As per ICH Q9 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the product throughout its life cycle.” There are many methods and tools to perform Quality Risk Management. It is important to understand that none of the tool or set of tools are sufficient to address every situation of Quality Risk Management. Some of the important tools are as follows:

  1. Basic Risk Management Facilitation Methods
  2. Failure Mode and Effects Analysis (FMEA)
  3. Failure Mode, Effects and Criticality Analysis (FMECA)
  4. Fault Tree Analysis (FTA)
  5. Hazard Analysis and Critical Control Points (HACCP)
  6. Hazard Operability Analysis (HAZOP)
  7. Preliminary Hazard Analysis (PHA)
  8. Risk Ranking and Filtering
  9. Supporting Quality and Statistical Tools

In this article we shall be discussing about one of the most important tool i.e. Failure Mode and Effects Analysis using a simple yet effective tool of 5W and 1H.

What is Failure Mode and Effects Analysis (FMEA)?

FMEA basically consists of two parts i.e “Failure Mode” and “Effects Analysis”. Failure Mode means different ways or methods in which a product/process/design may fail and Effects Analysis is the analysis of waste, defects or losses that may happen due to the said failure.

FMEA is a highly structured, systematic technique to define, identify and eliminate known and/ or potential failure that may exist within the system/ design/ process. The first step involves the establishment of the failure mode which is further followed by risk reduction to eliminate, contain and control the effects of failure. The purpose of FMEA is to anticipate and mitigate the potential failures.

What are the various types of FMEA?

The FMEA is of following major types:

  1. System FMEA (SFMEA): System FMEA is the highest-level analysis of an entire system that is made up of various subsystems. It focuses on System-related deficiencies, Interactions with the surrounding environment, Human interactions, Services etc. The System FMEA includes failure modes associated with interfaces and interactions in addition to considering single-point failures (where a single component failure can result in complete failure of the entire system).
  1. Process FMEA (PFMEA): Analyze potential failures and risk associated with manufacturing and assembly process. Hence, PFMEA is used to identify failures in process which may impact product quality, resulting in low yield, customer dissatisfaction, quality concerns etc. It includes assessment of man, machine, material, method, measurement and environmental conditions,
  1. Design FMEA (DFMEA): Analyze potential failures and risk associated with product design. During a product life cycle there might be an up-dation or modification of the product design. Also, there is a possibility of introduction of new product. Hence, DFMEA is used to identify possible product design failures such as stability, regulatory concerns, customer complaints etc.
  1. Service FMEA: Service FMEA focuses on potential failure modes caused by system or process deficiencies.

 

Who perform FMEA?

Preferably, no single individual shall individually perform FMEA. FMEA shall be performed by a team of cross functional experts. This helps to bring the knowledge and experience of the people from different fields. It also helps to remove the individual bias if any. Wherever required, additional support may also be sough from external vendors who are Subject Matter Experts. The cross functional team shall be selected based on the requirements of the project. The team may include personnel from production, quality control, quality assurance, regulatory, projects, engineering, administration etc.

Why to Perform FMEA?

FMEA when conducted properly and unbiased help to identify and prioritize the risks related to system, process and design. Early detection means more opportunities and less cost for improvement and correction before the product reaches the market. It helps to improve the quality, reliability and safety of products which in turn improves customer satisfaction.

 

Where to perform FMEA?

FMEA can be applied to processes, vendor selection, analysis, equipment, product design, facility design, inventory management, building management etc. FMEA is a universal tool which can be applied to any system/ process/ design/ service to understand the risk involved and taking corrective and preventive measures at the earliest.

When to perform FMEA?

FMEA is a proactive technique and it shall be performed during the development stage of System/ Process/ Product. It shall also be performed during modification, addition of processes in manufacturing, analysis, transportation etc. Change in vendor, regulatory requirements, continuous improvement, any failure may also require carrying out FMEA.

How to perform FMEA?

The step wise procedure for conducting the FMEA is as follows:

