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Integrated Management System Manual Based on ISO 9001, 14001 & 45001
Method · September 2019
DOI: 10.13140/RG.2.2.12486.42568
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Doc. # MGT/ISM-01
Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
Name:
Prepared by:
Designation:
Signature:
Name:
Reviewed by:
Designation:
Signature:
Name:
Approved by:
Designation:
Signature:
Initially Issuance Date:
Page 1 of 48
Issue date: 1st July 2019
Rev # 00
Doc. # MGT/ISM-01
Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
Amendment History Record
Revision
Number
DCR Number
Section
Amended Text
Page 2 of 48
Doc. # MGT/ISM-01
Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
Contents
Responsibility Matrix ........................................................................................................................................... 6
1.
Introduction & Scope................................................................................................................................... 8
1.1.
Introduction ........................................................................................... Error! Bookmark not defined.
1.3.
Clauses Exclude.................................................................................................................................... 8
2.
Normative references.................................................................................................................................. 8
3.
Terms and definitions .................................................................................................................................. 8
4.
Context of the organization......................................................................................................................... 9
5.
6.
7.
4.1.
Understanding the organization and its context ................................................................................. 9
4.2.
Understanding the needs and expectations of interested parties.................................................... 10
4.3.
Determining the scope of the Integrated management system ....................................................... 10
4.4.
Integrated management system and its processes ........................................................................... 10
Leadership ................................................................................................................................................. 10
5.1.
Leadership and commitment ............................................................................................................ 10
5.2.
Policy.................................................................................................................................................. 11
5.3.
Organizational roles, responsibilities and authorities ....................................................................... 11
5.4.
Consultation and participation of workers ........................................................................................ 11
Planning ..................................................................................................................................................... 12
6.1.
Actions to address risks and opportunities ....................................................................................... 12
6.2.
IMS objectives and planning to achieve them .................................................................................. 15
6.3.
Planning of changes ........................................................................................................................... 16
Support ...................................................................................................................................................... 16
7.1.
Resources .......................................................................................................................................... 16
7.1.1.
General .......................................................................................................................................... 16
7.1.2.
People ............................................................................................................................................ 16
7.1.3.
Infrastructure................................................................................................................................. 16
7.1.4.
Environment for the operation of processes ................................................................................ 17
7.1.5.
Monitoring and measuring resources ........................................................................................... 17
7.1.6.
Organizational knowledge ............................................................................................................. 17
7.2.
Competence ...................................................................................................................................... 18
7.3.
Awareness ......................................................................................................................................... 18
7.4.
Communication ................................................................................................................................. 20
7.5.
Documented information .................................................................................................................. 22
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Doc. # MGT/ISM-01
Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
8.
Issue date: 1st July 2019
Rev # 00
Operation................................................................................................................................................... 26
8.1.
Operational planning and control ..................................................................................................... 26
8.1.1.
Housekeeping ................................................................................................................................ 26
8.1.2.
Equipment Management............................................................................................................... 27
8.1.3.
Handling, Use, Transport and Storage of Equipment .................................................................... 27
8.1.4.
Preventive Maintenance ............................................................................................................... 27
8.1.5.
Corrective Maintenance ................................................................................................................ 27
8.1.6.
Equipment Calibration ................................................................................................................... 28
8.1.7.
Visitor Control................................................................................................................................ 28
8.1.8.
Electrical Inspection....................................................................................................................... 28
8.1.9.
Facility Security .............................................................................................................................. 28
8.1.10.
Asset Management........................................................................................................................ 28
8.1.13.
Emergency Preparedness and Response ....................................................................................... 29
8.1.14.
Emergency Response Team (ERT) ................................................................................................. 30
8.1.15.
Emergency evacuation plan .......................................................................................................... 30
8.2.1.
Customer Communication............................................................................................................. 34
8.2.2.
Receipt and Review of Clients’ Inquiries ....................................................................................... 34
8.2.3.
Preparation and Review of Contract ............................................................................................. 34
8.2.4.
Legal and Regulatory Requirements.............................................................................................. 34
8.2.5.
Customer Communication............................................................................................................. 34
8.2.6.
Customer Complaints .................................................................................................................... 34
8.2.7.
Customer Surveys / Feedback ....................................................................................................... 35
8.3.1.
General .......................................................................................................................................... 35
8.3.2.
Design and development planning ................................................................................................ 35
8.3.3.
Design and development inputs .................................................................................................... 36
8.3.4.
Design and development controls................................................................................................. 36
8.3.5.
Design and development outputs ................................................................................................. 37
8.3.6.
Design and development changes ................................................................................................. 37
8.5.3.
Identification and traceability ....................................................................................................... 38
8.5.4.
Property belonging to customers or external providers ............................................................... 38
8.5.5.
Preservation................................................................................................................................... 39
8.5.6.
Post-delivery activities................................................................................................................... 39
8.5.7.
Control of changes......................................................................................................................... 39
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Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
8.6.
Release of products and services ...................................................................................................... 39
8.7.
Control of nonconforming outputs ................................................................................................... 39
9.
Performance evaluation ............................................................................................................................ 39
9.1.
Monitoring, measurement, analysis and evaluation ......................................................................... 39
9.2.
Internal audit ..................................................................................................................................... 40
9.3.
Management review ......................................................................................................................... 43
10.
Improvement ......................................................................................................................................... 44
10.1.
Nonconformity and corrective action ........................................................................................... 44
10.2.
