Quality Assurance

Our quality assurance approach covers supplier qualification, incoming inspection, part approval, in-process controls, final validation, traceability and continuous improvement. Processes are adapted to the requirements of the customer, application and relevant industry standards.

A zero-defect approach aims to prevent defects rather than relying solely on final inspection to identify them. At Optimas International, this includes structured quality planning, risk assessment, root cause analysis and continuous improvement methodologies such as APQP, FMEA and Six Sigma.

Optimas International’s quality management systems are certified to ISO 9001. Specific certifications and approvals can vary by facility, customer and application. More information can be found on our Quality page.

We assess and audit suppliers against defined quality and performance requirements, monitor supplier performance and use structured improvement processes to address issues and their root causes.

We assess suppliers and manufacturing partners against criteria including quality management systems, financial stability, delivery performance, manufacturing capability and ability to respond to changing demand. Supplier audits and ongoing performance management help maintain the required standards.

By identifying quality risks earlier, controlling part approvals and monitoring supplier performance, quality assurance can reduce the likelihood of defective or non-conforming components reaching production and causing rework, delays or line disruption.

Advanced Product Quality Planning (APQP) is a structured process used to identify quality requirements and potential risks during product development and before production begins. For fastener supply, APQP helps ensure that the component, manufacturing process and supplier are capable of consistently meeting the required specification and quality standards.

Failure Mode and Effects Analysis (FMEA) is a systematic method for identifying how a product or process could fail, assessing the potential impact and likelihood of each failure, and prioritising actions to reduce risk. In fastener supply, FMEA can help identify potential design, manufacturing or process issues before they result in defective components or production disruption.

Production Part Approval Process (PPAP) is a formal process used to demonstrate that a production process can consistently manufacture components that meet the customer’s specification and quality requirements. PPAP is commonly required in automotive manufacturing and other applications where documented evidence of component and process capability is important before production begins.

RoHS (Restriction of Hazardous Substances) restricts the use of specified hazardous substances in electrical and electronic equipment, while REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulates the use and communication of information about chemical substances in the EU. Where applicable, Optimas International supports customers in meeting RoHS and REACH requirements for the components and materials supplied.

The 8D (Eight Disciplines) process is a structured, team-oriented problem-solving methodology used to identify, correct, and permanently eliminate recurring quality issues. Originally developed within the automotive sector, this framework guides organisations away from temporary “band-aid” fixes by systematically uncovering and addressing the root cause of a defect.

It is called “8D” because it consists of eight sequential steps (plus a preliminary planning stage) to ensure rigorous and lasting resolution:

• D0: Plan and Prepare: Recognise the initial problem symptoms and establish immediate safety bounds.
• D1: Form a Cross-Functional Team: Assemble a diverse group of experts who understand the product, process, and data.
• D2: Describe the Problem: Quantify the issue clearly by defining who, what, when, where, why, how, and how many.
• D3: Implement Interim Containment Actions: Deploy temporary fixes to insulate and protect the customer while investigations continue.
• D4: Identify Root Causes and Escape Points: Use tools like the 5 Whys or Fishbone diagrams to find out exactly why the defect occurred and why it went undetected.
• D5: Choose Permanent Corrective Actions (PCAs): Select the best long-term solutions to eradicate the root cause completely.
• D6: Implement and Validate PCAs: Roll out the permanent solutions and monitor performance data to ensure they work.
• D7: Prevent Recurrence: Update standard operating procedures (SOPs), manufacturing guidelines, and training to stop the issue from happening again.
• D8: Recognise Team Contributions: Formally close out the project and celebrate the hard work of the team.