Case Study Artwork management for a newly merged company
Case Study
Artwork management for a newly merged company
Situation:
Company x recently merged with a large rival. Both companies have functional and adequate Artwork Management processes. Client advices that in their opinion neither constituent company has superior nor indeed best in cass tools and processes.
Target:
Chose between the two legacy processes or to develop a best in class Artwork Management process.
SMC were initially chosen to carry out the scoping and assessment work.
Proposal (& Activity description)
SMC set about establishing a baseline for both legacy processes set in terms of Governance, Process, People and Systems together with a robust financial analysis. We quickly concurred with the believe that neither legacy company had an optimal solution, but by selecting some best practice from each, together with adopting industry best practice could yield a much improved way of working.
Governance:
SMC proposed that the client adopt and document a high level but tangible expectation for an Artwork delivery process. At the very least this needs to include a policy that will underline the expectation that the process be compliant with all regulations both in terms of content and timing. The inclusion of timing is critical as we observed that there was a less than robust emphasis on implementation of approved labelling variations. SMC pointed out that there is currently a real focus from the regulatory inspectors and is very easily identifiable at audit. To underscore the importance of the new policy SMC recommended that accountability be assigned to a senior high profile executive. Recognising that policies alone cannot produce results SMC proposed that the Governance structure be supported by small number of procedures and appropriate personnel.
People:
Structure
As stated above SMC recommended that there be a single point of accountability for Artwork development globally. Beneath this, we recommended that the client establish a line-management connection with artwork managers at the affiliates (operating companies). In order to establish this is would be necessary for some artwork groups to change their local reporting structure. Furthermore stronger relationships with supply chain and manufacturing personal ought be to established. Though not in scope we recommend that the client consider Communities of practice and perhaps setting up a company-wide Packaging Technology function which could include artwork development
Personnel Development
Interviews with the front line workers confirmed that many found it difficult to put their work in the context of the overall company with few having a good understanding of the regulatory requirements especially in relation to implementation. SMC recommended that all personnel associated with artwork management be brought through a programme of development. This should, at a minimum, include, GMP, Regulatory (labelling), Manufacturing (planning & change control), Risk Management, Failure Mode and Effects Analysis (FMEA). We also proposed to adopt a consistent approach to recruitment (active profiling) and more emphasis given to the career progression of Artwork Specialists.
Process:
Efficiency
In the initial observation and scoping we noted much redundancy of effort. Double handling was common and rework was alarmingly high. The level of Work in Progress for the given volume was far in excess of the industry norm. Furthermore there were many instances where responsibility and accountability were not at all obvious to the people carrying out the work. In particular there was evidence that input from the Labelling group was inconsistent and the relationship between the groups was not healthy. SMC recommend to hold a workshop to agree on the “as is” and develop the “to be” model” . This is with the aim of achieving a far higher Right First Time, a far lower degree of “Work in Progress” and overall a much more predictable and safer process. At a minimum SMC recommends the following groups are represented at the workshop: Artwork Development, Labelling (Regulatory), Procurment, Manufacturing (network planning, change control & quality) and Commercial (NPI/Marketing). The outcomes and recommendations of the workshop are to be presented to senior sponsor for formal approval.
Consistency
Currently digital artwork is provided by a mixture of internal and external resources. We observed in many cases a full rework of artwork was required to prepare for printing (post approval reprographics). This is a most avoidable situation. We recommend that the client consider a more consistent approach to digital artwork production. We suggest conducting a value analysis on Make (in house) or buy (from a single of small number of contractors). We strongly recommend that a single model be agreed upon as this will much better support good governance and process. There are good technical reasons for limiting the number of sources of artwork.
Reliability
The overwhelming message from the (commercial) business aspect is a desire for cost effective predictable and reliable artwork supply. SMC recommended that as part of the agreed proposal a set of simple metrics be developmed to ensure these criteria are measurable comprehensible and shared on a regular baseis.
Systems:
Currently the client employs a variety of electronic and semi manual systems (shared calendars, spreadsheets etc). These are located both centrally and within the affiliate countries throughout the network. SMC recommends that the client takes this unique opportunity to invest in a company-wide validated electronic artwork request and approval system. We further recommend that this be a global deployment covering all operating Companies, Packaging Sites, Third Parties Suppliers (with limited access), Third Party Customers, Repackaging Sites We noted that there are several COTS (Customisable Off The Shelf) solution available but not all are suitable for the regulated environment and for this scale of operation. We recommend that the company carry out a thorough analyse of the solutions market, establish what their rivals are doing. One this is done proceed to RFI/RFP to establish the suitability of the various offerings with respect to functionality, scalability, security and facility to customise and validate.
Financial analysis
SMC costed several options of delivering this proposal in terms of:
Tangible Benefits:
Total elimination of line downtime due to delayed artwork
Total elimination of Out of Stocks due to delayed artwork development
Reduction in at risk activities associated with new product Introduction
Reduction in cost associated with expediting submissions and artwork production
Possible reduction in overall personnel depending on organisational design decision
Costs:
Internal Project resource (required for project delivery and / or back fill position)
SMEs
IT
Work Stream Management
External Project resource (project management, Leadership)
Internal v external validation resource (IQ, OQ, PQ)
Preparation of materials and delivery of personal Development Programme as referenced in section above
Preparation of materials and delivery of training for configured workflow solutionz
Other project Budgets
Risk budget
Change budget
Conclusion and recommendation:
SMC can see value in establishing a new artwork strategy for the enlarged organisation. The time is excellent to make a decisive change. The development of a new process and the possibility of a new tool can definitely produce a win/win for the newly morphed entities. The new shared ownership can be a very beneficial by-product of a new way of working. The professionalisation of the people together with better career structure has been shown to yield great long term value.
SMC is in a great position to support and make this happen. From facilitating workshops right the way through to system validation and training our experience can help develop the strategy and deliver the solution. Our aim is to help the client deliver safe and compliant medical packaging at an optimal cost.