Quality Management Systems

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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?

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 café, and have mixed reviews?

Start by setting up your standard operating procedures;

– Opening and closing protocols,

– Advise your staff how they should interact with customers.

– Ensure that there is consistency.

– Clean down tables quickly and wipe down and DRY the table. Nothing worse than a sticky, crumb laden surface, eh?

– Consider leaving a comment card, with the servers name for each customer, offering 10% off next visit for a genuine review (which hopefully is positive).

– Have a floor manager who carries out this role if you have concerns that you aren’t getting genuine feedback…. or install and review video camera footage.


Process in place, and working? Good… next step.

– Replicate your wins, and reviews your fails.

– Trend activities.

– Learn from your mistakes.

– If you identify that most complaints are about the same individual(s) then it’s time to retrain or release.

– Pick staff who care and have the right work ethic and attitude… then train them into excellence.

– If staff names keep coming up in a negative way, then they don’t fit your company.

– Create a staff charter and get your teams to decide how they wish to set the standard. It’s all well and good delivering rules as a boss, but let your teams decide the expectations and punishments for tardiness, absence, lack of engagement etc.

– Don’t forget to focus on the positives and how people wish to be treated, supported, inspired, trained.

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 – training is essential.

– 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

– Procedures

– Processes

– Resources

– 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.


Need help?

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!


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