Supply chain risk, as well as business risk in general, come in many shapes and forms. The risk comes from the most basic everyday processes to some extraordinary circumstances that are often hardly identified.

With all of that being the case, organizations have found several different ways of managing risk, especially in the supply chain. To stay afloat and competitive in the market of the modern world, you need to have an excellent strategy to manage risk. Let’s take a look at some of the ways risk is managed.

The Change Management Process

The change management process should include the suppliers, because this way, you are making sure that they are notified of any change in the design phase. It means that the suppliers can always ensure that their components conform to the new design and are thus able to control the potential risks.

In essence, by doing this, you are making sure that your finished product has factored in both the supplier components and the production process, to ensure quality and reducing potential risks.

Supplier Performance Management

The accountability factor is the main obstacle to the quality in the supply chain. The suppliers have their standards, but if they can’t see your system, they cannot know how you’re rating them.

By having a proper supplier rating system that’s also tied to risk-based methods, you will ensure that your business truly measures the supplier’s performance. It will allow the supplier to see the ratings and they will then improve upon their quality if the grades are not good enough in their eyes. Every supplier wants to improve their quality and be the leading supplier to other organizations, so you can be confident that the rating will affect them.

Out-of-Specification and Non-conformance Management

Often, it can be the case that the components are out of specification. Usually, the business deals with the issue, inform the supplier and moves on. However, by automatically generating nonconformance and advising the supplier of what exactly is out of specification, you are ensuring that there is better collaboration involved.

All of this in effect ensures that both risk and severity of the said risk is reduced.

Corrective Actions

When it comes to managing any systemic issues in the supply chain, the corrective action process is your best solution, because it’s essential that there is a collaborative process that allows the supplier to finish some part of the corrective action.

In essence, it ensures that you are consistently able to improve the finished product, as well as allow the supplier to upgrade the components which are part of that same product.

The Post-Market Reaction

After the product is released, post-market feedback is inevitable. Complaints and a lot more are always a big part of this. If you want to respond to all this feedback adequately, it’s vital that you have all the information about the product. If the supplier is involved all the time, you will have additional information from the supplier as well. It, in turn, allows for better handling of the post-market.

Supply chain risk can effectively be managed with most of the techniques explained here, however, if you want entirely effective risk management that involves all of what we described here, an out of the box QMS solution is your best option. It is because the risk is no longer an isolated part of the Quality Management System, but more a feature of it.

In many industries, companies seek to improve their manufacturing and product development and have to go through many regulatory reforms to do so. They require them to adopt quality systems standards which reduce risk.

Clinical laboratories don’t find themselves often in front of similar legal challenges because patients are required to give written consent, and acknowledge that their therapy involves a certain level of clinical risk. Still, risk management in a laboratory environment has become necessary due to the evolution of quality systems requirements. For best risk management in laboratories, consider these practices:

Risk Identification

Testing and quality activities conducted in laboratories have documented vulnerabilities. The most common causes of error are in the pre-preanalytical and post-analytical phases of the testing process.

These include possible errors with order entries, various sample collection errors and inappropriate handling or storage, as well as incorrect interpretation or delayed reaction to laboratory reporting. Laboratories can sometimes struggle to implement even the subtlest changes in policy or practice because it makes the overall performance prone to failures. It’s essential to identify risks in a lab’s testing process and work on preventing them. Laboratories usually deal with this through a traditionally-oriented QC approach, but that’s not always effective.

Quality Management System for Laboratories

Laboratories aren’t free from having to address all aspects of a corporate quality management system. It’s necessary for them to maintain standard operating procedures and implement control measures that can identify potential risks to the system.

ISO 15189 guides laboratories when it comes to technical and quality requirements. Laboratories must be able to record performance data and audit the results of the system, among other things. Correction and prevention of any issues that might arise from using closed-loop processes to document procedures are also paramount.

Risk Management Plan Definition

A risk management plan is crucial for the lab’s quality management plan. Each laboratory can incorporate technical requirements for testing processes into its quality management system differently. Therefore, it’s important to understand how these work to assess the effectiveness of a laboratory approach to risk management. The litmus test for this is the lab’s ability to match its planned objectives to its actual activities. If a laboratory’s execution of its TTP, IQCP or QC plan employs risk-based thinking, that’s a useful approach.

Risk Assessment and Management

In assessing and managing risk, laboratories need to keep track of all the various testing scenarios and outcomes. Once labs can understand their planning and confirm it, they’ll know which measures they need to take to deal with an unwanted result. A risk-management solution that integrates with the lab’s existing QMS could be quite useful. With it, labs could capture, communicate and address all their risk-related documentation and activities. Learning to prevent risk issues is essential. Laboratories need to be able to track risk management issues and manage their risk reporting system efficiently.

Empower your lab staff to make smarter and safer risk-related decisions by using the risk-management software. A standardized system that can fit your unique requirements can be valuable for all aspects of a laboratory’s testing and quality management plan.

To ensure quality and safety, it’s critical for the food industry to manage and track non-conformances that can lead to product defects and disastrous mistakes.

