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Last updated on
September 21st, 2021
Quality Management (QMS) Software Buyer’s Guide
To get where you are, you’ve spent plenty of time and energy implementing operational best practices. The rapid pace of software innovation though has offered a new opportunity to savvy manufacturers. Market leaders and innovative competitors alike are looking to accelerate business growth with software-based quality management optimization.
Read on to find out about the range of quality management software available to you and how QMS can benefit your organization.
Quality management software (QMS) offers a comprehensive tool kit to analyze risks, set quality objectives, implement workflows to achieve standards, and audit for optimal performance.
It’s no longer enough to have engineering, the production floor, purchasing, sales, and service working independently to improve quality. Distributed systems are inherently inefficient. They’re a structural impediment to achieving your quality goals. An integrated approach that allows data to flow between each area is required.
QMS software is used on conjunction with other manufacturing software or MRP software options. These options may be general-use for all manufacturers, or focus on quality management capabilities unique to specific manufacturing industries (such as pharmaceuticals or chemicals).
Enterprise-level quality management systems (EQMS) have a greater scope than generic QMS solutions. EQMS assists businesses with globalization by enhancing their quality management practices across the supply chain.
Features of Quality Management Software (QMS)
Quality management system (QMS) software offers a wide variety of functionality. Core functions and features often include:
Compliance Control: Includes documentation, planning, scheduling, reporting, and auditing related to adhering to regulatory standards.
Quality Planning: Set quality objectives across a variety of dimensions including cycle times, scrap/waste percentages, defect rates, measurement deviations, durability metrics, and more.
Risk Management and Analysis: Create what-if scenarios to reliably analyze potential costs related to quality exceptions. Predict failure and service rates, as well as their financial implications.
Workflow Management: Define all processes involved in manufacturing an end-product. Includes reminders, timers, and alerts. Determine corrective action assignments.
Corrective Action/Preventative Action (CAPA): Includes task assignments, reporting, and monitoring to ensure that the right response has been implemented when quality has deviated outside of pre-identified standards.
Parts Non-conformance: Define the dimension your parts are measured upon for non-conformance. Track a database of standardized parts metrics. May include more sophisticated monitoring controls that integrate with operational equipment.
Approval Management: Submit requests and manage approvals. Ensure consistent process reviews are happening
Customer Complaint Management: Assist service personnel in quickly resolving customer issues.
Audits and Inspections: Define, schedule, and execute audits and inspections.
Document Management: Coordinate the data management challenge, facilitate collaboration, and ensure easy access to important quality management documentation.
Strong QMS is assisting manufacturers in meeting some of their most critical business challenges:
Ensuring Regulatory Compliance
Manufacturers are often subject to an alphabet soup of regulatory standards (FDA, ISO 9001, Title 21 CFR Part 11, NERC, SSOP, HAACP, and more). The ability to demonstrate compliance is critical. Compliance can be required for permitting, an eligibility condition for bid consideration, or a business necessity to avoid penalties or other legal action. Managing for regulatory compliance is complex work. QMS systems provide the monitoring and reporting tools you need to simplify the complexity.
Different types of manufacturers need to comply with different regulations. For instance, manufacturers of medical devices, food, cosmetics, and chemicals all have unique, strict regulations to abide by. Ensure the QMS system of your choice offers compliance for your industry.
Analyzing and Reducing Risk
Errors, defects, unexpected service work, lawsuits, and recalls each pose a threat to the financial health of your business. Improved quality management offers a chance to mitigate these business risks and smooth out the variance in your financial projections. QMS systems offer not only the functional tools required to more effectively manage for higher quality and fewer problematic products. They also include analysis tools to quantify the financial risks related to quality exceptions. Identifying the cost of quality management improvements versus the likely impact of reduced financial liability is one of the more challenging business issues facing manufacturers.
Increasing Customer Satisfaction
There is no industry or business model where quality is not a key competitive differentiator. Your customers are continually evaluating your products for their reliability, ease of use, and simply how well they do what they are supposed to do. Every sale is, in effect, a promise. Whether or not your customers feel the promise was kept will in large part determine your ability to gain future business, upsell related products, and generate continued enthusiasm for your goods.
Eliminating Inefficiency and Paper Waste
Defective unsold products are waste. Unexpected or early service work is a drain on company resources. Scrap is, well, scrap. eQMS systems offer you the transparency into your processes to help you create quality goods efficiently. You can eliminate manual paperwork by using an electronic quality management system.
Common Certifications, Standards, and Compliance with QMS Software
ISO 9001: Sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity
API Q1/Q2: Standards specific to the oil and gas industry that are similar in nature to ISO 9001. API W2 has the explicit requirement for contingency planning. Both API Q1/Q2 make the distinction between corrective and preventative action (something ISO 9001 does not)
ISO 13485: Similar to ISO 9001 but for medical devices. Has the specific requirement for software validation and requires validation reports to verify for the auditor that it will work as intended. Includes requirement for CFR 21 specific electronic signatures
ISO 50001: Energy management standard for addressing the energy consumption and use of an organization
ISO 27001: Information security, similar to ISO 9001 but with a change in focus to data security and integrity vs product quality
ISO 45001: Health and safety, similar to ISO 9001 but with a change in focus to employee safety vs product quality
ISO 14001: Health and safety, similar to ISO 9001 but with a change in focus to environment concerns vs product quality
ISO 17025: Laboratory testing and calibration
ASME: Highly focused on product specifications and work instructions. Little emphasis on standard QMS requirements such as nonconformities and corrective action
API Design Stamps: Similar to ASME. Components have specific technical requirements to be met. Generally coupled with API Q1/Q2
IATF 16949: Automotive quality management standard similar to ISO 9001 with additional requirements
AS 9100: Aerospace quality management standard similar to ISO 9001 with additional requirements
FDA 21 CFR Part 11: Electronic records and electronic signatures
FDA 21 CFR Part 211: Drug and pharmaceutical manufacturing
FDA 21 CFR Part 820: Medical device manufacturing and distribution
Non ISO Standards
Statistical Process Control (SPC): Identify product quality issues and process variations in order to take corrective action before extensive issues occur, as well as improve process performance. May pair well with a QMS but is better used to report on the output of the production process.
Production Design Lifecycle System (PDLC): Mainly used for showing verification and validation of a product design requirements. Focus on the interaction between suppliers, engineering, and test data. Includes production part approval processes (PPaP).
Integrating QMS With Other Business Software
Quality management software incorporates information from across the enterprise. Very often, QMS systems are found within larger ERP software solutions.
Because QMS systems typically operate best when they are taking a holistic approach to the enterprise challenge of optimizing quality, you may need to manage integrations with other information systems, such as:
Supply chain management systems manage the provisioning of goods from suppliers through to the customer. Relaying information regarding quality issues stemming from certain suppliers is an important piece of the quality management puzzle.
Customer relationship management software programs provide a coordinated approach to capturing customer specific information. Order histories and other customer interactions are logged to CRM programs. The ability to flow quality issue information from CRM software to QMS programs is important. It can assist in ensuring that quality issues addressed post-sale are being addressed both in terms of service work and process improvement.
Material resource planning and production scheduling software manages the materials required for production and the processes that go into the manufacturing operations. Importing quality related information from the QMS to the MRP system will help create more accurate manufacturing plans and forecasts.