What is a Quality Management System (QMS)? Well, it can be defined in many ways. One definition is: a collection of policies, procedures, plans and supporting infrastructure by which an organization operates in order to reduce and eventually eliminate non-conformances to specifications, standards and customer expectations in the most cost effective and efficient manner.
A shorter, more digestible definition is: documented and demonstrated control over all activities with the intention of meeting and improving upon customer expectations and regulatory compliance.
However defined, establishing a QMS may carry with it significant social and cultural implications within an organization, as it requires changes to existing systems and cultures which can result in sharp divides within an organization. With that said, top-level management’s commitment to this effort is undoubtedly the first rule of success. Without it, it is virtually impossible to create and sustain a functioning system. It is critical, then, that the executive team sincerely supports the QMS and actively participates in the implementation process.
Once the executive team’s on board, there are a few things to keep in mind as you start putting the details around your QMS:
- As you begin to develop your company’s QMS, defining the organization and delineating the structure will be key. Clear roles and responsibilities need to be defined and a quality department needs to be created, which depending on the size of your organization may consist of one person to hundreds.
- The quality department should not report directly to production management, as quality reporting to a person who’s directly responsible for meeting certain throughput or monetary goals would be a conflict of interest. This would render quality’s efforts to be ineffective, thus carrying no weight or credibility. As a result, this group typically reports to upper management (i.e. president, VP, CEO, etc.) in most organizations.
- After the organization is clearly defined, one of the first quality elements to address is the creation of a controlled documentation system. A formalized system defining the procedures, rules and responsibilities for document control is essential for laying the foundation of a QMS. Documents may include those that are internally generated (e.g. standard operating procedures, work instructions, etc.) and externally generated (e.g. published standards and methods).
Although not an exhaustive list, controls over internally generated documents should include and/or ensure:
- An indexing scheme is developed to uniquely identify each document.
- A master list is maintained that includes all current documents by name, number, revision level and distribution location.
- Documents are reviewed and approved by quality, relevant management (or management designee) and a representative of, or the user, of the document.
- Original documents are maintained in/by quality and are somehow identified as such.
- Changes are executed in a controlled manner.
- Distribution is controlled so that obsolete copies are removed from use after the document undergoes a change in revision.
- Obsolete original documents are maintained for historical and/or legal purposes and are unambiguously identified as “Not Current Revision” or equivalent.
The document control system is one of the first areas that is questioned and challenged during an audit. A tightly-controlled documentation system typically demonstrates a solid foundation and a strong commitment to quality control and quality assurance.
In the next issue, the Quality Management System Manual and the process approach to QMS will be discussed.
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Tricia Wood has more than 20 years of experience working in quality-related positions for several regulated industries, including pharmaceutical development and manufacture, medical device manufacture, and analytical services.