The top 15 reasons why pharmaceutical labelling and artwork proofreading fails to identify packaging labelling and artwork errors.
Proofreading is a critical quality control step in the process of ensuring that the packaging labelling and artwork of finished pharmaceutical product is correct. Mistakes in this artwork can put patient safety at risk. Therefore, ensuring that there are adequate processes, people, facilities and tools in place to perform high quality proofreading activities is essential to patient safety. This blog series identifies a number of errors which are typically seen in the design and execution of proofreading capabilities which should be avoided to ensure a quality proofreading result. Whilst this blog is written specifically with packaging labelling and artwork proofreading in mind, many if not all the points hold true for proofreading activity of any documentation or design. In parts 1 and 2, we looked at the first 6 causes of proofreading errors. Here in part 3 we study 3 further causes.
The act of proofreading inevitably means verifying information from source documents or systems with the information contained in the finished document. Many artwork errors have occurred because individuals have used the wrong source data or documents.
The first example of this would be the use of personal stores of information or documents. This circumstance frequently occurs when corporate information sources are difficult to access or use and individuals resort to holding their own store of information to make their jobs more efficient. The obvious risk here for proofreading is that the source information that is referenced from the local store is, in itself, incorrect. This may be because it has been incorrectly transposed by the individual collecting it, a situation often occurring when individuals collate their own spreadsheets of information useful to them in their day to day work.
Alternatively, the information may be drawn from a document which has subsequently changed in a later revision. Because the source document was held in a local uncontrolled store, the individual is not aware of the change to the information being checked.
Therefore, we would recommend that work instructions state clearly where source information is to be taken from in order to perform the proofreading activity effectively. It is important that anyone providing source information to the artwork process is responsible for ensuring the accuracy and currency of that information.
Artworks often exist in a number of different forms, each one having subtle differences. Take for example the situation where a single artwork is used to create one or more print ready files for one or more printing machines. In this case the artwork, although ostensibly the same, is actually two or more different artworks.
For reasons we discussed in 'cause 4', it is easy to assume that these different instances of the artwork are the same for all material purposes. After all, the printer’s artwork file only has some specific printer codes and markings added to it. Nothing in the artwork that will appear to the patient is changed. By now you will have realised that, even if the intent is not to change the artwork when creating these instances, it can happen by mistake.
Unless there is a validated method that prevents material changes to the artwork occurring, we would recommend that each time any iteration of the artwork is created that it is proofread appropriately.
Proofreading requires a great deal of concentration and can often take a considerable period of time. For example, it is not uncommon for a manual proofread of a long multi-language leaflet to take a day to complete. Furthermore, because of the nature of the task, proofreaders need to take frequent breaks to maintain adequate levels of concentration whilst proofreading.
Given that proofreading requires people to repeat many detailed tasks over a long period of time, it is not surprising that it is easy to forget to do certain tasks unless there is some aid memoir built into the process.
Checklists provide an excellent way to remind people of the detailed tasks they need to perform during each and every proofread and give them a convenient way to record their progress. Completed checklists can also form a useful part of the audit trail for a change at critical verification and approval points.
In our next blog we will look at three further causes of proofreading errors. In the meantime, if you have any questions, thoughts or feedback to share with us or indeed if we can help you with your proofreading matters, please get in touch on [email protected]