In part 4 of my blog series on how to create excellent packaging artwork capabilities, I looked at the third of our defined processes, Supporting Processes and the influencing aspects of organisation design. Here in the final part five I will look at our final two capabilities: the importance of establishing the right inclusive leadership and governance and the role technology plays in establishing artwork capabilities.

Leadership and Governance

Given the cross-functional and cross-organisational nature of the artwork capability, establishing the right inclusive leadership and governance is key to the long-term success of the capability. All stakeholder groups involved in the delivery of the artwork capability need to contribute effectively or the whole process will fail. Therefore, all parties must buy into their role in the process and actively contribute to it. This will rarely happen if they are simply passive bystanders in the design of the capability or the delivery of the resulting activities.

The role of an Artwork Governance Team

We would recommend establishing a cross-function governance team to steer the establishment, ongoing delivery and development of the overall artwork capability. This governance body should include membership from all stakeholder groups involved in the process, including, where appropriate, external service providers.

It is all too easy when forming and managing governance teams to focus on the steering and decision-making aspect of the activity. If you are not careful, this may result in the leadership responsibilities of the team being overlooked. The governance team needs to ensure that they provide leadership to the artwork function in a number of distinct ways. Firstly, they need to ensure that a vision and strategy for the artwork capability is developed, agreed across all impacted stakeholders and communicated effectively to the broader organisation. Secondly, they need to ensure that the journey to achieve this vision is structured and managed effectively and that progress is communicated to the wider organisation. Thirdly, the leadership of the governance team needs to manifest itself in decisive decision-making that supports the vision and goals of the artwork capability. Finally, the behaviours the leadership display need to actively model and support the key cultures that underpin the successful service delivery.

To support these leadership activities, some organisations purposefully put in place a number of key roles:

Senior sponsor – a senior member of staff who will represent and support the overall artwork capability at the highest levels in the organisation.

Governance team chairperson – the leader of the governance team who ensures that the governance team activities are managed effectively.

Artwork process owner – an individual who is responsible on a day-to-day basis for ensuring that the end-to-end artwork process operates effectively and that any improvements to the process are appropriately designed.

With all of this in place on an ongoing basis, the artwork capability should remain effective and appropriate for an organisation over time.

Technology

Technology is a necessary and useful part of any packaging labelling and artwork capability, indeed it is practically impossible to operate an artwork capability today without some elements of technology.

Technology helps address many issues which can lead to improvements in compliance, performance and cost. Some of these issues include:

- Eliminating human error, particularly prevalent in transcribing information and in proof reading

- Ensuring everyone has the right, up to date information available to them when they need it

- Ensuring process adherence

- Aiding coordination of the different people involved

- Helping individuals manage their own activities better

- Reducing lead times

- Reducing cost

Before I go on to discuss any specific IT capabilities, let me just pause to cover some of the potential downsides of technology. Before selecting and implementing any technology, the full implications and costs should be weighed against the benefits. Some of these costs include:

- Initial and ongoing cost of tools and software

- Systems maintenance and support capabilities

- User education, training and support capabilities

- Impact of the technology on other business processes

For the purpose of discussion here, I will break down the packaging, labelling and artwork related technology into a number of sub-groups. I will briefly describe each of them and you will find a more detailed discussion on each of them in our book, Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities. You should be aware that the solutions available from different vendors often provide functionality that crosses two or more of these areas and I expect this trend will continue over time.

Artwork Creation: the tools necessary to create such things as documents, artworks, drawings, 3D visualisations and the associated components such as barcodes, Braille etc. generally, this technology is available off the shelf. The principle issue in implementing these tools is deciding and controlling which of the many configuration options are used.

Document Management: the tools necessary to securely store documents, ensure versions are managed effectively and that audit trails are maintained.

Translation Management: the tools necessary to efficiently and effectively manage the creation, storage and use of translations. Companies use everything from simple documents through to complex and sophisticated translation management solutions in this area.

Image Management: the tools necessary to ensure that what the user is looking at is a true representation of the underlying document. This includes such things as pdf creation, printing, electronic image presentation and colour management.

Collaborative Review & Approval: the tools necessary to allow individuals and groups to review individual documents, create and manage comments and ultimately securely approve documents. This area would include such things as electronic signature management.

Proofreading: tools that help users to proofread documents and their associated elements such as barcodes and Braille. Whilst very useful in reducing errors in artwork, it should be remembered that these tools are only aids to skilled proofreaders and need to be used with caution.

Change Control & Authorisation: the tools necessary to manage the definition and authorisation of changes in a compliant environment. The change control aspects of labelling and artwork changes will often be managed as part of a larger corporate change control system.

Bill of Material Management: whilst often not considered part of the labelling and artwork suite of tools, bill of material management systems are key to the success of labelling and artwork management at either end of the process. Initially, they are key in ensuring an accurate and comprehensive impact assessment is carried out. At the end of the process, they are key to ensuring that the changed packaging components are implemented in a controlled way into production.

Planning and Work Management: tools such as workflow technology that allow activities to be planned and routed to the right individuals at the right moment. More sophisticated versions of these tools will have the ability to manage large numbers of individuals, locations, work teams and separate organisations.

Performance Management: the tools necessary to gather and report performance information across the end-to-end capability. Some organisations will use corporate business intelligence tools for this.

Forecasting and Budgeting: the tools used to help forecast workload, plan resource capacity and financial budgets.

Don’t forget that many of these technology elements will need to be validated as the implication of their failure could impact artwork quality and therefore patient safety.

I will close with a word of caution when specifying, selecting and implementing technology which I have learned the hard way from experience. Many of the technology elements I have described have subtle interactions and dependencies with each other. Unless these dependencies are fully understood, it is very easy to make a change in one area that has an unforeseen and detrimental impact in another.

In part three of my blog series on how to create excellent packaging artwork capabilities, I looked at two important artwork processes: the core and interfacing, examining some typical interfacing processes and their interaction with the artwork process. Here in part four I will look in more detail at the third of our defined processes, Supporting Processes and the influencing aspects of organisation design.

