especially in the food industry, any product can become the victim of a quality issue. It leads to costly recalls and damaged brand reputation. To prevent this, you need to be able to catch compliance issues before they become a huge problem. With automated workflows that can manage compliance issues before they escalate, you can avoid the brunt of the blow.

Learning How You Affect the Environment

Another thing that could become a problem is the sustainability costs. If you wish to have a clear picture of how much your operations cost, you can’t forget to include sustainability costs when measuring your KPI. Once you have the data, you can analyze it to see if it’s possible to improve the efficiency of your manufacturing process by reducing some of the costs. Use sustainability information along with your general production data to truly understand its impact.

Implementing Enterprise Systems

The right tools can be of immense help in your quest to achieve Operational Excellence. Use them to create a lasting foundation for conducting all your processes and improving collaboration while breaking down the silos in your organization. Enterprise systems like ERP and QMS can integrate and synchronize all the systems and methods in your organization to create a single, strong value chain.

Here at Intellect, we have an out of the box eQMS solution that can help you do it. Let go of outdated processes and achieve Operational Excellence by driving success with collected data and automation.

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.

For businesses to keep up with the competition and respond to the change in consumer demand, they need to let go of outdated interfaces and practices. But before a company can make the digital transformation, it needs to decide how ready they are.

Beyond adapting to new IT systems and equipment, business culture will also be transformed. Not only will leadership need to establish a digital transformation strategy in relation to systems, process, and technology, but it needs to manage any resistance from employees who may worry about being replaced by new technology.

As you prepare for your digital transformation, alleviate the fears of your employees by empowering them with knowledge through updates and training. Your compliance team should also be involved in the early stages of your digital transformation to ensure alignment and keep all departments on the same digital page with regards to conducting business in full compliance with all laws and regulations.

In preparation for the transition, establish where your company is currently and what your goals are. You also have to determine if your organization has the resources and expertise to get you there. There are three main categories that your company is probably currently in:

Legacy system -  A legacy system refers to old method technology or an outdated computer system. These systems do not integrate with IoT. And without the ability to connect via IoT, a company with a legacy system will be out of sync with real-time operations. These systems will not be fit to meet the demands of today’s digital environment.

Web-enabled – While not ideal for digital transformations that are data-intensive, web-enabled platforms provide some data interaction. They also have a more user-friendly interface.

Digital ready – Your digital transformation will be hindered if your company doesn’t have a digital-ready culture. Digital-ready cultures are those that are highly innovative and whose decision-making is data-driven. If digital ideas and solution are your default option, then your organization has a digital-first mindset and are, therefore, digital ready.

In preparation for a digital transformation, your company must have a digital-ready culture and systems. One of the crucial first steps towards your digital transformation is deciding the right type of cloud that meets your company’s specific needs. Choosing between public, private, or hybrid will depend on your budget, scalability, and how much control you want to maintain.

You will also have some decisions to make on services within the cloud itself such as Software as a service (SaaS), Platform as a Service (PaaS) and Infrastructure as a Service (IaaS). Each comes with their own pros and cons.

The next step is data migration. It’s a chance for you to eliminate the unnecessary data that will only clutter your new systems, slowing down the migration process. Think of data migration as an opportunity to start fresh with only the relevant data you need. Remember that as you migrate to a completely new system, you need to rethink best practices. What worked in the past won’t be as effective.

Remember that adapting to your new system will not happen overnight and means developing a plan that will keep your business running as changes take place. As your company embraces digital transformation, leadership must champion the change to help align employees.

Operating a business in a government-regulated environment carries a high expectation of compliance and strict adherence to guidelines and policies. For companies that operate in the hyper-regulated scope of the Food and Drug Administration, software compliance is a top priority that must meet rigorously enforced standards.

There is no room for error in either medical or pharmaceutical software applications. The greatest concerns in each area focus on electronic recordkeeping and signatures (ERES) as mandated by Title 21 Part 11 of the Code of Federal Regulations.

WHO MUST COMPLY

Part 11 compliance applies primarily to medical device manufacturers and pharmaceutical companies. However, business operating in any of a number of life science product related industries must also ensure software compliance:

● Biotech and nanoscience companies

● Biologic and other drug developers

● Some cosmetic company applications

● Contract research organizations

There are few exceptions, but generally speaking, any company involved in the research, development, manufacture, or distribution of an FDA regulated product must be operating ERES software that complies with Part 11 guidelines.

