Implementation of standard work in a medical-device facility
28 October 2014
Author: Noel Hennessy, continuous improvement director, Lake Region Medical
Lake Region Medical Limited (LRM) is an original development manufacturer of minimally invasive medical devices such as guide wires and other components to the medical device industry. Founded by Joseph Fleischhacker in 1947 and manufacturer of the first pacemaker leads, the company opened the Irish plant in New Ross, Co Wexford, in 1994 with an initial workforce of 15 to manufacture uncoat guide wires for the European market.
Today, the New Ross site has circa 750 employees and is the largest guide-wire manufacturing plant in the world, sending products to more than 50 countries in six continents across the globe. In March 2014, Lake Region Medical was acquired by Accellent. This report details how the implementation of standard work has played an important role in accelerating our lean journey and helped prepare LRM for our Shingo assessment in May 2012.Lake Region Medical Limited (LRM) is an original development manufacturer of minimally invasive medical devices such as guide wires and other components to the medical device industry. Founded by Joseph Fleischhacker in 1947 and manufacturer of the first pacemaker leads, the company opened the Irish plant in New Ross, Co Wexford, in 1994 with an initial workforce of 15 to manufacture uncoat guide wires for the European market.
Manufacturing guide wires is a very intricate operation involving a variety of both manual and automated tasks. Despite the heavy International Organization for Standardization/US Food and Drug Administration (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, who said: “There is only one best way. What is the best way? It is the sum of all the good ways we have discovered up to the present. It therefore becomes the standard. Today’s best, which superseded yesterday’s, will be superseded by tomorrow’s best.”
Ford’s 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 factual 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 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 standardization, there can be no stabilisation and without stabilization, there can be no maximisation.
LRM has, over the past three years, created a world-class standard work system and designed an innovative standard work auditing system that has drawn admirers from companies all over the world, as well as being referenced by lean manufacturing luminaries John Bicheno (author of The Lean Toolbox) and Donald Dinero (author of TWI: The Foundation of Lean).
Phase 1: Operator standard work
In 2003, like many companies, our lean journey began through a number of kaizen events facilitated by an external consultant. This involved the use of lean tools such as process mapping, takt time, line balancing, 5S and spaghetti diagrams which, along with waste identification and elimination, were used to bring some level of stability to what, on reflection, was a very poor process. In our innocence, we believed we now had standard work in place and it took a number of years before we realised just how wrong we were.
The catalyst was a scrap and rework reduction project that was launched in 2008 in the guide-wire assembly area and targeted specifically at products that had a history of technical difficulties in their manufacture.
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:
- Experienced production associates had a hidden layer of detailed tacit knowledge which was not shared or captured anywhere. In fact, this tacit knowledge was critical in getting to the root cause of variation.
- The majority of SOPs were written in engineering speak and very broad, e.g. detailing equipment settings, operation, asset care, maintenance etc, which resulted in a typical SOP being >30 pages long (with some even as large as 100 pages). This called into question their suitability as a training aid for new employees.
- 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 about the tasks they were performing. Therefore, they did not understand the reasons why certain critical tasks had to be performed in a particular way.
As LRM was already adhering to established best practice in the medical device sector, the continuous improvement (CI) director and his team decided that the best opportunity lay in conducting an intensive literature trawl. This resulted in CI engineer John O’Dwyer identifying training within industry/job instruction (TWI /JI) philosophy as a potential solution. Indeed, such was O’Dwyer’s enthusiasm for TWI that he subsequently based his lean operations MSc Dissertation (Cardiff University) on the subject.
TWI differs from traditional training systems in one fundamental aspect. Rather than just creating a set of instructions and training the associate to follow them, 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. Note: a key step is one that can adversely affect quality, safety, productivity or cost. This critical information is captured in Job Breakdown Sheets (JBS).
A pilot area (small diameter distal welding) was selected to conduct a controlled trial. The 35-page-long welding SOP was refined down to three specific JBSs – one detailing operation, one for welder asset care and one for set-up – that were developed by the CI engineer with input from the relevant operations, quality, training and maintenance personnel.
There were four key steps in developing the JBS:
- Go to Gemba (factory floor) 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 personnel were 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 newly recruited production associates were selected for welding training (two using the traditional method and two using the TWI method). This provided an opportunity to conduct an experiment to compare results using the standard training method against using the TWI method. The results were very dramatic (see the graphs below).
Based on these extremely positive results, the decision was made to restructure Lake Region Medical’s training in line with 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, i.e. 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, e.g. equipment settings for non-standard parts, troubleshooting guides, etc.
Phase 2: 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 the author is aware, this was 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 carry out a process compliance check on a production or packaging cell, which is chosen at random. 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 JBS are reversed to prevent the operators referencing them.
When the check is completed the audit team collates their final scores, gives feedback and circulates the results via e-mail to the key stakeholders. During a typical check, which lasts approximately 45 to 50 minutes, between 250 to 300 key points can be checked. One 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 guide wires of the highest quality while ensuring the health and safety of 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 (i.e. the suitability of JBS to deliver training), rather than the person.
In the event that an associate is observed not performing a key point correctly, he/she will be advised as to the correct method. This information will be passed on to the relevant team leader who will first organise for the associate to be retrained and will then audit them daily until he/she is satisfied that the associate’s performance is 100% satisfactory. In 2011, the goal of achieving >90% compliance to standard work in each area was set. The results are collected weekly and displayed on the area ‘key performance indicator’ boards.
The diagram above outlines how the auditing system is designed, not alone 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 New Ross has resulted in:
- Scrap <1% on all assembly and packaging lines;
- Rework reduced by ~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. The successful implementation of standard work on the shop floor has had far reached effects throughout LRM. Today, maintenance associates, team leaders, supervisors, engineers, managers and directors all have elements of standard work built into their daily and weekly schedules.http://www.engineersjournal.ie/2014/10/28/implementation-standard-work-medical-device-facility/http://www.engineersjournal.ie/wp-content/uploads/2014/10/New-Picture5.bmphttp://www.engineersjournal.ie/wp-content/uploads/2014/10/New-Picture5.bmpBiomanufacturing,medical devices,Wexford