Navigating Quality Management Systems
With continuous press reports on product recalls ranging from automobiles to pharmaceuticals to baby cribs, quality management (QM) takes on every greater importance for company management, its personnel, customers and shareholders regardless of size, product or service. The cost of product recalls in terms of lost revenues, reputation and lawsuits – let alone loss of life or health – presents a strong case for strong quality management systems in any company.
QM systems can be broadly divided into quality practices and quality standards. Learn which of these apply to your organization. Compliance procedures should be carefully spelled out in your company’s operation manual. Record-keeping is crucial. These must be maintained in a safe location and accessible by qualified third parties.
Some Examples of QM Practices
Here are some examples of QM practices. Detailed information on these and others is available on the Internet.
Good Laboratory Practice (GLP) looks at the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. They are intended to promote the quality and validity of test data.
Good Manufacturing Practice (GMP) – those relating to the FDA – are regulations enforced by law to ensure that products are safe, pure, and effective.
A certified calibrated HPLC liquid flow meter such as the FlowCal 5000 available from Tovatech is an important tool to support both GLP and GMP. Another useful tool is a Kern moisture analyzer, also available from Tovatech.
Good Clinical Practice (GCP) is an international quality standard that is provided by the International Conference on Harmonization (ICH). This international body defines standards that governments can transpose into regulations for clinical trials involving human subjects.
Equipment Validation
In a regulated laboratory newly installed equipment must be validated before being put into operation. This is often done by third parties such as Quality Solutions, LLC, which is used by Tovatech. Firms such as these offer documented calibration and validation services to satisfy initial and periodic audits by the FDA or other regulatory bodies.
As an example, installation qualification (IQ) documents that the installation adheres to approved specifications and meets design criteria.
Operational qualification (OQ) verifies that equipment meets its design criteria over the defined operating ranges and defined challenges.
Performance qualification (PQ) verifies that the equipment continues to do what it should be doing when in actual use. Periodic validation may be scheduled over the equipment lifetime.
The FlowCal 5000 liquid flow meter is widely used to support FDA compliance for IQ, OQ and PQ validations for HPLC pump flow rates.
Representative ISO Standards for QM (published by the International Organization for Standardization)
ISO 17025 specifies the general requirements for the competence to carry out tests and/or calibrations and outline what a laboratory must do to become accredited.
The ISO 9000 family of standards represents an international consensus on good quality management practices.
ISO 14001 focuses on environmental management systems.
Good quality management practices are essential to any company, but have added significance in the pharmaceutical, chemical and healthcare fields where personnel and customer safety are key issues to be addressed. Properly developed QM procedures will result in processes that are efficient, that are in compliance with regulations, that can lead to product and process improvements and leave a “paper trail” that can be easily followed.
—————
What QM practices are employed in your organization? How recently have they been reviewed and revised?