FOCUSED ON RELIABILITY

Prior to cloud origination, digital conversion, and full-software integration, FDA regulated companies stored and submitted records in paper form. Hard-copy records carried a certain degree of reliability and trustworthiness necessary in the closely watched industry of medical and pharmaceutical development.

As technology advances, so have storage solutions and records. It is no longer efficient or economical to maintain volumes of paper when digital storage and filing are industry-wide norms. Twenty years ago, the FDA implemented Part 11 as part of an effort to standardize and regulate the quality, reliability, and trustworthiness of non-paper records, signatures, and filings with the agency.

Since the implementation of Part 11, software regulations have become an integral part of compliance issues and guidelines. When any company generates reports and signs off electronically, and submits digital documents to the FDA, it must comply with Part 11 regulations. Any software application used in the process must meet strict requirements.

SOFTWARE REQUIREMENTS

The FDA mandates a wide-range of complex and technical software requirements that individual companies must meet to comply with Part 11 rules. Since the accuracy and reliability of ERES data is the key focus of FDA concerns, software must include:

● Some validation process to ensure accuracy and identify altered or invalid records

● The ability to generate complete copies in various forms

● Security controls to limit access to authorized users

● Long-term storage and retrieval

● Appropriate training and tracking of electronic signature use

● Time and date stamped audit trails

In addition to these compliance requirements, companies must also have written policies regarding the use, control, and authorization of ERES systems among other strictly applied security and authenticity issues.

As technologies change and become obsolete more quickly, companies experience regular software issues and compliance questions. When evaluating software compliance, a good rule of thumb is for companies to exercise Part 11 software practices in any instance where records meet Part 11 definitions.

If your company’s software is out of date, lacks security and verification assurances, or has other compliance issues, it is time to find a solution. Ensure your company’s systems meet the latest Part 11 iterations and do not risk FDA sanctions because of a failed software audit.

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. 

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.

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

Most mid-size and larger companies have already implemented compliance software, but it’s not uncommon for others to attempt to keep up with compliance manually or even with paper-based processes. With Sarbanes Oxley and ACA compliance becoming more regulated each year, increased accountability and visibility through all levels of management is mandatory for business.  GSA Compliance is as important. For example, if GSA finds an organization in non-compliance, auditors can suspend a contract while they determine debarment. Sarbanes-Oxley is about tracing and tracking information back to source business applications that generated the actual data. Process management, auditing functionality, cost analysis and reporting are required for any compliance based products. Documentation support and records management are other benefits that must be considered for proper compliance in any department.

The simplest solution to avoid any of these pitfalls is a compliance software or platform that can eliminate risk. A compliance assistance software integrated with an ERP or accounting system allows analysis of all source data. Intellect’s Accelerate Platform is a best-of-breed compliance assistance product that integrates with existing application program interfaces (APIs). With a compliance Platform as a Service (PaaS) all systems can seamlessly assemble information from a variety of databases to ensure compliance objectives are met.

Some benefits of compliance software is as follows:

• Automated management reporting overdue tasks.
• Real-time performance feedback to management.
• Automatic cross-referencing of processes, resources and activities.
• System reviews in workflow processes.
• Risk assessment and JSA activities on tasks.
• Records filtering with archived data.
• Interactive tools for troubleshooting root causes.
• Governance module for business planning to ensure proper outcomes.
• Integrating ISO31000 level proactive risk management.
• Cross referencing of documents to legislation, resources, historical activity, etc.

Managing and enforcing policy and procedures for compliance is a long-term objective and has many benefits. Reacting quickly to changes in law, enforcement actions and external events are immediate with compliance software. Creating a continuous state of readiness for audits, surveys and exams and increasing accountability and management visibility into compliance status are easily regulated with the right PaaS.  Decreasing labor intensive processes and documentation and enforcing standards and consistency throughout organizations are specific duties that can be tackled once compliance ready software is implemented. This also helps with streamlining internal audits into areas of high risk of non-compliance. Many organizations concur that by utilizing compliance software, the ROI is immediate, as is the peace of mind that comes with it. 

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