A good Quality Management System (QMS) software solution can be highly beneficial for manufacturing companies.
Manufacturers that implement QMS software stand to see quality improvements, cut costs, and drive up profitability. For instance, a chemical manufacturer improved First Time Right by 35%. Additionally, a plastic packaging company saved 10 hours per week on data cleansing alone after implementation.
Choosing the right QMS software that can meet your needs is challenging.
You want software that checks all the technical boxes, as well as fitting in with the workflows you already have in place. The stakes are high. If you make a mistake, you might waste time and resources, plus deal with a system that doesn't help you.
Good QMS software is user-friendly, cost-effective, and aligns with industry standards such as ISO 9001. It also integrates smoothly with your existing ERP systems. And those are only a few of its advantages.
This guide helps you choose the best QMS software for manufacturing. We'll outline the core features to look for and how to weigh up the different options.
Understanding QMS software
Sometimes, the best way to understand something is to see it in action. Let's take a look at how QMS software makes a difference in the real world.
- Document Control and Management
The QMS acts as the single source of truth for crucial documents. This means that everyone has access to documentation, quality procedures etc. The QMS replaces the error-prone paper trail and helps prevent accidents by ensuring only the correct, up-to-date versions are accessible to employees.
- Training Management
Rigorous training is essential not only when onboarding new employees but also to keep existing ones in the know. The QMS tracks employee certifications, schedules refreshers, and alerts management when updates are needed.
- Audit Management
Audits can be a stressful experience - data needs to be well recorded, processes need to be up-to-date, operations need to be compliant and people need to be in sync. A QMS can relieve the burden of auditing by alerting manufacturers about the smallest shifts in quality.
This was also the case of Delamine, a leading chemical producer who used the AlisQI QMS to streamline their audits. Delamine uses the QMS for easy scheduling, assigning auditors, conducting the audit, and tracking results. Regular self-assessments mean that the manufacturer can identify potential problems before they become major issues, impressing both internal and external auditors. For a more in-depth look at how AlisQI helped Delamine.
- Non-Conformance Reports (NCR) and Corrective and Preventive Actions (CAPA)
If a batch fails a purity test, the QMS doesn't just document the issue - it helps track the root cause. This leads to fixes such as recalibrating equipment or improving procedures. Effective CAPA, aided by QMS tracking, prevents the same problem from coming up again.
- Regulatory Compliance
Industries like chemical manufacturing have complex regulations. The QMS ensures manufacturers are up to date with the latest information, automatically flagging necessary updates to documents and processes. Being proactive like this protects them from costly penalties or product recalls that damage their reputation.
How to choose QMS software that meets your industry demands
Choosing QMS software isn't one-size-fits-all. Each industry has its own set of rules and quality requirements that need to be met.
Let's break down the must-have features of good QMS software, and how those features change depending on what you do.
Essential features of QMS software
The key QMS features that are applicable to most, if not all, industries are:
Document Control- Centralizes and manages all quality-related documents.
- Ensures only current documents are accessible, preventing the use of outdated procedures and policies.
- Automates revisions and approvals, streamlining workflow and enhancing compliance
Compliance Management - Ensures compliance with industry regulations and standards.
- Facilitates audits by maintaining records of compliance data.
- Provides tools for continuous compliance monitoring.
Analytics and Reporting - Provides reporting tools for real-time performance monitoring.
- Offers insights into quality metrics and KPIs.
- Facilitates decision-making through data-driven insights.
Risk Management - Identifies, evaluates, and mitigates quality process risks.
- Integrates risk assessment directly into quality management workflows.
- Prioritizes risks based on their potential impact.
Non-Conformance and Corrective Actions - Tracks and manages non-conformances and defects.
- Facilitates root cause analysis to better understand non-conformances and prevent reoccurrence.
- Streamlines the process of initiating CAPAs.
Employee Training Management - Manages employee training records and requirements.
- Schedules and tracks training activities.
- Ensures employees are up-to-date with necessary skills and qualifications.
Supplier Quality Management - Manages supplier qualifications, assessments, and rankings.
- Integrates supplier performance data into the overall quality system.
- Ensures suppliers adhere to compliance and quality standards.
Customer Feedback and Complaint Management - Collects and manages customer feedback to improve product quality.
- Tracks and resolves complaints efficiently to meet customer satisfaction.