Supporting Processes
The core processes described in a previous article define how individual labelling and artwork changes will be carried out. Whilst this is absolutely critical to the success of the artwork capability in an organisation, it is not sufficient in itself to provide a complete capability. A number of support processes need to be in place to achieve this. These include:

- Governance
- Performance Management
- Issue Management & Resolution
- Process Lifecycle Management
- Education, Training & Competence Management
- Information Technology Support
- Service Provider Management
- Project & Programme Management
- Forecasting & Budgeting
- Business Continuity Management

Many organisations will find that they already have one or more of these supporting processes in place that can be adapted or extended in scope to include the necessary artwork process areas. In many instances, this approach is to be recommended, as the artwork capability does not necessarily need its own unique iteration of a supporting process.

There are a number of questions that need to be considered when making the choice about incorporating artwork into an existing supporting process or creating a separate artwork-specific iteration. These include:

- Does a robust supporting process already exist elsewhere in the organisation which has a close fit to the supporting process requirements for artwork?
- Is the existing process owned and managed by a part of the organisation heavily involved in the artwork process?
- Would the owners of the current process consider artwork an appropriate extension of their scope?
- Is the existing process governed by an appropriate steering team that will take fair account of the needs of the artwork process when considering changes to their process?
- Is the artwork capability sufficiently small in scale to be successfully managed within another support process?

If the answer to any of the above questions is no, then careful consideration should be given to creating an artwork-specific support process rather than trying to force-fit artwork into an existing process capability.

For a more detailed discussion on each of the supporting processes, please refer to our book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities.

Organisation Design
Having discussed the various types of processes associated with packaging, labelling and artwork capabilities, I will now discuss some aspects related to organisation design.

Roles that support the process

Roles should be structured to support the business process. Therefore you need to have defined your business process before your roles and ultimately people’s jobs.

An individual role should be constructed by examining the tasks a process needs to have performed and the skills and knowledge that those tasks require to perform them successfully. Once all this is understood, a logical grouping can be performed to gather together tasks that require similar skills and knowledge.

Some of the typical roles that result from this include:

- Artwork Coordinator
- Artwork Operator
- Proofreader
- Local Market Representative
- Regulatory Affairs Representative
- Printer Representative
- Supply Chain Representative
- Packaging Technologist
- Packaging Quality Control
- ERP Data Management Representative
- Packaging Operation Representative
- Legal Representative

In a typical organisation there are a number of artwork capability related roles that tend to equate to full-time roles for individuals, or at least absorb a very significant portion of an individual’s time. This is a point that will become useful when we discuss organisation design later in this post. These 'full-time' roles are typically:

- Artwork Coordinator
- Artwork Operator
- Proofreader

Organisation structure

Having looked at the key roles that support the process, we can now start to look at the organisation structures that will best support the new capability. We will focus here on the roles and people who spend the majority of their time carrying out the artwork process.

For those people who only spend a small amount of their time carrying out artwork process related tasks, it is normal for them to remain within the structure of their current organisation and we will therefore not consider them any further here.

Co-locating the full time roles and putting them under the same management can bring significant benefits, as I will discuss next. Indeed, if you look at the way typical manufacturing site-based artwork studios have often evolved, these are exactly the roles that exist there, together with the management structure to support them.

Whilst not the only answer, creating one or more artwork studios to serve the whole organisation can have a number of key benefits which have proved to be very powerful in some organisations:

- With one or a small number of artwork studios driving the global artwork activity, it is much easier to create and maintain a truly single global process.
- The need to develop far fewer relationships results in higher quality relationships being formed, which in turn results in the process working much more effectively.
- Individuals in the consolidated operation can leverage their specific knowledge across many more artwork changes.
- It is much easier and more efficient to provide all users with the training and support they need to carry out their activities correctly.
- Furthermore, with a critical mass of key roles at the artwork studio, higher quality training and competence development becomes possible.
- Awareness of the overall picture is improved, allowing improvement in things like brand consistency.
- A larger artwork studio leads to benefits of scale in support services and management overhead.
- Improvement and change activity is much easier to implement as there are fewer nodes to deal with.

When deciding on how many service centres are needed, a number of factors need to be taken into account, all of which will be very different depending on the situation within each company. The types of things which impact the decision include:

- Number of countries in which products are sold
- Commercial, supply-chain and support functions organisation structure
- Existing resource levels and the potential impact of reorganisation
- The political will for change
- The budget available for re-organisation
- The quality and extent of the IT tools available to the artwork process

Depending on what other functions are or could be located in a similar way, an organisation might also consider expanding the service provided to include physical packaging design and packaging related Enterprise Resource Planning data management. I do not believe there is a one-size-fits-all answer here, the organisation structure has to fit the particular company’s circumstances and timing.

In part five, the final part in this series, I will look in more detail at our final two capabilities: the importance of establishing the right inclusive leadership and governance and the role technology plays in establishing artwork capabilities.

In part two of my blog series on how to create excellent packaging artwork capabilities, I looked at some of the main causes of artwork error and the importance of creating a service culture. Here in part three I introduce three important artwork processes and look in greater detail at the core and interfacing artwork processes. I highlight the 5 fundamental core process steps and examine some typical interfacing processes and their interaction with the artwork process.

As we have discussed in earlier articles, creating correct artwork is an activity that requires many groups to act together in an orchestrated way to deliver a successful result, on time. The way of ensuring that these people act together in a co-ordinated way is to define a set of processes that everyone adheres to.

Whilst there will always be many ways to reach the same result, and artwork creation is no exception, we will present a high-level process here as a basis for discussion. This process is based on experience working with a number of different companies, and if you are involved in artwork processes we are sure you will recognise many elements of it.

For the purpose of clarity, we will divide our discussions about artwork-related processes into three distinct areas:

Core Processes: The primary activities involved in defining and executing individual artwork changes.

