SOP

Standard Operation Procedure

Reliability Assessment
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Standard Operating Procedure Reliability Assessment

TABLE OF CONTENTS

Section Particulars Page

1 Purpose 1

2 Scope 1

3 Revision Log 2

4 Responsibility 4

5 Instructions 4

6 What is Reliability 4

7 Assessment 4

8 Methodology 5
8.1 Reliability in Development 5
8.2 Reliability in Manufacturing 6
8.3 Reliability Management Process 8
8.4 Reliability by Traceability 8
8.5 Failure Identification & Analysis 9
8.6 Eliminating Risks of Failures 11

9 Procedure of Reliability Testing 12

9.1 Reliability Testing for System (Final Product) 12
9.2 Reliability Testing for critical Components/Parts 12

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Standard Operating Procedure Reliability Assessment

OBJECTIVE

Objective of this SOP is to lay down a standardized procedure for assessing reliability of Company’s
products. The product can be a complete system (Final Product) or any equipment (components)
of a system

PURPOSE

Purpose is to assess performance of company’s products when commissioned in service. The

assessment helps to find ways and means to enhance reliability.

SCOPE:

Scope of this SOP is limited to assessment of Reliability of only Vending Appliances, refrigerated
or non-refrigerated systems produced by COMPANY.

RESPONSIBILITY

Engineering department of COMPANY is responsible for making reliability assessment of

company’s products, System or any equipment/component of a system.

Marketing department is responsible for submission of the reliability information to customer.

INSTRUCTIONS

Sl. No Activity Description Responsibility

1 Collection of Instruction to COMPANY’s service Marketing
field Data Department
2 Calculation of Procedures to assess reliability Engineering
Reliability
3 Submission of Instructions to submit Reliability Marketing
Reliability figures to customer

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WHAT IS RELIABILITY

Reliability is a Probability that EQUIPMENT or a system will perform the required function under
specified conditions, without failure, for a specified period of time.

ASSESSMENT

To assess reliability, failures of each item of equipment have to be taken into account for the
assessment of overall reliability.

The frequency of occurrence of these failures during operation of equipment is the result of the
number of discovered failures per unit of time (e.g. Total running hour, equipment operation hour,
number of ON-OFF cycles)

METHODOLOGY

At COMPANY, quality is not only a mindset, but also a formalized system. Through strict
documentations and procedures, our engineers and operators maintain control of quality throughout
every step of production.

Figure 1: Quality Flow at COMPANY

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8.1 Reliability in Development

Quality and reliability of Vending Appliances are determined to a large extent during the design
stage: accordingly, these aspects are of primary focus in the development cycle. This has been
reflected in the Development Process Model, established and followed at COMPANY.

Thus, at design stage, thorough Planning for Quality and Reliability is executed and documented,
and all design results are subject to formal, systematic and critical Design Reviews at the conclusion
of each design phase.

Verification by appropriate experiments and routine testing according to standardised Inspection

and Test Requirements, are performed in the course of the development cycle. Design for Reliability
and Design for Manufacturability are the two main concepts and methodologies applied.

8.1.1 Design for Reliability

When reliability problems turn up during the system qualification phase at a customer’s site, this
engenders not only a loss of confidence and image, but also represents a loss of precious time to
market.

COMPANY strives to avoid this situation by proactive engineering at early stages of development.
This includes:

• Use of well documented and standardised process steps.

• Use of "predictable" technologies.
• Adequate safety margins in design rules based on root cause analysis of failure modes.
• Use of state-of-the-art methodology and analytical equipment.

8.1.2 Design for Manufacturability

Our key design goal is to have one basic process sequence for each product group. Simulation,
modelling and statistical tools are used to perform a sensitivity analysis of designed performance
versus process variation, in order to define design rules and required process capabilities.

Theoretical cycle time is an important criterion in any new product design. Minimising theoretical
cycle time not only brings cost-reduction, but also reduces the complexity of process and logistics,
and increases reliability.

Theoretical yield has to be maximised, by setting specs such that there is a sufficient margin
between typical values and specified values. A high theoretical yield is a prerequisite for a stable
and predictable production process, and thus is a necessary condition for product quality and
reliability.

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8.2 Reliability in Manufacturing

Based on a master schedule and backlog, the manufacturing department commits to meet a
customer’s requirements regarding product quality, costs and service quality. Materials, wafer
fabrication, assembly, final testing, environmental condition, and production facility are all carefully
controlled. Whenever possible, statistical methods of control are applied.

8.2.1 Material Control

After thorough evaluation and qualification, all materials are purchased according to COMPANY’s
in-house specifications. All suppliers have to be approved. Suppliers for key materials have to
participate in a certification process, and thus be committed totally to COMPANY success. This
includes periodic auditing of the supplier’s quality management system, facilities and product
quality.

Material Receipt Verification By stores Stores receipt Register IQC Inspection as per plan

Fail Intimate to stores,

Inspection CAPA plan for the
Purchase & Supplier Non conformance

Pass
Coordinate with
Approval in System
Intimation to IQC Purchase & supplier
on serious failure
Attach approval tag
And moved to stores Review & close the
Non-conformance
Track Quantity of lot
Issue of material to
Production Stock in stores
No Disposal of
Check Rejected material
Hold the lot
Problem Yes
in Yes
Coordinate with Purchase for
No disposal action

End
CAPA implementation
Intimation to marketing

Figure 2: Material Flow at COMPANY

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8.2.2 In-Process Control

The quality of a product is built-in during the manufacturing and assembly stage. The basis for each
lot run sheet is a type-generic product flow chart, where all operations and control points are
specified. Inspection results at the control points are plotted at the work station on xbar/-R-charts.
This data is the driver for continuous improvement in the process capability.

