Sample Procedure

DOCUMENT Managing Q-Changes DOC NO.
CQA/19/2016/001
DIVISION All Divisions of Tata Steel REV. NO. 00
DEPARTMENT All EFFECTIVE 01.07.16
SECTION DATE
TITLE Procedure for Managing SHEET 1 of 12

Quality Changes
To explain the procedure for Managing Q-Changes in a Department/Division.

1.0 PURPOSE
This is aimed towards standardization.
This procedure is applicable to all mining, manufacturing & support service

2.0 SCOPE units across Tata Steel, involved directly or indirectly in the (intermediate or
final) product or service quality.
(a) Proceedings of QA conference on MQC

3.0 REFERENCES (b) MQC process of various industries
(c) Quality management system ISO: 9001-2015
(d) MOC process of Safety Department
Roles & Responsibilities

4.0 DEFINITIONS
Types of MQCs
Annexures:
5.0 ANNEXURES
(i) Form A1, A2, A3 (ii) Checklist Form B
(i) Vice Presidents (ii) Chiefs (iii) EICs (iv) GMs of Mining, Manufacturing and
Service providing Departments /Divisions of Tata Steel where changes occur
6.0 DISTRIBUTION to maintain consistency of product and service quality those are required to
be captured, recorded, archived and referred for standardization of processes
and systems.
::ampclopn02.doc
PREPARED BY APPROVED BY AUTHORISED BY
NAME Alok Kumar Manash Banerjee Alok Krishna
DESIGNATION Sr. Mgr. CQA Head CQA Chief (TQM, BPE & CQA)
SIGNATURE
DATE 25th June 2016 30th June 2016 30th June 2016
DOCUMENT Managing Q-Changes DOC NO. CQA/19/2016/001
SECTION DATE

Quality Changes
Introduction
Different triggers lead to requirements of change (e.g. Int. /Ext. Customer demands, Product
specification, Process layout, Technology, Supplies from vendors, People), which involves a
meticulous planning of the change process. These changes may affect product & service
quality either directly or indirectly.
The various types of changes (temporary/permanent, emergency, trial) must be captured,
analyzed, recorded, communicated and archived for future references. This helps alignment
of our manufacturing/service processes with the changing needs and demands of the
customer/next process.
Therefore, the following procedure is prepared for carrying-out Quality changes for
implementation across all functions of Tata Steel.
This procedure provides details on how to manage a Q-change and can be used as per the
requirements of respective department or division. Implemented of this procedure may be
done through a manual or IT based system as per the convenience of the department.
However, each of the steps given needs to be adhered to.
::ampclopn02.doc
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SECTION DATE

Quality Changes
Process to carry-out Management of Quality changes (MQC)

Management of Quality changes can be explained through a comprehensive 8 - step process.
However, there are some preliminary activities that are required to be done before starting of
any MQC process. The activities are: (i) Scoping, (ii) Formation of MQC structure.
In Scoping, the boundary of work under consideration is identified and what will qualify for MQC
is defined. In formation of MQC structure, various stakeholders like initiator, manager, technical
review committee (TRC), approver etc. are finalized. Guideline for preliminary activities can be
obtained from senior leaders.
The step-by-step process has been explained as following:
1. Identification and Initiation:
As a preliminary step, the identification for change should be as per the need or urgency
felt by the user (Initiator).
Initiator should start the process by filling up the Form A1: Information on Change which
is basic identification of the trigger, domain of change and proposed change. Detailed
description of As is condition and concerns as well as proposed change and desired
outcome through change should be mentioned.
Recommendation: All types of changes: small or big, temporary or permanent,
emergency or planned, trials etc. must be done following all the steps. Replacement in
Kind (RIK) (Refer Definition) changes does not qualify for MQC process.
Note: If in doubt over RIK or a change, MQC should be followed.
2. Impact Analysis and Risk Mitigation:
In this step, Initiator along with Manager needs to complete the work in cross-functional
team.
As an impact analysis, potential effects of the change are analyzed and evaluated on
various processes e.g.
::ampclopn02.doc
SIGNATURE
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Quality Changes
i. Customer processes & satisfaction

