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