Interfacing Processes: Those business processes that interact directly with the core process, will have an influence on the core process and may be modified as a result of this interaction.

Supporting Processes: The business processes that are required to support the core process and other artwork capabilities.

We will deal with each of the process areas in turn and will start here with the core process.

High level core process steps

At its highest level, creating artwork is no more complex than defining what is required, creating a work product such as an artwork and then verifying that this output meets the requirement initially defined. This is a very familiar process to anyone involved in quality systems.

For the purposes of this discussion, we have defined a high-level process consisting of five fundamental, or level 1 steps:

1 – Create Local Language Text

2 – Define Change

3 – Produce Artwork

4 – Produce Printer Proof

5 – Implement

We define each of these steps very briefly below. For a much more in-depth discussion on the Level 1 and 2 process in each of these steps please get a copy of our book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities.

1. Create Local Language Text

Create and approve local language source text document(s) for each of the packaging components to be created or modified.

2. Define Change

Define exactly what is required to be created or modified as part of this change.

3. Produce Artwork

Produce a new or revised artwork that complies with the requirements defined in the Define Change step.

4. Produce Printer Proof

Produce a modified artwork file that can be used directly in the packaging component printing process. This file differs from the artwork produced in step 3 in that it is modified to include all features that will allow it to be successfully printed via a specific printing route.

It is possible to eliminate this step through the use of a print ready process.

5. Implement

Ensuring that, at minimum, the first time a new or modified artwork is used to create packaging components for use in the manufacture of real product, that they are correct.

Critical control points

It is worth pausing at this point and briefly discussing process critical control points. Given that this process produces information that, if incorrect, can have a significant and potentially fatal impact on patients, it is critical that there are defined control points in the process to ensure that the quality of the output of the process is to the highest standard practically achievable.

To achieve this, companies have found it useful to define critical control points in the artwork process to ensure that all necessary tasks have been completed to a high quality before moving to the next phase. Each control point would normally include a quality check for accuracy as well as a formal approval by key individuals to proceed. In addition, some control points will provide an approval of a master document which will form a part of a master record source for GxP information.

Interfacing processes

The artwork process does not operate in isolation. It is a process which relies on information and activity in many other processes in order to operate successfully. Furthermore, some of these processes are owned and operated by organisations external to the company who owns the core process. Some typical examples of these interfacing processes include:

- Change control process

- Production planning

- ERP data management process

- Physical packaging development process

- Company core datasheet development

- Component code management

The design of the artwork process must clearly take account of each of these interfacing processes. For each process it should be clear at which point the interface(s) occur, what information is interchanged between the processes and in what format.

When designing the artwork process, it is highly unlikely that all of the interfacing processes will provide exactly the right information in the ideal format to support the new artwork process. Consequently, analysis will have to be carried out in each case to decide the best way forward. In some cases it will be necessary to modify the interfacing process to meet the ideal needs of the artwork process. In other cases, it will be necessary to modify the design of the artwork process to accommodate the constraints of the interfacing process. In many cases a compromise solution will result. In some cases it may be necessary to phase the implementation of the new process, initially implementing a less optimal solution which can later be optimised when the corresponding interfacing process can be modified.

In part four I will look in more detail at the third of our defined processes, Supporting Processes and influencing aspects of organisation design.

In the opening part to my new blog series examining how to create and apply excellent artwork capabilities, I looked at why packaging artwork matters so much and what happens when you get it wrong. Here in part two I take a closer look at some of the main causes of artwork error, how to prevent them and how to create right-first-time packaging artwork. I also examine the importance of creating a service culture around the provision of labelling text and artwork and the benefits this can bring to the packaging artwork process.

Causes of artwork errors
I have divided the many causes of artwork errors into categories, discussing each of them in turn.

Process gaps and inconsistencies Alternatively termed as systematic errors, these occur when the design of the business processes is incomplete or are 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.

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 I discuss later is that of ensuring the competence of people who perform tasks in the process only very infrequently.

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 in 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 headcount resource. Clearly, this may also be a symptom of ineffective process and/or tool design.

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

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 significantly increases the possibility of individuals misinterpreting instructions which are not entirely clear.

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 and the use of uncontrolled information sources such as ad hoc personal spreadsheets.

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 and performing multiple complex or repetitive tasks. It is natural for human beings to make mistakes; this can be for many reasons. Sometimes it will be due to limitations described elsewhere in this blog, sometimes it may just be because we are having a bad day. Whilst 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.

Technology errors Technology in the form of computer software and tools is often used to perform or aid the 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 document and font transcription errors when moving information from one document to another.


Creating a service culture

The development of packaging labelling and artwork involves many different groups across the company and, more often than not, external service providers and supply-chain partners. As I have already discussed, the creation of artwork requires many elements of information to be drawn together in a way that ensures that every detail is correct in the end-result. Without careful orchestration, the separate groups involved in the artwork creation process, both from within and external to the company, will not deliver artwork of the required quality standard. Each person involved in the process must perform their task in the process in the correct sequence, using the right information and tools in order to achieve a quality result.

To facilitate this, it is beneficial to consider the provision of labelling text and artwork as a business service. In our experience, the best artwork capabilities are those that consider themselves to be providing a service to the key business stakeholders and strive to understand their service role and deliver it. Like any service offering, this will evolve over time as the customer’s needs change. The management of the artwork capability should recognise these changes and adapt the service accordingly in a managed and considered way.

The development of clear mission, vision and performance measures can go a long way to orchestrate the successful delivery of the service across the diverse groups that are involved.

Defining service requirements

When designing an artwork service, we have found it useful to take a systematic approach to the definition of the service requirement based on a number of key questions, which we discuss in more detail in our book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities.

- What is the service producing?

- What is the scope of the service?

- Who are the customers?

- How do you measure success?

- What do you need the service to achieve?

- Who “owns” the service?

- Who is involved in the service?

