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Standard Operating Procedure

Standard Operating Procedure, or SOP is a set of step-by-step instructions to achieve a
predictable, standardized, desired result often within the context of a longer overall process.
SOP, is used in a variety of different contexts, including healthcare, aviation, engineering,
education, industry, and military.

A Process Failure Mode Effects Analysis (PFMEA)
A Process Failure Mode Effects Analysis (PFMEA) is a structured analytical tool used by an
organization, business unit, or cross-functional team to identify and evaluate the potential
failures of a process. PFMEA helps to establish the impact of the failure, and identify and
prioritize the action items with the goal of alleviating risk. It is a living document that should be
initiated prior to process of production and maintained through the life cycle of the product.




PFMEA evaluates each process step and assigns a score on a scale of 1 to 10 for the following
Severity — assesses the impact of the failure mode (the error in the process), with 1
representing the least safety concern and 10 representing the most dangerous safety concern.
In most cases, processes with severity scores exceeding 8 may require a fault tree analysis,
which estimates the probability of the failure mode by breaking it down into further subelements.
Occurrence — assesses the chance of a failure happening, with 1 representing
the lowest occurrence and 10 representing the highest occurrence. For example, a score of 1
may be assigned to a failure that happens once in every 5 years, while a score of 10 may be
assigned to a failure that occurs once per hour, once per minute, etc.
Detection — assesses the chance of a failure being detected, with 1 representing the
highest chance of detection and 10 representing the lowest chance of detection.
RPN — Risk priority number = severity X occurrence X detection. By rule of thumb, any
RPN value exceeding 80 requires a corrective action. The corrective action ideally leads to a
lower RPN number.

Control Plan
Control Plans assure a system is in place to control the risks of the same
failure modes as identified in the PFMEA. While Control Plans can be
developed independently of PFMEAs, it is time and cost-effective to link
Control Plans directly to PFMEAs.

A Control Plan deals with the same information explored in a FMEA plus more.  By making the FMEA a living document. . Don’t let Control Plans become static.  The control method. update the control plan. The major additions to the FMEA needed to develop a Control Plan are:  Identification of the control factors.  Just like work instructions. make Control Plans a living document.  Sample size.The primary intent of Control Plans is to create a structured approach for control of process and product characteristics while focusing the organization on characteristics important to the customer.  Sample frequency.  Special attention is typically given to potential failures with high RPNs and those characteristics that are critical to the customer.  A Control Plan does assure well thought-out reaction plans are in place in case an out-of-control condition occurs and provides a central vehicle for documentation and communication of control methods. control methods.  The specifications and tolerances.  The reaction plan.  Use the revision as a communication tool to spread the word of the changes to the supply chain. specifications.  The measurement system. sampling. you can be sure that potentials for failure are continually being eliminated or reduced. measurements systems.  As changes in product or process characteristics. At JCB I along with my team member prepared these documentation of 2DX King Post Carriage which is new to JCB Ballabhgarh as earlier JCB Jaipur was responsible for the same. or the reaction plan are identified.