Risk Management tools and practices were specifically developed to protect against these food safety dangers. By leveraging them, the food industry can protect itself from the risk of a lawsuit, accident, deliberate acts, and even acts of nature.

From supply chain to food health, the food industry cannot be entirely free from internal failure or external events that can threaten productivity and safety. However, having risk management practices in place puts you in a better position to protect yourself from the risks your business is exposed to every day.

If you want your food business to be profitable, you need to pay close attention to all the details; this includes everything from ingredients to equipment to your workforce; most importantly, it involves focusing on defining processes and policies. Here are some best practices in risk management:

Identify Responsible Parties

The key to managing risk is to identify all parties that are involved. It’s critical to understand who is accountable for food safety risk, quality, and compliance. 

When it comes to minimizing risks with manufacturing foods, everyone should recognize that it is a responsibility shared across all levels; this involves plant managers, quality, and food safety group, corporate supply chain, operations staff, QA personnel, and your maintenance crew.

Your QA personnel plays a significant role at all stages of production, making them critical to your overall risk management plan. Without diligence in documenting areas of high risk and communicating concerns to relevant stakeholders, risk cannot be mitigated.

Prepare Employees with Thorough and Continuous Training

Your employees handle day-to-day processes; therefore, risks start with your people. To lessen the possibility of devastating situations, your team should be properly trained in equipment handling, customer service, and safety procedures. Ensure they’re across on employee health codes that outline employee hygiene, inspections, regulated equipment, and even which cleaners are acceptable to use on facilities and surfaces.

While equipment may seem self-explanatory, it would surprise you how many times the wrong assumptions on how to operate equipment has led to disastrous accidents. To boost compliance, train employees how to properly handle all equipment. Thoroughly explain safety protocols that include proper handling, storage, and preparation of food items.

Leverage Technology 

Empower staff with food safety software that complements your overall risk management efforts. Visibility, communication, and compliance can all be improved by using the right solutions.

Communication is crucial. Without it, contamination risks may not be addressed immediately. Safety and quality are all put at risk when there is a breakdown in the exchange of information, leading to dangerous consequences.

With the right food safety and risk management software, you can establish a safety plan that meets FDA Food Safety Modernization Act (FSMA) compliance requirements and optimize operations by standardizing practices and eliminating duplication of documentation. You can increase productivity by automating manual processes that are repetitive and slow down productivity. And because you have access to historical data, you can analyze and predict trends and identify risks.

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.

The purpose of document control is to enforce controlled processes and practices in industries such as pharmaceutical, nutrition, and medical where there is a need to create, review, modify, issue, distribute, and access documents. Document control ensures critical data is indexed and searchable. It helps reduce errors in documentation and allows automation of tasks.

Document control ensures that documentation is accessible at all official points within an organization and is trusted by its users to contain accurate, up-to-date information that’s reliable and formally approved.

Document control applies to any business as it ensures efficiency, reliability, traceability, performance, quality, and safety. It is also a requirement from the ISO 9001 international standard which improves your market entry chances and gains your business a decisive competitive advantage.

ISO 9001 sets the foundation for you to increase efficiency and improve your processes and structures while minimizing your liability risk as it establishes the standards for creating and maintaining a quality management system (QMS).

Requirements of ISO 9001

• Maintain a set of procedures that cover all key processes in the business
• Monitor processes to ensure that they are effective
• Keep adequate records
• Check product output for defects, and use appropriate corrective action when necessary
• Regularly review individual processes and the quality system itself for effectiveness
• Facilitate continual improvement according to ISO 9001 standards

The Pharmaceutical Industry

In the pharmaceutical industry, document control is closely intertwined with quality control. According to the Good Manufacturing Practice (cGMP) regulations that are applied in the pharmaceutical industry, the responsibilities and procedures applicable to the quality control unit be in writing. These written procedures must be followed, and any deviations from them must be justified and documented.

The Food Industry

At the core of food control activities is the establishment of standards for safety, quality, and labeling. The food industry has a broad view of food control that involves factors such as safety, nutrition, quality, and value.

In nutrition, controlled processes include maintaining nutrient levels in food ingredients and formulating nutritional profiles that contribute to consumer interest. Appropriate documentation of procedures must be established to ensure that their control systems are defined, recorded, and maintained to permit auditing and verification that the systems have been correctly applied.

The Medical Industry

In the medical industry, document control systems are also at the heart of an effective quality system as it allows organizations to centralize their documents which include everything from work instructions to policies and procedures. An automated document control system has been the key to avoid errors committed by manual and time-consuming processes.

Document Control and Risk Management

These automated document control tools impact risk management as it significantly improves project accountability. Routing for revision and approval is automated, and access to essential documents is centralized.

Having accurate records requires access controls and tracking. Access is limited to individuals with the relevant permissions thus eliminating versioning issues, delays, or lost items. Only a system that automatically creates and stores copies of all date and automatically collects acknowledgment receipts whenever people access specific documents can accomplish that.

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