Service statement

In order to answer the above it is good practice to capture the requirements of the service in a service statement of some kind. This may take the form of a service level agreement or any other similar document used in your company. It gives clarity to everyone within and outside the service on what the service is and is not there to do, how success is measured and how the service is expected to grow.

Guiding or underpinning principles

To support the service statement, it is also useful to define a set of guiding or underpinning principles on how the processes and capabilities will operate. These define the “rules of the game” and will help all parties involved in delivering the service when having to make decisions about how to move forward in a particular situation. We discuss typical principles further in our book.

Service culture

Developing a common service culture across the various teams involved in delivering the overall artwork capability is also a useful means to ensure successful delivery of the service. It must also be recognised that, in providing a service to a broad group of stakeholders, it is rarely, if ever, possible to please everyone all of the time. An element of good service management not only recognises this, but actively helps to ensure its key stakeholders also recognise this and are involved in collaborative decision-making for key aspects of the service delivery.

It is easy for an external supplier to develop a service culture; after all, it is inherent in the nature of the relationship between the two parties. Not pleasing your customer on an ongoing basis more often than not results in a clearly recognisable termination of the relationship.

When managing internal service functions, the service nature of the relationship between the artwork capability and the rest of the organisation is not as obvious to everyone involved unless it is carefully orchestrated. This requires activity not only on the part of the group providing the service, but also on the part of the customer groups. As with relationships with external providers, it is all too easy for a customer group to abuse the relationship and blame the service provider for all manner of issues. To be successful, the service group and the customer groups should strive to see the relationship as a meeting of equals for mutual benefit, not a master and servant relationship.

You will also recognise that the artwork service relationship, if it is to be successful, will last a considerable period of time. Indeed, if the service is provided by a largely internal team, there is little or no practical opportunity to stop the relationship. Everyone in a long-term relationship will recognise that, for the relationship to be successful, effort needs to be put into it from all parties. Managing an artwork service capability is no different and this effort needs to be budgeted for and the necessary work planned and executed.

In part three of my blog series on Excellent Packaging Artwork Capabilities I’ll be looking at the core artwork process and interfacing processes.

 

In the opening part to my new blog series examining how to create and apply excellent artwork capabilities, I look at why packaging artwork matters so much and what happens when you get it wrong. What are the far-reaching impacts of artwork error on the various stakeholders involved?

Packaging artwork is an often-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 licences.

Maintaining this reputation whilst rapidly growing the number of products is particularly challenging when one considers that one of the largest single causes of product recall is packaging errors. In recognition of this, regulators around the world are focusing 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 is 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 organisations. To orchestrate all this activity, the right combina­tion of business processes, organisation design, information technol­ogy, facilities and suppliers must be managed. For smaller organisations, whilst the scale of the problem may be reduced, all of the same challenges have to be met.

So, what are the types of packaging labelling and artwork errors (which we refer to as “artwork errors”) that often occur and what are their significant and far reaching impacts? This will provide some context for later posts discussing the capabilities that need to be put in place to prevent them.

Whilst written from the perspective of a typical pharmaceutical company, we believe the points made apply equally well to other supply chain partners and other regulated industries.

What is an artwork error?

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

Gross errors - 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.

Context and meaning errors - Where 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.

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.

Technical errors - Where 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 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.

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 any 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.

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 more unwell. 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 also a serious per­sonal impact for some prescribers involved in incidents leading to patient harm. Indeed, some prescribers involved in such incidents subsequently go on to leave their chosen profession altogether.

Impact on regulators - The remit of the pharmaceutical regulators, amongst 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.

Impact on pharmaceutical company staff - 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 need 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. Whilst challenging, this work is often 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.

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 unfavourable 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.

The benefits of getting it right

There are of course very tangible benefits to getting your artwork right. Achieving excellence in this area can help deliver many significant strategic benefits including:

• Increased patient safety

• Improved regulatory compliance

• Increased sales

• Improved profit margin

• Improved reputation

• Reduced cost and valuable resource absorption

In part two of this blog series I will take a closer look at some of the main causes of artwork error, how to prevent them and how to create right-first-time packaging artwork. I’ll also discuss developing a common service culture, internally and externally across an organisation.

I always consider that ‘Right-First-Time’ is the fundamental metric for an artwork service. This is a simple pass or fail metric – did the artwork pass through the process once or was any change required? This is difficult to achieve on a consistent basis and requires focus and persistence. This is the subject I am exploring further in this series of Right-First-Time blog posts, along with 10 essential tips to help you get it right-first-time.

Here in part 4 we look at the final two tips, focusing on the importance of quality time, quality facilities and how to create a winning culture in the workplace.

Tip 9: Ensure there is quality time and quality facilities to do quality work

Leadership needs to take accountability for the performance of their function

Reviewing the right-first-time figures at the governance meeting, with sufficient root-causing activity, should highlight areas where the process just seems to ‘get stuck’. Each representative then needs to work to resolve issues that have arisen in their areas of responsibility, in the interests of the whole artwork supply chain.

Quality time for quality work

We talked early in this series about the ‘concertina’ effect in artwork projects, where numerous rounds of rework occur but the deadline is fixed so work gets continually squeezed into faster and faster rework cycles. This is a downward spiral as the increasing pressure likely results in either shortcuts being taken or more errors being made. How often have you seen the situation where an artwork has to be sent out at 5pm on a Friday followed by a phone call asking if you have approved it yet?

One of the greatest benefits of achieving a high right-first-time is to get out of this whirlwind of rework and chasing. Schedules become more stable and outcomes become more predictable. People get the quality time to do the quality work required because they don’t have to do it again and again.

We often hear, ‘Let’s get the artwork started now because is takes forever’. Invariably this means starting without knowing all of the information – this is just a guaranteed way of generating rework. Surely the better way is ‘Let’s get all of the information together and correct and then do the artwork really quickly – ONCE!’

Quality facilities – a tidy desk is a tidy mind

Line clearance procedures in pharmaceutical packaging facilities are a critical quality process. Why? To avoid the risk of cross contamination of products or components from one batch to another.

