A common pitfall of many start-up organisations is to define and formalise quality processes too late: serious errors might already burden the service being launched or the product that is already being introduced into humans. The greatest quality risks are taken when quality is only a concern of senior management, and when submission of a marketing application (CTD) is being planned or is already written.
A common pitfall of larger organisations is that the definition of quality processes is mistaken for an SOP writing task. SOPs are an important element in a Quality Management System but they represent the end of the QMS definition process, not its starting point. Another frequent pitfall is to “delegate” the definition of quality processes to staff who are supposed to carry out this mission-critical task in addition to their full-time work. It is no surprise that with such an approach, quality will be a lower priority. This problem is compounded when those made responsible for the task have never had proper education or training in quality management.
How can Widler & Schiemann assist you with the definition of your Quality Strategy, Quality Policy and Quality Manuals?
Both partners have worked with large and small organisations and helped them develop a “fit for purpose” QMS with a Quality Policy and Manual tailored to the organisation’s specific needs. In these projects, emphasis was put on identification of the quality drivers as well as essential process steps that directly impact the quality of the service or product, and a bureaucratic formalisation was successfully avoided. The outcome is a lean, easy to maintain Quality Manual that summarises the nuts and bolts of the Quality strategy and policy.
Widler & Schiemann will work with your management, experts and process owners to create (throughout your organisation) a shared understanding of the key processes, the key process steps and deliverables and where controls should be put in place. Roles and responsibilities, as well as clear process ownership, will also be defined and formalised with your experts and teams. Widler & Schiemann can draft the necessary documentation – e.g. formalising the Quality Policy and Quality Manual – or coach your designated responsible staff through the writing, review and approval processes.
Download as PDF