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 - 4, we looked at the first 12 causes of proofreading errors. Here in part 5 we study the final 3 causes.
One very simple reason for inadequate proofreading being performed is that the appropriate tools are not available.
At it’s simplest level, we have come across situations where there was no way for the proof reader to print out documents at full size and perform the required technical dimensional checks.
More often, this situation arises when features like barcode and Braille are present in the artwork. In these cases it is necessary to provide validated tools to inspect these features and report to the proof-reader what is found.
Furthermore, when considering features such as barcodes, the process must ensure that both the information contained in the feature is correct (e.g. the product code) and the specification of the feature is correct, e.g. barcode type, cell size, modulation, quiet zones etc.
Modern electronic proofreading tools provide an excellent way of minimising the risk of artwork errors going undetected. Table 14.1 lists the typical types of tools used during proofreading activity.
Firstly, before any such tools are used, they need to be validated, managed under an appropriate quality system and users need to be adequately trained to use them. Like all sophisticated tools, it is easy for operators to adjust settings and misuse them in such a way that the results will be misleading and errors will not be detected.
Secondly, all these tools have their limitations which must be understood and then the process designed to mitigate these short comings. As an example, many text comparison tools have limitations when it comes to comparing text in tables due to the differing ways that source document software and artwork graphical software manages the text in tables. This often leads to the need for manual proofreading of all tables in documents, which sometimes represent the majority of the artwork.
Furthermore, the residual risk of errors going undetected when relatively comprehensive electronic proofreading tools are employed can be significantly increased if the remaining manual activities are undervalued. The residual manual activity still needs to consider all of the causes of error we discuss in this document.
Proofreading is a critical quality control step in the process of ensuring that the artwork that appears on finished product is correct. Mistakes in this artwork can, and have, put patient safety at risk. Therefore, we would recommend that any tools that are relied upon to carry out part of the proofreading verification activity need to be validated and managed under an appropriate quality system.
The process of validation and subsequent management will ensure that the tools perform as they are intended to do so initially and on an ongoing basis.
We would caution against arguing that these tools are “just back-ups to the manual process” and therefore do not need to be validated. In our experience, once tools like this are in place, people rarely continue to perform a rigorous manual process, believing that the electronic tools will find any errors they miss. Clearly this is an unacceptable risk situation where non-validated tools are being used.
In our next blog we will look at the key bear traps in splitting an organisation’s serialisation operation. 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]