4 Packaging Artwork Errors To Avoid — And Their Implications

By Stephen McIndoe, VP Consulting, Be4ward

Packaging artwork is often a forgotten back room process in most pharmaceutical companies, but the changing business environment has brought issues from this capability to the fore. Pharmaceutical and other healthcare companies are facing one of the most difficult periods in their history. Current products are rapidly going off patent leaving significant revenue challenges. At the same time, weak product pipelines are failing to fill the gap. Furthermore, global markets are changing rapidly, traditional mar­kets are stagnating, and new markets are evolving at a rapid pace. Everywhere, key healthcare purchasers are putting increasing pres­sure on drug prices.

In response to these significant challenges, pharmaceutical compa­nies are looking to make the most out of their current assets. This often manifests itself in a drive to launch as many product variants in as many markets as possible. For the traditional molecule-based global pharmaceutical companies, this represents a significant change in strategy. The rapid growth in the number of drugs coming off patent, together with the increasing pressure on price from the major purchasers, has led to a huge opportunity and growth for generic pharmaceutical companies. For them, the challenges are very similar to the phar­maceutical companies — namely to market as many product variants in as many markets, as quickly as possible.

In today’s world, all drug companies have an increasing need to develop and maintain an excellent reputation with a diverse group of stakeholders. Pharmaceutical companies are looking to develop and maintain trust with governments and purchasing groups in order to help maintain the product prices necessary to support their significant drug development spending. The increasing competition amongst generic companies means that they each need to develop and sustain their reputation in order to win business and maintain their production licenses.

Maintaining this reputation while rapidly growing the number of products is particularly challenging, considering  that one of the largest single causes of product recall is due to packaging errors. Regulators around the world recognize this and have focused on driv­ing improvement in all business capabilities associated with the management of packaging design and manufacture.

When launching product variants in new markets, much if not all of the physical packaging design is already established. The text and graphics, or artwork as it is known, that are placed on these physical components is what changes every time. It is this artwork design and maintenance capability that becomes critical to achieving and maintaining the objectives of both pharmaceutical and generic drug companies.

For a large global pharmaceutical company, developing artwork for tens of thousands of products is typically a process involving thou­sands of people, in over a hundred countries, from tens of different organizations. To orchestrate all of this activity, the right combina­tion of business processes, organization design, information technol­ogy, facilities, and suppliers has to be managed.

For smaller organizations, though on a lesser scale, face the same challenges.

Packaging Artwork Errors To Avoid

So, what are the types of packaging labelling and artwork errors (which we refer to as “artwork errors”) that occur and how do their significant and far reaching impacts affect the companies involved?

We categorize artwork errors into four groups for the purposes of discussion:

1. Gross errors

This is where significant information is omitted from an artwork. An example would be completely missing the need to change a piece of artwork in response to a new regulatory requirement.

2. Context and meaning errors

This means that information is presented in an ambiguous or incorrect way on the artwork. An example of this might be the inappropriate use of hyphenation, causing ambiguous or incorrect meaning.

3. Content errors

Where there are errors and omissions in the detailed content of the artwork. An example of this would be incorrect symbols being used in the artwork.

4. Technical errors

In this case,  there are errors or omissions in the technical aspects of the artwork. An example of this would be the wrong specification of barcode being used in an artwork.

The Harmful Implications Of An Artwork Error

The implications of an artwork error can be as far-reaching and serious as any other error with the supplied product. Artwork text and graphics describe the product and provide information and instruction for its safe and effective use.

1. Impact On Patients: The bond between the patient and their medicine is deep-rooted. Patients trust that the product will make them better and expect that it has been developed, manufactured, and supplied to the highest quality and ethical standards. Errors in the information provided with the product are significant and can be life-threat­ening. We are sure that you will agree that this risk to the patient’s well-being is not acceptable, and their confidence in the treatments they are taking must be maintained. Trust is easily lost and almost impossible to recover.

2. Impact On Prescribers: All prescribers (whether doctors, pharmacists, nurses, or other healthcare professionals) are busy people with a clear mission – to make the patients they treat better. They expect that the products and information they are provided with are fit for purpose, error-free, and safe to use. They don’t want to administer products that will make their patients sicker. Rectifying the patient issues cre­ated by artwork errors is a burden they neither want nor welcome. Furthermore, the remedial action following an incident diverts their limited resources away from their core purpose

These healthcare professionals are often the final decision makers when it comes to selecting the product that is prescribed or used in the future. Hence, any lack of confidence that they may have in a particular product, brand, or company can have a direct impact on the products that get used.

Also, it must not be forgotten that there is a serious per­sonal impact for some prescribers involved in incidents leading to patient harm. Indeed, a number of prescribers involved in such incidents go on to leave their chosen profession altogether.

3. Impact On Regulators: The remit of the pharmaceutical regulators, among other things, is to set and enforce the standards by which the industry must operate to ensure patient safety. They have the authority to allow or block product use and the power to take punitive action against companies who they see fail to meet expected standards. The regu­latory environment is becoming ever more complex and stringent, and there is less and less tolerance for artwork error. Moreover, as we have already observed, the information age means that an incident in any country has visibility to all regulators worldwide.

