Tosara Pharma

Case Study 3 – Operational Excellence

Our final case study was identified at Tosara Pharma by the Site Production Specialist/OPEX Site Lead.  His project related to operational excellence.  Prior to 2009, Tosara Pharma could be considered a traditional manufacturing company.  As the company was growing, they focused on market growth with little consideration for all other aspects of the business.

Things had reached crisis point around this time.  New markets were expanding at approximate 3% growth year on year.  Customer orders were not being met.  Inventory control levels were out of sync with their production forecasts.  Subsequently, the company was left with two options:  1. Continue to drive the business using the current traditional model, or 2. Create a continuous improvement culture, centred on people development and employee engagement.

So, from 2009, they started on their Continuous Improvement Journey.  In 2016, the company realised that with the continued growth of their business into new emerging markets, they had to improve their equipment performance.  If they were to continue meeting their customer demand, they had to eliminate non-value adding activities.  All while improving on their schedule adherence and equipment utilisation.

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Key Challenges

By way of background, the average time for a SKU (size) changeover on the packaging lines was taking approximately 8 hours.  However, this type of performance was unsustainable if they wanted to grow the business at current growth forecasts.  The OPEX Site Lead and team members identified the need to reduce their equipment changeover cycle time with the introduction of Standard Work.  Moreover, improvement would only be achieved by using SMED (Single Minute Exchange of Die) and TPM (Total Productive Maintenance).

In 2020, Tosara Pharma reduced the average changeover time from 8 hours to 1.5 hours.  This was achieved through a collaborative multi-departmental effort.  Subsequently, they identified opportunities for improvement.  This involved making changeovers more efficient and training operators to maintain their own equipment.

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Key Actions

To clarify, Line 8 is a high speed line producing 60g, 125g and 175g jar sizes.  So, this packaging line was selected as the pilot line to start their SMED and TPM programmes.

As part of the team selection, they found that it was going to be very important to identify employees who were self-motivated.  In addition, these employees had to take an extraordinary interest in adapting, implementing and supporting change.  Furthermore, it was vital that they identified any potential safety hazards before they encouraged their untrained packaging operators to take responsibility for changing equipment parts.  It is widely recognised within Industry that most safety incidents occur through unsafe behaviours, rather than unsafe conditions.  Only through developing a culture of safe practices and employee behaviours were they able to sustain a safe working environment for everyone.

Moreover, Tosara Pharma measures and records all potential safety hazards, or “near misses”.  They use them as teaching points that are communicated universally at local team huddle board meetings weekly.  To date, they are an injury free site for more than 3 years.

Traditionally, all changeovers were carried out by Maintenance Technicians.  However this resulted in non-standardised, time-consuming and personalised changeovers.

Kaizen Card Programme

With the help of their Lean Champion, the company introduced a Kaizen Card programme.  This encouraged employees to suggest items for continuous improvement.  With the support of the Maintenance Team, they used a Kaizen Card.  This helped them identify daily, weekly and monthly checks of equipment. Furthermore, this included a monthly checklist to reduce variation in performance. 

Their Lean Champion was responsible for the implementation and employee training for their TPM and SMED programmes with the support of the Maintenance Technicians.

Tosara Pharma Brainstorming

Then, they set about using the 8 Pillars of TPM building a robust programme in reducing defects, maintaining equipment and training people to maintain their own equipment.  This brought about a shared responsibility between Operations and Maintenance Departments.  For instance, typical daily activities included precision checks, lubrication, parts replacement, simple repairs and abnormality detection.

Tosara Pharma T Cards

TPM & T-Card Checks

After compiling and analysing the equipment downtime data, the SMED team developed a series of T-Cards checks.  These cards were colour coded.  One side was coloured red to indicate a check was required to be completed.  Next, information was provided to staff members describing the importance of the check.  Then, the opposite side of the card was green to indicate that the check was completed and provided information on the expected result.  It also described “Why” the inspection was important.  This was a great success and helped the Packaging Team to maintain their own equipment.  These T-Cards were located in full view, beside each piece of equipment.

After the success of this pilot programme on Line 8, the company rolled out the TPM programme along other packaging lines.  In total, 140 T-Card Checks were identified over a 3 month period, across all 5 packaging lines.  Since the implementation of their TPM programme, a number of employees are SME’s (Subject Matter Experts).  Their roles allow in-house training known as TWI (Training Within Industry).  In other words, they have supported other departments as they introduced TPM Checks into their own respective operations.

Standardising their SMED Programme

The company adopted SMED as a site strategy in 2016 with dramatic results in the speed of changeovers.  As a result, the business was able to be more flexible and agile with their production scheduling. 

That being said, by the end of 2016, their Maintenance Department was still involved in line changeovers as they were reluctant to relinquish control of certain aspects of the equipment changeover.  If changed incorrectly, it would lead to high levels of scrap with the possibility of damaging the equipment itself.  Each Maintenance Technician had a different approach and was based on their own notes, with no two ways being the same.  Finally, they agreed to standardise this part of the line changeover, and training of operators would be required with the support of the Maintenance Technicians.

Following on from SMED training, the team developed a set of work instructions manuals for each piece of equipment.  This was supported by the Maintenance Technician responsible for training the Packaging Operators.

SMED Training Programme

Since the initial rollout in 2011, every employee within the Packaging Department has received a level of training in completing a section of changeover.  This has been seen as a huge Cultural Enabler as they have trained unskilled operators to become experts.

Key Outcomes

Their SMED and TPM programmes are on a continuous cycle of review.  This ensures that the standards they set for themselves are sustained.  In addition, they regularly challenge themselves to reduce their cycle time further by eliminating change parts both internally and externally.  Finally, they use regular brainstorming/Kaizen Events to challenge the current status quo.

Tosara Pharma have dramatically reduced downtime across all lines.  In addition, they have reduced maintenance call-outs to repair lines as a result of trained operators being more confident.  In addition, they are competent in seeing issues as they arise and fixing them in real time.

Similarly, the reduction in maintenance call outs has freed up available time for Maintenance Technicians to be more proactive in carrying out preventative maintenance.  This has further reduced their downtime stoppages. 

As a direct result of their TPM and SMED programmes, employee engagement and morale is very high.  They have built up a self-confidence in their Packaging Operators to maintain and change their own equipment parts.  Most importantly, this has given the company better time to market, kept their costs down and has enabled them to stay ahead of their direct competitors.


ETAC came on site to support the rollout of their SMED and TPM improvement programmes.  The first phase was to make a video of the current changeover as recommended by (Shingo, 1985) in his book “A revolution in Manufacturing: the SMED system”.  This helped to  identify areas of waste and the lack of standard work. However, Line Operators and Maintenance Engineers were unfamiliar with the application of Lean tools and techniques such as: (5/6 S Workplace Organisation, Visual Management, Value Stream Mapping (VSM), Kanban, Poka- Yoke, A3 Methodology, SMED, TPM, Kaizen and Standard Work).  These Lean tools are designed to improve and support them in their daily work activities.
We firmly believe that the expertise to develop business process improvements already exist in every organisation.  This has clearly been the case in Tosara Pharma.  Through their employees’ Lean projects and in particular their Site Production Specialist/OPEX Site Lead, the company has made significant continuous improvements to their business.  They are also working towards achieving operational excellence.
ETAC has worked with Tosara Pharma to streamline their business and improve their processes.  We hope you enjoyed reading about this case study on Operational Excellence.  You may be interested in reading the two other case studies featured here: Case Study 1 – Regulatory Training and Case Study 2 – Label Applicator.  All our case studies are available here.