Focus on the Fundamentals
By Suzanne Ivory
COO, Global Software Division, Perigord
Fundamentals. The drab cousins of the headline grabbers like AI or Pharma 4.0. But focussing on them can be the investment that offers the most long-term rewards for companies in terms of risk mitigation, cost reduction and improved overall agility.
In pharmaceutical packaging and labelling, the key fundamental is the process that answers the question – “how do we get our drugs to market as quickly and efficiently as possible without compromising patient safety?”
The danger of adhocracy
At its most basic level pharmaceutical artwork process maps the movement of the brief for a carton, label or leaflet (digital assets) through multiple reviews; through its physical preparation as an artwork file, further approvals, and final delivery to designated printer or factory. The process should also define who’s responsible for individual tasks and how long they should take.
In terms of potential risk, the process is one of the most vulnerable elements of a product’s overall life cycle. Research suggests the primary cause of issues in the artwork process stem from the absence of a robust, clearly documented process.
The complexity of artwork version control, the number of unnecessary proof cycles and the limited reuse of digital assets can all have a financial impact on the process. Other errors, ranging from incomplete product information; translation errors; or incorrect specifications could lead to a regulatory breach, a delay in getting a product to market, a recall, or even a critical consequence for the patient.
A poorly defined process or one that is ad hoc, is vulnerable to mistakes and misunderstandings at the most basic levels. Clearly defining who is responsible for what and when tasks should occur is difficult. This lack of transparency makes change difficult and communicating up and down the supply chain inefficient and spotty – sometimes dangerously so in the case of an emergency.
A reliance on paper-based systems presents similar risks. Dealing with products being released across multiple markets requires a huge and varied amount of regulatory requirements to be adhered to. Eschewing a digital method of managing this requires both a huge investment in staff, time, and faith that everything that must go right, will go right.
Employing a linear approach to a process makes every task owner a gatekeeper. Essentially the progress of the process is entirely at the mercy of whomever is responsible for completing the latest task in the sequence. This makes estimating the time to complete a project less of a science and more of a wet finger in the wind. Under these circumstances, strict deadlines are tough to enforce and rejection loops create the potential for tasks to be unnecessarily replicated.
Embrace the AMS
The best way to sidestep these risks and issues is to employ an industry-specific artwork management system (AMS), like GLAMS.
An AMS will typically offer its users the ability to implement controls on its process; centralised control of all the data variables being dealt with; some sort of interface with a suite of proofing tools to limit text-based errors; and a clear chain of custody regarding who is responsible for what task, when they should be doing it and how long it should take.
In order to get to this promised land, however, every AMS implementation involves an organisation to have a clear grasp of its process. No matter how smart technology is, it is still subject to the principal of “Garbage in, garbage out”. Therefore time must be spent mapping the end-to-end artwork process in order to model it in the AMS.
In some cases a platform like GLAMS Q, which offers pre-defined workflows, is suitable for companies that might not have a defined process yet or may not have the time or staff resources available to develop their own.
Fully validated and with a rollout period of roughly two weeks, this sort of option is perfect for SMEs looking to improve productivity without a significant financial outlay. GLAMS Q is also designed to grow with a business and has a upgrade path baked in to allow a seamless move to a larger more complex platform, GLAMS Enterprise.
For more established organisations, a platform like GLAMS Enterprise offers the opportunity to create more complex, configurable workflows. Perigord, will offer assistance for this, providing a dedicated business analyst to walk through the mapping process and, if required, lend advice on areas where an existing workflow could be improved according to industry best practice.
Reaping the benefits
Based on this firm grasp of the end-to-end process, and the implementation of an AMS, a huge number of options become available to the pharmaceutical or life science company three main areas:
1. Overall agility
With the advent of Pharma 4.0 and the evolution of the digitisation of the supply chain, it is vital that companies first create optimised process flows before automating them.
Mapping the packaging process for an online platform like GLAMS Q, allows organisations to establish a definitive model of their workflows. In doing so pain points, bottlenecks or unnecessary tasks can be removed.
As well as the overall process management, an AMS allows restrictions to be put on the data entered into it, significantly reducing the risk of incorrect or incomplete data, documents or specifications being used to complete an artwork. Users can also track artworks on a task-by-task basis, and take a deep dive into any of the data the system records to start building future strategies.
Meanwhile, implementing a suite of built-in proofing tools means every user that needs to can perform as many checks as they need to ensure artwork is right-first-time and the need for repeated review cycles and the associated risk is significantly reduced.
2. Risk reduction
While the packaging process is designed to identify, eliminate, and correct artwork issues, it is also subject to the law of unintended consequences, meaning the process itself could cause new defects to be created.
The basic arithmetic of risk assessment – risk = probability x potential loss – shows that more cycles mean more touches; and more touches means an ever-rising risk of new and unintended defects being introduced.
A lack of transparency in who is responsible for what, and the sequence in which approvals need to occur, can lead to unnecessary repetition of tasks – resulting in the unnecessary introduction of risk to the system.
GLAMS can aid in reducing this risk by allowing multiple users to approve a single artwork in parallel, bundling their rejection reasons together and ensuring that if corrections are required, they are communicated and completed in the most efficient manner possible.
3. Process transparency
The less transparency there is in a process and the poorer the communication of information – from a change requirement to some sort of supporting information – the more likely an artwork will have to go through multiple change cycles.
This is particularly prevalent in paper-based systems, or processes managed through ad hoc Franken-systems of interconnected excel sheets, an overload of emails, and unconnected apps. Systematic errors are tough to track, and data that could reveal valuable insights about the company and its individual products is often squandered.
While not every error necessitates a recall, there are still quality control issues in the artwork process which need to be managed and taken seriously.
Although the cause of the defect may lie elsewhere along the supply chain, the buck stops with the company with its name on the box. As does the responsibility of maintaining an efficient and dynamic supply stream to manage multiple versions or revisions of the same artwork element simultaneously.
It is the responsibility of the pharmaceutical or life science provider to know where their packaging assets are and what is happening with them at all times. Having full visibility of all artwork assets insulates a company from the risk of an obsolete or archived version of an artwork accidentally being printed, and allows greater opportunities for leveraging previously approved artwork to shave valuable days and weeks off a move into a new territory or the launch of a new product.
To provide the this level of visibility and traceability, GLAMS applies a unique ID to every entity within the system and an automatic version number to its artworks thus ensuring no confusion about which revision of an artwork is approved or not, and which one is the latest version.
Similarly, by separating the in-progress artworks from the approved and automatically archived superseded versions, the risk of the wrong artwork being used in the system is reduced and users gain the ability to quickly and easily meet any audit requirements they may encounter.
Finally, by allowing users to link centrally managed assets like keylines, pictograms or barcodes, the risk and effort of making sure the right supporting document is available is severely reduced.
Optimised processes start with control. And for packaging, that control starts with the artwork. Having credible, consistent answers to the questions of which users access artwork, how they access it, from where, and in what way is of paramount importance to mitigating risk. Too often, however, this lack of control is at the heart of packing recalls.
By focusing on the fundamental element of the artwork process and managing these risks effectively using an AMS like GLAMS, organisations of all sizes and maturity levels create the opportunity to deliver huge savings in terms of time spent on projects, resource requirements and overall costs.
Centralised Global QMS Certified to ISO 9001:2015 & PS 9000:2016