ii. Product application and performance
iii. Process for operation and maintenance
iv. Financial impacts
v. Process and Personal Safety,
vi. Environmental hazard
vii. Any other area, as applicable
These analyses are to be carried out as per the Checklist on Impact Analysis (Reference:
Form B)
Accordingly, the changes are classified as Simple, Moderate or Complex change (Form A2:
Analysis of Change)
Various risk mitigation steps can be opted to reduce the impact severity or probability of
occurrence. This will help in smooth implementation of change process.
3. Planning of Approved Change:
After the Risk mitigation step, a detailed plan (considering step-by-step progress,
clearance, related agency approvals etc.) for implementation of change should be
prepared and attached with Form A (A1, A2) & Form B. Manager shall work out the
details and present it to TRC for comprehensiveness and review.
4. Approval for Implementation:
The planned Change Proposal along with Form A (A1, A2) & B should be brought to the
TRC (Technical Review Committee). The committee should review in detail the proposed
change and impact as identified before giving the go ahead for change process. This
committee can provide necessary guidance (through Form A3) after consultation with
external or internal experts.
::ampclopn02.doc
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Quality Changes
The committee, as understood, may approve, reject or cancel the proposed change.
Rejection of proposed change implies that further work is required to be done to bring-
out more insight in to various aspects of the change proposal.
5. Communication:
Approved change should be communicated to all concerned for various preparation and
approval activities with external/internal agencies. Any awareness/training session, if
required should be imparted to the change execution committee within the time
proposed to carry-out the change.
6. Implementation/Installation:
The change proposed, once approved, should be executed as per the plan by MQC
execution team.
The processes to manage the change and final desired outcome should be documented
and communicated.
7. Confirm Effectiveness:
To confirm the effectiveness of change carried out, it is required to verify the outcome
with intended results. Holding the gain report should be generated and audited to
capture the long term effectiveness. This effect and outcome should be reviewed.
8. Closure:
Once the verification of satisfactory implementation is done, the change is required to be
closed formally. (sign off, physical or on net)
When the change has been confirmed to be effective, and all of the MQC action items
have been confirmed to have been completed, then and only then, may the MQC be
confirmed closed and records updated accordingly.
Approver should finally approve of the processes as completed and allow of closure
through online or system as established.
::ampclopn02.doc
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Quality Changes
MQC Metrics
Carrying-out management of Q-change has various metrics which defines the success of MQC
process as a system; its liveliness & effectiveness. Various metrics can be listed as:
Number of MQCs initiated
MQC Execution Compliance (Percentage of MQCs executed vs. Initiated)
Percentage of audited changes that used MQC as change procedure
Average time taken between MQC for same area and job
Percentage of work orders/requests that were wrongly classified as Replacement-in-
Kind (RIK) but should have been MQCs
Percentage of changes that went through MQC process but was reviewed incorrectly
Errors identified through audit in MQCs
Percentage of temporary MQCs where the temporary conditions were not
corrected/restored to original state by the deadline
To review the effectiveness of the system, further metrics may be added as required by
department or division.
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Quality Changes
A typical MQC Process Flow Chart

Structure for Managing Q - Changes
Initiator Manager Tech. Review Comm. MQC Exec. Team Approver
Document for
Individual or team
Review & Approval
requirement for
MQC
4
Analysis of 8
Closure
Resources & Impact
1
Is MQC
Required? Analysis of Trial
5
Execution of MQC, Report
Approval Yes
No 2 Post change review
Yes of MQC
Prepare MQC 6
No
document 7
MQC Rejected
MQC falls under
Replacement in 3 Trials &
Kind RIK category Commissioning
Make Corrections &
Amendments
N Indicates the step no. in carrying out the MQC process
::ampclopn02.doc
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Quality Changes
FAQs/Common Misconceptions of MQC:

1. I dont have time to wait for the MQC evaluation. This is an emergency!
Explanation: Carry-out emergency Q-change without following the documentation; however it is
recommended to complete the impact analysis through assigned cross functional team. After
completion of the change process, complete the documentation.
2. Routing this form for approval takes so long we can never get anything done
Explanation: Following a laid out process helps sail smooth & reduces the chance of error. It also
helps in archiving of the document for future reference.
3. We are a warehouse / light manufacturing / data center / repair facility We dont have anything
that could impact adversely.
Explanation: Analyze risk proactively. It is strongly recommended that impact of failure for not
making/ while carrying the change be studied comprehensively.
4. But MQC wont catch every possible issue, so why do it?

