Control 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 control phase of this project, I utilized the following tools:

·         Develop Control

·         Review of metrics

·         Establish or Update SOPs- Complete during the improve phase

·         Establish or Update Training Plan- Complete during the improve phase

·         Cost/ Benefit Analysis

·         Further developments

For the purposes of this blog, I will focus on the use of the development of control, review of metrics and further developments.

Develop Control: On implementation of the associated procedural updates and re-training, changes were monitored closely by ensuring that any concerns were communicated to me at the time or within our weekly complaints meeting. I ensured that any clarifications were communicated during the weekly meeting or through email where immediate clarification was required.

Timelines for closure will be monitored closely through weekly team meetings and cross functional meeting with the Regulatory department. The metrics for complaint closure will continue to be highlighted to management through our monthly metrics updates. Finally, the updates to the procedures and practices will be assessed in an ongoing manner through the internal audit system and also through any notified bodies performing re –certification or surveillance audits. These controls will ensure that the updates to the system have been successfully implemented and monitored for compliance going forward.

Review of metrics: On review of the metrics established at the beginning of this project, it will not be possible to measure the benefit of the closure date for reportable and non reportable complaints during this control phase of this project. However, it is possible to measure some of the reduction in time per complaint as a result of the changes. On review of the updated system the time per complaint has been already been reduced by on average 99 minutes. In addition, the peer review has also been reduced by 10 minutes as a result of the attachments and information which has been removed and no longer needs to be verified. As stated above in the improve phase there are a number of changes which were also implemented which at this point in time are not measureable but will ultimately reduce the time of the complaint investigation.

 

Further developments: Following the implementation of the project and the measureable and foreseeable improvements which have been made to the system, there were a number of further improvements which were highlighted during the project which will be reviewed for further analysis to determine if the updates to the system will have a positive output. The structure used in this project could be applied to further projects to ensure that the project is scoped out accordingly, resources allocated and the tools can be utilized to ensure the correct root cause and solutions are assigned for the improvements going forward. The following points are areas which could be reviewed for further improvement to reduce the timelines even further.

• Too much detail in lab evaluation
• Difference in failure modes tracker and Trackwise
• FMEAs not up to date
• Business objects often failing
• Business objects takes too long to run
• Trackwise locking out after certain time
• Too many fields in Trackwise
• End user information insufficient

Lessons Learnt: The utilization of the six sigma tools has proven to be successful for this project. As this was my first time using these tools in practice it was quite daunting but I now have an appreciation for how useful following the DMIAC structure can be for a project. The following points were key to the implementation of this project:

·         The day to day users of the system are essential for input

·         Ensure all stakeholders have their voice

·         Do not jump to the corrective action

·         Invest the necessary time into the six sigma tools

·         Ongoing communication on the status of the project is essential to ensure that implementation can be successful

·         Be willing to embrace change

 

Improve 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 improve phase of this project, I utilized the following tools:

·         Brainstorming

·         Risk v benefit chart

·         ID Alternative Solutions

·         Determine optimal solutions

·         Update FMEA

·         Value Stream mapping(future state)

·         Validate improvements

For the purposes of this blog, I will focus on the use of the brainstorming, risk v benefit chart, ID alternative solutions, determining optimal solutions and validate improvements.

Following on from the brainstorming session in the measure phase, the team met again to review the possible solutions highlighted at the time and reviewed to determine if there were any other solutions which may be viable for consideration. During this session, the cause and effect diagram was also reviewed again to ensure that all problem areas were considered for possible improvement.  

 

A risk versus benefit chart was utilized for each of the headings highlighted within the brainstorming session. Solutions from the brainstorming sessions and any appropriate solutions from the cause and effect diagram were also slotted in accordingly under each of the headings: investigation write up, risk, software and additional tasks during this session. Out of a possible 33 possible solutions, the review yielded the following results: Implement: 11, Possible: 9, Challenge: 2, Kill: 11.

 

 It was agreed that for the purposes of this project, the implement and possible phases would be implemented and that the challenge solutions would be reviewed with the project sponsor to determine the possibility of implementation within the agreed timeframe. The kill solutions for the purposes of this project would not go ahead however they will begin to form the list for possible solutions for future improvements in the system.

On review, it was determined that the implementation of the challenge solutions would not be implemented within the timeframe of the project and would be added to the list for future improvements.