Continual improvement ................................................................................................................ 46
Annexure: List of Annexures ......................................................................................................................... 47
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Doc. # MGT/ISM-01
Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
Responsibility Matrix
Responsible
Area
Understand the
needs of interest
party
Internal and
external issues
identification
IMS risk and
opportunity
identification
Defining IMS
objectives and its
management
program
Changes in IMS
Defining IMS
policy
Training and
awareness
New product
development
Document and
record control
Externally
provided services
and product
Nonconformance,
Corrective &
preventive action
Top
Management
Factory
Manager
(Production)
Accounts &
Finance
Approval of
interest parties
Identify
relevant
interest party
Identify
relevant issues
Identify
relevant
interest party
Identify
relevant issues
Sales &
Marketing
Functional
Incharges
Identify
relevant
interest party
Identify
relevant
interest parties
Identify
relevant issues
Identify
relevant issues
Conduct
risk Conduct risk
assessment in assessment in
its area
its area
Conduct risk
assessment in
its area
Conduct risk
assessment in
its area
Annually define
his department
objectives and
its program
Suggest and
analyze change
Annually define
his department
objectives and
its program
Annually define
his department
objectives and
its program
Authorize for
changes
Annually define
his department
objectives and
its program
Suggest
and
analyze change
Suggest and
analyze change
Suggest and
analyze change
Approval of
policy
To Follow it
To Follow it
To Follow it
To follow &
align objectives
Conduct TNA
Conduct TNA
Conduct TNA
Conduct TNA
Give input if it is Give input if it
relevant to him is relevant to
him
Relevant
Relevant
document
document
preparation & preparation &
modification
modification
Demand raise Demand raise
and inspection and inspection
of items
of items
Give input if it
is relevant to
him
Relevant
document
preparation &
modification
Demand raise
and inspection
of items
Developed &
QA of new
systems
Relevant
document
preparation &
modification
Demand raise
and inspection
of items
CPA raise
CPA raise
CPA raise
Address the
issues
Provide
resources for
risk elimination
or reduction
Approval of all
department’s
objectives
Provide
resources and
approval of
Training plan
Approval of new
design
Approval of
level 1
document
Give approval of
purchasing
Provide
resources for
CPA
CPA raise
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Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
Management
Review Meeting
Chair MRM
MRM agenda MRM agenda
completion
completion
MRM agenda
completion
MRM agenda
completion
Internal System
Auditing
Approval of Plan
Audit
conduction
Audit
conduction
Audit
conduction
Audit
conduction
Resolve
customer
complaint
relevant to him
Resolve
customer
complaint
relevant to him
Resolve
customer
complaint
relevant to him
Take Feedback
through online
portal
Maintain
knowledge in
his area
Maintain
knowledge in
his area
Customer
Feedback and
complaints
Knowledge
Management
Nominate
person for
Complain
resolve
Provide
resources
Maintain
knowledge
his area
Maintain
in knowledge in
his area
Page 7 of 48
Doc. # MGT/ISM-01
Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
1. Introduction & Scope
Company introduction???
Scope Statement:
“Manufacturer of ----------- Product”
1.1. Clauses Exclude
Following Clauses are not applicable to the company’s Integrated Management System:
Clause 8.5.3 is not applicable as the company does not hold any customer property (ISO 9001:2015)
2. Normative references
The following documents, in whole or in part, are normatively referenced in this document.
ISO 9001:2015 Quality management systems — Requirements
BS EN ISO 14001:2015 Environmental management systems — Requirements with guidance for use
ISO/FDIS 45001:2015 Occupational health and safety management systems —Requirements with
guidance for use
3. Terms and definitions
ABC
ABC Packaging Industries (Pvt) ltd.
Organization
Person or group of people that has its own functions with responsibilities,
authorities and relationships to achieve its objectives.
Auditor
A person with the competence to conduct an audit
Context of the
Organization
Combination of internal and external issues that can have an effect on an
organization’s approach to developing and achieving its objectives.
Continual
Improvement
A recurring process of enhancing the ISO system in order to achieve
improvements in overall ISO performance consistent with ISO Policy
Corrective Actions
Actions to eliminate the cause of a detected nonconformance
Compliance
obligations
Legal requirements and other requirements (admitted term) legal requirements
that an organization has to comply with and other requirements that an
organization has to or chooses to comply with.
Customer
Person or organization that could or does receive a product or a service that is
intended for or required by this person or organization
CPA
Corrective and Preventive Action
Document
Information and its supporting medium
Page 8 of 48
Doc. # MGT/ISM-01
Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
Interested Party
Internal Audits
Issue date: 1st July 2019
Rev # 00
A person or group concerned with or affected by the performance of ABC
A systematic, independent, and documented process for obtaining audit
evidence and evaluating it objectively to determine the extent to which the
Integrated Management System audit criteria set by ABC are fulfilled
IMS
Integrated Management System (ISO 9001, 14001 & 45001)
ISO
International Organization for Standardization; part of ABC Integrated
Management System used to develop and implement its System Policy and
manage its quality concerns, customer requests and issues. The management
system is a set of interrelated elements used to establish policy and objectives
and to achieve those objectives. The Integrated Management System includes
ABC structure, planning activities, responsibilities, practices, procedures,
processes, and resources
ISO Objective
An overall quality goal, consistent with the IMS Policy that ABC has set itself to
achieve
Nonconformance
The non-fulfillment of a requirement.
Preventive Actions
Actions to eliminate the cause of a potential nonconformance
Policy
The overall intentions and direction of ABC related to its ISO performance, as
formally expressed by top management. Our IMS Policy provides a framework for
action and for the setting of ISO objectives and targets
Quality
Conformance to the requirements of interested parties or absence of variation
Risk
A combination of the likelihood and consequences of a specified event
Risk Assessment
A protocol to estimate the magnitude of risk and decide whether or not the risk
is tolerable
4. Context of the organization
4.1. Understanding the organization and its context
•
ABC Management has determined the external and internal issues (arising from legal,
technological, competitive, market, cultural, social and economic environments, whether
international, national, regional or local) that are relevant to its purpose and its strategic
direction and that affect its ability to achieve the intended result(s) of its integrated management
system.
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Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
•
•
•
Issue date: 1st July 2019
Rev # 00
Management of ABC Packaging monitor and review information about these external and
internal issues. These Issues can include positive and negative factors or conditions for
consideration. Understanding the external and internal context related to values, culture,
knowledge and performance of the ABC are also taken to consider these issues.
To evaluate the internal and external issues relevant to the context of the organization,
functional heads conduct SWOT Analysis relevant to their own department annually.
Internal issues to be considered during SWOT analysis include technological concerns, employee
concerns, culture of organization, management concerns, etc. and external concerns which
needs to be considered include the concerns arising from competition, society and culture,
statutory and regulatory issues, supply chain, economic issues, etc.
4.2. Understanding the needs and expectations of interested parties
• All the functional In-charges shall have an annual meeting to evaluate the needs and expectations
of relevant interested parties in “Interest Party Analysis Sheet”.
• For each interested party, related issues of concern are identified in the “Interest Party Analysis
Sheet”. It is taken input for quality risk assessment. These issues may reflect direct concerns of
the party or they may be indirect concerns. Such concerns may impact on the interested party or
may be concerns derived from the party that impact on the company operations.
4.3. Determining the scope of the Integrated management system
Refer section 1.2 & 1.3 of this document
4.4. Integrated management system and its processes
ABC Packaging Industry has documented, implemented and maintained a Integrated Management System
in accordance with the requirements of all applicable standards and regulations and continually improves
the effectiveness of its system. ABC utilizes the following documents for identification of processes,
determining sequence and determining criteria for various activities:
a.
b.
c.
d.