Explanation: MQC should be carried out for all changes affecting Quality. It should be made
customary and given wide publicity to follow all procedure for every change.
5. But my manager already has the fund to approve the changes

Explanation: Monetary/non-monetary, all kind of impacts are required to be recorded, for future
references.
6. This is just a platform / procedure change. Its not like we were changing a pipe or something. We
dont need to approve or document
Explanation: Platform or Procedural change also requires training and user involvement. This is
for wide publicity and subsequent training to user community.
7. But I am not making a real modification. I am just making it a little better

Explanation: Every small or big change can have seen or unseen impact on any of the areas.
Therefore, MQC will bring the holistic approach towards carrying on the change.
::ampclopn02.doc
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Quality Changes
Definitions:
Roles & Responsibilities
Roles Responsibilities Hierarchical Position
Initiator Frontline engineer/manager who has felt IL6 to IL4
need for the change; Should propose the
change and prepare the necessary
documentation
Manager Senior to Change Initiator from the same IL3 (Sectional Head)
vertical. Potential effect analysis through
Checklist and risk mitigation to be
completed under Managers ownership.
Technical Review A cross-functional team of experts from Seniors in different
Committee operation, maintenance, QA & TG to do domain; IL4 to IL3
the impact analysis and approve the go
ahead for changes
Change Exec. Group A team of frontline engineer/ managers IL6 to IL4
to execute the change after the due
diligence is complete. Change initiator
must be a part of this team.
Approver To check the effectiveness & approve the IL3 to IL2
closure of change after reviewing the
documents; guide for any post change
activity (training etc.)
Coordinator Custodian of MQC documents; arranges IL5/IL4; Improvement
for Audit, training, renewal and record Manager
keeping of MQC
::ampclopn02.doc
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Quality Changes
Domains of MQCs: There are multiple areas which may require changes to bring in
desired results. The various areas for changes are:
Equipment Change Procedural Change
Chemical Change Process Change
IT Change Control Limit Change
Personal Change Infrastructure Change
This is required to be understood that a change may be required simultaneously in one or
more domain. The nature of changes may also differ like temporary, permanent, trial or
emergency. The nature of change requirement must be understood clearly after proper
deliberation within the Approver or TR committee.
Types of MQC:
RIK (Replacement In Kind)
An item (equipment, material used in the process, procedures, organizational structures,
people, etc.) that meets the design specification, for the item it is replacing. This can be
an identical replacement or any other alternative specifically provided for in the design
specification, as long as the alternative does not in any way adversely affect the function
or safety of the item or associated items. For nonphysical changes (relating to
procedures, personnel, organizational structures, etc.), no specification, per se, may exist.
In these cases, the reviewer should consider the design and functional requirements of
the existing item (even if nothing is written down) when deciding whether the proposed
modification is an RIK or a change.
Permanent Change
Any change with an intention of not returning the system to its original design falls under
this category. E.g. A product specification change making the previous grade obsolete.
::ampclopn02.doc
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Quality Changes
Temporary Change (Planned & Emergency)

Any change that ensures that the equipment, procedure & processes return to their
original conditions or design intent after the change has been restored.
A time limit must to be established and process conditions monitored during the change
process. Mandatory approval is required before implementation & all proceedings must
be recorded.
Trials
Trials are deliberate planned operation of a process outside of Standard Operating
Conditions or limits. E.g. change in critical raw materials to produce the product
specification. All the test formats & document results must be recorded.
Control of Document:
Control of document is essential/must do process after MQC. The document must be
completed in all respect and archived on an IT based system or document register so that
the same is easily retrievable.
The document should be so retained that it is available as long as the changed entity
(system/process/equipment etc.) is in use.
Renewal of Process:
The procedure shall be reviewed and revised as necessary and, at a minimum, not later
than one year from the date of the last revision. Any necessary change, if felt so, should
be incorporated in the procedure as per the requirement of the departments & divisions.
::ampclopn02.doc
SIGNATURE
SECTION DATE

Quality Changes
Management System of MQC:

