We live in a world where we constantly deal with documents in different interchangeable formats. Rarely are the documents we deal with today created on paper, normally they are created electronically and shared using a number of different electronic and paper formats. Artwork and it’s associated documents are no different.

It must be recognised that different documents may need to be prepared using different software tools, e.g. MS Word for source text documents, Adobe Illustrator for artwork, etc. It is often not practical or desirable to share these “native” documents using their creation tools. Therefore, facsimiles of these native documents are created and shared (see Tip 16). This immediately creates different forms of the same document.

Also, electronic documents may need to be printed, signed, scanned and submitted into an electronic records system. This again creates other forms of the same document.

What must be ensured in the process of dealing with these various forms of a document is that everyone is seeing the same thing when they should be.

When auditing artwork capabilities look for procedural evidence that the methods by which users view documents, particularly during review and approval are defined. This will typically be on screen or via printout.

From an information technology perspective, look for evidence that the risks of errors being introduced in rendering artwork images and printouts have been considered and that the appropriate risk mitigations have been put in place.

As with all document management activities, it is essential that everyone is clear which iteration of a document needs to be used at any particular time in the process.

Many errors have occurred in artwork management processes because this has not been clear. For example, necessary changes have been accidentally omitted because a previous iteration of a document was carried forward in the process. Alternatively, approvals can be incorrectly given if the wrong iteration of a document is used by the approver.

One solution to this problem is to ensure that there is a robust document revision numbering system put in place which:

• Ensures that each iteration of a document is given a unique revision or version number.
• Each and every time a document is modified in any way, that it’s revision or version number is changed.

In this way there will be a high degree of confidence that all iterations of a document can be clearly identified to everyone concerned.

When auditing artwork management processes, look for procedures which govern how revisions to documents will be managed. Pay particular attention to areas of the process where small changes to artworks may occur on a regular basis and ensure that unique version numbering is applied here as well.

An adequate audit trail should be maintained to ensure that it can be demonstrated that the process was carried out completely and correctly.

It can also be beneficial to record additional information in the audit trail to assist with continuous improvement activities. For example, where an error is detected in an artwork during routine checking, it can be beneficial to capture reason “codes” for the errors in order to facilitate easier analysis of the process performance.

Typically, the audit trail would include the following:

• All approved documents, both specifying the requirements for change and the resulting artworks.
• Signature records from all approving stakeholders.
• The results of all critical quality checks.

A company needs to have a mechanism in place to ensure that the audit trail is maintained for the minimum period as required by local regulations and as defined in their corporate record retention policy. All audit trail records need to be kept in a manner that will prevent their loss in the event of such occurrences as fire or theft.

Look for evidence of audit records containing all of the above items when auditing artwork capabilities. Referring back to Tip 2, look for this evidence for all areas of the business, product groups, geographical regions, etc.

It is important that checks are carried out to verify that changes to an artwork have been performed correctly and that no unintentional changes have been made by mistake. For this latter reason, we would recommend carrying out full checks at all verification steps, regardless of the scope of the change that was intended to be made. We are aware of many instances where unintentional changes have occurred to an artwork that would not have been picked up if people were only verifying that the intended changes had been made correctly.

Typically, artwork checks are categorised into four areas:

• All text, characters and symbols are present, correct and, where appropriate, consistent with source text documents.
• All graphical elements are present and correct.
• The intended meaning of the information is clear and as intended.
• All technical requirements have been met, e.g. barcodes, Braille, size, varnish finish etc.

Clearly, in order to verify the above, the individuals performing the checks need to have access to the appropriate requirements information. This is one of the reasons why we would recommend the preparation and formal approval of a change requirement or “brief” document to be included in the artwork process.

It may also be appropriate for different people to verify different aspects of the artwork. For example, qualified proof readers may carry out detailed text and symbol verification activity, whilst local country representatives might verify that the intended meaning of information is still clear when laid out on the artwork.

As an auditor, you should look for evidence that all aspects of the artwork are formally reviewed at the appropriate critical control points. Furthermore, it should be clear who is checking which aspects of the artwork and that all aspects are being verified.

In our opinion, ensuring that the roles and responsibilities are clear for the artwork process is important for a number of reasons.

