Proofreading is a critical quality control step in the process of ensuring that the packaging, labelling and artwork of finished biotech and medical devices is correct. Mistakes in this artwork can put patient safety at risk, damage reputations and lead to recalls. Therefore, ensuring that there are adequate processes, people, facilities and tools in place to perform high quality proofreading activities is essential.

For the purpose of this document, proofreading is taken to mean any activity which seeks to verify that the content of a finished document, namely the artwork, meets the appropriate requirements and its content is correct.

There are three elements to successful proofreading:

  1. Text content review

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 onto all relevant faces of the artwork and that none of it has been inadvertently changed
  • Secondly, checks should be made to ensure that critical information such as product name, strength and dosage is correct
  • Finally, it is important to check that the layout of the text has not altered its meaning
  1. Graphical content review

The graphical checks verify that all the graphical elements of the artwork are as required. Graphical elements may include logos, branding images and colours.

  1. Technical review

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 and varnish layers are correct.

Where to start

Companies who look to improve their proofreading capabilities generally feel it is necessary because they have had an artwork error that was identified as a failure in proofreading or is thought to be due to poor proofreading (these are not necessarily the same thing, it depends upon the thoroughness of the root cause assessment). In either case, the logical place to start is to assess the current state of your proofreading capabilities, so you understand what you have and what your issues are. The assessment needs to consider your processes, organisation, people, tools, systems and capabilities involved in proofreading. In many companies, this can impact a number of functions, depending on how responsibilities are assigned.

At Be4ward, we have developed a comprehensive Proofreading Gap Analysis tool to enable such assessments, comparing your company’s capabilities against best practice, a benchmark we have gained from our experience across the industry. This provides a comprehensive and structured output of improvements needed. From here the improvements to processes, role-definition, tools and systems can be defined. Be4ward has developed strawman materials for each improvement to facilitate development of your improved capabilities. In addition, Be4ward offers comprehensive training materials to help with staff capability.

What we've learned

In the past, proofreading was seen as a key competency within a labelling and artwork service. Skilled proofreaders were seen as a critical control in ensuring artwork was accurate and fit for use. Over the years, we have seen this capability eroded. It is now often difficult to determine where proofreading responsibilities lie within an organisation, training is limited and accountabilities are unclear.

Some of this change can be attributed to the adoption of electronic proofreading tools. These tools have brought many benefits, providing system solutions to many checks, reducing the risk of human error and dramatically increasing repeatability. We strongly advocate the use of such tools and they should be considered a prerequisite in any labelling and artwork service.

However, as with the application of most technologies, there is a downside to the increased implementation of such tools, the apparent ‘dumbing down’ of proofreading. Many companies now consider that the use of electronic tools solves their proofreading requirements and so skilled personnel are no longer required. Unfortunately, even the best electronic tools cannot undertake all checks required and the use of some tools requires capable operators. Therefore, we see that the requirement for skilled proofreaders still exists but is often a capability-gap in clients. Clear processes, capable personnel and comprehensive education and training are still essential for a fully effective proofreading service.