The principle also applies to artwork. A routine source of error is when source information gets mixed up and the wrong documents are compared. This can be a particular risk when there are a number of strengths of a product being compared against a number of reference documents – it can be easy to be looking at a wrong combination. A clean-down of the work-space between each artwork should be undertaken.

Think about workplace design

Most artwork activity is desk-based in offices, but there are some specific facility requirements that should be considered. Proof reading and artwork review needs good lighting, space to lay out large documents and quiet areas. Many of the roles need two screens so they can be looking at an artwork and a set of instructions, or comparing two artworks.

Think about the facility and equipment needs of the people who undertake the tasks in your processes. If they don’t have what they need, they will be unlikely to be able to do quality work.

Tip 10: You need to have the right culture, displayed across all teams involved in the end‑to‑end process to ensure success

Why think about culture?

So what do we mean when we talk about culture in the context of the workplace? Culture is a facet of the way people engage and behave towards each other. It is prevalent in the way people respond to instructions and rules. It affects the way people respond to different types of recognition and reward. Workplace culture is influenced by the different national and geographic cultures present in the workplace.

Culture could be considered as the informal rules in the workplace or ‘the way things get done around here’. Therefore if you want certain behaviours from your team, you need to make sure you have a culture that promotes those behaviours.

What would define a winning culture?

There are lots of ways you could define your target culture. We typically use nine parameters as a starting point:

This list is not exhaustive but covers the key elements we consider most important. However, this isn’t necessarily a list you can just lift and use. Many companies have culture and value statements at a corporate, if not also functional, level and so your target culture needs to align with these. This may impact the parameters you chose or the language you use.

Once you have agreed your parameters, you need to decide what good would look like for each. If you were displaying a successful outcome for each parameter, how would that manifest itself? How would it look and feel? Could you measure it? It is best doing this as a team exercise to build buy-in to the desired outcomes.

How do I get the right culture?

Once you have defined your target culture you can look at how you can achieve it. What is different from today and what will need to change to make that happen? Changing mindset and behaviours is difficult and takes time and perseverance. Do you need to change any management processes? Do you need to do team working training? Do you need to change the way people are measured? How do you reward the people who are doing what you want and what do you do about the people who are not?

Your culture will not change automatically – you need to define the actionable steps that you will take to make it happen. Again, work with your team on this transition plan to build their buy-in..

The role of leaders in attaining the right culture

Leadership is key in realising and sustaining cultural change. Leaders need to express, model and reinforce the new culture you want to achieve. They need to role model the new behaviours – if they don’t, people will not believe it is real. They need to be seen to actively promote the culture you want, recognising teams and individuals who are displaying your new culture and behaviours. Therefore your target culture needs to align with the expectations of your governance, so you need buy-in from leadership as well as the teams involved.

Series summary

In this series of blogs, we have covered a number of tips for how to improve your right-first-time. Summarising these, we have discussed:

Tip 1 – Measure your right-first-time.
Tip 2 – Use codes to categorise errors, then ensure a thorough root cause analysis to eliminate the source of errors.
Tip 3 – Make sure all of the input information is correct before starting.
Tip 4 – Ensure there is a comprehensive and effective end-to-end process with clear roles and responsibilities.
Tip 5 – Make sure the right quality of checks is undertaken by the right people.
Tip 6 – Ensure all people in the process have the appropriate skills, competencies and capabilities through effective training.
Tip 7 – Ensure there is effective cross-functional governance.
Tip 8 – There needs to be an appropriate and scalable suite of IT tools to support the process and people working with it.
Tip 9 – Ensure quality time and quality facilities to do quality work.
Tip 10 – You need to have the right culture, displayed across all teams involved in the end-to-end process to ensure success.

We all understand that packaging and artwork still present a significant compliance risk and delivering right-first-time artwork is a complex endeavour involving many moving parts. Furthermore, being right-first-time increases speed, reduces waste and raises confidence. From this series, we can see that achieving high right-first-time is doable, but there are many parts to be addressed, requiring focus and persistence. As such, right-first-time is as much a mindset as an outcome.

Should you have any questions about this or our artwork or our proofreader and document verification training, please contact Be4ward at [email protected].

I always consider that ‘Right-First-Time’ is the fundamental metric for an artwork service. This is a simple pass or fail metric – did the artwork pass through the process once or was any change required? This is difficult to achieve on a consistent basis and requires focus and persistence. This is the subject I am exploring further in this series of Right-First-Time blog posts, along with 10 essential tips to help you get it Right-First-Time.

In parts one and two of this blog series, we've looked at why right-first-time matters, how to measure it and manage it and the importance of a strong artwork brief and clear process mapping. Here in part three we examine effective staff training and suitability, cross functional governance groups and some of the key tools available for IT support in the artwork process.

Tip 6: Ensure all people in the process have the appropriate skills, competencies and capabilities through effective training

Each role has a different set of requirements, you need the right ‘fit’ for each role

You need a range of skills throughout the end-to-end process. Each step requires a different set of abilities, from creation of the artwork through to the several review and approval stages. People need to show they have the right skills to perform the role but also demonstrate they can use their skills to perform the job successfully. Having the right mind set gives the complete capability for the role.

The artwork coordinator who orchestrates the whole process will require a different skill set to the proof-reader who does the most detailed check of the artwork. The proof-reader needs to be highly detail conscious and be comfortable working alone for most of their working day. The coordinator must be much more people-oriented to ensure the artwork is progressed through the business. So, it’s important to define what you are looking for in each role, value the differences and select people accordingly.

Recognise some staff are performing tasks daily, some more infrequently

It’s important to recognise that, although there are many people involved in this process, many do it only as a small part of their role. In addition, regulatory people in the affiliates who perform the local language review and approval checks, will be doing these tasks quite infrequently. Also, these people tend to change more frequently than those in the central artwork and regulatory teams.