To continue with a live system of carrying out MQC, a system of review and audit should
be developed within the department/division. A cross-functional team or committee of
MQC review shall have following key areas of work:
I. Auditing: MQC coordinator should arrange to conduct the audit at least one per
Quarter and cover 80% of the MQCs carried during the period. Auditing may
include documents, records, personal interview and site inspection.
It will also ensure the quality of impact analysis, implementation of changes as per
approved MQC, necessary documentation & communication as well as the
training to the employees based on changes done.
II. Training: MQC coordinator is responsible for training/education of all the
personnel having major roles in the MQC process. They should also be educated
on how to recognize the changes within MQC scope.
III. Records: Records should be so archived that it is retained for lifetime of facility.
IV. Renewal process: Procedure to carry-out the MQC shall be reviewed & revised as
necessary, at a minimum, not later than one year from the date of last review.
V. Deviation Process: Any deviation in the process to carry-out MQC must be
documented and the documentation must include the relevant facts supporting
the deviation decision.
::ampclopn02.doc
SIGNATURE
Form No: CQA/MQC/2016/01 (A) Rev: 0.0 Eff. Date: 01.07.2016
DOCUMENT: FORM SHEET 1 OF 3

DEPT/PLANT: TITLE - FORM A:
MQC - Request for Q Changes
RQC No. : DATE:
Form A1: Information on Change

Unit Area
Change Title:
Trigger for Change. (Tick the relevant box/s)
Customer Requirement Self-Initiated Improvement Input/Supplier

Support Function Others, Please specify
Domain for Change (Tick the relevant box/s)
Through Process Maintenance Warehouse & Logistics Supplier Premise

Existing Systems (As is) & Concerns:
Description of proposed Change:
Type of Change Temporary Permanent Emergency Trial
1

RQC No. : DATE:
FORM A2: Analysis of Change

Change Classification: Risk Score:
RISK Sum (Cx + Cn + F) = Complexity (Cx) of Change (e.g. Not Complex Moderately Extremely
Cross department, Nos. of processes (1) Complex (2) Complex (3)
Score = 3: Simple Change involved, Level of approval)
Consequences (Cn) of Failure Small (1) Moderate (2) Severe (3)
Score 3 - 6: Moderate Change (e.g.Impact on Cost/Time/Customer)
Score > 6: Complex Change Familiarity with new System (F) Existing (1) Similar (2) Novel (3)
Simple Moderate Complex
IMPACT Analysis Required Not Required
Post Change Quality

Required Not Required
Review?
Estimated Cost of
Implementation
Tentative Execution date
Remarks (If any)
Name / Signature / Date
Initiator *
Operations
IEM
Mechanical Maintenance
Tech./TS/QA
Safety/ Others
*Please note signature of Operations, IEM, Mechanical Maintenance, TS/QA and Safety is mandatory
and all checklists are required to be attached for carrying changes.
# In case of Emergency Change Senior most employees will fill the form and take written / oral approval
from the Head / Chief.
2

RQC No. : DATE:
Technical Review Committee:
FORM A3: Review and Approvals

Remarks Date and Signature
Head Operations/
Head of Department
Head IEM
Head Mech. Maint.
Others (Technology
Group/ QA, Safety
etc.as applicable)
Approvals: Change Approved / Rejected
Head
(Tech. Review
Committee)
Change Implemented and Completed
(Signature of Sectional Head)
Restoration Date (for Temporary Change Only)

Verifying Authority
(Approver)
Note:
For all types of changes Form A and Form B should be filled in and forwarded to technical review
committee
All Impact Analysis and Post Change Review on Quality & Safety are mandatory for Medium and
Complex Changes; however exemptions can be obtained with permission of technical review
committee.
3
Form No: CQA/MQC/2016/01(B) Rev: 0.0 Eff. Date: 01.07.2016

DEPT: TITLE: FORM B: MQC - CHECKLIST
ON IMPACT ANALYSIS
RQC No. : DATE:
Form B Checklist
Applicable Action Target

