5 ways to simplify quality management
Quality management is a comprehensive approach to ensuring that products or services meet or exceed customer expectations. For the pharmaceutical industry that could mean ensuring patient safety, meeting regulatory requirements, maintaining reputation and trust, minimizing product recalls and business advantages such as global competitiveness.
But what do we mean when we say quality management?
Key components of quality management
Quality management is a holistic approach that encompasses all aspects of an organization's operations, from initial planning through to delivery and beyond. It requires a commitment to excellence, continuous improvement, and an end-user mindset to ensure an organization, product, or service consistently functions well.
A quality management process consists of four main components described below, or in simpler terms: Plan, Do, Check and Act.
So, let’s go through them and suggestions on what you should be doing during each step:
Quality Planning (Plan):
Identify your goals and baseline.
Assemble internal resources.
Determine quality standards and the requirements to meet those standards.
Determine what procedures will be used to ensure criteria are being met.
Quality Assurance (Do):
Organize supporting documentation such as:
ISO documentation
Policies
Procedures
Training material
Work instructions
Etc.
Train employees on new processes
Optional: Deploy the QMS.
Quality Control (Check):
Control measure and monitor your outputs to ensure they meet expected criteria.
Identify areas where there is an opportunity for improvement.
Quality Improvement (Act):
Review findings in your QMS.
Re-evaluate both the process and the product.
Begin the QM process again.
These steps can include more detailed steps depending on if you are striving for a particular certification but should never include less. The goal of quality management is customer satisfaction. Meeting or exceeding customer expectations defines quality.
Quality management systems today
Quality Management System (QMS) is defined as a structured system that will provide a systematic approach to help improve quality controls, eliminate nonconformance issues, reduce audit risks, and streamline new product development processes.
The goal of implementing a quality management system is to establish a structured framework that enhances communication, fosters collaboration, and ensures consistency throughout your organization. Additionally, it aims to minimize waste and encourage ongoing enhancements through continuous improvement initiatives.
Looking at the key components of quality management it may seem like a lot of work, especially if you have a smaller business at the beginning of your journey. A standard QMS might be able to offer an easy way of achieving a higher level of quality, but let’s break it down to what’s required by a QMS:
Electronic Documentation
Visualization of Process maps
Sharing capabilities
Flexible workflows and structures
Training management
Default security
In-depth reporting
The question we ask ourselves, why does it have to be a separate system when so many other systems can offer the same features?
How to simplify quality management
Not only will the costs of having separate systems rise as you expand (as more functionality is needed for a larger number of people) but the user acceptance of working between multiple solutions will be hard to achieve, as well as integrating the separate systems with each other. This can still be true if you select separate systems from only one vendor!
So, on these premises we have gather some tips on how your quality management can be simplified utilizing this mindset:
Streamline documentation processes: Start by implementing a document management system (DMS). Previous manual, paper-based processes will become more efficient, and it allows for centralized storage, easy retrieval, and version control of documents such as SOP’s, batch records and quality manuals.
Centralize Data Management: Centralize data management by integrating your DMS with other business systems such as quality management system (QMS), enterprise resource planning (ERP) and laboratory information management systems (LIMS) in one centralized solution. This allows for seamless data exchange, real-time reporting, and improved visibility into quality metrics and performance indicators.
Standardize Training Programs: Standardize training programs to ensure consistent understanding and implementation of quality requirements across the organization. Choose a solution with built-in training capabilities to be able to build courses with material already existing within the same platform, follow up on progress easily and finally, reduce software costs.
Automate Compliance Tracking: Choose a robust solution to automate compliance tracking and reporting. This includes tracking regulatory requirements, audit findings, corrective and preventive actions (CAPAs), and training records. Automated reminders and notifications can help ensure timely completion of tasks and adherence to regulatory deadlines.
Utilize Data Analytics: Leverage data analytics tools (preferrable a solution with built-in reporting) to gain insights into quality trends, performance metrics, and process deviations. Analyze data from manufacturing operations, quality control testing, and adverse event reporting to identify patterns and root causes of quality issues. Use predictive analytics to anticipate and prevent quality problems before they occur.
Many of these tips could be used by any company, no matter the industry or size, wanting to increase their overall quality.
Conclusion
The common denominator of all our tips is to look for one integrated solution that can handle all the key components of quality management to simplify and streamline processes and increase user acceptance.
BIP 365 is a integrated solution with a built in Intranet that can handle all your content and processes connected to quality, structure, security, and collaboration. Consolidate your QMS, ERP, LIMS, or other business system into one GxP-compliant platform while integrating directly with your existing tools such as Microsoft 365.
Contact us today if you have any questions about BIP 365 or how to simplify quality management in general.