Standard Operating Procedures
Job Descriptions
Risk Assessment
Work Instructions
5. Leadership
5.1. Leadership and commitment
5.1.1.
General
ABC Top Management is fully committed for development and implementation of the IMS and
continually improving its effectiveness. Management regularly involve in organizational meetings, ISO
reviews before MRM to show their commitment.
5.1.2.
Customer Focus
Top management of ABC demonstrates leadership and commitment with respect to customer focus by
ensuring that:
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Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
•
•
•
Issue date: 1st July 2019
Rev # 00
Customer and applicable statutory and regulatory requirements are determined, understood and
consistently met;
The risks and opportunities that can affect conformity of services and the ability to enhance
customer satisfaction are determined and addressed;
The focus on enhancing customer satisfaction is maintained as per Procedure for Customer
Related Process section 8.2.1
5.2. Policy
ABC has developed the Policy (MGT/POL-01) as per the requirements of ISO 9001, 14001 & 45001.
Policy Statement
5.3. Organizational roles, responsibilities and authorities
ABC management has assigned responsibilities and authorities for all relevant roles in the organization.
These are communicated through the Organogram and Job Descriptions (JD).
Reference: Job Description Manual
5.4. Consultation and participation of workers
ABC Packaging has established, implemented and maintained a process(es) for consultation and
participation of workers at all applicable levels and functions, and, where they exist, workers’
representatives, in the development, planning, implementation, performance evaluation and actions for
improvement of the OH&S management system.
The ABC has:
a. Provided mechanisms, time, training and resources necessary for consultation and participation
b. Provided timely access to clear, understandable and relevant information about the OH&S
management system;
c. Determined and removed obstacles or barriers (include failure to respond to worker inputs or
suggestions, language or literacy barriers, reprisals or threats of reprisals and policies or practices
that discourage or penalize) to participation and minimize those that cannot be removed;
d. Emphasize the consultation of non-managerial workers on the following:
1.
2.
3.
4.
5.
6.
7.
8.
determining the needs and expectations of interested parties;
establishing the IMS policy;
assigning organizational roles, responsibilities and authorities as applicable
determining how to fulfil legal requirements and other requirements
establishing OH&S objectives and planning to achieve them
determining applicable controls for outsourcing, procurement and contractors
determining what needs to be monitored, measured and evaluated
planning, establishing, implementing and maintaining an audit programme(s)
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Manual
Based on ISO 9001, 14001 & 45001
e. Emphasize
1.
2.
3.
4.
5.
6.
7.
the
participation
of
nonmanagerial
workers
Issue date: 1st July 2019
Rev # 00
in
the
following:
determining the mechanisms for their consultation and participation;
identifying hazards and assessing risks and opportunities;
determining actions to eliminate hazards and reduce OH&S risks;
determining competence requirements, training needs, training and evaluating training;
determining what needs to be communicated and how this will be done;
determining control measures and their effective implementation and use;
investigating incidents and nonconformities and determining corrective actions
6. Planning
6.1. Actions to address risks and opportunities
ABC Management has planned a system to addressed the risk and opportunity related to Quality,
Environment and Occupational Risks as per following criteria:
6.1.1.
Risk Identification
Select one area and consider Issues of interest parties to identify the risk related to all routine and nonroutine activities (Maintenance, repairs, generator etc.). Then, identify the issues related with each activity
considering but not limited to following:
a. Activities of all internal and external persons having access in ABC
b. Human behaviors and capabilities
c. Social & human Factors
d. Infrastructure, equipment and materials
e. Design of work areas/facilities
f. Potential Emergency Situations
g. Areas of concern in each area
Other than this environment aspects and impacts related to environment are identified which include
change, planned or new developments, and new or modified activities, products and
services; abnormal conditions and reasonably foreseeable emergency situations
6.1.2.
Risk Evaluation
Significance of Environment, Health & Safety and Quality are evaluated from likelihood and severity as
per risk assessment criteria in “Risk Assessment Sheet”.
Likelihood
Description
Certain (10)
Incident is expected to happen most frequently (e.g. may be daily basis or every time
certain activity is performed)
Very Likely (8)
Incident is expected to happen frequently (e.g. maybe once a week or historic data
showed that it happened many times in past)
Likely (6)
Incident is expected to happen sometimes if proper care is not taken (e.g. maybe once a
month or historic data showed that it happened few times)
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Manual
Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
Possible (4)
Incident can happen with negligence (e.g. exceptional cases, maybe it happened once or
twice in past one year or so)
Unlikely (2)
No possibility of having an incident in this case (e.g. No past history)
Severity
Trivial (2)
Description
OHS: Discomfort – first aid not required/ No action required
EMS: Routine disturbance of environment / No environmental Impact
IMS: Routine operational issues without affecting conformance or service
Minor (4)
OHS: Minor cuts, bruises, burns, twists etc. – onsite first aid required or
EMS: Environmental contamination but easily reversible or
IMS: Minor operational issues causing minor schedule modification
OHS: Severe cuts, burns, twisted joints etc. – hospitalization required or
EMS: Contamination in a restrained area but effort required to reverse
IMS: Operational issues which cause minor delays or conformance issues
Medium (6)
Serious (8)
OHS: Fractures, joint dislocation, loss of conscious, 3rd degree burns or
EMS: Irreversible contamination but in a limited area or
IMS: Delays/conformance issues which result in public dissatisfaction.
Fatal (10)
OHS: Permanent disability, death, injury among a group of people etc.
EMS: Irreversible contamination in an uncontrolled manner or
IMS: Severe customer complaints/Regulatory issues
Use the following chart to measure the acceptability of the risks.
Likelihood
Risk Matrix
Severity
Trivial (2)
Minor (4)
Medium (6)
Serious (8)
Fatal (10)
Unlikely (2)
4
8
12
16
20
Possible (4)
8
12
24
32
40
Likely (6)
12
24
36
48
60
Highly Likely (8)
16
32
48
64
80
Imminent (10)
20
40
60
80
100
Acceptability
Acceptable
Risk Score
Description
4≤8
No further control is required under most cases.
Limited Time Acceptability
12 ≤ 24
Reduce risk to acceptable level within a month.
Conditionally Acceptable
32 ≤ 48
Apply temporary controls & reduce risk within a
month.
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Manual
Based on ISO 9001, 14001 & 45001
Unacceptable
60 ≤ 100
Issue date: 1st July 2019
Rev # 00
Stop the activity & risk should be reduced
immediately.
6.1.3.
Risk Controls
Establish the control measures for all the identified risks. While establishing control measure, consider
the following risk control hierarchy:
Control Type
Description
Effectiveness
Elimination
Total eliminating the risk.