Sl. No. Activity Responsibility
(Y/N) Details Date
Checklist for Is there a change required in
Impacts on Process? (PFD, Equipment
Processes Layout, Plant layout etc.)
Is update required for
Process design, Equipment
design and Automation
Design?
Is the possible risk analysis
(FMEA & CP) completed for
Process, Equipment and
Design change?
Is there revision required for
SOPs for Operating &
Maintenance Procedures etc.
Are consequences of process
change on Equipment
studied? (Temperature,
pressure, flow, vibration, etc.)
Checklist for Is there any deviation from
Impacts on Design limits of affected
Plant, plant, equipment, structure?
Equipment, Is the Reliability/Availability
etc. plan developed for
Equipment? (considering
shutdown requirements)
Is the updating required in
Quality Assurance Plan
completed?
Is the change in compliance
to Codes and Standards (TSL
Standards etc.)?
Checklist for Are all internal stakeholders
Impacts of (TG/TS/QA/Process etc.)
Changes on considered while bringing in
Personnel. the change?
Is the communication done to
all the stakeholders including
employees?
Is the training imparted to all
employees for competency
required as per change?
PREPARED BY APPROVED BY
NAME : NAME :
DESIGN. : DESIGN. :
SIGNATURE : SIGNATURE :
DATE : DATE :
Form No: CQA/MQC/2016/01(B) Rev: 0.0 Eff. Date: 01.07.2016

DEPT: TITLE: FORM B: MQC - CHECKLIST
ON IMPACT ANALYSIS
RQC No. : DATE:
Is the change done in SOP

for procedure and
maintenance according to the
requirement?
Is there clarity on instructions,
procedures etc. for
installation, commissioning,
Operations, Maintenance,
Repair.
Is there clarity on
Responsibility/Accountability
Checklist for Whether the Job Hazard
Safety Analysis related to change
done?
(Is it safe to implement the
changes with respect to the
safety of men & material?)
Checklist for Is the change communicated
Impacts on to customer?
Customer Is there any likely effect at
customer premise?
Is the effect at customer
premise included in our
product/process manual?
Are the people interfaced with
customer aware of the
changes?
Is the change integrated and
well synchronized with
customer?
Checklist for Is our change requirement
Impacts on communicated to supplier?
Supplier Is Supplier agreement taken
for required changes?
PREPARED BY APPROVED BY
NAME : NAME :
DESIGN. : DESIGN. :
SIGNATURE : SIGNATURE :
DATE : DATE :

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DOCUMENT Managing Q-Changes DOC NO.

TITLE Procedure for Managing SHEET 1 of 12

To explain the procedure for Managing Q-Changes in a Department/Division.

This procedure is applicable to all mining, manufacturing & support service

(a) Proceedings of QA conference on MQC

Roles & Responsibilities

TITLE Procedure for Managing SHEET 2 of 12

TITLE Procedure for Managing SHEET 3 of 12

Process to carry-out Management of Quality changes (MQC)

TITLE Procedure for Managing SHEET 4 of 12

i. Customer processes & satisfaction

TITLE Procedure for Managing SHEET 5 of 12

TITLE Procedure for Managing SHEET 6 of 12

TITLE Procedure for Managing SHEET 7 of 12

A typical MQC Process Flow Chart

N Indicates the step no. in carrying out the MQC process

TITLE Procedure for Managing SHEET 8 of 12

FAQs/Common Misconceptions of MQC:

4. But MQC wont catch every possible issue, so why do it?

5. But my manager already has the fund to approve the changes

7. But I am not making a real modification. I am just making it a little better

TITLE Procedure for Managing SHEET 9 of 12

TITLE Procedure for Managing SHEET 10 of 12

TITLE Procedure for Managing SHEET 11 of 12

Temporary Change (Planned & Emergency)

TITLE Procedure for Managing SHEET 12 of 12

Management System of MQC:

DOCUMENT: FORM SHEET 1 OF 3

Form A1: Information on Change

Trigger for Change. (Tick the relevant box/s)

Customer Requirement Self-Initiated Improvement Input/Supplier

Through Process Maintenance Warehouse & Logistics Supplier Premise

Description of proposed Change:

Type of Change Temporary Permanent Emergency Trial

DOCUMENT: FORM SHEET 2 OF 3

FORM A2: Analysis of Change

IMPACT Analysis Required Not Required

Post Change Quality

Tentative Execution date

Remarks (If any)

Name / Signature / Date

DOCUMENT: FORM SHEET 3 OF 3

Technical Review Committee:

FORM A3: Review and Approvals

Head Mech. Maint.

Approvals: Change Approved / Rejected

Change Implemented and Completed

(Signature of Sectional Head)

Restoration Date (for Temporary Change Only)

DOCUMENT: FORM SHEET 1 OF 2

Applicable Action Target

DOCUMENT: FORM SHEET 2 OF 2

Is the change done in SOP

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