SQC & Iso 9001-2015

Statistical Quality Control
Part A
Prepared & Presented by
Pramod S Mathad
Department: QA.QC
Sensitivity : L&T Oman Internal Use

Buildings & Factories IC
History
In 1924, Dr Walter Shewart at Bell Telephone Laboratories was conducting research on

methods to improve Quality & to lower costs. He developed concept of control with regards to
variation and came up with "Statistical Process Control Charts" which provide a simple way to
determine if the process is in control or not.
Further later in the century W.Edwards Deming, an American statistician, continued to build on
the work of Dr Walter Shewart & Developed concepts to help improve the production of
munitions (i.e., Military weapons, ammunitions, equipment's) manufacturing for companies
during world war II
In 1946, The American Society for Quality Control (ASQ) was formed & this organization
promotes the use of Quality Improvement techniques for all types of products & services.
In 1950s & 1960s saw the emergence of reliability engineering, the introduction of several
important textbooks on SQC.
Since 1980, there has been a profound growth in the use of statistical methods for quality &
overall business improvement.

Statistics is the discipline that concerns the collection, organization, analysis, interpretation, and presentation of data.
Quality control defined as part of quality management focused on fulfilling quality requirements.
Quality assurance relates to how a process is performed or how a product is made
Statistical Quality Control involves inspecting a random sample of the output from a process and deciding weather the
process is producing products with characteristics that fall within a predetermined range
Statistical quality control (SQC) is the term used to describe the set of statistical tools used by quality professionals and
encompasses three broad categories of;
1) Descriptive statistics: These are used to describe quality characteristics and relationships. This group includes the mean, standard
deviation, range and distribution of data.
1) Statistical Process (Quality) Control: This involves inspecting a random sample of the output from a process and deciding whether the
characteristics of the products in the sample fall within a predetermined range. SPC is used to determine whether the process is
functioning properly or not.
1) Acceptance sampling: This involves random inspection of a sample of goods. Based on the results of the sample, a decision is made as
to whether a batch of goods should be accepted or rejected.

Statistical Tools

The 7 Basic Quality Tools for Process Improvement

Flow Chart
Flowcharts provide an excellent form of

documentation for a process operation,
and often are useful when examining
how various steps in an operation work
together.

Cause & Effect Diagram
This diagram is created by Kaoru Ishikawa, one of the founding fathers of modern management → Ishikawa
diagram/ fishbone diagram.
Cause-and-effect diagrams are typically constructed through brainstorming techniques.
The diagram are frequently arranged into the four most common major categories:
▪ Manpower, methods, materials, and machinery (for manufacturing)
▪ Equipment, policies, procedures, and people (for administration and planning)

Control Charts
A control chart is a graphic display of the actual quality performance judged against a reference frame showing a central
line representing the average quality value and upper and lower lines called the upper control limit (UCL) and lower
control limit (LCL).
General model for control chart

UCL = μ + kσ
CL = μ
LCL = μ – kσ
where
✓ μ is the mean of the variable
✓ σ is the standard deviation of the variable
✓ UCL=upper control limit;
✓ LCL = lower control limit;
✓ CL = center line.
✓ k is the distance of the control limits from the center line,
expressed in terms of standard deviation units.
▪ When k is set to 3, we speak of 3-sigma control charts.
▪ Historically, k = 3 has become an accepted standard in industry

Histogram
CUSTOMER SATISFACTION REPORT ANALYSIS
5 5 55 5 5 5 5 55
5
4.4
4.2
44 4 44 4 44 4 44 4 4 44 4 4
A histogram is used to graphically summarize and 4
display the distribution of a process dataset. 3
SCALE: 1-POOR, 5-
3
It can be constructed by segmenting the range of
EXCELLENT
Aug-20 to
the data into equal-sized bins (segments, groups, 2
Feb-20
or classes). Mar-21 to
Nov-21
1
The vertical axis of the histogram is the
frequency (the number of counts for each bin), 0
and the horizontal axis is labeled with the range
of the response variable.
ATTRIBUTES
Example for CSR

Check Sheets
The check or tally sheet is a very basic tool. A check sheet can be
used for collecting both quantitative and qualitative data. When
used to collect qualitative data, a check sheet collects data in
the form of checkmarks.
They are used to collect process data in the form of counting the
number of occurrences of a specific event, that is, how often
does an event occur?
Example, in processing a particular part, four possible types of

fault may occur. Over a particular period of time, the process
operator may complete a defective-item check sheet similar to
that illustrated

