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.
For the purposes of this blog, proofreading is taken to mean any activity which seeks to verify that the content of a finished document, artwork etc. meets the appropriate requirements and it's content is correct. We will consider proofreading to include the
• Text content
• Graphical content
• Technical aspects
The text verification ensures three aspects of the text in any given artwork. Firstly, it is important to verify that text has been correctly transcribed from source documents. It must be verified that all text has been transcribed on to all relevant faces of the artwork and that none of it has been inadvertently hidden. Secondly, checks should be made to ensure that critical information such as product name, strength, dosage etc. is correct. Finally it is important to check that the layout of the text has not altered its meaning.
The graphical checks verify that all the graphical elements of the artwork are as required. Graphical elements may include logos, branding images, colours etc.
The technical review ensures that all other aspects of the artwork are correct. This will
include checks to ensure that items such as dimensions, barcodes, varnish layers etc.
Just like any other task, anyone responsible for performing proofreading activities needs to understand exactly how they are supposed to perform each task in an optimal way. Work instructions and procedures should be designed to explain exactly what needs to be done and the best methods for carrying out individual tasks. As we discuss later, the specific methods used in proofreading are particularly important given the human mind’s ability to subconsciously correct mistakes without an individual being aware of it.
Education and training needs to ensure that these work methods are explained, demonstrated and practiced sufficiently in order to ensure that people can reliably repeat the tasks required of them each time they are required to perform them. Particular attention should be paid to people who will not perform their proofreading tasks on a regular basis, or who perform the tasks in isolation, to ensure that methods are consistently and completely adhered to.
Given the critical role of proofreading in the artwork context in ensuring that artwork mistakes do not find their way into finished products, the competence of individuals should also be verified before they are allowed to proofread production artwork. Answering a small number of questions to demonstrate a procedure has been read is very unlikely to be adequate to ensure proofreading competency.
As we discussed in the introduction, proofreading in the context of this discussion consists of a number of distinctly different types of checks. Furthermore, artwork typically contains information from many different sources. We have observed many instances where individuals are asked to check a document, but when asked, they have little or no idea exactly what they are being asked to check. At best this results in several checks on the same information being performed. At worst, it results in elements of the artwork not being checked at all, with the inherent risk that errors will then make their way through to the finished product.
Another symptom of a lack of clarity in this area is that comments and requests for change come from people who have no accountability or responsibility for the element of the document being commented upon. This tends to lead to inefficient operations
and extended lead times. Therefore, it is essential that any individual asked to perform a proofreading activity is clear exactly what they are being asked to check. Furthermore, it should be recognised that it is highly likely that different people will be required to check different things during the overall proofreading and approval process.
Packaging artwork contains information and elements such as barcodes and Braille from many different sources. In many cases, this information becomes available, or final, at different stages in the process of preparing and approving the artwork. We have encountered situations where artwork has been proofread and approved at a stage in the process where all the information was not yet included in the document. Subsequently, this information was added to the document without further adequate proofreading activity being performed. Clearly this situation introduces the risk that the new information added to the artwork is incorrect and finds its way onto finished product unchecked. Furthermore, as we will discuss in greater detail later, there is also the opportunity for inadvertent changes to be made to the artwork during this information addition which again could find their way onto finished product. Therefore, the artwork process should ensure that all elements of the artwork are present and appropriately proofread.
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]