The eyes of the world may have been on London this summer, but in the meantime Lake Region Medical won a prize of its own, becoming the first Irish company to be awarded a Shingo Accredition Bronze Medallion. How did it do it? Continuous improvement Director Noel Hennessy talks about the company’s successful approach to standard work.

Manufacturing guidewires is a very intricate operation involving a variety of manual and automated tasks. Despite the heavy ISO/FDA focus on procedures, the majority of medical device recalls can be traced back to a failure to follow procedure. Therefore, within the manufacturing of medical devices, a company’s adherence to standard work is critical.

The concept of standard work goes back as far as its first major advocate, Henry Ford, whose philosophy is just as relevant today as it was over 100 years ago. The design and implementation of standard work for medical device production has proven a major challenge: it forces management and engineering staff to clearly identify and define the one best way. Standard operating procedures have tended to be voluminous documents, difficult to understand and open to interpretation. Standard work is very definitive: it leaves no room for error and forms the basis for understanding and learning.

There is a people paradox in managing improvements and change in the medical device sector. While today’s production associates are very well educated and highly skilled they tend towards innovation as a means to achieve improvement. While this is sought in employees it must be controlled, or it may become a source of inefficiency and the antithesis of that improved performance that standard work enables.

As well as ensuring that every single product is manufactured fit for its intended use, standard work also acts as the baseline for all future improvements. Without standardisation there can be no stabilisation, and without stabilisation there can be no maximisation.

Lake Region Medical Limited has created a world class standard work system and designed an innovative standard work auditing system that has drawn admirers from around the world.

THE NEED FOR STANDARD WORK

Loss makers – every manufacturer has them. They are the parts you wish you didn’t have to make and only do because the customer also buys lots of other products from you. In LRM, such a part was 3564.090-011 and in 2007 and 2008 ten separate orders for 500 pieces per year were shipped to one of our biggest customers in the USA. Such were the technical difficulties in manufacturing these parts that over 14,500 components had to be made to allow for unusually high levels of rework and scrap. While a source of frustration, this situation was tolerated because these orders represented only a tiny fraction of the company’s annual sales of over 30,000,000 units. Improvement and problem solving activities were directed at areas where it was anticipated greater savings could be achieved.

However, in early 2009 the goalposts moved when our customer announced plans for a major launch of a new product which required 3564.090-011. When advance orders were placed for 10,000 units per week alarm bells began to ring. LRM’s OUSVP set up a cross functional project team to address the rework and scrap issues.

The resultant investigation of the manufacturing processes showed the root cause of the problem to be the level of process detail and technique required for these particular products. This was despite the fact that the quality of the standard operating procedures (SOP) documentation was of the highest level and the systems in place to manage and record employee training were extremely effective. However, while all these systems were adhering to best practice in FDA regulated industries, three major opportunities for strengthening the systems were identified:

  1. Experienced production associates had a hidden layer of detailed tacit knowledge which was not shared or captured anywhere. In fact, this tacit knowledge was key in getting to the root cause.
  2. The majority of SOPs were written in engineering speak and very broad, for instance detailing equipment settings, operation, asset care, maintenance, etc. which resulted in a typical SOP being over 30 pages long (with some even as large as 100 pages). This called into question their suitability as a training aid for new employees.
  3. While all production associates had been trained and were certified to carry out their duties as prescribed in the SOPs, in reality they had no real or deep understanding of the tasks they were performing. Therefore, they did not understand the reasons why certain critical tasks had to be performed in a particular way.

LRM’s VP tasked the continuous improvement team with addressing this problem as a matter of urgency. As the company was already adhering to established best practice in the medical device sector, my team and I decided that the best opportunity lay in conducting an intensive literature trawl. This resulted in CI engineer John O’Dwyer identifying the TWI philosophy as a potential solution.

TWI differs from traditional training systems in one fundamental aspect. Rather than just creating a set of instructions and training for the associate to follow it embeds a real understanding of the process. This is achieved by teaching them, in a layered manner, the significance of each key step in the process and the consequences if these key steps are not performed correctly.

PRODUCTION ASSOCIATE STANDARD WORK

DEVELOPING JOB BREAKDOWN SHEETS

A pilot area (small diameter distal welding) was selected to conduct a controlled trial. The 35-page welding SOP was refined down to three specific JBSs; one detailing operation, one for welder asset care and one for set-up, which were developed by the CI engineer with input from the relevant operations, quality and maintenance personnel.

There were four key steps in developing the JBS:

  • Go to the gemba and involve the associates at every stage of the project;
  • Watch every motion in great detail, using video analysis where required;
  • Use data to determine the current one best method;
  • Capture this method in non technical language.

At this stage quality assurance was invited to review the three documents to ensure that they complied with ISO 14001 and FDA requirements as per the company’s quality management system. To trial the system, four production associates were selected for welding training (two using the traditional method and two using TWI). This provided an opportunity to conduct an experiment to compare results using the standard training method against TWI. The results were dramatic.

Based on these extremely positive results the decision was made to restructure Lake Region’s training in line with the TWI philosophy. This resulted in a complete review of all production SOPs and the creation of over 100 job breakdown sheets. These JBSs were laminated and installed where they could be of most benefit to the production associates, for example at his/her work station. Likewise, they are available for team leaders to pick up and observe immediately whether standard work is being performed correctly.

It is important to reiterate that the main purpose of these job breakdown sheets is to assist in the training of manufacturing personnel and to instill understanding and knowledge of the processes.

There is still a requirement for the detailed SOP and in fact every production line is equipped with a PC to enable the production associates to access broader details, like troubleshooting guides.