Pareto Chart
A Pareto chart graphically summarizes and displays the relative importance of the differences between groups of data.
A Pareto chart can be constructed by segmenting the range of the data into groups.
Pareto's 80/20 rule often holds in many instances, that is, 80 per cent of all faults are due to just 20 per cent of the
fault types, although some suggest that often a 90/10 split is more typical (Bicheno, 1991).
This allows the major problems to be identified and allows the biggest improvement to be gained from the least effort

Scatter Diagram
Scatter Diagram is also known as Correlation Chart,

Scatter Plot, Scatter Chart, and Scatter Graph.
Scatter Graph is used to find out the relationship
between the two variables.
Independent variable data and dependent variable data
are customarily plotted along the horizontal X-axis and
Vertical Y-axis respectively
According to the correlation, scatter plots are divided into
the following three categories.
1) Positive Correlation
2) Negative Correlation
3) No Correlation
Example: Motorcycle Speed Vs Accident.

In the below diagram, the independent variable is speed, and
the dependent variable is an accident. As the speed of the
motorcycle increases on the highway, the accident rate also
increases accordingly.

SQC Case Study for PQC Concrete
Case Study
Consideration of below main common test data’s during Construction of PQC, the analysis has been made by using
Descriptive statistics (Standard Deviation), statistical process control (Control chart, Pareto chart and Fish bone
diagram), and Acceptance sampling;
1) Cube Strength (Hardened Concrete)

2) Core Strength (Hardened Concrete)
3) Spot Elevation (Dip level)
4) Straight Edge
5) Texturing

Before Implementation of SQC (Descriptive statistics & SPC)
site and
Example of case study for PQC

Before Implementation of SQC (Acceptance Sampling & SPC)
site and
Example of case study for PQC

Remedies for problems encountered at the job site & Implementation of Repair method for Early Distress
Problem, Probable Causes, Action
1. DLC Preparation (Cracks & Curing issues Remedies) - Rapid Evaporation of water leaks cracks, Curing method
2. Document approval i.e., Shop Drawings, MST, ITP
3. Strength Variation in Concrete Samples – Error in Batching, Sample preparation, curing, handling, or testing
4. Reinforcement issues Remedies - Dowel bar Misalignment, Spacing due to poor workmanship
site and
5. Joint Sealant (Saw-cut & Joint Spalling i.e., Breaking of edges) - Sawing too soon, Excessive hand finishing
6. PQC Cracks issues Remedies
✓ Repair cracks adjacent Cracks starting from Saw-cut
✓ PQC Fine Plastic Shrinkage
✓ PQC Cracks Extending from the corners of Manhole / Openings

Before & After SQC Implementation for Texturing test Results (SPC i.e., Control Chart)

Before & After SQC Implementation for PQC NCR’s (SPC i.e., Pareto Chart)

Improvement Made
The main objectives is, use statistical quality control module to control the inspection rejections, improve in good
construction, reduce of client’s complaints, improve in productivity, product quality control and implementation of
corrective actions.
Improvements made: (Data collected & analysis has been made)
a. The standard deviation of cubes (28% improvement)

b. The standard deviation of cores (42% improvement)
c. The non-conformities reduced for PQC cracks from 6 nos. to 2 nos. (66% improvement) and DLC preparation from
5 nos. to 1 nos. and Reinforcement from 3 nos. to Nil and documentation-shop drawing from 2 nos. to Nil and
Joint sealant from 1 no to Nil.
d. The spot elevation total average readings (49% improvement)
e. The straight edge total average readings (34% improvement)

Conclusions & Recommendation
Based on the effectiveness achieved it is concluded that use of SQC tools has been effective in improving Quality levels
by early identification of issues/ applying the 80-20 rule to isolate key issues & intervention by using tools like control
charts & corrective actions on the field.
Benefits of Statistical Quality Control:

1. It provides a means of detecting error at inspection.
2. It leads to more uniform quality of production.
3. It improves the relationship with the customer.
4. It reduces inspection costs.
5. It reduces the number of rejects and saves the cost of material.
6. It provides a basis for attainable specifications.
7. It points out the trouble spots.
8. It promotes the understanding and appreciation of quality control.

Part B
ISO 9001: 2015 overview /
Implementation in LTO
Prepared & Presented by
Pramod S Mathad
Department: QA.QC

ISO Fact

About ISO 9001:2015- Quality management system
ISO 9001:2015 specifies the requirements for a quality management system.
Organizations use the QMS 9001:2015 standard to specify the ability to consistently
provide products and services that meet customer and regulatory requirements.
It is the most popular standard in the ISO 9000 and the only standard of the series to
which organizations can be certified.

