KEY ELEMENTS OF A QUALITY MANAGEMENT PLAN

Performance Baseline

Organizations should obtain a snapshot of where they stand in terms of quality. This is achieved by accessing information such as customer complaints, survey results, return material authorizations, corrective action requests, and internal audit reports. Findings from the performance assessment will serve as the basis for the quality policy and objectives.

Quality Policy, Objectives, and Scope

A quality policy is a brief statement that outlines the overall purpose of a QMS. It highlights the corporate mission and reinforces a company’s commitment to driving continuous improvement and meeting customer demands and regulatory requirements.

Quality objectives are an extension of the quality policy. They provide measurable outcomes related to areas such as product performance, safety, efficiency, and customer service.

The scope defines all products and operational functions that are impacted by the QMS.

Quality Manual

The quality manual outlines the QMS scope and references documented quality processes and procedures.

Organizational Roles and Responsibilities

Roles and responsibilities should be clearly defined for employees across the organization—from engineering, quality assurance, and customer service to operations and senior management. Everyone must have a clear understanding of how they contribute to meeting the company’s quality objectives.
To support ongoing awareness and proficiency with policies and procedures, employee training requirements and materials should be established as part of a company-wide training program.

IT infrastructure, equipment, and other necessary resources that transform inputs into outputs and support the QMS should also be defined.

Procedures and Records

Manufacturers must establish and document procedures to ensure that product development processes are carried out consistently and efficiently. This includes procedures pertaining to:

• Document and record control
• Quality control (e.g., inspection procedures)
• Product assembly and maintenance (e.g., work instructions)
• Contamination control
• Software validation (e.g., installation qualification [IQ] and operational qualification [OQ])

Records to support the design and development of the product should also be gathered. These include:

• Customer requirements
• Design and development plans and output
• Verification of materials and outsourced products
• Device master record (DMR) and technical documentation
• Calibration and installation records
• Approved supplier/vendor lists (ASLs/AVLs) and agreements
• Employee training

Quality Measurement and Monitoring Tools

Organizations should identify and document how they plan to measure and track performance throughout the product lifecycle. This could include:

• Customer surveys
• Adverse event reports
• Internal audits
• Corrective and preventive actions (CAPAs)
• Nonconformance reports

QMS IMPLEMENTATION AND MAINTENANCE CONSIDERATIONS

Once you’ve established your quality policy, manual, internal processes, performance metrics, and other QMS essentials, you will need to determine how the QMS will be implemented and maintained across the organization.

Having a robust system to retain, track, and control product design and quality documentation is critical to demonstrating compliance and avoiding audit risks.

If you are planning to use paper, spreadsheets, and other disconnected systems, it will be difficult to quickly locate files and keep track of the latest revisions. Manually routing documents through the engineering change cycle and obtaining approvals also becomes a tedious task that leads to confusion and data errors.

In contrast, enterprise quality management system (eQMS) solutions automate the management of quality information. This enables you to apply best practices in documenting and managing processes essential to achieving compliance. Product-centric eQMS solutions centralize all your quality and product records in a single system and allow for:

Document and Record Control

Automated change processes and revision controls are applied to product documentation and records, ensuring that everyone is always accessing the most accurate and up-to-date information.

Training Management

Organizations have a controlled and automated system to create employee training plans, assign training records, and demonstrate competency.

CAPA Management

CAPAs and engineering changes are linked directly to the product record. This enables greater visibility and traceability of nonconformities throughout the product lifecycle and allows for closed-loop CAPA processes.

Design Controls

Design control elements such as user needs, design inputs, design processes, and design outputs are established and tracked throughout the product development cycle. This helps simplify review, verification, and validation processes as companies move from early design phases to commercialization.

When evaluating different eQMS software solutions for your business, consider the following:

• Is the system built with a cloud-native architecture?
• Does the system have robust security and access control measures to protect your company’s privacy and intellectual property (IP)?
• What is the resource and time investment needed to complete the software implementation?
• Does the software include quality templates to help you develop different processes and procedures and avoid starting from scratch?
• Will the software vendor provide your teams ongoing education and support?
• Are IQ and OQ software validation procedures included with the system?
• Does the system link CAPAs directly to the product BOM to support closed-loop CAPA processes?
• Does the software scale with your business?
• What is your total cost of ownership (TCO)?