Substitution
Replace the risky item/activity with one with less risk.
Depends
Engineering Control
Modifying the process or equipment to reduce the risk.
70%-90%
Admin. Control
Control such as training, instructions, signage etc.
10%-50%
PPE (OHS)
Safety goggles, ear plugs, gloves, masks etc.
100%
≤20%
6.1.4.
Risk Assessment Review
ABC Packaging has determined and have access to the compliance obligations related to its environmental
aspects; which include determining:
a. how these compliance obligations apply to the organization;
b. ABC management take these compliance obligations into account when establishing, implementing,
maintaining and continually improving its environmental management system;
ABC management has documented information of its compliance obligations in the form of NEQs and
PEQs
Review the risk assessment at least once in a year on regular basis in addition to following situations:
a. New process or modified process
b. Introduction of a new material
c. Start of construction work
6.1.5.
Communication & Training
Managers should communicate the risk assessment and any following updates/modification to all the
relevant sections and training should be conducted for the new staff members on the awareness of risks
and their controls.
Associated Records
• Quality Risk Assessment Sheet
• Environmental Risk Assessment Sheet
• Health & Safety Risk Assessment Sheet
6.1.6.
Legal requirements & Compliance Obligation
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Manual
Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
The ABC Management has:
• determine and have access to the legal requirements and compliance obligations related to its
environmental aspects and occupational health & safety management system;
• determine how these compliance obligations and legal requirement apply to the organization;
• take these compliance obligations and legal requirements into account when establishing,
implementing, maintaining and continually improving its environmental management system.
ABC Management has maintained documented information of its compliance obligations.
6.2. IMS objectives and planning to achieve them
ABC Packaging has established IMS objectives at relevant functions, levels and processes needed for the
ISO as per following procedure:
To initiate the process, Director hold a meeting with all the Departmental Heads (HODs) to set O&T the
objectives and targets are set keeping in view the following;
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.
l.
m.
n.
IMS Policy
Process, Production and Quality Targets
Performance of Management System
Significant Health and Safety Hazards
Prevention of Ill Health and Injuries
Significant Risks
Internal and External Issues of Organization
Significant Environmental Aspects and Impacts
Applicable Legal and Other Requirements
View of Interested Parties
Technological Options
Financial Losses
Operational Issues
Any other requirements that can have adverse impact in overall performance of systems
in the organization
Note: Objectives and Targets are set in such a way that they must be S.M.A.R.T (Specific, Realistic,
Measurable, Achievable and Time Bound).
To achieve the set objectives and targets, management program is established which translates the goals
into concrete actions
To ensure its effectiveness the management program describes the following;
a.
b.
c.
d.
e.
Stepwise actions to be taken
Resource requirement for each step/ target
Responsible person(s) for each step
Target date
Status
Progress of objectives and targets is reviewed on a regular basis in management review meetings and it
is reviewed by top management (Director/Manager) at least on quarterly basis
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Manual
Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
Associated Records
• Summary of Departmental Objectives
• Management Program for Objectives
6.3. Planning of changes
When the ABC determines the need for changes to the integrated management system, the changes are
carried out in a planned manner.
ABC Management consider:
a) the purpose of the changes and their potential consequences;
b) the integrity of the integrated management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities and authorities;
All changes are carried out after discussion with management and minutes of meeting is recorded. Minor
changes are also brought through CPA after getting approval from Top Management but considering
above a, b &c points.
7. Support
7.1. Resources
7.1.1. General
ABC top management provides the resources needed for the establishment, implementation,
maintenance and continual improvement of the Integrated management system.
Associated Records:
a. Accounts record
7.1.2. People
ABC Management has determined and ensures that sufficient human resource is provided for the
effective implementation of its ISO and for the operation and control of its processes. Recruitment is
performed as per government policies and records are maintained accordingly.
Associated Records:
a. HR Personnel Files
b. Service Rules
7.1.3. Infrastructure
ABC Management maintains the infrastructure necessary for the operation of its processes and to
achieve conformity of services. ABC Manufacturing Plant at Sunder IE is the key contact area that
connects all interest parties of ABC. It is properly secured and maintained. For proper ventilation, ABC
has installed air curtain that helps in maintaining the temperature of production halls.
For IT technology, IT department is looking after it. Account is created in ABC domain for every new
employee hired.
Associated Records:
a. Service Rules
b. Accounts record
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Manual
Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
7.1.4. Environment for the operation of processes
ABC provides a clean, safe and healthy working environment. Each section manages the work
environment needed to achieve conformity to related requirements. Office and production area
working environment are completely controlled; and on daily basis janitorial staff clean work area.
Furthermore, firefighting equipment and CCTV are installed in Office and Production area for safety &
security purpose.
To create a culture of team work & harmony and reduction in psychological pressure; management of
ABC organized trainings and other sport events.
Working methods are developed and maintained to perform the specific activities/ tasks safely and
effectively.
Associated Records:
a. Service Rules
b. Environment Monitoring Form
c. Housekeeping Form
7.1.5. Monitoring and measuring resources
7.1.5.1.
General
ABC has determined and provided the resources needed to ensure valid and reliable results when
monitoring or measuring is used to verify the conformity of its services to requirements.
7.1.5.2.
Measurement Traceability
Where measurement traceability is a requirement (Weighing balance, gauges, lab equipment etc.). It
is
• Calibrated or verified, or both, at specified intervals, or prior to use, against measurement
standards traceable to international or national measurement standards;
• Identified in order to determine their status;
• Safeguarded from adjustments, damage or deterioration that would invalidate the calibration
status and subsequent measurement results. The ABC has determined, if the validity of
previous measurement results has been adversely affected when measuring equipment is
found to be unfit for its intended purpose and take necessary action accordingly;
7.1.6. Organizational knowledge
ABC has determined the knowledge necessary for the operation of its processes annually and to
achieve conformity of services through feedback, audit reports, CPA (corrective actions, preventive
actions (risk assessment) and suggestions for improvement), complaints and analysis of the data.
If further knowledge is required to any employee of ABC related to his work area, he/she request to
Admin/HR to arrange that knowledge.
Knowledge sources could be:
a.
b.
c.
d.
knowledge related to intellectual property,
knowledge gained from experience (lessons learnt),
lessons learned from project failures,
Projects success
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e.
f.
g.
h.
i.
j.
Issue date: 1st July 2019
Rev # 00
Results of improvement in processes , products and services
National and international standards and guidelines
Conferences and workshops,
Training materials,
Academia,
Customers or external providers
Admin should intimate each employee before his departure for external training, conference or
seminar that employee should submit the copy of reading material upon his/her return.