Importance of ISO 9001:2015
ISO 9001: 2015 applies to any organization, regardless of size or industry.
Over a million organizations in worldwide about 160 countries have applied the
requirements of ISO 9001 for their quality management systems.
Organizations of all types and sizes find that the use of ISO 9001 enables them in:
• Organize process
• Improve process efficiency
• Continuously improve

ISO Standards Development Sequence

Time Frame Revision Process

Revision History
ISO 9001 Revision History Reason for Revision

Revision of Quality Management Principles

Terminology Change

New Concept
ISO 9001:2015 uses risk-based thinking in the following way:
Clause 4: The organization is required to determine its QMS processes and to address its risks and opportunities
Clause 5: Top management is required to
• Promote awareness of risk-based thinking
• Determine and address risks and opportunities that can affect product /service conformity
Clause 6: The organization is required to identify risks and opportunities related to QMS performance and take appropriate actions to address them
Clause 7: The organization is required to determine and provide necessary resources (risk is implicit whenever “suitable” or “appropriate” is mentioned)
Clause 8: The organization is required to manage its operational processes (risk is implicit whenever “suitable” or “appropriate” is mentioned)
Clause 9: The organization is required to monitor, measure, analyse and evaluate effectiveness of actions taken to address the risks and opportunities
Clause 10: The organization is required to correct, prevent or reduce undesired effects and improve the QMS and update risks and opportunities

Risk Based Thinking

PDCA Cycle

ISO 9001:2015, New Structure

Expanded: Clause 8 - Operation

Mandatory Requirements - Documents & Records
Non-Mandatory Requirements - But Often Included

1) Procedure for determining context of the organization and interested parties
2) Procedure for addressing risks and opportunities
3) Procedure for competence, training and awareness
4) Procedure of equipment maintenance and measuring equipment
5) Procedure for document and record control
6) Procedure for design and development
7) Procedure for production and service provision
8) Procedure for management of nonconformities and corrective actions
9) Procedure for monitoring customer satisfaction
10) Procedure for internal audit
11) Procedure for management review

To retain something is to keep it & To maintain something is to take care of it Buildings & Factories IC
ISO 9001:2015 (QMS) implementation in LTO
Larsen & Toubro (Oman) LLC
LTO has a well-established and documented Quality Management system and is taking appropriate steps to
improve its effectiveness in accordance with the requirements of ISO 9001:2015.
Relevant procedures are established to clearly specify the criteria and methods for effective operation,
monitoring, maintaining and control. Necessary resources and information to support the operation and
monitoring of these processes are established.
This is to ensure
All Business Units would Function systematically in accordance with L&T vision and
Quality policy

ISO 9001:2015 implementation Concept methodology
Implementation Plan (Concept) Process Approach

ISO Standards
ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary.

ISO 9001:2015, Quality Management Systems -- Requirements.
ISO 9004:2018, Quality Management. Quality of an organization. Guidance to achieve sustained success.
ISO 10005:2018, Quality management - Guidelines for quality plans
ISO 10006:2017, Quality management - Guidelines for quality management in projects.
ISO 10012:2003, Measurement management systems -- Requirements for measurement processes
and measuring equipment.
ISO/TR 10013:2001, Guidelines for quality management system documentation.
ISO 19011:2018, Guidelines for auditing management systems.
ISO 21500:2012, Guidance on Project Management.
ISO 31000:2018, Risk management. Guidelines.
ISO Guide 73:2009, Risk management – Vocabulary
IEC 31010:2019, Risk management -- Risk assessment techniques

Leadership
Leadership & Commitment
The project management team is fully committed to the proper implementation of the Quality Policy and this PQP
and top management is committed to promoting continual improvement of the quality culture within the
organization.
LTO strives to identify Customer needs, meet their requirements, and exceed their expectations.
Top management and the project management team ensure that the focus on improving Customer satisfaction is
maintained by setting and reviewing project-specific objectives at management review meetings.
Top management and the project management team are in constant communication with the Customer to ensure
that their needs, expectations, and requirements are understood and met.
Customer complaints and other feedback are continually monitored and measured to identify opportunities for
improvement.

