Quality can be built in to your systems… and it should be.
For those of us who want to build and run a successful and consistent wholesale business, standard operating procedures are a good start… but not everything.
If you have Standard Operating Procedures (aka SOPs) do you follow them? Are they reflective of the processes in your business, do they prevent confusion and miscommunication from the spoken word?
SOPs are just the start of your Quality Management System.
A Quality Management System is a GDP requirement, but can benefit you in many other areas of business or life.
So what is a Quality Management System?
A Quality Management System, or QMS, can be described as;
“The organisational structure, procedures, processes and resources needed to implement quality management.”
Problems at home? Build your own quality management system or success system, almost an expansion on house rules, but defined;
1) Take off your shoes when you come into the house
2) Always say please and thank you
3) Eat your vegetables
4) Clean up after yourself, leaving the room as you found it
5) Bring your wife flowers, and nice surprises
You could create a protocol for anything that comes up in your life as a problem.
Do you run a restaurant or cafe, and have mixed reviews?
Start by setting up your standard operating procedures;
Process in place, and working? Good… next step.
Your quality and service drives your business, and it’s your responsibility to maintain it… unless you don’t care or have given up.
So… In relation to Good Distribution Practice Quality Management Systems, how do we build a good one?
– Start with your essential Standard Operating Procedures, ensuring that they are compliant with the EU Guidance to GDP, 2013/C 343/01. Ensure that this reflect what you do!
– Ensure you have sufficient, competent (and confident) personnel.
– Make sure your facility is up to standard, and all equipment is serviced/maintained/calibrated/validated as required.
– Understand your processes, and ensure that all responsibilities and duties are listed (have an available deputy). An organisation chart works well here.
– Break processes down into logical, bite size pieces.
– Create flow charts and pictures if it helps. Don’t forget to version control and index these to your SOPs.
– Put checks and double checks in place.
– Make sure you include Quality Risk Management principles in everything you do.
– Ensure all critical steps are clearly defined and systematically reviewed. We recommend monthly quality and improvement meetings – can include elements of management review, self-inspection, review of changes, deviations, complaints, CAPAs, etc.
– Ensure all change is managed.
– Ensure that computer systems are validated, and that records are stored safely and accessibly for at least five years. Storing data with suitable backup is essential, as well as making sure that the most up to date copies of all documents are the ones in use at any given time.
Remember that evidence is king… if you haven’t documented it, you haven’t done it!
Remember that your quality and customer service drive your business, and that your Quality Management System must encompass;
– The organisational structure
– Any activities necessary to ensure confidence that the product remains within the legal supply chain during storage and/or transportation.
Remember that a decent GDP Quality Management System can take 2-3 years to fully evolve, as you learn and develop your processes. A set of SOPs from a colleague is NOT a good start, especially if you’re not planning on tailoring them to your company.
Would you like a bespoke QMS/Quality Management System writing, or a review of your existing one?
Contact us for a free, no obligation conversation.
Welcome to a new paradigm!
12 Feb 2019
24 Jan 2019
24 Jan 2019
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