Knowledge Retention Admin will maintain a knowledge base for all types of knowledge items he/she
keeps. All types of knowledge when received or collected will be entered in ABC ERP portal
Knowledge Sharing and Access: Employees of ABC can collect his relevant knowledge though online
ABC portal and knowledge relevant to specific product can be taken through principle trainings. For
knowledge regarding ABC technical aspect (manuals, reports, project details etc.) is stored at relevant
section under supervision of its Manager.
Knowledge Usage: When addressing changing needs and trends, ABC Management consider its current
knowledge and determine how to acquire or access any necessary additional knowledge and required
updates.
7.2. Competence
Management staff, non-management staff is competent on the basis of appropriate education, training,
skills and experience. The section 7.3 for Competence, Training & Awareness defines these activities in
detail to provide the competent work force.
Competency criteria required for any job is mention in Job Description/Competency Policy and on the
basis of this criteria new hiring is done.
Associated Records
a. Personnel files
b. Job Description
7.3. Awareness
ABC Management run a training program to increase competency of its employees for this purpose
following procedure is followed:
7.3.1.
Identification of IMS Training Needs
At the start of each year, Admin in consultation with the head of departments reviews the current IMS
performance levels and identifies the IMS training and awareness needs of the personnel. Following
factors are taken into account while identifying the training needs;
a.
b.
c.
d.
e.
Changes in the IMS System, such as new or revised procedures, or changes in the IMS policy;
Changes in processes, or operations;
Changes in applicable laws, regulations, and other requirements;
New significant IMS issues, objectives, or targets;
New management programs;
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Based on ISO 9001, 14001 & 45001
f.
g.
h.
i.
Issue date: 1st July 2019
Rev # 00
Results of internal audits of the IMS System;
Non-compliance against applicable laws, regulations, and other requirements;
Non-attainment of specified IMS performance, or decreasing performance;
Inadequate performance of individuals or groups of personnel.
Training needs are identified and send through email to Admin by department heads. Based on the
identified training needs assessed, Admin prepares a yearly IMS Training Plan. Training Plan is reviewed
and approved by Director. Admin then follows-up the implementation of IMS Training Program with
coordination of concerned HOD and reports the progress to IMS Management Review Committee.
7.3.2.
IMS Awareness and Training Program
7.3.2.1.
General IMS Orientation Training
Manager provides orientation training to all new and existing employees. It presents basic concepts,
principles, and requirements of the Integrated Management System, discusses the IMS policy, the
company’s significant IMS issues, objectives, and targets. Participation in the general orientation training
is recorded. The records are maintained by Admin department.
General Awareness on IMS is also communicated through banners/postings, IMS awareness
programs/events, etc.
7.3.2.2.
Training on IMS (ISO 9001, 14001 & 45001)
Training sessions of management and section in charges are carried out on the understanding and
implementation of IMS Requirements (Policy, objectives, CPAs, MRM etc.). The records of training are
maintained by Admin department.
7.3.2.3.
Training on Emergency Preparedness and Response
Personnel assigned with specific responsibilities in implementing emergency response procedures are
trained in how to carry out the tasks and activities assigned to them. This training may include operating
emergency equipment (Fire Extinguisher) coordinating evacuation, notifying external emergency services,
and so forth. Section Incharges ensure that all personnel designated for specific emergency response
activities are adequately trained.
7.3.2.4.
Competence and Skill Training
Departmental Heads and Admin are responsible for ensuring that personnel whose work can have effect
on the quality of service are sufficiently competent and skilled in performing their work.
Personnel who have proven experience in operating relevant processes and equipment are also required
to undergo any refresher training program to update their skill level. Competence acquired through
experience may be identified and recorded in the form of experience certificates or bio-data, which are
maintained by HR department.
7.3.2.5.
External Training
The company also directs employees to participate in approved seminars, conferences, and other forms
of external training. Departmental Heads recommend employees for external IMS training, which is
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Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
reviewed by Admin and approved by Director. Admin department then makes arrangements for
registration of participants in the training program. Copies of certificates of training are maintained in the
personal files by the HR department.
7.3.2.6.
Training Effectiveness Evaluation
After attending training employee(s) submit copy of the certificate of training (if any) attended to the
Admin. Certificate of training is placed in the employee personal file. To ensure the effectiveness of the
provided training (internal or external) Head of Department (HOD) will carry out assessment of the
trainee(s) with at least one of the following methods.
a. Oral Test: This method is used when level of awareness needs to be assessed
b. Written Exam/ Test: This method is used when understanding of the trainee needs to be assessed
c. Practical Demonstration: This method is used when coordination between procedure and practical
application the trainee needs to be assessed
Evaluation of the employee, who has attended the training, is conducted by his immediate incharge /
HOD who fills the Training Effectiveness Evaluation form and forwards it to the Admin department to
evaluate and to maintain the record in the employee personal file.
7.3.3.
a.
b.
c.
d.
e.
Associated Records
Training Need Assessment Form
Annual Training Plan
Training Evaluation form
Leave Form
Training Attendance Sheet
7.4. Communication
Organization has determined the internal and external communications relevant to the integrated
management system,
7.4.1. Internal Communication
Major topics of internal communication include:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
Production Plan
Raw Material Purchasing from local market
Raw Material Import
Compliance requirements for concerned departmental head
IMS policies, objectives and targets
IMS roles and responsibilities
Organizational performance compared to IMS objectives and targets
Integrated System Procedures and emergency situations
Legal requirements for related functions
Other matters
Section Incharges are responsible for communicating IMS Procedures and related policy (and any
changes to the procedures), with staff working under them. Factory Manager will facilitate all
Incharges accordingly being custodian of IMS Master folder
7.4.2. External Communication
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Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
General rules for external communication shall require that the information provided by the company;
a) Be understandable and adequately explained to recipient
b) Present an accurate and verifiable picture of the company and its Integrated
Management System or other related matters
Inquiries and other communication (received by mail, fax, telephone, social media or in person) from
external parties concerning company’s quality, health, safety or environment performance may be
received by a number of company’s representatives. All such communication and replies before reply
shall be copied to Section Incharges and Director.
On an as-needed basis the company may solicit the views of the interested parties on its Integrated
Management System, and other related matters.
As a part of the management review process the team member nominated to conduct the review shall
evaluate the effectiveness and the efforts made in the formal/ informal meetings.