LTO Quality Policy & ISO 9001:2015 Certificate

Quality Management Principles
There are 7 key principles of quality management that form the foundation of ISO 9001:2015 and are relevant to
the entire organization.
1) Customer focus: is about how you meet customer and regulatory requirements,
assessing customer satisfaction and exceeding their expectations by the quality of
your products and services
2) Leadership: is about establishing strategic direction and operational purpose
3) Engagement of people: is about providing sufficient training, knowledge,
competence, and empowerment to improve quality
4) Process approach: is about the Plan, Do, Check, Act (PDCA) cycle and the
sequence and interaction of inputs, activities and outputs
5) Improvement: is essential to the ISO 9001 quality management system and
should be organization's core objective. Implementing processes for identifying
The QMS approach adopted by LTO enables us to:
risks and opportunities, spotting & solving non-conformities, measuring &
1. Reduce duplication; monitoring your efforts means that you will be able to find ways to improve &
2. Reduce risks; make your business even stronger
3. Balance incompatible objectives; 6) Evidence‐based decision making: is about analyzing process data, levels of
4. Eliminate conflicting responsibilities and relationships; customer satisfaction, process performance assessment, and risk-based thinking
5. Turn the focus onto business goals; 7) Relationship management: is about maintaining relationships with relevant
6. Harmonize and optimize practices; interested parties and providers in the supply chain
7. Create consistency;
8. Improve communication;
9. Facilitate training and development.

LTO Documentation Structure as per ISO
QMS documentation consists of two 4-tier levels, a corporate level, and a project level. Both levels follow the general principles set
out by standard ISO 10013:2021, Guidelines for documented information
The first or corporate level comprises QMS documentation, which is universal in that it is common across all countries and projects. It
is fully compliant with the requirements of the standards.
The second or project level documentation comprises documents that are unique to each project. Project-level documents, which
are fully aligned with the corporate documentation, are developed taking account of the applicable contractual documents and
drawings, local codes, regulations, and specifications, and legal or other requirements operative in the countries that fall under the
QMS scope.

PQP Procedures
Sr. No Doc. No. Description of Procedure Rev No.

1 PQP P GEN 01 Procedure for setting of Quality objectives, targets, and programs 0
2 PQP P GEN 02 Procedure for creating, approving, updating and control of documented information 0
3 PQP P GEN 03 Procedure for corrective action and continual improvement 0
4 PQP P MR 01 Procedure for management review 0
5 PQP P MR 02 Procedure for Internal Audits 0
6 PQP P MR 03 Procedure for customer feedback and resolution of complaints 0
7 PQP P MR 04 Procedure for competence, training, and awareness 0
8 PQP P QAQC 01 Procedure for control of monitoring and measuring equipment 0
9 PQP P QAQC 02 Procedure for Inspection and testing and control of non-conforming product 0
10 PQP P PRC 01 Procedure for selection, approval of suppliers & procurement 0
11 PQP P STR 01 Procedure for receipt, storage, Preservation, and issue of materials including identification & traceability 0
12 PQP P PLN 01 Procedure for project planning, scheduling, contracts management and monitoring 0
13 PQP P PLN 02 Procedure for mobilization, review & monitoring of project 0
14 PQP P EXE 01 Procedure for execution of project 0
15 PQP P EXE 02 Procedure for selection, approval & sub-contractor management 0
16 QMS P GEN 02 Procedure for identifying internal & external issues and needs & expectations of interested parties 0
17 QMS P GEN 03 Procedure for Identifying, analyzing & evaluating risk and opportunities for all processes 0

Risk Management
One of the key changes in the 2015 revision of ISO 9001 is to establish a systematic approach to considering risk, rather than treating
“prevention” as a separate component of a quality management system.
Risk-based thinking should ensure that risks and opportunities are considered throughout your business's operations, and activities
& it makes preventive action part of strategic and operational planning.
LTO Procedure for “Risk Management” (QMS P GEN 02 & QMS P GEN 03)
When evaluating risk, it is helpful to use two metrics or parameters:

✓ Severity (If the risk occurs, how serious is it?)
✓ Probability (What is the probability of the risk occurring?)
There are many other tools and methodologies that you can adopt to help
manage risks and identify opportunities including; learning from the past (Lessons
Learned), PESTLE (Political, Economic, Social, Technological, Legal, Environmental),
SWOT (Strengths, Weaknesses, Opportunities, Threats), FMEA (Failure Modes and
Effects Analysis)
1) The analysis of external and internal issues (Clause 4.1);

2) Requirements of relevant interested parties (Clause 4.2);
Risk Log: GEN 03 F01
Opportunity Log: GEN 03 F02

