In doing it right and doing it once, QiQ coaches your organization’s champions in thes implementation of Quality Management through the eight principles outlined by the (ISO); (1) Customer focus, (2) Leadership, (3) Involvement of people, (4) Process approach, (4) System approach to management, (6) Continual improvement, (7) Factual approach to decision making, and (8) Mutually beneficial supplier relationships. We do this by looking at the following areas:
The on-site analysis of your workflow evaluates current state against a suitable model, standard, or regulatory requirement such as ISO 9001:2008, Good Manufacturing Practices, Marihauna for Medical Purposes Regulations (MMPR) ICH Q7A, ISO22716, ISO17025 etc. This analysis identifies the missing, nonconforming, insufficient or misapplied elements in your organization relative to the applicable standard. These are classified as 'lacks' - that which is not there; 'gaps' - that which is not sufficient; and 'mismatches' - that which is not compatible.
Process mapping involves an on-site review of workflow processes and practices. This information gathering exercise, QiQ involves your process experts and operators to a process map that identifies all your process variable and controls points. A well-mapped process is a road map for managing and controlling your process based on fact, experience and real time data.
Quality Process Implementation
From the GAP analysis, the identified GAPs present a foundation for crafting the policies and procedures to build a Quality Manual that includes the documents that specify your standardized process and practices. The roll-out and implementation of your QMS starts with personnel training following by an executive authorization of the Quality Manual and the implementation of the Standard Operating Procedures in you Quality Manual.
"Joseph Wu is passionate about quality and fulfills his leadership role with integrity. He brings with experience as a quality professional in the industry a wealth of content knowledge on the practical implementation of Quality Management Systems to the organization he works with"
- D Cox, Former CEO of KS Avicenna and Radient Technologies Inc.
Do it RIGHT, do it ONCE!