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Refining a QMS with Technology

Dayna Nicholas, Director of Quality & Regulatory Affairs Manager, Land O' Frost
Dayna Nicholas, Director of Quality & Regulatory Affairs Manager, Land O' Frost

Dayna Nicholas, Director of Quality & Regulatory Affairs Manager, Land O' Frost

Quality Management Systems (QMS) have been the mainstay for Quality department professionals since the Industrial Revolution. The American Society of Quality (ASQ) explains that a QMS was originally a set of standards to control the product or process but became more encompassing and is now defined as “a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.”

For many years, a QMS was a collection of three-ring binders containing procedures, policies, product specifications, and other documents to describe the many programs designed to ensure product safety and quality throughout the production flow. Quality Managers are typically responsible for creating, revising, and training for each program that comprises the QMS. Internal and external audits then verify the effectiveness of the overall system. Typically, the programs are created and managed in some type of electronic system but printed for easy access by employees, managers, and auditors. While this works, it is unwieldy. Maintaining the same information in multiple sites or even binders allows for outdated or multiple versions of the same document and makes updating cumbersome.

There are, of course, many choices in software to move the entire system from simple electronic procedures and spreadsheet databases to more interactive systems allowing real-time data entry on the production floor and access from any location. At Land O’ Frost, the implementation of a new Enterprise Resource Planning (ERP) system provided the opportunity to modernize the entire Quality Management System at the same time. The ERP system contains a Document Management application that provides robust but customizable security along with a document approval process flow. Because documents are maintained in the ERP, product specifications, and Standard Operating Procedures can be assigned to products so that every time a shop order is generated, the most current document for that product is automatically attached, so the machine operator has easy access to that information.

  In today’s fast-paced manufacturing world that is leaner than ever, departments must bring their resources together and collaboratively drive improvements​  

Another module, or application, allows for materials, work-in-process, or finished goods to be retained in the inventory system and print the retain tags on the production floor. The nonconformances can be classified to restrict material or product movement based upon the classification, and to document the final disposition, notes, and corrective actions linked with each retain. With the auto-generated reports feature, production supervisors and Quality Managers can receive a real-time list of retained inventory or perform a simple query at any time. All queries in every module can be saved and shared with others to further simplify the process to find information quickly. The Corrective Action / Preventive Action, or CAPA, the application allows separate CAPA projects to be tracked for any process need.

Additionally, the Customer Complaint module is used for multiple parts of the QMS. First, it’s used as intended for consumer and customer feedback, whether complaints, questions, or compliments. This allows us to document the information during a phone call or upon receipt of an email. Investigation and corrective action information can be completed with each case, and trend reports are generated to understand continuous improvement project needs. We created additional categories and sub-categories to also use the same module for the Cost of Quality and Foreign Material tracking. The significant advantage of building all of these QMS components within the ERP system is able to link retains, CAPA projects, and complaints to inventory in a real-time environment. With older systems, we were always struggling to ensure the information in the inventory system matched the information in the QMS components. Microsoft’s Power BI is then used to pull data to create user-friendly and customizable dashboards for all Quality reports that were previously laboriously generated from Excel workbooks.

There is also Overall Equipment Effectiveness (OEE) software programs that go beyond production needs by being advantageous to the quality professional. Land O’ Frost utilizes RedZone, which goes beyond OEE tracking to also include a compliance element. Their system not only captures OEE and process checks but also builds a connectivity system between employees and actively engages them to find and sustain improvements. The compliance element provides the ability to create checklists, process control checks, and internal audits. These are completed on iPads on the production floor by operators, line leads, supervisors, maintenance, sanitors, techs, and auditors with prompts when to do the checks and notifications to an assigned list when a check is missed, canceled or fails. Failures automatically create additional checks. This automated system has enabled us to evaluate the correct schedule for each check or audit, and whether it should be based upon a static frequency or upon an event, such as a line startup, a product changeover, or specific downtime code. This greatly improves process control as it targets checks and verifications to the issues that matter, preventing redundant checks, and improving employee efficiency. Data is easily retrievable, making analysis and third-party audits more robust. Our third-party auditors have been complimentary of the ability for us to share exact information quickly during audits, including graphs, trends, notes, and corrective action.

Technology hasn’t changed what the quality professional must have in a well-managed Quality Management System. But Technology has made the QMS more robust by connecting all components allowing for better data retrieval and analysis. This allows the Quality Manager or Director to focus their efforts on identifying trends and concentrate team efforts on process improvements to ensure process capability and desired product performance. In today’s fast-paced manufacturing world that is leaner than ever, departments must bring their resources together and collaboratively drive improvements. Technology is the platform that allows for better interaction, data collection, data analysis, and solution building.

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