This situation means it is likely there are less experienced people performing tasks in some roles, so it is important to plug this gap with good standard operating procedures (SOPs) and training. Procedures in these areas must give the correct level of detail to enable people to do the job effectively and controls need to be in place so access to systems only happens when the staff have completed the required training modules. Unfortunately, often when we review the SOPs, held centrally and at the affiliates, we discover that the comprehensive SOPs cover the tasks done centrally but SOPs for work done in the affiliates are very high level, lacking essential detail. It should be almost the other way around.

Education and training are key – monitor the effectiveness of the different approaches

SOPs are important but to ensure people have the correct skills and are competent to do the role means effective education and training needs to be provided. Initial training when a process is revised, new starter training, specialist training for certain roles like proof-reading and special focus for those involved in the review and approval steps needs to be considered.

The range of people to reach means a variety of approaches need to be taken. Staff in more remote areas may have web-based training, on and offline training and even recorded videos. There should be a requirement to pass an assessment, following the SOP training.

The effectiveness of the different approaches needs to be monitored, so when issues arise it is useful to identify if inadequate training has been the root cause.

Tip 7: Ensuring there is effective training and cross-functional governance

Governance group – required as the process works across many departments

When you ‘walk’ the complete artwork process from end-to-end you realise it touches many departments and external groups. If the ambition is to achieve an excellent artwork service, then each part has a contribution to make in achieving right-first-time.

I always recommend putting in place a governance group with representatives of the key functions. In most cases this is a new group, as existing groups do not have appropriate cross-functional or geographical representation, or do not have the bandwidth to do the job effectively. If a steering committee was in place for a process redesign the governance group may grow out of this but potentially with more senior members. The members need to be selected with enough authority to carry out their responsibilities and represent their functions/geography effectively.

Leadership needs to take accountability for the performance of their function

Reviewing the right-first-time figures at the governance meeting, with sufficient root-causing activity, should highlight areas where the process just seems to ‘get stuck’. Each representative then needs to work to resolve issues that have arisen in their areas of responsibility, in the interests of the whole artwork supply chain.

The leadership team needs to agree to a common vision and sponsor improvements

Good sponsorship means ensuring they agree to a common vision and this vision is communicated out to the organisation, resources provided and any stakeholder conflicts resolved. The team should set out the standard required of the service and agree how its performance will be measured, of which right-first-time will be one of the main measures. The group will also agree priorities for improvement projects identified.

The frequency of meetings will depend on the organisation but I would recommend setting them up on at least a quarterly basis.

Tip 8: There needs to be an appropriate and scalable suite of IT tools to support the process and people working with it

There are a range of tools available to support artwork operations

I am not going to go through every tool in this blog but instead highlight some of the key types.

Document management and workflow tools allow you to manage your documents in a controlled electronic environment and route them to key users to perform the process tasks necessary. These tools sometimes also permit planning of artwork projects. Document review and approval tools allow users to view, comment and approve documents electronically (usually with an electronic signature). These above tools are the typical functionality of Artwork Management Systems.

Electronic proof reading tools allow you to electronically check text, graphics, barcodes, Braille and, depending on the package, other artwork elements. Artwork and drawing tools are typically used by artwork operators to generate artwork and engineers to create the profiles and templates for components.

Technology helps right-first-time

Two of the ways technology can assist with right-first-time is to automate activities and reduce opportunity for human error. A frequent source of error in a manual process is mistakes with document versions. An electronic document management system can avoid this as they typically provide closed loop version management, automatically version-numbering iterations of a document and ensuring it is obvious which is the most recent version.

Human error is always a challenge when proof reading large documents which require long periods of focused attention. Electronic proof-reading tools can assist here by providing an electronic means of proofing that is consistent and accurate.

Technology presents some downsides that need to be considered

We often hear the same thing when we engage with a client that has undertaken a major technology project – ‘We have implemented a new system but our right-first-time performance has not improved – why?’. The answer to this is pretty simple – application of technology is part of the solution, not the whole solution. If you look back through this set of blogs, there are many things that need to be done to raise performance beyond technology: addressing process, people and organisational issues. Missing these means that you are unlikely to achieve an holistic outcome.

Another downside is that technology costs money, both in the initial cost of the tool and in implementation, maintenance and support requirements. We often find that people trying to implement systems look only at the initial license costs, which once you have considered project resource and validation costs and ongoing running costs, are a small part of the total lifecycle cost of a system. This total cost is often a surprise.

Finally, technology is used by people, and in the case of artwork systems, many of those people may use the system only occasionally (think of the regulatory staff in your different countries). So even a technology project is really about people, as you have to give them the motivation and capability to change and the education and training to be able to use the tools correctly.

Choose a strategy that fits with your needs

Therefore, in defining how to move forward with technology you need to consider the needs of your individual company. As a broad generalisation, the technology needs become greater the larger the size of your company. We typically measure this in the number of artworks required. If you have 360,000 artworks to manage you need some sophisticated capabilities. If you only have three, your approach can be much simpler. But remember that technology takes time to implement, so if you are growing fast you need to be thinking ahead.

In the fourth and final part of this right-first-time blog series we examine the benefits of quality time and quality facilities and how to create a winning culture in the workplace.

Should you have any questions about this or our artwork or our proofreader and document verification training, please contact Be4ward at [email protected].

I always consider that ‘Right-First-Time’ is the fundamental metric for an artwork service. This is a simple pass or fail metric – did the artwork pass through the process once or was any change required? This is difficult to achieve on a consistent basis and requires focus and persistence. This is the subject I am going to explore further in this series of Right-First-Time blogs, along with 10 essential tips to help you get it Right-First-Time.

Tip 3: Make sure all the information is correct before starting, using an artwork brief

People mistakenly think starting early will make it faster

Why is it that there are so many issues with pharmaceutical artwork? Well, getting artwork right is tricky. It requires gathering all the correct different elements, from different departments in the company, often from different countries and making sure they are placed onto a piece of artwork in exactly the right position, accurately.

