SMS-oncology: Q, Q, Q!
26 October 2015, Paul Mooney, Consultant Quality Manager
SMS-oncology’s Quality Management System (QMS) is currently being overhauled to facilitate better compliance with International Conference for Harmonization - Good Clinical Practice (ICH-GCP) guidelines and with the EU “Clinical Trials Directive”, and to improve its effectiveness.
To do this, we are replacing/merging our 160 existing Standard Operating Procedures (SOPs) into a new set of about 70 new SOPs, accompanying supportive templates, and another 20 manuals and policies. Staff are gradually being trained as the new documents are implemented. This initiative has also prompted us to decide not to pursue our ISO 9001:2008 certification; we are instead focusing on industry specific reQuirements and client needs.
We realize that, historically, “Quality” has often been perceived as a “necessary evil” whereas at SMS-oncology we think it should be perceived as a “learning opportunity”. With this idea of continuous improvement in mind, we have come up with a series of “Q,Q,Q” mnemonics (we’ll not go as far as calling them “Quality Qommandments”). We hope these will help all readers realize the importance of Quality in our industry and understand how it can be incorporated into their daily work:
- Quiet Quest for Quality – SMS-oncology’s mission is to keep on striving towards the highest possible Quality standard, ultimately for the benefit of the patients we are trying to help, i.e. we are Quietly but steadily continuing to improve the Quality of our work all the time.
- Quit the Quality Quibble – Quality is high on competitors’, customers’, investors’ and regulators’ agendas. We must therefore not hesitate to allocate time and resources to improve the Quality of our work; its importance should not be disputed.
- Quash Quaky Quality – Mistakes and occasional slippage in Quality standards are almost inevitable but should be minimized. Regular training sessions provide a platform for healthy and informative debates, and actively encouraging feedback and suggestions for improvement from all staff has shown to be helpful.
- Questions at Quality Quorum – SMS-oncology’s QA team has an open-door policy, i.e. there is an informal QA Q&A (Questions and Answers) service. These Q&As can be compiled into an database accessible to all staff or discussed openly at project or staff meetings.
- Quality Quotas Quantified – In order to assess compliance by staff, vendors and sites, it is appropriate (and indeed mandatory) to measure these stakeholders’ performance through audits and/or Quality Control (QC) mechanisms, i.e. to Quantify the Quality.
- Quick Quality Quandaries – Trial personnel can Quickly deviate from the protocol and/or ICH-GCP. As a result, patients may be withdrawn, the site closed and/or data deleted from final analysis; hence the importance of training, communication and constant monitoring.
- Quintessential Quality Quirks – Across the industry, inspectors’ and auditors’ findings show recurrent problems with (1) patient consent form completion, (2) protocol adherence, (3) patient records and source data verification. SMS-oncology knows these fundamental issues need special attention.
- Quotable Quality Quips – The following findings are also often Quoted, they are recurrent all over the world: (1) filing not up to date; (2) information sent to/from Ethics Committee incomplete; (3) product accountability, handling and/or storage unsatisfactory; etc.
So, remember to think Q, Q, Q!
Thank U & Thank Q.