ComplianceQuest: A Preferred Solution to automate Quality Control Processes
Just – Evotec Biologics, a wholly-owned subsidiary of Evotec, is a biotechnology company that is focused on the development of high-quality biotherapeutics. One of the company’s key goals is to reduce the overall cost of manufacturing and streamline the efficiency of operations.
The company’s leadership understood the value of top-notch Quality Control to improve manufacturing performance. In line with this vision, Just-Evotec implemented ComplianceQuest EQMS to enhance productivity, improve quality metrics and reduce manufacturing costs.
While the company implemented several of our EQMS modules (including CAPA, Document, Change, Supplier and Training), from a Quality Control perspective, the trio of Inspection, Equipment, and Nonconformance Management played a key role.
As per ISO, Quality Control (QC) is a “set of procedures and processes that ensures all aspects of quality are adhered to during production and manufacturing.” For any company, it is important to catch quality issues before it leaves the proverbial four walls of the company and a robust nonconformance management process can do just that.
At Just Evotech, the company roped in 135 users (into CQ EQMS) responsible for various manufacturing processes, defined Standard Operating Procedures (SOPs), then automated these processes using CQ making sure production quality wasn’t compromised.
In this post, we highlight the role of QC in manufacturing and why automation, digital transformation and data-enabled decision-making have become a necessity.
Reducing Cost of Quality (CoQ) during Manufacturing
Reducing the Cost of Quality (CoQ) is essential for manufacturers both from a regulatory perspective and to keep manufacturing costs low. This requires minimizing non-conformances by ensuring products meet design specifications before it leaves the production facilities.
There are two aspects that have a direct impact on manufacturing quality:
- Supplier Quality – the quality of input raw materials
- Reliability of QMS processes across the manufacturing lifecycle
A robust, well-designed quality control process will include the following critical steps:
- Nonconformance Management: Have in place an automated, data-driven process for identifying and managing nonconformance of both products and processes.
- Inspection Management: Implementing a world-class product inspection management system that simplifies the product inspection process for input raw materials, manufacturing process, and finished goods inspection as well.
- Equipment Management: All equipment – including instruments – have to be tested for deviations and corrected quickly to prevent nonconformance. Whenever needed, a CAPA must be initiated based on the severity of variations and establish parameters for future maintenance and calibration for equipment.
At ComplianceQuest, we published a Whitepaper titled ‘Robust Quality Control: How Intelligent Automation of Nonconformance, Equipment and Inspection Management Processes Will Save Time and Costs’.
Download it here for a more detailed perspective on the importance of Quality Control:
https://www.compliancequest.com/whitepaper/robust-quality-control/
CQ Guide: Reduce CoQ with Better Quality Control by ticking off the following questions
Ensuring workplace safety for both contract and permanent workers is essential. As OSHA says, “Whether temporary or permanent, all workers always have a right to a safe and healthy workplace.” To ensure this, enterprises must create safety management that rests on the following three pillars:
- Is your NC (Nonconformance) management process robust enough? Are you using data to analyze the effectiveness of your past corrective actions?
- Are you using AI to identify similar NC records?
- Does your EQMS tool automatically categorize and prioritize risks?
- Is your inspection process exhaustive across all stages?
- Inspection of incoming materials
- Inspection during manufacturing (in-line inspections)
- Inspection of finished goods
- Supplier Quality – the quality of input raw materials
- Is your equipment management process reliable?
- Are maintenance schedules on track?
- If you are outsourcing equipment calibration, are you taking necessary steps to make sure it is being done by the right partner?
- If you are having quality control issues and not seeing continuous improvement, are these problems typically people-related or process-related?
- What can you do in terms of upgraded training to improve QC?
