What does the das „p“ i qm stand for?
An excessive QM system is primarily good for one thing: to generate costs. On the other hand a standard QM system safeguards the quality of the products and consequently the company’s existence. I am addressing the fine line between „too much“ and „not enough“ for my customers with the 5 P’s:
P … for „perfect fit“
Each medical and pharmaceutical product (or service) is individual and has to undergo specific and in parts legally protected formation processes. The QM system has to map these specifics in the framework of tight regulatory requirements without overdoing efforts. A customized QM system focuses on the concrete product (or service) that is being produced or offered with special technologies and under specific market and production conditions.
P … for “process oriented“
Each product (and each service) is based on processes that are established in a company: Raw material, information as well, are turned into semi-finished products or finished products during the main processes while sub-processes create the framework. The QM system must cover both types of processes in order to produce in accordance with regulations and audit requirements. For this reason, in my offering I put emphasis on process improvement with the goal of achieving stable and efficient production conditions and therefore providing the basis for a cost-effective production.
P … for „practicable“
Does ‚„GMP“ really only stand for „give (me) more paper“ in your company? A QM system whose only reason for existence is itself and its auditor is expensive and ineffective. For a QM system to be effective, employees at every level must accept it and it has to be easily manageable. That’s when it’s guiding you to your goals, allowing you to calmly approach any audit.
P … for PDCA
Literature is full of truisms and acronyms. PDCA is a good, but erroneous example: The correct application of the PDCA cycle for each process improvement, qualification, validation or the processing of an NC notification or a CAPA helps to avoid mistakes before they occur, to work effectively conserving resources and, above all, to avoid making the same mistake twice. Current regulations model the PDCA cycle.
P … for low-priced
If you believe a QM system to be expensive … think again and check out ignorance. You may read here what the consequences were for your competition.
An external consultant who is familiar with the current regulations and capable of applying them to your established company and production processes will help you to uncover weak points devoid of emotions and free of operational blindness and eliminate them if desired. The sector-specific hourly wages are not higher than those you will have to calculate for your own employees taking into account all overhead costs and reserves. The risk to end up in the wrong hands is comparatively low due to short notice periods.
True quality is the return of the customer, not of the product.
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