Companies often jump straight into designing the artwork thinking that getting ahead of the game will speed up the overall process, but they are mistaken. Consistently, I have seen that proceeding this way not only makes it more likely for mistakes to happen but often the overall timescales are longer.

One analogy is to think of the situation where you are arranging for your house to be painted. You test to get the colours you want and then agree that up front with your painters. You don’t get them to try different colours until you see one you like and you don’t want to have to pay them again if they use a colour you don’t like!

A good artwork brief defines ‘the change’ completely, with no ambiguity

Events either inside or outside a company will result in the need to introduce new artwork or change existing artwork. So a ‘change’ is required. I always recommend to clients, to have all the information before starting and make sure it is correct. The ‘change’ is captured in an artwork brief and signed off as approved by key parties before starting. A perennial source of artwork not being right-first-time is incorrect input information or a key stakeholder not agreeing the change during artwork approval.

A good brief is a clear and concise record of the change required with no room for any misinterpretation and containing the following information:

All this information is collated and presented as one brief.

It is important the same groups who approve the artwork also sign off the brief

A powerful use of the brief comes from the key stakeholders agreeing this is the change required. The signatories will need to be defined for each part of your company and their approval forms a critical control point in your process.

The final artwork review and approval would be made against the artwork brief, by the same signatory departments and ideally the same people who approved the brief, making sure all the changes required have been implemented and that no other changes have been made inadvertently.

Tip 4: Ensure there is a comprehensive and effective end‑to‑end process with clear roles and responsibilities

Map the end-to-end process

When you start to measure the right-first-time figures, your approach to improve it may be to root cause each incident as it arises. This is a good idea. However, there is a risk, even when you have thoroughly investigated incidents, that you only fix parts of the problem. Issues continue to arise because fundamentally the current process is not ideal.

To really improve your right-first-time metric it is best to review the process as a whole and where possible get external independent expertise. This will enable you to design a process which uses best in class principles and is more likely to include elements which ‘future proof’ the process.

Map the end-to-end process considering the various different scenarios that arise in your company. The steps for external artwork approval in the EU will differ to that of the US.

Mapping the ‘as-is’ process and redesigning it will require a number of workshops and support from the senior management team. However the effort will be worth it as you will end up with a process that works, is understood by all and has received full team commitment.

Define the outcome for each step

When mapping each step be clear what should be done, by whom and ensure the performance expectations for each step are defined and agreed. Look at it with fresh eyes where possible. Take the opportunity to achieve your ideal process.

Map the roles and responsibilities for each step

It is useful when mapping the process not to be too bound by the current staffing structures as this can constrain the thinking and prevent a more streamlined process from emerging. This process will almost certainly result in changes in certain roles and you can expect some friction but if this mapping process is done as a group and agreed with the senior team, then it is more likely people will be engaged and go along with the changes.

Make sure there is a clear information flow

Once you have designed the new process, you should ‘trial’ it prior to implementation or configuring any software. Choose a number of scenarios and trial it with the people from each department involved on a day-to-day basis. Then walk through each scenario testing each step and checking they work as expected. Doing this properly will ensure that all the steps are there and in every case, someone is accountable. Only then should you have the confidence to update procedures and configure any systems.

Tip 5: Make sure the right quality of checks are in place and undertaken by the right people

The importance of the review and approval steps in the process

There is typically a four-step process to assure the quality of the master artwork file.
- The initial check carried out by the artwork operator who has created the file, following the brief.
- The second check is a full and independent proof read, carried out by the proof reader, reviewing all text and graphics against the brief and including a detailed technical check.
- The third check is done by the regulatory group reviewing the text and content, ensuring any local requirements are met.
- The final check is done by QA or their representative, checking only that the correct process has been followed and documented.
All these people in the chain must be aware of the responsibilities they are undertaking when reviewing and approving at each stage.

The danger of being vague

There is a danger that we are not prescriptive enough when saying what needs to happen when performing a check. If procedures are too vague there is the potential for elements of the artwork to not be correctly reviewed. In particular we often see ‘thick’ SOPs in the central artwork team versus very ‘thin’ SOPs for the regulatory checks done by the affiliates.

Be clear who checks which elements

So it's important to spell out in SOPs the responsibilities for each stage and back this up with detailed checklists showing which elements must be checked and by whom. Don’t fall into the trap that everyone checks every element, because actually not everyone is qualified to perform some checks. Only the local language expert can check the context of the language on a leaflet, for example, to confirm how the text will be understood by the local patient or medical professional.

Define the ‘what’ and the ‘how’

It is important to define not only what needs to be checked but how it will be done and with what equipment, if required. State exactly what is involved in each check and what to check against. Regulatory checks will need to be referenced to listed key documents, for example, as well as the brief. Proof readers will need to be clear what equipment they need, for example, to check bar codes and braille.

In the next article, I will explore the topic of right-first-time further and present tips six, seven and eight, which look at the importance of effective staff training and suitability, cross functional governance groups and some of the key tools available for IT support in the artwork process.

Should you have any questions about this or our artwork or our proofreader and document verification training, please contact Be4ward at [email protected].

I always consider that ‘Right-First-Time’ is the fundamental metric for an artwork service. This is a simple pass or fail metric – did the artwork pass through the process once or was any change required? This is difficult to achieve on a consistent basis and requires focus and persistence. This is the subject I am going to explore further in this series of Right-First-Time articles, along with 10 essential tips to help you get it Right-First-Time.

The Importance of accurate artwork for your company

Is the importance of having accurate artwork stressed in your company? Do people assume that artwork needs several versions before it is approved? What happens when your affiliates spot errors that, thankfully, have not reached the customer and what is the reaction when unfortunately there is a recall, when one gets through?

It is essential to remember, a company can only sell its product when they are correctly packaged, can only ship its product when the text on the packaging is correct and at the end of the day, patient lives rely on the text being absolutely correct. If this is forgotten and management live with a lacklustre right-first-time record then the company’s reputation and profits will be directly impacted when errors do occur.