8.2.3 Equipment Control

Equipment, facilities, and instrumentation are statistically controlled. Preventive maintenance is
executed according to a predefined plan. Periodically, a Measurement System Analysis is
performed for all equipment used for electrical testing, in order to guarantee accuracy, repeatability
and reproducibility. If an equipment breakdown occurs, recovery and re-qualification follows a
predefined process.

8.3 Reliability Management Process

Reliability Management Process is designed to cover the entire life cycle of a product, starting with
the initial checklist of requirements, and finishing with the final evaluation of field experience.

As illustrated in the Fig.3 below, the Reliability Management Process is orthogonal to other company
processes, like Product Definition, Development, Manufacturing and Customer Service (Field
Deployment). The process utilises individual sub-processes from other processes, but at the same
time adds or superimposes unique and challenging elements (e.g. stringent qualification and test
procedures for materials, products, and processes, as well as advanced methods and tools for
failure analysis).

Customer and End Customer

Requirements
Experience

Product life
Cycle
Components of Reliability Management Process
Definition Development Manufacturing Field
Deployment
Specification of: Manufacturing Field Process
• Function, Deployment Qualification
Field Tracking
• Load Profile, Failure Analysis Statistical Process
• Failure, Reliability Database
Control (SPC)
• Reliability
Characteristics Reliability and Reliability Growth
Environmental Tests
Failure Analysis
Failure Analysis
Contract Review Material Qualification

Review Review

Figure 3: Reliability Management Process

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Effective Reliability Engineering demands special skills and knowledge, acquired from a plethora of
different engineering sciences. To fulfil this requirement, special reliability training is given to
process owners/ stakeholders.

8.4 Reliability by Traceability

Traceability, from production, assembly and test, to the customer and into service, is guaranteed by
relating all manufacturing and test data to the unique and individual batch and Part number. This
number is engraved /Stickered on the surface of each component.

8.5 Failure Identification & Analysis

At COMPANY Quality and Reliability Department focuses the company’s resources on identifying
the root cause of failure, and in implementing corrective actions. Using circumstantial information
from the customer, together with state-of-the-art analytical techniques, the Failure Analysis Lab
establishes a failure analysis report, which is sent to the customer and circulated internally to initiate
corrective actions, where required.

8.5.1 Types of failures

There are various types of failures:

a. Failures may occur suddenly

b. Failure may occur progressively
c. The failure may be partial or
d. Failure may be total.

For assessment of reliability, only sudden and total failures will be considered.

8.5.2 Periods of failures

a. YOUTH PERIOD is the initial period when the failure rate is declining over the period of
time.
b. UTILIZATION PERIOD when the failure rate is minimum and stabilized.
c. WEARING PERIOD is near the end period when the failure rate is ascending and the
equipment requires replacement.

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8.5.3 Measuring Rate of Occurrence of Failures (ROCOF)

Youth Period Utilization Period Wearing period

Figure 4: ROCOF Curve for a Machine (i.e. a System of Parts) Design

The ROCOF is representative of the reliability of the machine design, the quality of manufacture,
the precision of its installation, its production abuse, the purchasing and storage quality control,
along with the standard of maintenance and workmanship care.

The ROCOF curve for a machine reflects what happens to its parts, and moves up and down as
parts fail. When we take the parts failure history of many identical machines, we get the mean, or
steady average ROCOF shown in Figure 4.

Figure 4 also lists many of the reasons why equipment and machines fail during their lives.

First parts fail and then machines stop. The solution to equipment reliability is to improve parts
lifetime reliability. The limiting (maximum) reliability of parts is set by their design. Once a part is in
a machine, we are limited to its characteristic performance. At best, it will behave as its design
allows. This is the limit to how much reliability you can get from a part without redesign.

Figure 5 below shows what happens to the ROCOF when “parts failures” are removed

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Youth Period Utilization Period Wearing period

Figure 5: Improving the Reliability of Machines and Equipment

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8.6 Eliminating Risks of Failures

• “Stop the Risk of Excessive Stress and You Stop Equipment Failures.
• Control the Chance of Overstress and Fatigue Occurrences and You Control Reliability.

RISK CHANCE CONSEQUENCES

= X

Chance Reduction Consequence Reduction

Strategies Strategies
remove opportunity for failure reduce the loss after a failure has
to start started

• Engineering and Maintenance Standards

• Preventive Maintenance
• Standard Operating Procedures (SOPs)
• Corrective Maintenance
• Hazard and Operability Study (HAZOP)
• Total Productive Maintenance (TPM)
• Hazard Identification (HAZID)
• Non-Destructive Testing
• Root Cause Failure Analysis (RCFA)
• Vibration Analysis
• Training and Up-skilling
• Motor Current Analysis
• Quality Management Systems
• Emergency Management
• Planning and Scheduling
• Key Performance Indicators (KPI)
• Continuous Improvement
• Risk Based Inspection (RBI)
• Supply Chain Management
• Operator Watch-keeping
• Total Quality Control
• Logistics, stores and warehouses
• De-rate/Oversize Equipment
• Maintenance Engineering
• Reliability Engineering

Figure 6: Various Risk Management Methods

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PROCEDURE

9.1 Reliability Testing for System (Final Product)

9.1.1 Functional Testing
9.1.2 Performance Testing
9.1.3 PAT (Portable Appliance Test)
9.1.4 Life-cycle Testing/ Accelerated Life Testing
9.1.5 Testing Packaged Products
• Free-Fall Drop Test
• Conditioning, testing atmosphere

9.2 Reliability Testing for critical Components/Parts

9.2.1 Accelerated Life Cycle Testing
9.2.2 Life Cycle Testing with Environmental Exposure

RECORDS

PREPARED BY:

APPROVED BY:

NAME / FUNCTION DATE

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