Anirudh Kund

How can specification limits be decided for characteristics of an innovative new product with which customer neither has an experience nor an expectation? Assume that the company creating such an innovative product does not want to expose it to the market or customers before launch.  
Asking foundational consumer questions is a good starting point when translating a concept into specific product attributes and guardrails.
The objectives of this research are to
Establish the absolute must-have product attributes in order to deliver on consumers’ expectations set by this concept.
Create clear product and package guardrails, within which further product development should occur.
Prioritize potential process or formulation options by obtaining consumer feedback on early product or package prototypes, and
Explore with consumers any potential areas for further concept optimization.
 
 Though we know that New Product development passes through 5 stages like Idea Concept, Initial Feasibility, Development, Scale Up, and Lunch & learn. However in the above condition the Organization wants to lunch an innovative product but does not want to expose to the market or customer before lunch. 
In such scenario, following questionnaires may help in Idea Concept phase  …
a. What is the target consumer experience and emotional cues?
b. What are the key "must have" attributes? Is there a priority?
c. What are the key "delight" attributes that should be included if feasible?
d. What are the key differentiator attributes that uniquely drive marketplace differentiation?
f. What will make this product most usable for the consumer?
e. 5 Senses Attributes: Sight / appearance
h. 5 Senses Attributes: Smell / aroma
i. 5 Senses Attributes: Sound
j. 5 Senses Attributes: Taste / flavor
k. 5 Senses Attributes: Texture / mouth-feel
l. What are the conditions under which this is likely to be consumed/used
j. Regulatory considerations for product or ingredients – Domestic/International
K. Product manufacturing platform
L. Can we use existing equipment, or modified or new equipment is needed?
m. Packaging requirements
 

What is Failure Mode Effect Analysis (FMEA)? 
The FMEA is an team oriented analytical methodology which aims for identifying and correcting potential failures in a systematic and structured manner
 
The FMEA is already implemented in an early phase of the product engineering process and tries to identify imaginable/possible failures and implements corresponding corrective actions. 
The FMEA aims for reducing the risk of possible failures in the best possible way. The method records the generated knowledge to the advantage of the organization and integrates the lessons learned into future tasks and scopes.
 
The FMEA is living documents that must be reviewed and updated whenever the process has been modified 
There are three basic cases for which FMEA process is to be applied….
 
New designs, New Technology or New Process  
Modification to existing design or process
Use of an existing design or process in a new environment, location or application usage on the existing design or process. 
In Six sigma DMAIC methodology, Initially, FMEA is done in Measure phase and provides recommended actions for the team to minimize risk to the customer. Its revision continues up to the Analyze and Improve Phase to ensure that the evaluation criteria and cause/effect relationships are updated with data-driven conclusions. During the Control phase, the FMEA needs to be updated to reflect the final state of improved project. The information from FMEA is then summarized in the control plan documents
 
Process of Carrying out FMEA
 
Review the process and list the Process steps and key Process inputs  – can be derived from process maps, cause and effect diagram, brainstorming sessions or existing process data.
Brainstorm all the expected potential failure modes for each key process input – can be described in physical/technical terms ,not as a symptoms noted by the customer
List the potential cause for this failure mode – May be several causes for such failure, here consider the operating conditions, usage or in-service, and possible combinations as potential causes.
List the controls that are existing in place to detect the cause of the failure mode.
Rate the severity of the failure effect  the customer experiences  in a Scale of 1 to 10 (1 being no effect and 10 being the Hazardous without warning)
Determine how often the cause of the failure mode occurs and rate the occurrence in a scale 1 to 10 (1 being unlikely to 10 being almost inevitable)
Determine the effectiveness of the current controls to detect the cause of the failure and rate the detection criteria in a scale of 1 to 10 (1 being very effective detection and 10 being no detection.)
Calculate the risk priority number(RPN)by multiplying Severity, Occurrence and detection together.
Note : Risk priority number (RPN) = (probability of occurrence) x (severity ranking) x (detection ranking).Highest RPN would be 1000 and lowest would be 1 , lowest RPN is lower risk. However if the severity rating is 9 or 10 ,efforts should first focus on these key process inputs to ensure detection is at least 1 or 2 and occurrence is also low.
Establish the action plan which can help to minimize the risk to customer by using the RPN value –recommended action can only impact the detections or Occurrence. Severity will remain same until and unless the product/service or information is used for a different intent.
 Identify the person responsible to complete the recommended action with target date
Once the action taken, list the specific actions taken, along with the actual completion date
Calculate or reevaluate the resulting RPN, based on the completed action.
After finishing the above-mentioned steps, sort the RPN numbers and identify most critical issues and where to focus first 
For understanding clarity, tried to describe the rating scale elaborately as below, which can be used as reference for FMEA RPN calculation  …  
 