7.4.3. Internal and External Communication Mechanism
Selection of the most appropriate mechanisms used for internal communication is left to the
discretion of the responsible head. Mechanism that shall be used for the various types of
communication includes, but not limited to:
a.
b.
c.
d.
e.
f.
g.
h.
i.
Job Cards
Social Media Groups
Notice Boards
Intercom
Display Boards / Safety signs
Electronic Mail (Internet and intranet)
Inter Office Memos
Formal / In Formal Meetings
Company Published Material
External Communication mechanisms, used for the various types of communication includes, but not
limited to:
a.
b.
c.
d.
e.
f.
g.
Electronic Mail
Postal Mails
Tele Phone
Fax
Meetings
Company Published Material
Company Website and Social Media
7.4.4. Notice Boards
Company Notice board facilitates in-house communications. Admin section is reserved for personal
notices and advertisements by employees.
Normally, employee personal notices may be posted for a period of maximum one week. All
personal notices approved for posting must have removed date inserted on them.
7.4.5. Electronic Mail
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Manual
Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
Company has various email groups for ease of communication between the departments and
between different regions. These email groups for business correspondences only. It is also the
responsibility of the employees to use the company equipment for official use and to ensure that all
the equipment is operational and in good working condition. Antivirus must be installed and
updated regularly as it has an impact on the internal communication of the company. Also, the
backup of the computer is taken regularly if required.
Email templates are defined for internal and external communication.
7.4.6. Meetings (Internally & Externally)
When meetings (internally & externally) are required for specific purpose communication meeting
agenda is properly communicated to all the concerned personnel. Minutes of meeting are recorded
and record of participants is maintained. Decisions taken in the meeting are assigned to the
concerned personnel with target date and follow ups are taken on the actions taken to check the
effectiveness of the actions taken.
7.4.7. Associated Records
• Job Card
• Email Records
7.5. Documented information
ABC management create, up-grade, distribute and dispose the document as per following criteria.
7.5.1.
Levels of Documents
The documents of Integrated Management System (IMS) are categorized into four levels due to their
nature.
Level I: Organizational Chart, Policies & IMS
Manual
Level II: Integrated System Procedures
Level III: JDs, Standard Operating Procedures,
Work Instructions
Level IV: Forms & Formats
7.5.2.
Document Coding Scheme
ABC has established a document coding system, which is applied to all levels of documents being created
or maintained by ABC. The detail of document coding scheme is given below;
All the documents will have a unique identification code according to this
“DEPT/AAA-NN”
Where,
DEPT
AAA
NN
Department
Represents the code for type of document (such as Policy, Procedure, Manual etc.)
Represents the serial number of documents starting from 01, 02 and so on. The serial number
is reinitialized if the document type changes.
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Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
And in case of form unique identification code according to this
“DEPT/FRM-PP. NN”
DEPT
FRM
PP. NN
Department
Represents the form
PP Represents the serial number of relevant procedure/Manual Section and NN form starting
from 01, 02 and so on. The serial number is reinitialized if the document type changes
Codes:
Following codes are used for different types of documents.
Code
Type of Document
ORG
Organizational Chart
ISM
Integrated System Manual
POL
Policy
ISP
Integrated System Procedure
SOPs
Standard Operating Procedures
JD
Job Descriptions
WIs
Work Instructions
PFD
Process Flow Diagram
Following codes are used for different departments /sections e.g.
Code
MGT
MKT
MNT
ACT
FIN
P&D
PRO
STR
A&HR
Department / Section
Management (IMS Compliance)
Sales and Marketing
Maintenance
Accounts
Finance
Planning and Dispatch
Production (Plant)
Stores
Admin & Human Resource
External Documents are identified by their code if provided by the originator. In case the document does
not bear any code; it is then identified by nomenclature. Following documents used in the company are
of external origin and maintained in logged in Master List of files/folders
•
•
•
•
•
7.5.3.
Legislation and Regulations
Product Standards/Specifications
Material Safety Data Sheets
Equipment Manuals
Any Document Provided by Customer or Supplier
Document Format
• All documents are generated with following standard header and footer in the order of
occurrence.
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Manual
Based on ISO 9001, 14001 & 45001
Document Name
Issue date: 1st July 2019
Rev # 00
Doc. # DEPT/AAA-NN
Issue date: To be decided
Rev # NN
• Footer will have page number at its mid
• Following document approval box will be placed on the title page of; only Integrated System
Manual of LEVEL I, each document of LEVEL II, and SOPs of LEVEL III documents.
Prepared by:
Name:
Designation:
Signature:
Reviewed by:
Name:
Designation:
Signature:
Approved by:
Name:
Designation:
Signature:
Initially Issuance Date:
7.5.4.
Document Preparation, Review and Approval
•
Level
I
II
III
Documents to be used in the ABC will be prepared, reviewed and approved according to the
criteria given below in the table.
Doc. Type
ORG, POL, JDs Manual
ISP, ISM
WIs, PFDs, SOPs
Prepared by
Manager Accounts
Manager Accounts
Relevant Incharge
Reviewed by
Factory Manager
Factory Manager
Factory Manager
Approved by
Director
Director
Director
Relevant Incharge shall ensure that all documents (whether new or revised) are approved by
concerned authority prior to put into practice.
7.5.5.
Document Distribution Management
This method of distribution applies to all documents to be issued in hard form and this portion is not
applicable on Forms and Formats being used; only documents such as Policies, Procedures, Work
Instructions and Standard Operating Procedures etc. are covered here:
•
All printing rights of IMS system documents shall reside with the Factory Manager (FM).
•
All Original IMS documents shall be maintained by FM. They have original signs of relevant
persons on it.
•
All copies used for distribution shall be stamped CONTROLLED in “Blue Color” in the footer
of all the pages of the document.
CONTROLLED
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Copy No.
•
A document bearing no stamp will be considered “UNCONTROLLED”. Distribution and use
of uncontrolled documents shall be considered nonconformity.
•
For distribution of documents in electronic/soft form FM upload relevant document at “ISO
folder” on Company Internal Server. Company employees has access at this folder. All
folders share at server in non-editable form (PDF or any other) with “CONTROLLED” mention
at the footer of document. As new document is uploaded on Server FM inform to ABC
employees through email.
7.5.6.
Document Change Process
•
Any person can initiate a request to introduce new revision of the existing document /
format by raising Document Change Request (DCR) Form. The DCR after being raised by the
initiator is submitted to;
a. Director through Factory Manager for IMS documents / formats
b. Concerned Incharge in case of departmental documents / formats
•
Director / concerned Incharge will accept or reject the request after proper analysis in
consultation with related authorities.