ISO 9001 Audit Types and How They are Executed in LTO
There are two main categories of audits: internal and external. Audits are a key component for becoming ISO
certified and you must have internal auditors and pass the 2-stage registrar audit by an external party in order to
become ISO 9001 certified.
DISTRIBUTION OF
PREPARATION OF AUDIT
CONDUCT AUDIT AUDIT PREPARATION OF REPORT &
AUDIT PLAN By CONDUCT AUDIT COMPLIANCE /
AS PER PLAN NOTIFICATION AUDIT REPORT DISCUSSION IN
MR CLOSE OUT
Internal Audit MRM CLOSEOUT
QA/QC Engineer prepares internal Audit plan covering all dept. at project site for the year (Jan to Dec). Refer the
audit plan of Head office to match the schedule. Audits are conducted at pre-determined intervals. QA/QC Engineer
fix the frequency of internal audit depending on project requirement.
Discuss audit findings in management review for the improvement in process / product quality and implement
action plan as discussed.
External Audit
QA/QC Engineer coordinates with the customer representative / Head-QMS for third party audits. Informs &
coordinates with site team for audit schedule & notification, conducting audits, reports, corrective, risk log status &
review in MRM. Further Head-QMS / QA/QC Engineer updates the external audit in audit plan, NCR / observation log
as per audits conducted.
Internal Quality Audit Plan: MR 02 F 01
Audit notification: MR 02 F 02
Audit Report MR 02 F 03
Non-Conformance Report (NCR): MR 02 F 04
Sensitivity : L&T Oman Internal Use NCR Log: MR 02 F 05 Buildings & Factories IC
MRM Meeting
To review and ensure that the Project Quality plan, Quality Policy & Objectives are suitable, adequate and effective.
and also, continual improvement of the Quality Management System to meet the needs of customer, statutory
bodies and organization.
COMMUNICATE MINUTES
PREPARATION OF QEHS PREPARATION OF MRM REVIEW OF QEHS
MRM NOTIFICATION PENDING POINT IF ANY TO PARTICIPANTS, PM &
OBJECTIVES PLAN OBJECTIVES
QMS HEAD
QA/QC Engineer Plans Management review meeting for the project minimum once in two months interval.
Agenda for MRM shall be as follows:

The status of actions from previous management reviews
Changes in external and internal issues that are relevant to the quality management system
Information on the performance and effectiveness of the quality management system, including trends in:
a. Customer satisfaction and feedback from relevant interested parties
b. The extent to which quality objectives have been met
c. Process performance and conformity of products and services
d. Nonconformities and corrective actions
e. Monitoring and measurement results MOM of Management Review Meeting: MR 01 F 01
f. Audit results MRM notification with agenda: MR 01 F 02
g. The performance of external providers
The adequacy of resources
The effectiveness of actions taken to address risks and opportunities
Opportunities for improvement

SQC & Iso 9001-2015

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Statistical Quality Control

Sensitivity : L&T Oman Internal Use

In 1924, Dr Walter Shewart at Bell Telephone Laboratories was conducting research on

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

Flowcharts provide an excellent form of

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

General model for control chart

Sensitivity : L&T Oman Internal Use

CUSTOMER SATISFACTION REPORT ANALYSIS

Example for CSR

Sensitivity : L&T Oman Internal Use

Example, in processing a particular part, four possible types of

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

Scatter Diagram is also known as Correlation Chart,

Example: Motorcycle Speed Vs Accident.

Sensitivity : L&T Oman Internal Use

1) Cube Strength (Hardened Concrete)

Sensitivity : L&T Oman Internal Use

Example of case study for PQC

Example of case study for PQC

Problem, Probable Causes, Action

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

Improvements made: (Data collected & analysis has been made)

a. The standard deviation of cubes (28% improvement)

Sensitivity : L&T Oman Internal Use

Benefits of Statistical Quality Control:

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

ISO 9001:2015 specifies the requirements for a quality management system.

Sensitivity : L&T Oman Internal Use

ISO 9001: 2015 applies to any organization, regardless of size or industry.

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

ISO 9001 Revision History Reason for Revision

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

ISO 9001:2015 uses risk-based thinking in the following way:

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use

Non-Mandatory Requirements - But Often Included

Sensitivity : L&T Oman Internal Use

Larsen & Toubro (Oman) LLC

Sensitivity : L&T Oman Internal Use

Implementation Plan (Concept) Process Approach

Sensitivity : L&T Oman Internal Use

ISO 9000:2015, Quality management systems -- Fundamentals and vocabulary.

Sensitivity : L&T Oman Internal Use

Leadership & Commitment

Sensitivity : L&T Oman Internal Use

Sensitivity : L&T Oman Internal Use