RQM+ is a strategic partner that helps you prioritize the needs that are most critical to the health of your organization. Our team understands your unique business goals and creates tailored strategies and plans to support your manufacturing objectives.
Your quality team should have independence within the overall organizational structure, making it a perfect fit for outsourcing support as needed. We understand the perception that quality teams create limitations rather than solutions. However, we also understand the importance of integrating quality into your company culture, which is why we act as an extension of your business to support embedding quality into your systems.
Regulatory requirements aren’t static and even products that are already on the market must comply with new quality standards for manufacturing. RQM+ takes a proactive approach to keep your manufacturing systems compliant so that you will always be ready for an audit or inspection.
RQM+ ensures you are prepared for the gamut of challenges you will encounter once you have started manufacturing your product, including supplier audits, site transfer, manufacturing quality, and process validation/qualification. Our team can expand as needed, so when you start to feel overwhelmed, we have your back.
Quality Support at Every Stage
Whether you are designing a new device, transferring to manufacturing, or struggling with day-to-day challenges, RQM+ has qualified resources to support you.
The choice of sample size starts in Risk Management. You need to determine what defect rates are allowed based on classifying the defect types. More critical defects that cause serious harm to the user require better quality. Acceptable rates may vary from 0.1% for very serious defects up to 6-10% for cosmetic issues. You also must choose a confidence level for your final conclusions. 90% or 95% are common values. Once those two values are determined, calculating a sample size is just a math problem. Remember, you will have to justify the acceptable defect rate to outside auditors.
PQ run have to be representative of actual planned production. If your normal release batch takes eight hours, then your PQ runs must also be eight hours. Why? Because you must prove you cover all normal sources of variation within the PQ runs.
Validations intend to show a high level of confidence for overall patient safety. ANSI Z1.4 is designed to release most lots that are near your acceptable defect rate. That equates to very low confidence of patient safety.
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