It is therefore understandable that regulators expect companies to be continually striving to eliminate artwork errors, and take appropriate actions to reinforce that view.

4. Impact On Pharmaceutical CompanyStaff: Two groups of pharmaceutical company staff are typically impacted by an artwork error: the team managing the recall and the operations teams who support the artwork process in which the error occurred.

The team managing the recall needs to focus on the immediate and urgent tasks related to identifying the impacted product, with­drawing it from the supply-chain, and reinstating adequate supply as quickly as possible. While challenging, this work is, more often than not, very motivating for those involved — as a great deal of satisfaction can be derived from solving the immediate and significant recall problem.

The impact on the staff involved in the operation of the artwork process is somewhat different. Not only are they likely to be involved in the rectification activity, they will be heavily involved in the incident enquiry and corrective and preventative actions. Furthermore, there are the undoubted performance and morale issues that will likely need to be addressed.

5. Impact On The Company: The impact on the company can be significant. The patient safety implications are counter to any pharmaceutical company’s core values. This is compounded by the sales, reputation, and sanction impacts, through unfavorable publicity, loss of customer con­fidence, possible loss of licence, and increased regulator scrutiny and action. As we discussed earlier, in today’s business environ­ment, these impacts are potentially significant to the success of the company.

The cost impacts of these errors are also substantial. There are the immediate tangible costs of recall, product write-off, repacking, and market re-supply. However, these can be overshadowed by the less tangible follow-on costs occurring through loss of sales and market share, customer reimbursement, and litigation. In the extreme, these not only impact the bottom line, but can directly influence the company’s share price.

So How Do These Errors Occur?

There are a number of causes of artwork errors and we we have divided them into eight categories to discuss below.

1. Process gaps and inconsistencies : Alternatively termed as systematic errors, these occur when the design of the business processes are incomplete or conflicting, leading to errors in the content of the artwork. A typical example of this would be a gap in the process definition for the provision of a particular piece of information.
2. Lack of competence : Here, operators do not have the necessary skills, knowledge or instructions to carry out the tasks that are required of them in the business process. This may be due to issues such as an inadequate level of process definition or inadequate training and competence assessment.

An issue of particular concern in artwork processes which we discuss later is that of ensuring the competence of people who only perform tasks in the process very infrequently.

3. Lack of quality time : It does not matter how competent people are, if they do not have enough quality time to perform the tasks required of them then they are likely to make forced errors of one form or another.

A lack of quality time to perform tasks is typically due to unrealistic process step times being expected, or an overall lack of adequate resource headcount. Clearly, this may also be a symptom of ineffective process and/or tool design.

4. Inappropriate decision-making : In this type of situation, people will make inappropriate decisions during the execution of the business process which lead to errors in the resulting artwork. For example, management may set priorities which are interpreted by operations staff to put moving an artwork to the next stage of the process ahead of doing a task completely and correctly.

5. Ambiguity : The artwork process involves many individuals providing detailed instructions to other individuals in the process, with the resulting opportunity for ambiguity in these instructions to lead to errors in the artwork. A lack of templates or instructions on how to pass on information and instructions in an unambiguous way can be examples of this type of issue.

It must be remembered that many people working in the artwork process do so in their second language. This in itself significantly increases the possibility of individuals misinterpreting instructions which are not entirely clear.

6. Errors in source information: The age-old phrase “garbage in, garbage out” applies very well to the artwork process. If incorrect source information is used in the process then it is highly likely to cause errors in the resulting artwork.

Typical examples of this type of issue include: people using the wrong or incorrect versions of documents; the use of uncontrolled information sources such as ad hoc personal spreadsheets.

7. Human error : A typical artwork process includes many steps where people are directly responsible for carrying out activities such as: transcribing information from one source to another; performing multiple complex or repetitive tasks.

It is the nature of human beings that we make mistakes for many reasons. Sometimes it will be due to limitations described elsewhere in this article, sometimes it may just be because we are having a bad day.

While many steps can be taken to help reduce the possibility of human error, the fact remains that it can still happen and needs to be taken account of when designing artwork capabilities.

8. Technology errors : Technology in the form of computer software and tools is often used to perform or aid many artwork process steps. However, without careful design and control, this technology can introduce errors into an artwork.

Examples of the types of issues which may cause such errors include: software operating incorrectly; systems not providing the user with a true image of a particular document; font transcription errors when moving information from one document to another.

The Benefits Of Getting It Right

Achieving excellence in this area can help deliver many significant strategic benefits:

• Increased patient safety.

• Improved regulatory compliance.

• Increased sales.

• Improved profit margin.

• Improved reputation.

• Reduced cost and valuable resource absorption.

Now that we have looked at the types of errors which occur and their causes, we are in a position to start to focus on how to prevent them and create right-first-time packaging artwork. In the next article, we will start to explore some of the capabilities required to deliver right first time artwork.