Artwork Errors: Detecting them and minimising their impact

Artwork errors are an ongoing risk in a Pharma organization. I already listed the different types of errors you can have in my blog post Excellent Packaging Artwork Capabilities 2 – Consequences of errors, and whilst a number of errors present minimal risk to the safety of the patient, for example non-consistent spacing between paragraphs, others can have a major impact such as putting a wrong dosage on the packaging. In this blog we discuss the different approaches required depending on where in the supply chain the error is spotted.

The artwork errors can be detected two ways. They can be spotted internally at the various verifications through the supply chain or they can be identified externally, for example by a healthcare provider. Each case leads to specific actions to correct the issue to minimise the impact and to prevent the issue happening again.  Here some of the priority actions that should be integrated very quickly after the incident.

When the error is spotted internally

  • Key Quality and Operational personnel have to be informed to decide on corrective actions that need to be taken to address the quality issues with products.
  • The affected product and all associated components held in inventory must be quarantined
  • The Quality function has to make appropriate decisions about the severity of the error, whether the incorrect components can be used or not, and if the product can be released or will require rework with revised packaging components.
  • Once the immediate supply issue has been resolved, a more thorough investigation should be conducted to determine the root cause and learn from the incident to stop it happening again.

When the error is spotted externally

Recall from the external marketplace is obviously a complex activity requiring significant communication to ensure the safety of the patient is protected:

  • The organisation should have robust communication mechanisms as the error could be conveyed through local country operations, customer service help-lines or even through local county Regulators.
  • As the product is already out in the supply chain, the first steps of the company communication would include the impacted local Regulatory authorities and an assessment of the error to determine what level of recall is appropriate.

The scope of the recall can vary from a wholesaler level right through to patient level.  This has an obvious impact on the patient and healthcare professional’s trust in the product and the company. An immediate comprehensive response is key to address the error and minimise its impact on the patient. As described with internally discovered errors, there then follows a series of corrective actions to resupply the marketplace and preventative actions to ensure the root causes of the incident are identified and addressed to prevent reoccurrence.

In my next post I will discuss on how to work effectively with your external partners to minimize the impact of a drug recall.

To help you in your Artwork Improvement Program, you can also find useful information in my book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities

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Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities Book

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.

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Packaging Artwork and Labelling: a hidden nerve centre of your operation

Pharma and healthcare companies are currently facing many challenges from operating in the global market. Organisations are launching new products and expanding into many new markets resulting in a more complex product portfolio. Added to this, they need to interact with many different stakeholders such as governments, purchasing groups and regulatory organizations from all around the world. Companies need to recognise the growing complexity on their organisation and the impact on their resources.

Maintaining a high focus on patient safety and strong corporate reputation is essential to keep and win new business. Companies need to maintain trust with authorities and customers to enable them to be in the position to offer and further develop innovative pharmaceutical treatments.

Artwork errors represent one of the largest sources of pharma recalls. Therefore, the organisation has to give special attention to the packaging artwork and labeling process.  They need to ensure they have the right capabilities in place to enable the effective creation and adaptation of texts and graphics, meeting the regulatory requirements of dozens of countries with different languages.

And this is where the biggest challenge lies, being able to orchestrate all the related activities with the right process design, good technological systems in multiple facilities and with different suppliers. Oddly enough, there is a risk this complexity is not fully recognised in some companies, so assessing and redesigning the process to be compliant, efficient and effective is missed despite its critical role in the supply of product. This challenge exists whether you are a large pharma group or a smaller company, it is just then a matter of scale.

We’ll see in the next posts, the many risks the packaging, artwork and labeling process can represent to the smooth running of the business operations of a pharma company.

To help you in your Artwork Improvement Program, you can also find useful information in my book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities

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Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities Book

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.

Posted in Artwork Auditing, Artwork Management | Leave a comment

My February column has just been posted with Pharma IQ

To read it please click here:

http://www.pharma-iq.com/clinical/columns/ensuring-effective-translations-%E2%80%93-approving-translation

We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

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10 Key Learnings you should consider for your Artwork Programme Implementation – Key Learning 10: Make sure your solutions stick

Like all significant change activity, many artwork improvement programmes commence, but not all are successful.

We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. After ensuring there is effective cross-functional governance, we continue this series of posts of 10 Key Learnings for Artwork Improvement Projects with the topic of making sure the new ways of working stick.

Key Learning 10: Sustainability– Make sure your solutions stick

This is it. Everything is in place and you have passed all the hurdles along the way to implement your Artwork Program and you think your job is finished? Not so fast, now you have to see all the hard work put into implementing new solutions and new processes lasts and is adopted by all the stakeholders and ensure that the old ways of working are disabled.

They say ‘old habits die hard’. We have seen on pretty much all the Key Learnings such as the Key Learning 7 that the change management factor is really strong in all the aspects of implementing a new Artwork Programme. New ways of doing things is scary and unsettling for everybody. Therefore, the need to ensure that changes are sustainable is key to make the project a success. To do so, a list of key components must be addressed.