Firstly, it is critical that, where an individual needs to carry out tasks in the process, they are clear which specific tasks they are expected to complete. Poor definition of roles and responsibilities will often leave detailed task responsibility ambiguous. At best this may mean that certain activities are performed by multiple individuals unnecessarily, wasting some resource effort. At worst, tasks will be omitted completely, leading to the risk that artwork errors will occur.

Secondly, for the end-to-end process to be robust, it is imperative that all the right stakeholders are involved in each step of the process, particularly at review and approval stages. There should be safeguards in place to ensure the appropriate minimum stakeholder involvement at each stage of the process.

When auditing artwork capabilities, look for evidence that roles and responsibilities are defined for all steps of the process. Furthermore, check to ensure that there is a mechanism to define the appropriate stakeholder involvement in the process and then ensure that that involvement is achieved.

 

Having established the status, scope and critical controls of the artwork management process in the relevant Quality Management Systems, the next area to look at is the definition of the process activities themselves.

Given the detailed nature of the artwork process and the fact that it often involves many individuals from all over the world doing the same tasks, it is important to ensure that the description of tasks are sufficiently detailed to ensure work is carried out consistently, completely and correctly.

To achieve this, companies employ a variety of different process documentation tools, each with increasing levels of detail contained within them. Typical document types may include:

• Policies.
• Standard operating procedures (SOP).
• Checklists.
• Work instructions, guidelines, job aids.

We often find that the process is only documented in SOPs at a very high level, with the focus being on “what” needs to be done, and very little explanation of “how” activities must be performed. It is our experience that, unless there is consistency around “how” critical tasks in the artwork process are performed, there will be a high risk of artwork errors.

When reviewing an artwork capability, look for evidence that the way in which key activities are to be performed is documented at a level of detail that will ensure complete and consistent execution of the tasks.

 

We have encountered a number of occasions where errors occurred because the artwork that is initially developed and approved by the relevant stakeholders is not complete. Subsequent additions to the artwork, say to add product barcodes, create errors which are then not caught in any subsequent quality control steps.

For this reason we would recommend that, when approved by the necessary cross-functional stakeholder group, the artwork is complete with respect to all information that will be presented to the prescribers and patients.

Furthermore, any information on the artwork which is used to identify it throughout it’s subsequent development or use should also be present at this time. This helps avoid gross errors caused by the wrong artwork/packaging component being used.

In addressing this last point, it will often be necessary to understand how any 3rd party service providers identify artworks and packaging components in their processes.

We have observed many artwork errors occurring because the artwork process has continued despite the fact that a previous stage of the process has not been fully completed.

A typical artwork change management process will divide the development of new or changed artwork, and it’s subsequent implementation, into a number of logical steps. Ensuring that there are clear control points in the process that must be fully completed before proceeding is a useful way to minimise this risk.

Typical control points might include:

• Approval of the definition of the change requirement.
• Approval of the artwork.
• Approval of any printer proofs.
• Approval of packaging components for use.
• Batch release to ensure correct version of artwork used.

Look for evidence of clear control points in the process when auditing artwork capabilities. We would suggest that these control points should include the requirement for the appropriate group of stakeholders to sign that they are happy to proceed.

One of the most basic causes of artwork error is not carrying out every change that is necessary as a result of a change trigger. For example, if a local regulator introduces a new packaging regulation requirement, one of the first questions that needs to be answered is: which markets; products; packs; components and therefore artwork is impacted.

For this reason it is critical that there is a robust process in place to assess the impact of any trigger for change and ensure all the existing and new packaging components which are impacted are identified. For each component that is impacted, there needs to be a robust mechanism to ensure the required changes actually occur.

This is often achieved by formally triggering an artwork change process at this point.
For changes such as critical safety changes, it may also be necessary for a company to be able to report on the successful completion of the resulting pack changes to some external regulators.

When auditing artwork processes, we suggest you look for evidence of the following:

• Change triggers are documented in a formal change control process.
• An effective impact assessment is carried out to identify ALL impacted markets; products; packs; components and therefore artworks.
• The artwork change process is triggered for all artworks identified in the impact assessment.
• The original change control is not closed until successful completion of all impacted artwork changes.
• There is a management mechanism in place to address artwork changes that were identified as necessary in an impact assessment, but have either not been triggered or completed on time.

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.