INTRODUCING STANDARD WORK COMPLIANCE CHECKS

In order to support the roll-out, the implementation team developed an auditing system to measure how well standard work was being followed. As far as I am aware, this is the first time such an auditing system has been created specifically for this purpose.

Each week, an audit team consisting of a CI engineer, production manager and training specialist carries out a process compliance check on a production or packaging cell randomly chosen. Each audit team member (using the relevant JBS) observes a different production associate performing their work and records the result on the sheet. While the audit is being carried out, the line JBSs are reversed to prevent the operators from using them.

When the check is completed the audit team collates the final scores, gives feedback and circulates the results via e-mail to the key stakeholders. During a typical check, which lasts between 45 to 50 minutes, 250 to 300 tasks can be checked. One key refinement that the team has made to the check is that in the event of a production associate either missing or performing a critical quality or safety step incorrectly, production is immediately stopped until the issue is resolved and 10% is deducted from the final score. This supports the company’s key objectives of supplying guidewires of the highest quality while ensuring the health and safety of their employees.

As well as auditing how work is being performed, this check also presents an opportunity to assess the quality of the JBS and look for opportunities to improve the process. Input from operations personnel was key in the creation and introduction of these standard work compliance checks.

In particular, the team wanted to assure the production associates that the focus of the compliance check was on the process rather than the person. In the event that an associate is observed not performing a keypoint correctly, he/she will be advised as to the correct method.

This information will be passed on to the relevant team leaders who will first organise for the associate to be retrained and will then audit them daily until the associate’s performance is 100% satisfactory. In 2011, the goal of achieving over 90% compliance to standard work in each area was set. The results are collected weekly and displayed on the area KPI boards.

SUMMARY

The figure below outlines how the auditing system is designed, not only to check if the production associates are performing the task correctly but also to ensure that the work instruction is adequate and that the training has been delivered correctly.

The implementation of standard work in Lake Region Medical Limited has resulted in:

  • Scrap of less than 1% on all assembly and packaging lines;
  • Rework reduced by about 73% on assembly and packaging lines;
  • Compulsory destructive testing is now consistently the main cause of assembly scrap;
  • Maximum scrap and rework limits set across all assembly and packaging lines;
  • Machine uptime increased by 28%;
  • Improved production and maintenance associate morale and job satisfaction.

Standard work however is not just confined to the factory floor. Just as there is only ‘one best way’ to carry out a production task, exactly the same philosophy applies to all other functions. Groups as diverse as production team leaders, maintenance fitters, technicians and senior managers were invited to hear for themselves, production associates explaining how having a standard process (with minimum variation) affects their working day.

TEAM LEADER STANDARD WORK

Before the introduction of standard work, team leaders gravitated towards the part of the job they preferred and were most comfortable with.

Today approximately 80% of the team leaders’ day is prescribed to support the key requirements of the position, for example ensuring the production associates are carrying out standard work and that the focus at all times is geared towards the voice of the customer. Team leader standard work is captured and controlled in a day specific log.

MAINTENANCE STANDARD WORK

Maintenance standard work began when maintenance personnel and production associates joined together to create machine specific ledgers. These ledgers captured ‘the one best way’ to carry out all equipment asset care and PMs. Tasks which did not require specific technical training or equipment were transferred from maintenance to production associates who were delighted to be given more ownership of the equipment. This facilitated time for the fitters and technicians to become trained in scientific problem solving tools which they now use on a daily basis to find the root cause of equipment failure. An enhanced associate asset care system was also developed and is managed through a T card system.

In November 2008, a group of independent auditors (MCP) were selected to benchmark Lake Region Medical Limited maintenance system using the AMIS model (Asset Management Improvement System). The audit was carried out over two days by a cross functional team of ten LRNR employees under the supervision of an MCP consultant.

It is significant to note that AMIS establishes the threshold for world class performance at an overall score of 75%. Today routine asset care and maintenance is performed by the production associates. This has allowed time for the maintenance associates to be trained in the use of scientific problem solving tools to enable them to get to the root cause of reoccurring problems and implement permanent solutions.

DIRECTOR STANDARD WORK

While standard work has been in place for production associates and team leaders since 2008, it was only in early 2011 that standard work for senior management was introduced. This arose from a requirement to:

  • Document current management best practice;
  • Define the expected behavior of Lake Region Medical leaders;
  • Ensure that all daily activities are focused on our KPIs and are in line with the company’s five-year strategy;
  • Confirm that the management system is working correctly;
  • Cement the use of scientific thinking on the factory floor;
  • Develop employees, acknowledge good work and identify improvement opportunities.

While it is acknowledged that each director will have a particular area of focus and expertise, Lake Region’s leader standard work system ensures that he/she must also have time allotted within their schedule towards supporting all of the key elements required of senior management team members.

Leader standard work is managed through a T card system located in each director’s office. A day specific card details the area and time the director is required to spend on the factory floor. A total of ten T cards are required to ensure that all areas are covered over a two week period.

To date the feedback has been extremely positive. Production supervisors and associates really appreciate having members of the senior management team available on the floor, every day to provide support and direction when it is required.

TO CONCLUDE

The successful introduction of standard work throughout Lake Region has without a doubt created a revolution within Ireland. Over the past three years virtually all of the major medical device and pharmaceutical companies in the country have benchmarked themselves against Lake Region Medical Limited standard work system. This in turn has led to the Irish Centre for Business Excellence sponsoring Standard Work & TWI experts like Bradley Willis (ex Toyota & University of Kentucky) and Donald Dinero to come to Ireland to deliver workshops on this subject.

Unquestionably LRML standard work system has laid the foundations for the successful introduction of scientific problem solving methodology and was a key enabler in the company’s achievement of the Shingo accreditation this year. The New Ross site is in a unique position now to present itself as a centre of excellence.