Measure Phase

 

Project Name: Streamlining Customer Complaints Investigations

Problem Statement: The time to complete a complaint investigation needs to be shortened to accommodate for the frequency of complaints throughout the year to ensure timelines are met.

Moving onto the measure phase of this project, I utilized the following tools:

·         Brainstorming/ Voice of Customer

·         High Level Process Flowchart

·         Create data collection plan

·         Data collection

·         Value Stream mapping(current and future state)
 

I further developed the output from the brainstorming/ voice of the customer meetings during the define phase and transferred the affinity diagram into excel with the possible solutions detailed. During the brainstorming session, there were some ideas which were generated outside the scope of this project. During the team development meeting I had discussed what was outside the scope of this project, however, there are a number of areas which has been a struggle for some time, with some team members and therefore it naturally came up as a discussion point. However, these areas are corporate systems which would not be feasible for change in the timeframe of this project. I included these points for future reference and highlighted them in red for the team.  This was to indicate that these items will be reviewed for further development after this project.

The process flow chart developed during the define phase was transferred into visio to ensure that everyone was working off the same set of process steps. These process steps were grouped together under a number of high level headings as part of data collection.

In order to help determine the baseline for our current process, I developed a data collection plan that people could utilize over the space of two weeks where the complaint investigators and quality engineers would record the length of time it took to complete an investigation for a set number of complaints. This data collection plan helped to ensure that everyone was using the same method for collecting the data and a template was provided to that everyone would record the time per step in the same format. One of the requests for this data collection was to ensure that the device was returned as part of the investigation. Not all complaints have a device available for evaluation and therefore I wanted to ensure that the worst case scenario was timed for this project.

Given that no two complaints are the same in that they range in complexity depending on the device, what happened to the patient and the amount of information that is available to the investigator, an average time was calculated as the baseline for complaints. This will be reviewed further during the analyze phase.

With the results from the data collection, I was able to generate a value stream map for the current and future states. I have no experience with value stream mapping before so I had to complete quite a lot of research as to how to construct them. I used visio to construct the current and future value stream maps.

As highlighted also during the brainstorming session, it is not necessarily the complaint investigation process which takes up the time of the investigators but other tasks which feed into the 39 hour working week which take up time such as monthly, weekly reports, meetings and request for information from other departments. These tasks will also be reviewed as part of this project to ensure a more efficient process is developed for the team.

Assessment of Measure Phase: I found the measure phase tricky for some of the tools as I have no previous experience with them. However, as I mentioned in my introduction, this is the best method for me to learn is to execute through trial and error. The information pulled for this phase gave a much better picture of where we are compared to what I had estimated reviewing as a possible project last year.

 
Next Step: Analyze. Identify the cause of the problem.

Define Phase

Project Name: Streamlining Customer Complaints Investigations

Background: There is no control over the number of complaints received per year. There are number of factors that influence the number of complaints raised. Some examples listed below:

·         The use of medical devices is largely dependent on the user and the training and the experience of the end user.

·         There is no control over the rate that complaints are received during the year, for example there is a lull through the Summer and peak in the Winter time.

·         There is no control over the rate that complaints are received for certain devices, this is dependent on sales and marketing.

These elements combined can lead to peaks and troughs of complaints raised throughout the year. Therefore, in order to meet the needs of both internal and external customers regarding the quality of the investigation and the length of time it takes to complete, the complaints process needs to be as efficient and effective as possible.

Problem Statement: The time to complete a complaint investigation needs to be shortened to accommodate for the frequency of complaints throughout the year to ensure timelines are met.

Current set up: There are five complaint investigators working full on time on assessing the complaint and documenting the investigation. All complaints received for devices manufactured within the company are investigated no matter what the issue is.

The Regulatory Affairs department determines if a complaint is reportable or non reportable. This dictates the amount of time an investigator has to investigate and document the complaint.

“Improvement usually means doing something that we have never done before” Shigeo Shingo

Starting Point of the Define Phase

·         How long has the problem existed? Always (in a way). Complaints occur in every industry. However, being in a regulated industry timelines for investigation and the method of investigation is more specific and locked down. The length of time to investigate a complaint is dependent on the execution of the current procedures.  

·         How did the problem begin? There was no one specific element the triggered the problem. The method of investigation is as per corporate procedure as well as a number of other tasks which must be complete as part of the system. The method through how this system is executed needs to be reviewed. 

·         Will we need a project team to work on the problem? Yes. This project is dependent on getting feedback from the people who are working on this system every day and getting their feedback, generating ideas and suggesting improvements. 

·         What will be the savings if a solution is found? By reducing the amount of time it takes to complete aspects of complaint investigation, it has been estimated that a cost savings of over €37k could be generated. 

