Non-Conformances & Deviation Management

Unaware of non-conformances and deviations?

When a lack of adherence or poor attention to detail creeps into the daily activities of a licensed premises, the site can quickly fall into a non-compliant state…  

It can be all too easy to find yourself choosing to ignore “small” non-conformances and unplanned deviations, believing them to be too small to warrant a CAPA. Or it might be that you’re too busy and may forget. We suggest that this points to more systemic issues, like lack of sufficient competent personnel, or lack of a dedicated quality function. 

Consequences of overlooking them may be:

~ Abberations in Documents
~ Improper handling of goods
~ Unscripted Procedures being copied by other personnel
~ Poor tracking of stock movement throughout the GDP process
~ A compromised Quality Management System
~ Compromised loading or unloading of goods
~ Compromised storage procedure and quarantine actions
~ Goods requiring specialist storage (eg; cold chain) at risk
~ Enhanced likelihood of falsified / counterfeit medicines slipping through checking procedure

All of the above would be picked up by an inspection, and it would be very difficult to explain away or justify. Consequences will almost certainly be embarassing and costly.

The risk of ignoring these small things, is that they can mount up and become a significant larger issue, especially at regulatory audit. Any deviation or non-conformity should be investigated, root cause found, and appropriate corrective measures applied, and learnings shared. 

A planned deviation, whether temporary or permanent, should be captured as an approved change control. These occur by design; an example would be a potential improvement to a Standard Operating Procedure being tried out. The correct SOP for this action would apply here. Whether planned or unplanned, our training course shows you how to process and manage deviations and non-conformances.

Patient Safety

Correctly following procedures and abiding by Good Distribution Practices when managing and processing Deviations (planned or unplanned) and Non-Conformances, means risk is mitigated both for the product, and the patient. 

Deviations & Non-Conformances Management Training

Management of non-conformances and deviations require specific procedures and protocols to be observed and engaged at all times. Planned deviations also require specific procedures to follow.

It would be very unwise and a high risk (not to mention illegal), to attempt to manage these issues with no apparent formal training.

We Can Help

Paradigm Shift Consulting have a comprehensive training platform, which includes a course specifically for the Management of Non-Conformances and Deviations. The course is clearly laid out and well priced. New start-up businesses are encouraged to engage general GDP Awareness training at the outset. Successfully completing the course will produce a certificate that is valid evidence of training, and presentable to inspectors, valid for 12 months.

Everything that Paradigm Shift Consulting does, is designed to help you do your job correctly and in a way that is with GDP compliance. We never “take the money and run”. However, if we can see you heading into dark and dangerous waters, we will advise you to stop what you are doing, and do everything we can to steer you away from (very expensive) trouble.

We treat your business as though it were our own.

Get In Touch

If you or your staff do not have GDP certification for this topic, apply for training as soon as possible. If you’re just getting started, train your staff immediately, as you cannot have staff engage their tasks without initial certificated GDP training (EU GDP Guidelines 2013/C 343/01, Ch 2.4, para 1).

You can call us anytime between 9am and 5.30pm GMT for advice, or contact us with your enquiry using the form below, quoting “Deviation Management” in your message.