- Analyzes feedback patterns or trends to drive product development.
Change Management - Controls and documents changes in processes, equipment, or materials.
- Ensures all changes are evaluated, approved, and implemented consistently.
Audit Management - Supports planning and execution of internal and external audits.
- Tracks audit findings and manages follow-up actions.
- Enhances the preparation and accuracy of audits through detailed record-keeping.
Which QMS features are best for your Industry?
Picking the perfect QMS can feel a bit overwhelming. You need a solution that understands the specific challenges of your industry and can adapt to its needs. Let's dive into a few examples and see which QMS features are must-haves for each:
Life Sciences
In the highly regulated field of life sciences, rules are everything. With strict FDA or EMA regulations in place, you should look for a QMS with features such as electronic signatures, audit trails, and detailed record-keeping. This helps you handle complex clinical trials, ensure validation is correct, and report any unexpected issues clearly.
For example, if you're in pharmaceuticals, your QMS should keep perfect records for audits. You need to prove you follow frameworks such as the FDA's 21 CFR Part 11 to the letter, especially when it comes to electronic records.
If you're making medical devices, ISO 13485 compliance is a must. This means your QMS needs to handle design controls, document management, and risk analysis. After all, medical devices need to be absolutely safe.
Manufacturing
For the manufacturing sector, the QMS should cover the product lifecycle from initial design to final distribution. Look for systems that integrate nicely with your other tools, such as MES and ERP. Features that help maintain machinery, track equipment calibration, and improve safety will save you time, money, and reduce stress.
Food Processing
Food processing companies need to ensure safety and compliance with standards like HACCP or FSMA. A good QMS software solution tracks where every ingredient came from and where it went. Then, if there's a recall (hopefully not!), you can pinpoint the problem quickly, keeping your products consistent and customers safe.
Scalability
If business is booming, it's obviously good news, but it also means things are getting a whole lot more complex.
A good QMS software needs to handle that growth without breaking a sweat. It should manage the increased amount of data that comes with success, any new workflows, and the ever-changing rules and regulations.
Let's picture a manufacturing company with factories all over the world. Each site varies in size and often has its own local regulations. A scalable QMS is key here, as it lets you use the same system everywhere. You get to keep quality standards high, but still adapt to its specific locational needs.
Cost considerations and ROI of QMS Software
When you buy QMS software, you're buying more than just a product. You're investing in a solution that changes how your business handles quality control. Choosing the right QMS software can improve your cost of quality (COQ) results, and increase your return on investment.
Let's take a closer look at the potential cost considerations.
Initial Costs
The upfront cost of a QMS varies depending on the scale of the deployment. Costs might include licensing fees, system setup, customization, integration with existing systems, etc.
Staff training is another initial cost to consider.
Although the initial costs might seem relatively high, you need to put them in the context of long-term efficiencies and COQ savings.
Potential ROI
QMS software saves time and money by making everything run smoother and automating tedious tasks. Plus, it reduces the risk of costly fines and penalties for not following the rules, as well as cutting scrap and wasted resources. The overall reduction in COQ means your QMS software will probably pay for itself over time..
For example, let's say your team spends hours updating documents and preparing for audits. QMS software can automate that, freeing up your people and making sure you're always in compliance. This should result in a positive ROI over the long-term.
Choosing the right QMS software
Follow these three steps to find the best fit:
- Define your must-haves. Do you need streamlined compliance? Automated audit features? Cloud-based document control? List out all the things that are non-negotiables for your QMS software.
- Think about the future. Ideally, you would like a QMS that is future-proof and grows with you. Look for a system that is continuously developing and using technologies such as AI and machine learning to stay at the cutting-edge.
- Estimate the costs and ROI. Work out the initial costs, but also savings such as improved efficiency and fewer errors.
AlisQI checks all the boxes. It's a cutting-edge cloud-based QMS solution that integrates smoothly with any manufacturing processes. The user-friendly interface means you and your team won't be bogged down with a steep learning curve.
With AlisQI, you get to leverage an integrated platform for Quality Control, Document Management and ESH Management. It also provides built-in statistical process control (SPC) toolbox, smart alarms and advanced analytics. This helps you to respond faster and adapt to changing requirements and regulations.
To find out more about AlisQI, contact us today.
