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.

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PFMEA evaluates each process step and assigns a score on a scale of 1 to 10 for the following
variables:
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.

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.

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.

Special attention is typically given to potential failures with high RPNs and
those characteristics that are critical to the customer.

A Control Plan deals with the same information explored in a FMEA plus
more. The major additions to the FMEA needed to develop a Control Plan
are:

Identification of the control factors.

The specifications and tolerances.

The measurement system.

Sample size.

Sample frequency.

The control method.

The reaction plan.

Dont let Control Plans become static.

Just like work instructions, make Control Plans a living document.

As changes in product or process characteristics, specifications,

measurements systems, sampling, control methods, or the reaction plan are
identified, update the control plan.

Use the revision as a communication tool to spread the word of the

changes to the supply chain.

By making the FMEA a living document, you can be sure that potentials for
failure are continually being eliminated or reduced.

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.