·         What will be the damage if a solution isn’t found? Timeline metrics will not be met, raising awareness in the system by competent authorities and management.  

·         What will be the benefits if a solution is found?

o   Reduce the amount of time it takes to complete the investigation.

o   Free up time for investigators to help on other projects within the quality engineering group which are currently on hold due to the current resource time availability.

o   Provide Regulatory Affairs more time to complete and submit the complaint report to the competent authorities.

o   Improve the closure time for complaint files for quality engineering.

o   Reduce potential for documentation errors.

The next steps involved in the define phase are to use the relevant tools to generate the necessary interest, involvement and information required to progress onto the next stage of the DMAIC process. I utilized the following tools for this phase:

·         Team Development

·         Project Charter

·         Voice of Customer

·         Brainstorming

·         Process Flowchart

·         SIPOC

·         Gantt Chart

I will provide some detail on the generation of the team and the project charter in this define blog.

Due a corporate driven project underway in the company at the moment, resources and time is limited, therefore it was very important to clearly define the roles and responsibilities associated with this project over the next few months.

The team will compromise of the following:

·         Senior Quality Engineer (Champion, Project Leader)

·         Quality Engineers

·         Complaints Investigators

The quality engineers and complaint investigators will be involved heavily in giving their input in the specific problem areas and possible solutions however I will be the main driver for this project and pulling together the necessary meetings and system changes.

The initial meeting I had with the team I defined the problem from my point of view. During this meeting it was important to establish the scope of the project and the project charter was useful to step through each of the questions that were being raised surrounding the project.

The project charter clearly identified the scope, objectives, metrics, risks, the timelines for each phase and most importantly what was included within the scope of the project. This was the item that was most up for debate as there were quite a number of areas which the team felt could be worked upon and changed for the better. However, given the timeline associated with the project it was important to chase after the low hanging fruit first which is achievable. Therefore, a list of items were generated which could be and could not be included within the scope of this project. I felt it was important to do so to ensure that project creep does not occur over the course of the project.

The goals generated for this project are high level and there seemed to be a general consensus that these could be met.

Metric	Baseline	Goal	Blue Sky
Reportable Complaints	27days(average time to closure)	26days(average time to closure)	25days(average time to closure)
Non reportable Complaints	55days(average time to closure)	53days(average time to closure)	50days(average time to closure)
Time per complaint	8 hours	6.4 hours	5.6 hours

I felt it was important to iterate to the team during this meeting that items that were not included within the scope of this project would not be excluded from further reviews of this system.

Assessment of the Define phase: There was a lot of information generated during this phase of the project and therefore I found the tools very beneficial to ensure focus was maintained on the problem statement and the goals of the project. I have learnt through this process how important it is to get everyone’s input to ensure the most accurate picture of the system is generated to ensure that we can chase after the true low hanging fruit within this system.

Next Step: Measure. Objectively establish current baselines as the basis for improvement.

“Without change there is no innovation, creativity, or incentive for improvement. Those who initiate change will have a better opportunity to manage the change that is inevitable.” William Pollard

Introduction

Me: My name is Sinead O’Leary. I am a Senior Quality Engineer working for a Medical Device company in Limerick. I have been with the company since graduating and through the years I have gained a vast amount of experience in the medical device industry through my involvement with different systems and projects as well as growing in knowledge from the experience of my colleagues. Some departments see Quality as being negative stopping a project or preventing progress however I see it as quite the opposite and would consider myself lucky in how many areas my job allows me to gain experience in and work with people with such different personalities, experience and knowledge which I can then use to generate new ideas for improvements.

My team: I was promoted to Senior Quality Engineer last year which has been a great challenge. Studying for a BSc. in Manufacturing Management has really helped me with the tools and theoretical knowledge I need to manage a team as well as projects on a day to day basis. As part of this role it is important for me to motivate my team as well as create an efficient and effective working environment. In my role, I supervise a number of Quality Engineers who specialize in a particular product line. They see these products from birth to the customer including everything in between. I also manage a number of complaints investigators again who specialize in the analysis and investigation of customer complaints for a particular product line. In addition, I manage the customer complaints system and am responsible for the system as well as any improvements that are required.

My project: Studying to become a Green Belt in Six Sigma, I saw the project required for this course as a great opportunity to use the tools I have learnt during the course to date and apply them to a review of the customer complaints system. As the rate and type of customer complaints is unpredictable it is important for the system in operation to be as efficient and effective as possible so it can cope with any eventuality.

My company does not utilize lean or Six Sigma methodology and as I have not other experience outside of this company a lot of the tools and terminology have been foreign to me during the course of this degree, however as I have always found, the best method of learning is through doing so let the journey begin!