So why is getting artwork right-first-time so important?

Accepting that the first version is unlikely to be correct is a risky business. The closer you get to the launch or the implementation deadline you see what I refer to as the concertina effect – less and less time to deliver. In this environment when chasing for the final version through multiple iterations, the stress increases, confidence drops and the potential for mistakes increases.

Alternatively, when you focus on getting artwork right-first-time, things that are not correct are eliminated early in the process and potential sources of errors are designed out. When lead times are squeezed, as they often are in these types of situations, your risk of an error has hopefully passed and the likelihood of a recall reduced. Focusing in this area will have the additional outcome of more consistent lead-times, capacity will increase and everyone will have more confidence in schedule adherence.

Achieving a high standard in right-first-time requires focus and attention to detail

Best in class organisations achieve a right-first-time figure in excess of 95%. However, to achieve this requires continual focus and likely enhancement or redesign of your artwork process, combined with a degree of focus on what is required at each stage. It will also require regular support from a senior management team, made up from the groups involved. Technology will have a part to play to enable a high quality process, both for the production and checking of the artwork itself but also in the tracking and approval process. Finally, the right culture will be required, displayed across all the teams, to ensure success.

Tip 1 - Measure your right‑first‑time — if you don’t measure, you don’t manage

How to measure right-first-time and where are the figures reported

There are many ways you could measure right-first-time, but in our view it is a simple pass or fail metric – did the artwork pass through the process once or was any change required? The calculation should be straightforward – the number of artworks completed right-first-time divided by the total number of new artworks created (note: we would not include non-right-first-time revisions in this total). This gives a percentage right-first-time. This can be used to give a baseline performance and set targets for the process. As you remove sources of error this will enable the team to track the improvements.

You manage what you measure

It is important the team own this measure and use it to drive improvement and there are a few points to consider here. Trending the measure will show all if performance is improving or declining. Setting clear targets to be achieved shows the performance gap to be closed. A process for the team to analyse the reasons why the artwork requires reworking will help understand what is going wrong (and I will talk about this later in a further tip).

In addition, the figures need to be reviewed regularly by the cross-functional governance group. Errors can arise from many sources and the support of the governance team will be required to help resolve these across the many impacted departments.

So where in the process do you measure and what do you include?

Many companies already measure right-first-time, but there are many differences in the scope of what is measured.
There are numerous points through the end-to-end process where right-first-time should be checked: at the approval of the artwork brief, after creation of the artwork, after proof reading, after artwork approval, after receipt of packaging materials, to name a few. You need to consider the milestone and rework points in your process and measure right-first-time at those points. To avoid the risk of an error being released to the public, you need to drive your right-first-time performance as early in the process as possible.

There are numerous types of artwork change – new products, safety updates, technical changes, line trial components. Some are easier than others, but even though it may be difficult to achieve right-first-time for some, it doesn’t mean you shouldn’t manage. However, you may wish to report different types of change separately with different initial targets for each.

Artwork quality standards should be as high as expected for a production document

GMP drives your manufacturing and packaging operation to produce a high quality process so the products produced are safe for the patient. Producing artwork should be considered in the same way. Errors need to be driven out so you end up with a safe, repeatable right-first-time process.

Tip 2 - Use codes to categorise errors, then ensure a thorough root cause analysis to eliminate source of errors

Categorise the types of errors

Measuring your right-first-time will tell you what your performance is but not why. You will need to delve deeper into the data. I suggest you set up a system for collecting and categorising the errors found, reporting them monthly. You need to determine the broad categories, and recognise this list may change, as you understand the issues more clearly. A typical set of error categories may include errors attributable to file identification/properties, text content, graphical content, supplied data, process failures and the technical aspects of the artwork. You may even need to break these broad categories into more specific error types.

Recording the reasons for a non-right-first-time artwork will then let you track the frequency and volume of different types of error, to identify the ones that are most significant. This is where you then need to target your energy for improvement.

A clear differentiator of companies that have excellent right-first-time performance is that they are obsessive about eliminating sources of errors by designing them out of the process. They have managed to minimise the effort they expend on cleaning up after an incident and instead channel that resource and energy into eliminating the potential for errors to occur.

Develop a good root cause process - consider the five why's approach

Once you have decided which category you need to focus on, you need to make sure you root cause the sources of the failures. This will ensure you are applying the right corrective actions.

Every company has their preferred method to root cause but I will suggest you consider the 5 why’s method as it is easy to train and very effective. Simply, you ask ‘why’ for as many times as you need to, until you get to the ultimate root cause.

Looking at an example: an error has been discovered where the braille on a launch pack is obscuring some key information and there have been complaints.

Why has this happened?
Answer: The job was rushed and the team say they were not clear braille was needed until the last minute.
Why did they not know it was needed and where it was to be positioned?
Answer: This information was not clear at the point prior to when the artwork was being generated and had to be added later.
Why was this information not available at this point in the process?
Answer: There is no discipline for providing all the information prior to starting the artwork and people put the braille where it normally fits.
Why is there not the discipline at this point for both of these points?
Answer: There is no process for gathering all the information and signing it off prior to starting. People don’t know where to put the braille in general.
Why don’t people know where to put the braille?
Answer: The line drawing doesn’t show where braille should be.
The actions from this process would be to update the drawings to show the braille location and put into your process the discipline of having all the information available, using an artwork brief, prior to the artwork generation process starting.

Having implemented solutions continue to measure to ensure sustainability

Once improvements have been made you should continue to measure the error categories to ensure the frequency of occurrence for the ones you have targeted for improvement have reduced. This will tell you if your improvements have been effective and also sustainable. The last thing you want is the same errors occurring again, especially if you think they have been addressed.

In the next article, I will explore the topic of right-first-time further and discuss my third, fourth and fifth tips, which look at the artwork brief and raising the need for a comprehensive and effective end-to-end process with clear roles and responsibilities.

Should you have any questions about this or our artwork or our proofreader and document verification training, please contact Be4ward at [email protected].