We can design, correct, or improve your QMS to be proportional and correctly aligned to your business size and scope, with seamless integration to your management approach and available resources.
Our approach to operational risk management incorporates extensive use of Failure Mode and Effect Analysis to optimize the allocation of available resources. Data-validated Risk Priority Numbers provide for an efficient data-driven decision making approach.
Your procedures are one of the main causes for discrepancies. Getting those right implies adequacy to satisfy applicable requirements and the simplicity to be clearly understood by your manufacturing personnel. We are as technically correct in Spanish language as we are in English.
A corrective action request should not stress you out or give you nightmares. Understanding the mechanical nature of a nonconformity is not about a 5-Why or a Fishbone, or even a form. It is about the basic understanding of your processes, their interaction and interdependencies...easier than what it seems to be
Your business should not need "preparation" for audits. It should perform to expectation and be ready to show on any given day/time. If it's not, we can get you there, as quickly and practically possible.
We do not call ourselves consultants. That term detaches our approach from our mission: We not only tell you how it is done, we show you, and do it for you.
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