After implementing the changes, you have to ascertain people understand and agree to this changes, this new ways of working and behaviours are modeled and rewarded. The processes have to be built into technology solutions and measures must demonstrate successes of the changes introduced. Appropriate support capabilities need to be established – where do users go when they need help or discover things that don’t work as envisaged?  Finally, the old ways of working must be completely disabled. All of these elements can be achieved by architecting the project from design, through implementation, to operation to consider your implementation a real success.

We hope these key learnings will help you and wish you the best for your Artwork programme implementation.

To help you in your Artwork Improvement Program, you can also find useful information in my book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities

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Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities Book

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.

Posted in Artwork Auditing, Artwork Management | Leave a comment

10 Key Learnings you should consider for your Artwork Programme Implementation. Key Learning 9: Partners

 

Like all significant change activity, many artwork improvement programmes commence, but not all are successful.

We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. After ensuring there is effective cross-functional governance, we continue this series of posts of 10 Key Learnings for Artwork Improvement Projects with the topic of selecting your solution partners carefully.

Key Learning 9: Partners – Select your solution partners carefully

We are now pretty much near the end of our journey and we have to talk about the solution partners being established as part of an Artwork implementation program. They include translation firms, consulting firms, IT solution providers and graphics houses. After spending a lot of time on designing the solution that fits your organization needs, the time has come to pick the right providers that will support your vision for a long time.

Choosing the right partners can be very daunting to serve the best interests of the organisation in the long run. Therefore, using appropriate criteria and evaluation processes are critical to make sure that you have qualified and agree decisions on the partners that will ensure the ongoing successful performance of your overall Artwork Service. Keep also in mind the level support needing to be provided during and after the implementation of the improvement program as per your contract with your solution providers, both from them to your company and from your company to them.  The relationship with a solution provider needs to be a partnership to make it successful in the long run.

One of the most common errors is to have selected a solution provider and then try to force-fit it into the Artwork program with strategy and business cases that are extrapolated backwards to permit this. The vision must be initiated directly from the organization’s strategy for its future development and not the other way around and most of all be capable of standing the test of time. Keep this in mind, when the time comes to select the most appropriate solution partners for your Artwork service.

To help you in your Artwork Improvement Program, you can also find useful information in my book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities

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Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities Book

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.

Posted in Artwork Auditing, Artwork Management | Leave a comment

10 Key Learnings you should consider for your Artwork Programme Implementation – Key Learning 8: Governance

 

Like all significant change activity, many artwork improvement programmes commence, but not all are successful.

We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. Following on from the previous article on ensuring focused and accountable leadership and the holiday break, we continue this series of posts on 10 Key Learnings for Artwork Improvement Projects with the topic of ensuring there is effective cross-functional governance.

Key Learning 8: Governance – Ensure there is effective cross-functional governance

We have now a pretty good idea of the main components of the structure and content of an artwork improvement programme. The cross-functional nature of it involves all kind of stakeholders located in different organisations and countries. This represent a big challenge to get a sound project correctly delivered.

Many parts of the organisation, very different from one another, such as Supply Chain, Marketing, Quality, IT, Regulatory and Third parties have their own needs and objectives in an Artwork project. Not only they have to own their specific part of the program, they have also to be held accountable for delivery. Decision making must ensure these disparate needs are considered in the management of the Artwork project.

Use of an appropriate Governance structure will help to gather these functions together and ensure their different needs are identified and represented appropriately. The Governance will have to integrate the functions in a cohesive way to maximize the outcome of the Artwork project and its adoption by the entire organization.

To help you in your Artwork Improvement Program, you can also find useful information in my book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities

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Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities Book

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.

Posted in Artwork Auditing, Artwork Management | Leave a comment

10 Key Learnings you should consider for your Artwork Programme Implementation – Key Learning 7: The right leadership

 

Like all significant change activity, many artwork improvement programmes commence, but not all are successful.

We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. After keeping momentum in your project, we continue this series of posts of 10 Key Learnings for Artwork Improvement Projects with the topic of ensuring to have a focussed and accountable leadership.

Key Learning 7: The right leadership – Ensure focussed and accountable leadership

We have already mentioned the importance of identifying the right sponsor to champion the change across the organisation for complex programs such as Artwork ones in the Key Learning 2 post . It is also important to have leaders capable to pilot this improvement project through all the challenges present in a cross-functional and cross-organisational change management project. Not only do leaders have to show technical knowledge, they have to be capable of dealing with people elements that are a huge part of a change management project.

Good leaders have to connect across the organisation to promote the Artwork Project to bring visibility and interest. They have to be capable of advocating their project outside of their close circle to engage and influence across the extended organisation to get a broad range of stakeholders on board. This require networking and communications skills to inspire and drive the project to the desired outcomes.

This cannot be achieved alone. In the same order, a leader will build up an effective network of change agents located at all the levels of the organisation that are just as enthusiastic about the project and ready to help deliver it.

The combination of all these qualities allows the leaders to overcome the difficulties and hence deliver superior results.

To help you in your Artwork Improvement Program, you can also find useful information in my book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities

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Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities Book

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.

Posted in Artwork Auditing, Artwork Management | Leave a comment