The necessary actions required to implement the solutions agreed included various quality system instruction updates, development of access database and retraining on practices and procedural updates with investigators and quality engineers.

For example, some of the implement solutions have seen the following time savings:

·         Remove requirement to view work order, do not attach the work order.

o   QSI1426 (Complaint Investigations) updated to remove the requirement to attach the work orders linked to the complaint. Work orders are in excess of 10MB which required to download, then import to Adobe X standard to reduce the size of the file and then attach to Trackwise. Time saved: 18 minutes

·         Do not attach the review of JBASE (manufacturing operations system).

o   QSI1426 (Complaint Investigations) updated to remove the requirement to attach the screen shots of JBASE. There were 5 menus to be reviewed within JBASE to pull the necessary information required. A print screen was taken of each menu reviewed, cropped and formatted into word and attached to Trackwise. Time saved: 10 minutes.

·         Limit the level of review, remove requirement to attach.

o   QSI1426 (Complaint Investigations) updated to remove the requirement to attach the documents reviewed. The following documents were downloaded and re-attached to Trackwise for each complaint: production, final quality control, packaging instructions and the IFUs. In most cases the IFU as well as some production instructions were also larger than a 10MB file and therefore had to be downloaded, then import to Adobe X standard to reduce the size of the file and then attach to Trackwise. Time saved: 27 minutes                   

The implementation of the solutions listed within the implement and possible buckets of the risk versus benefit charts have resulted in measureable improvements and therefore it is possible to move onto the final phase of this project, the control phase.                                                                                  

Assessment of the Improve Phase: The risk versus benefit charts were very beneficial for pulling all the possible solutions from the tools used to date and determine what was worth the effort for implementation. All solutions were viable and agreed at the time however when it comes to the implementation the risk can often outweigh the benefit unless it is reviewed beforehand. With the successful implementation of the solutions, we are already seeing the benefit of our choices which validates the improvements made and makes to possible to move onto the final phase of this project.

Next Step: Control. Maintain the solution.

 

Analyze 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 into the analyze phase of this project, I utilized the following tools:

·         Micro level Process Flowchart

·         Cause and Effect Diagram

·         Failure Mode Effects Analysis (FMEA)

·         Data Analysis

For the purposes of this blog, I will focus on the use of the micro level process flowchart, cause and effect diagram and the FMEA tools.

During this project, it has been identified that there are only a limited number of areas which can be modified due to restrictions with global procedures and the software in use for this system. So during the analyze phase, we looked to the areas over which we would be able to influence change.  On review of the process flow chart from the measure phase, we focused in on four key process steps and from those tried to develop the flowchart further. To help develop the micro level process flowchart, we utilized a training presentation that is used for any new employees into the group to step down each step of these process steps. On review of this, it was determined not to create an additional flowchart as the steps involved were too detailed to create a flowchart. Instead a summary document of each of the steps was created. An extract of this summary document can be seen below:

Reviewing the outputs from the brainstorming session during the define and measure phases, a fishbone diagram was developed to help pull together the problems under the appropriate headings and review if there were any further problem areas which could be reviewed as part of this project. The output from this diagram will be used within the next phase to help determine the areas which can be improved.

Further to this, the FMEA tool was utilized to help determine what high risk areas there are and what areas can be improved within the scope of this project. There was no existing FMEA for this process developed within the company before, so the high level process flow was utilized as a starting point to help create this FMEA. From the process steps, the failure effect and cause for failures were developed. An appropriate severity, occurrence and detection were then assigned. Based on company standard, where the RPN is greater than 125, action is required. There was only one area highlighted as having an RPN of 125. However, there were a number of areas close to this action figure which highlight other areas for improvement which can be reviewed after this project.

Assessment of Analyze Phase: The analyze phase was very useful to help determine the key areas which are feasible for improvement. The FMEA analysis helped to show that even though the severities associated with the process steps are quite high, our detections in place are good. This is apparent with the low occurrences for each of the process steps. However, this project will look to improving the detection scores even further and reducing the occurrences to the lowest possible score where feasible. The output from the tools in the analyze phase will be used to determine what improvements can be made in the next phase to meet the metrics set out in the define phase of this project.

Next Step: Improve. Implement and verify the solution.

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