Once the existence of a Quality Management System (QMS) is established, the next thing to verify is that all artwork changes are managed within this framework. We have come across several situations where there was a good artwork capability in place, but unfortunately, it was not used to manage the creation or changes to all packaging artwork for the business.

Typically, it’s the products which fall outside of the mainstream of activity for a company that find themselves with no adequate packaging artwork management process. Product areas to look out for include:

When auditing artwork capabilities, look for these types of products and then seek evidence that their pack changes are being managed under a QMS which meets the standards we discussed in Tip 1.

 

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.

Cause 13 – Not proofreading all elements because of a lack of tools

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.

Packaging example

Cause 14 – Relying on electronic proofreading tools to do everything

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.

Table 14.1 Typical Proofreading Tools

table detailing typica proofreading tools

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.

Cause 15 – Electronic tools not identifying errors due to a lack of validation

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]

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 - 3, we looked at the first 9 causes of proofreading errors. Here in part 4 we study 3 further causes.

Cause 10 – Not ensuring that people have the right skills and temperament

If we were to list some of the attributes of someone ideally suited to the proofreading task it might look something like this:

• High process compliance focus.

• Strong attention to detail.

• High self discipline.

• A completer finisher.

• Ability to concentrate on a task for long periods.

• Happy working alone for long periods.

• Low natural tendency to subconsciously correct errors in text.

• Ability to resist management pressure to rush work.

Without these attributes, it is highly unlikely that an individual is going to be able to do a good job of proofreading if they are called upon to do so for a significant proportion of their time. Some would argue that, even if they only perform proofreading for small periods of their time, unless they have most of these attributes, they will still do a poor proofreading job.

Firstly, we would recommend selecting individuals who meet a profile suitable for proofreading if they are to be asked to perform proofreading duties for a significant part of their jobs.

Secondly, we would recommend that organisations look closely at the roles which are required to perform proofreading in the artwork process and consider if the typical skill set of individuals in these roles lends itself to effective proofreading. If not, then consideration should be given to changing the process to put critical proofreading activity in the hands of those with the appropriate skills.

Cause 11 – Not ensuring people have the right environment to work in

Proofreading requires concentration on often large documents for extended periods of time. A small desk and laptop in a busy, noisy open plan office is hardly conducive to performing this task well.

In all cases we would recommend that the office environment in which proofreading is performed has the following features:

• Ergonomic desk and seating design to ensure comfort for long periods of sitting still.

• Comfortable temperature for sitting still for long periods.

• Lighting suitable for long periods of concentration on documents containing small text.

• Quiet area, free from audio and visual distractions.

• Adequate clear desk space to lay out large documents and checklists.

If proofreading is to be done on-screen, then we would also recommend:

• Large high quality screens.

• Multiple screens to allow easy comparison of multiple documents.

Cause 12 – Not ensuring that people have quality time to do their work

As anyone involved in Quality will tell you that not providing adequate quality time to perform tasks is a sure way to introduce errors and non-compliance. Proofreading is no exception to this rule and seems to suffer particularly badly due to the nature of artwork changes and the position of proofreading in the artwork process.

Firstly, for many organisations, the artwork process is often poorly understood or appreciated. This often leads an organisation to systematically expect the tasks involved in the process to be performed in less time than can be reasonably expected.

Secondly, the nature of artwork changes means that they are often on the critical path of getting product out of the factory. This further increases the time pressures.

Thirdly, proofreading occurs towards the end of the process, at which point, any time pressures are magnified as things are often already running late.

It is easy for management to forget that, even if only small changes are being made, there is no essential difference to the time it takes to perform proofreading tasks.

Therefore, we would recommend that effort is put in to a number of things to help this situation:

• Explaining to the organisation the requirements of proofreading.

• Setting standard times for proofreading activity.

• Monitoring performance and taking corrective action where issues occur.

• Monitoring workload on proofreaders to ensure they have adequate capacity on an ongoing basis.

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]

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.

Cause 7 – Not Ensuring Source Data And Documents Are Correct

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.

Cause 8 – Not proofreading all instances of an artwork

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.

Cause 9 - Not using checklist to ensure everything is being done

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]