•
If Director / concerned Incharge after review, accepts the document change request then
documents will be reviewed and approved by defined authorities.
•
Hand written amendments are not allowed.
•
The details of the changes are entered into the “Amendment History Record” table.
•
All changes made will be highlighted as; “UNDERLINED” for addition and “STRIKETHROUGH”
for deletion in the column headed “Amendment Text” of “Amendment History Record”
table.
•
After final approval has been made, the original Master Document and its controlled copies
will be recalled. The original Master Document is stamped OBSOLETE in “Red Color” and
placed in the obsolete documents file till the arrival of next revision. All the retrieved back
copies are shredded as per instructions provided in section 4.7
OBSOLETE
•
7.5.7.
The updated documents will be distributed again according to the defined methodology in
this procedure.
Access and Disposal of Obsolete Documents
•
Director / concerned Incharge have the authority to access the obsolete documents.
•
When the retention period of document is expired, Director / concerned Incharge review
the validity and usefulness of IMS / departmental documents respectively. He then decides
whether to:
a. Shred the record through shredder in his / appointee’s presence.
b. Create scanned images for reference purposes, in case of any requirements in the
future, and then shred them through shredder in his / appointee’s presence.
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Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
7.5.8.
File Management
ABC has established a filing system to manage and control all the files, folders and registers being
maintained which provides the details about uniquely identifying and file labeling.
All files, folders and registers will have a unique identification code according to this scheme;
“DEPT/FIL-NNN”
Where,
DEPT
FIL/REG
NNN
Department (codes are mentioned in section 4.2)
File/Register
Represents the serial number of documents starting from 001, 002 and so on. The serial
number is reinitialized if the document type changes
All the files, folders and registers will be pasted with following labels;
Front Label
Side Label
<Department Name>
<Name of Department>
<File Name>
<File Name>
Code
<Code>
Volume #
<Number>
Date Started
<Date>
Date Closed
<Date>
Keeper
<Responsible Person>
Location
<Location>
Code
< Code >
Volume #
<Number>
Date Started
<Date>
Date Closed
<Date>
Keeper
<Responsibl
e Person>
Location
<Location>
NOTE: All registers and note books have page number to ensure traceability. Page numbering can
either be done manually or by pasting stickers with numbers imprinted or through printing (in
case company has the option to print registers via printer).
7.5.9.
Associated Records
•
•
•
Master List of Documents
Master List of files and folders
Document Change Request Form
8. Operation
8.1. Operational planning and control
ABC Management has planned, implemented and controls the processes needed to meet the requirements
for the provision of services, and to implement the actions as per Standards (Quality Plans) and routine
Procedures through Meetings.
8.1.1. Housekeeping
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Manual
Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
ABC Packaging facility are maintained sufficiently clean and orderly to prevent contamination and to
facilitate the efficiency of ABC operations.
Housekeeping as a minimum includes following activities:
•
•
•
•
Sweeping or Mopping of Floors
Cleaning of Windows, Ceiling Fans and Tube Lights.
Cleaning up Spills immediately
Emptying Trash Cans
Admin is responsible through janitorial staff for housekeeping of halls, corridors and offices. Daily basis
cleaning activities are recorded on housekeeping and lavatory inspection sheets that are pasted at the
gate of relevant area.
8.1.2. Equipment Management
All equipment / machines are properly placed at their designated places. Work instructions are
provided with all the equipment. Equipment manual(s) provided by supplier (manufacturer) are
readily available to personnel as and when required.
All equipment is uniquely identified (refer section 4.6 for coding) for effective traceability. If
equipment is in parts, each of its part is uniquely identified in a manner that it remains traceable to
the main equipment.
8.1.3. Handling, Use, Transport and Storage of Equipment
Equipment is only allowed to be transferred / transported to an external location in following cases;
a. If equipment’s maintenance requires it to be taken to the supplier’s or manufacturer’s
premises
b. Equipment requires calibration services which require equipment to be taken to
calibration lab
Maintenance staff ensure that equipment is properly working and operational when it is returned
back to ABC; in case found any problem, staff does not accept equipment from third party until and
unless it is fully operational.
After ensuring that the equipment is in operational condition, it is accepted and placed at its
designated place
8.1.4. Preventive Maintenance
Maintenance Incharge develops service plan for equipment based on frequency defined by
manufacturer (Machines, Generator etc.) which depict the detail of preventive maintenance require
to equipment. As per this plan service of equipment will be done. If due to any unforeseen reason
breakdown occur in equipment, it will be properly recorded and CPA will be raised on it.
8.1.5. Corrective Maintenance
In case of malfunctioning in any equipment it will go through the corrective maintenance process. The
equipment user informs the maintenance section (electrical/mechanical) on Maintenance Work
Order/Permit. In response Maintenance Incharge assesses the work order and job nature is identified
which can be of two types;
Major: Maintenance is carried out according to the nature of problem and machine/equipment is
tagged as “Under Maintenance” and time frame of machine maintenance is given to user section.
Maintenance department carries out maintenance activities and transfer the machine/equipment to
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Issue date: 1st July 2019
Rev # 00
user section control after completing the maintenance. After maintenance, signatures are taken on
the Maintenance Work Order/Permit from the process staff.
Minor: In case of minor issues, maintenance department (Electrical/ Mechanical) fix the problems on
the spot
8.1.6. Equipment Calibration
Equipment Calibration is performed (in most cases) once each year from external. Maintenance
department can perform this activity in following ways;
a. Master equipment is calibrated from external calibration providers and rest of the
equipment are calibrated against master equipment on monthly basis
Calibration service provider labels the master equipment with their own sticker; in case they don’t,
responsible personnel labels equipment with calibration sticker as sample is provided in section 4.6
8.1.7. Visitor Control
Detail of all visitors that visit ABC Packaging entered in Visitor Register by gate keeper. Detail must
include following:
• Name of visitor
• CNIC
• ABC host name
• Purpose for visit
• Time in and out
• Initial of visitor
Gate keeper will issue visitor card and guide visitor toward host room. Gate keeper will ensure that
visitor will not move freely in ABC until his/her host arrive.
8.1.8. Electrical Inspection
Maintenance Incharge will assign a responsibility of relevant person for electrical inspection of area.
This inspection will be done on monthly basis to find out any electrical non-conformity.
8.1.9. Facility Security
Office keys are divided into two sets. Master keys are under custody of Admin and other one is
available at gate office who will ensure that at the day end, all offices are under lock and key. On daily
basis after office closing security guard visit the offices and premises to ensure the security of ABC and
he will record his findings in security guard report.