Severity
Rating
Occurrence
Rating
Detection
Rating
No effect -None (Unable to realize a failure has occurred.)
1
Very Low
<1 /1500000 (Failure is unlikely)
1
Almost certain (Defect is obvious and can be kept from affecting the customer)
1
Annoyance- Very Minor
(Very Minor on product or system performance.
Minor defects noticed by discriminating customers. No disruption to product line.
No effect to performances. Inconvenience to administration of customer)
2
Low- 1/150000 (Relatively low failures)
2
Very high (Very high chance of detection. All units are automatically inspected.)
2
Annoyance - Minor
(Minor on product or system performance. Minor defects noticed by some customers)
3
Low- 1/15000 (Relatively low failures. Isolated failure associated with similar process,)
3
High (High Chance of detection. SPC is 100% inspection surrounding out of conditions)
3
Annoyance - Very Low
(Small impact on product performance. The product does not require repair. Minor defects noticed by most customers.                               Major disruption to production line. Significant delays in delivery to end customer. No effect on performance)
4
Moderate -1/2000 (Occasional failures. Generally associated with processes similar to previous processes which have experienced occasional failure, but not in major proportions)
4
Moderate high (SPC is used with an immediate reaction to out of)
4
Loss or degradation of secondary function -Low (Moderate impact on product performance - The product requires repair. Reduced secondary function performance.)
5
Moderate -1/400 (Occasional failures. Occasional failures. Generally associated with processes similar to previous processes which have experienced occasional failure, but not in major proportions)
5
Moderate (Process is monitored and manually inspected)
5
Loss or degradation of secondary function -Moderate (Product performance is degraded. Comfort or convenience function may not operate. Loss of secondary function performance. Major disruption to prod line. Customer product may have to be reworked. Customer product operable. End use experiences some dissatisfaction.)
6
Moderate - 1/80 (Occasional failures. Occasional failures. Generally associated with processes similar to previous processes which have experienced occasional failure, but not in major proportions.)
6
Low (Manual inspection with mistake proofing modification)
6
Loss or degradation of Primary function -High
(Product performance is severely affected but functions. Reduced primary function performance. A portion (<100%) of customer product may have to be scrapped. Customer product operable but at a reduced level of performance. End user dissatisfied.)
7
High- 1/20 (Repeated Failures. Generally associated with processes similar to previous processes that have often failed)
7
Very Low (All units are manually inspected)
7
Loss or degradation of Primary function - Very High
(Product is inoperable with loss of primary function. The system is inoperable./ Loss of primary function. 100% of customer product may have to be scrapped. Customer product inoperable, loss of primary function. End user very dissatisfied.)
8
High- 1/8 (Repeated Failures. Repeated Failures.
Generally associated with processes similar to previous processes that have often failed.)
8
Remote (Units are systematically sampled and inspected)
8
Failure to meet safety/regulation - Hazardous with warning (Failure involves hazardous outcomes and/or noncompliance with govt. regulations or standards)
9
Very high -1/3 (Failure is almost inevitable)
9
Very Remote (Occasional units are checked for defects)
9
Failure to meet safety/regulation - Hazardous without warning (Failure is hazardous, and occurs without warning. It suspends operation of the system and/or involves noncompliance with govt regulations)
10
Very high >1/2 (Failure is almost inevitable)
10
Almost impossible (Defects caused by failure is not detectable)
10
 
 
As we know, the latter the failure is detected, the higher will be the corrective cost and customer dissatisfaction. If FMEA is done in the early stage with right way it will help in reducing the risk of possible failures in the best possible way. While FMEA as a preventive tool is highly beneficial for the organization, but it has certain limitations too.
 
Limitations: 
Team Formation: Depends on how the interdisciplinary team is formed and what is their expertise on subject knowledge (product, process) and FMEA methods – If team is good, output will be good.
Team members Involvement: Whatever the subject matter expert team may be, If the team is not actively involved, a superficial look at the process will miss many failure modes.
FMEA Moderator: if the moderator is not expert, competent, target orientated and biased towards certain opinion, it may derail from its objectives.
Prioritization: The initial output of an FMEA is the prioritizing of failure modes based on their risk priority numbers. Mostly Severity and occurrence ratings are often difficult for individuals or teams to estimate.  
Time factor: This process takes time for discussion/brainstorming session
Rating Scale Customization: Generic rating scale may create confusion; creation of meaningful rating scale plays a vital role in rating.
Unknown Failure mode: Certain failures which is outside of the team experience, may be left in discussion and documentation.
FMEA Timing: FMEA not initiated on early stage or design stage, may miss certain design /process verification
Target Customer: Customer is both internal and external, but if the FMEA is targeted considering only external customers, internal process failure impacts may be missed from consideration.
Product/Process: Every product /process is not similar and different from others and FMEA should be carried individually not coping & pasting from one to another.
Detection Control: Assuming detection controls are more effective while in real they are not
Action on Recommended failure mode: FMEA is a prioritization tool. It doesn’t eliminate failure modes or effects by itself. Organization need to apply mistake-proofing tools to eliminate the root causes of failure modes, especially true with failure modes that have very severe effects.
FMEA/Control Plan Update: It is a live document, needs regular review and update if a new potential failure mode is identified, that should be added to the FMEA and control plans developed for that. The control plan tells people how to react when a failure mode occurs, if FMEA is not tied to control plan, people would not be aware how to react in case of failure.
Note : FMEA Worksheet template is attached for better understanding
FMEA-template.xls
Rating Template.docx