  1. Identification of team: As explained above in detail, it shall be carried out by a team of cross functional experts. Hence, in-house as well as external experts from various functions shall be identified to perform FMEA.
  2. Scope: The foremost activity in front of the FMEA team is to define the scope of FMEA. The purpose, the extent of FMEA if defined shall help to finite the limits of work. Scope can be further divided into separate sub-systems, items, processes, steps etc.
  3. Each individual in the team shall be provided information to understand the process. This may include process flowcharts, fault tree analysis etc.
  4. Next step involves identification of system, process, key input for carrying out FMEA. The function identified may be divided into various parts, sub-parts, systems, sub-systems to understand it better. It is important to be noted that all function requirements shall be within the ambit of scope.
  5. For each function, all the possible failure mode shall be identified. This requires knowledge, experience, historical data etc. Also, the FMEA team shall also be able to foresee any type of failures that may occur in future due to changing regulations, technological advancements etc.
  6. The team shall in detail discuss all the possible consequence or effects of the failure on the system, process, product or service.
  7. The effect of failure shall then be assessed on the basis of severity i.e. the impact of the failure. The severity shall be rated from 1 to 10, 1 being the lowest and 10 being the highest on severity scale.
Ranking Severity of Effect Effect
1 No effect None
2 Product/item operable, but is in noncompliance with company policy. Very Minor
3 Product/item operable, but may possess some defects noticeable by discriminating customers Minor
4 Product/item operable, but possesses some defects (aesthetic and otherwise) noticeable to most customers Very low
5 Product/item operable, but may cause slight inconvenience to related operations. Low
6 Product/item operable, but may cause rework/repair and/or damage to equipment. Moderate
7 Product/item operable, but at reduced level of performance. High
8 Product/item inoperable, with loss of primary function. Very High
9 Very high severity ranking when a potential failure mode affects safe operation and/or involves noncompliance with regulations with warning Hazardous with warning
10 Very high severity ranking when a potential failure mode affects safe operation and/or involves noncompliance with regulations without warning Hazardous without warning

The above table indicates severity ranking for illustration and reference purpose.

  1. For each failure mode, all the probable root causes shall be established using various tools such as Cause and Effect (Fishbone or Ishikawa).
  2. For each cause, occurrence rating shall be established which is based on the probability of occurrence of a failure mode. The occurrence probability shall be rated from 1 to 10, 1 being the lowest and 10 being the highest on occurrence scale.
Ranking Effect Failure Rate % Defective
1 Remote ≤1 in 1,500,000 0.000007
2 Very Low 1 in 150000 0.0007
3 Low 1 in 15000 0.007
4 Unlikely 1 in 2000 0.05
5 Marginal 1 in 400 0.25
6 Marginal 1 in 100 1
7 High 1 in 20 5
8 Very High 1 in 8 10-15
9 Very High 1 in 3 33
10 Extremely High ≥1 in 2 50

The above table indicates occurrence ranking for illustration and reference purpose.

  1. For each cause, identify current process controls. Process controls are the various in-built controls available with a firm to detect the failures before it reaches to the end user. The controls can be through automation, procedural controls through SOP, training, check sheets etc. These controls might prevent the cause from happening, reduce the likelihood that it will happen or detect failure after the cause has already happened. Controls are assessed in terms of prevention control and detection controls.
  2. For each control, detection rating shall be established which is based on the probability of detection of a failure cause. The detection probability shall be rated from 1 to 10, 1 being the easiest to detect and 10 being the most difficult to detect.
Ranking Likelihood of Detection Detection
1 Control will almost certainly detect a potential cause/mechanism and subsequent failure mode Almost Certain
2 Very high chance the Control will detect a potential cause/mechanism and subsequent failure mode. Very High
3 High chance the Control will detect a potential cause/mechanism and subsequent failure mode. High
4 Moderately high chance the Control will detect a potential cause/mechanism and subsequent failure mode. Moderately High
5 Moderate chance the Control will detect a potential cause/mechanism and subsequent failure mode. Moderate
6 Low chance the Control will detect a potential cause/mechanism and subsequent failure mode. Low
7 Very low chance the Control will detect a potential cause/mechanism and subsequent failure mode. Very Low
8 Remote chance the Control will detect a potential cause/mechanism and subsequent failure mode. Remote
9 Very remote chance the Control will detect a potential cause/mechanism and subsequent failure mode Very Remote
10 Control will not and/or cannot detect a potential cause/mechanism and subsequent failure mode; or there is no Control. Absolute Uncertainty

The above table indicates detection ranking for illustration and reference purpose.

  1. Calculate Risk Priority Number (RPN) as an arithmetic multiple of Severity (S), Occurrence (O) and Detection (D).

RPN = Severity (S) × Occurrence (O) × Detectability (D)

Higher the RPN, higher is the associated risk and higher priority shall be given to take the corrective and preventive action.

  1. Based on the RPN classify the risk as High, Medium Low.
  2. The team shall recommend corrective and preventive actions to reduce the RPN score. Person responsible shall be identified and target closure date of the actions shall be fixed.
  3. The action shall be designed in a way to reduce severity and occurrence by change in process and product design etc. Detectability can be increased by implementing automation of controls. It should also be understood that normally severity cannot be reduced, however, steps shall be taken to reduce occurrence and increase detectability.
  4. The action taken shall be evaluated again by the team.
  5. The RPN score shall be recalculated after completion of the recommended actions on the basis of revised Severity, Occurrence and Detection ratings.
  6. The RPN number shall reduce which proves the effectiveness of corrective and preventive actions taken.

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