The existence of nonconformance can only mean that something has gone wrong and that a particular set of specifications wasn’t followed. It means that the company’s standard operating procedures (SOP) were not followed, and in a broader term, it means that the requirements set out by ISO 9000 were not met.

When this occurs, it naturally has to be handled. Thankfully, it’s no longer required to document the whole procedure of finding, reporting, and fixing nonconformance issues, so this entire ordeal is a bit easier. But keeping a record of nonconformity and how it was corrected is still necessary.

The things that have to be done to correct the problems can only be done after the problems have occurred. It’s far easier to have measures that will prevent nonconformance issues from appearing altogether.

The easiest way to reduce nonconformance is employee training. Let us explain how to proceed.

The Causes

It’s good to identify the cause first, to find a solution. Whatever the business in question might be, reasons for nonconformity issues can usually be boiled down to the same things:

• Poor or lack of documentation
• Poor communication or miscommunication
• Poor personnel training
• Poor personnel motivation
• Dysfunctional operating environment
• Poor quality or lack of materials
• Poor quality or lack of tools and equipment

As you can see when taking a better look at the causes, most of them can be, in one way or another, attributed to employee training. Some of them individually are lousy employee training while some others are indirectly or directly connected.

Naturally, it doesn’t mean that you can eliminate nonconformance through employee training, but it indeed is the best way to avoid it in most cases.

How to Achieve the Desired Effects

Proper employee training is vital for several reasons, not only for reducing nonconformance. To achieve quality training, you need to nurture and maintain the knowledge base of your employees and suppliers.

In essence, you need to get all personnel up to speed with several issues: from policies, regulations, SOPs, and many other relevant quality metrics. The baseline is for the achievement of quality, and violations need to stop happening.

It, in turn, can almost eliminate the possibility of nonconformity.

However, achieving quality training is not an easy feat. Plenty of periodic training sessions must be conducted, tests as well, and even awareness programs for all of your personnel, including suppliers. This way you can ensure that everyone in your organization and those connected to it, are on the same page and have the same goal.

The training can also improve motivation of employees through unity. It will enhance communication as well and creates a better operating environment. Also, even documentation can be improved. As we have already said, these are some of the most common causes of nonconformity. They practically eliminate with the improvement of employee training, which will reduce dissent.

Dealing with nonconformity and other quality issues is best achieved through a Quality Management System. Intellect offers an out-of-the-box solution through its eQMS platform that already incorporates workflow in several modules like CAPA, Doc Control, and more.  

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