WL and WDL holders have to have a QMS or QRS in place by September of this year, many are finalising their SOPs as we speak .
PCL would like to offer some basic tips and hints:
Keep it simple, use as little jargon as possible , do not see the QMS SOPs as a set of rules to be followed or broken as the case may be.
Look upon them as a ” Risk based continual improvement” tool , a vehicle for everyone in the organisation to be involved with and to help manage risks and deliver the highest quality of both service and product in order to keep your customers, patients and fellow workers safe.
Often organisations and their management are reactive to their shortcomings and this would be seen as corrective actions, but a true risk based quality management system should have proactive risk assessments as an integral part of the system. Corrective actions rarely lead to sustained improvement , it just fixes the problem for the moment. Sales led entrepreneurial organisation are high risk takers where quality professionals are risk averse and this is the true dichotomy. A QMS needs everyone, sales teams should be reminded that without sustained quality products they will not see continual growth and quality professionals need to be mindful of the commercial aspects of the business and if they have no sales they will have no job.
The secret is to involve everyone, there is no ” I ” in team and everyone has a valuable point to make. When the SOPs are reviewed formally ask for comments and feedback it is amazing what you might learn. Encourage everyone to use the change management “Request a change forms” these may be discounted at the first hurdle, usually the department manager, however they may make it to the quality department they will review the request and will issued and log the official change management form.
The suggested change should be risk assessed in a proactive manor and may be piloted prior to being rolled out across the whole business. Large changes which may impact on many other processes or procedures , may require a ” CIP” a Change Management Plan to mitigate some of the risks identified by this process.
Hold monthly quality review meeting and set an agenda. Discuss customer complaints and deviations and carry out your root cause analysis and follow this through into your management reviews and the change management process.
Set a review date to review your changes and they may require fine tuning, encourage feedback ! Two way communication is good, it helps the QMS come alive .
Remember it is a living breathing process , it is the delegation tool for the management team and it will mitigate your risks and help you to deliver consistent quality.
Finally with any good system it has to have the buy in of everyone to make it effective and it must be lead from the top