8.1.10. Asset Management
Assets are categorized into two types:
a. Fixed Assets
Assets that cannot move outside from its specified area like AC, Extruders, Generator etc.
b. Mobile Assets
Assets that are allotted to the ABC staff for its use like Laptops, USB, office vehicle etc.
All assets that are purchased in ABC; Manager Accounts is responsible for its coding. Coding
Scheme is done as per following format and sticker is attached on it:
Asset Type/ NN
Asset Type
Chair
Abbreviation
CHR
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Computer Table
Printer
CTB
PRT
Xerox Machine
Car
Motorbike
Laptop
Couch / Sofa
Table
Air Condition
Extruder
Printing Machine
Slitter
Sealer
XER
CAR
MBK
LTP
COU
TAB
AC
EXT
PNM
SLT
SLR
Issue date: 1st July 2019
Rev # 00
Asset. Code
Name:
Due:
By:
Asset Code: Asset Code defined based on Type/NN like for printer PRT/01
Date: Name of Equipment/ Asset
Due:
Date of Next Calibration/Maintenance
By:
Calibrated on/Maintenance done on
8.1.11. Issuance and return of Mobile Assets
For issuance of asset Accounts Person will prepare Asset Issuance agreement by writing type of asset,
its code and other relevant detail. When this form is final, initial of receiving person is compulsory on
it. If due to some reason person to whom ABC assets are issued transferred or leave the organization
then he will return all of his issue assets to account officer by undertaking Asset issuance and return
form.
8.1.12. Associated Records
a.
Master List of Equipment
b.
Equipment Service Plan
c.
Housekeeping Sheet
d.
Visitor Register
e.
Lavatory Inspection Sheet
f.
Environment Monitoring Sheet
g.
Security Roster
h.
Security guard report
i.
Asset Log
j.
Asset issuance and return form
8.1.13. Emergency Preparedness and Response
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Issue date: 1st July 2019
Rev # 00
ABC Management has defined, establish, implement and maintain the process(es) needed for emergency
situations:
All emergencies such as fire, oil spill or any other health, safety and environmental incidents where there is
damage to life, environment or property must immediately be reported to the concerned supervisor who will
then handle the situation according to the circumstances.
Emergency preparedness includes the following: a. Emergency Response Team (ERT)
b. Emergency Evacuation Plan
c. Emergency Exit Points
d. Emergency Assembly Areas
e. Emergency Contact Numbers
f. Fire Extinguishers
g. Spill Kits
h. First Aid Boxes
i. Trainings
j. Emergency Drills
8.1.14. Emergency Response Team (ERT)
The emergency team members are company’s employees who are, or may be required at an emergency site.
The emergency response team includes representatives from different sections. In any emergency situation
ERT mission is to;
a.
b.
c.
d.
Protect life safety
Secure company’s critical infrastructure and facilities
Resume the process and production
Protect environment from adverse environmental effects of any incidence
Names of the emergency response team members are displayed at appropriate locations in each department.
Emergency response team leader leads the team in case of emergency, guide and assign different
responsibilities to other team members. ERT leader establishes a coordination point for all the activities that
are taking place around the company.
8.1.15. Emergency evacuation plan
Emergency evacuation plans including the information of exit points, detail of fire extinguishers and potential
hazards and aspects are displayed in all the sections and appropriate places, so that employees know which
way to go in case of any emergency.
8.1.16. Emergency Exit Points
All exit and emergency points are marked and emergency lights are provided at each exit to avoid the
confusion in case of any emergency when there is an electricity shutdown.
8.1.17. Emergency Assembly Areas
Assembly areas adjacent to all departments and sections are identified. All the emergency assembly areas are
clearly marked and communicated.
8.1.18. Emergency Contact Numbers
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Emergency numbers are displayed at appropriate locations in order to provide awareness to all the personnel
so that they know whom to contact in case of emergency. Emergency contact numbers includes Fire Brigade,
Rescue, Ambulance/first aid, Civil Defense, Bomb Disposal, nearest Hospital, nearest Police Station, Wapda,
factory concerned officers, etc.
8.1.19. Fire Extinguishers
Fire extinguishers are installed at appropriate locations inside the departments and office areas as well. All
these fire extinguishers are also marked in the displayed maps. Fire extinguishers are periodically inspected
and record of inspection is maintained.
8.1.20. Spill Kits
All the potential areas where spill can occur are identified and all these areas have been provided with the
spill kits which are used by the concerned personnel in case of chemical, oil or dye spill.
8.1.21. First Aid Boxes
To deal with the medical emergencies and personal injuries, first aid kits/boxes are placed in each
department. Department Incharge is responsible to maintain the first aid kits/boxes. He will ensure that
first aid items are not misused.
8.1.22. Trainings
Trainings of the employees are conducted on planed basis related to each type of emergency situation.
Trainings provided include but not limited to the following;
a. Firefighting training will be given to all factory personnel as a part of the regular training
program. Firefighting training and qualification will be given to all operating and maintenance
staff. Selected personnel will be required to attend advanced firefighting courses.
b. First Aid training is provided to the members of Emergency Response Team related to the
medical emergencies and personal injuries like electric shock, cuts, unconsciousness etc.
c. Spill control training is also provided to the personnel where there is a chance of oil, chemical
or dye spill.
d. Waste Management training is also provided to the personnel to provide them awareness on
how to handle each type of waste.
8.1.23. Emergency Drills
HOD’s and Factory Manager make proper arrangements for emergency drills quarterly in Plant.
a.
Potential Emergency Situations
Following are the potential emergency situations which can create serious health, safety and
environmental issues.
•
•
•
•
•
•
Fire
Medical Emergency
Personal Injury
Chemical Spill
Oil & Gas Spill
Air Emissions
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Earthquake
Action in Case of Fire
In case of fire, follow the procedure step by step:
•
•
•
•
•
•
•
•
•
c.
The person who sees the fire is required to shout “fire, fire, fire” loudly or sound the alarm.
Fire alarm is raised by the person working near to alarm so that alarm is raised in minimum
possible time.
Put off main switch of the premises
Inform the Emergency Team and Security Office
Use the fire extinguisher and fire buckets to put off the fire if it is in a smaller area
If the fire is out of control then immediately call Rescue Service
Move to assembly point
Shift the injured / burned persons to safe place
Provide first aid to injured / burned person(s)
Action in Case of Medical Emergency
If you are a trained at First Aid and the patient is unconscious:
• Check airways, breathing and circulation
• Start administering CPR if necessary
If the patient is conscious:
•
•
Reassure and monitor. Remain with the person until medical services arrive
Ask another staff member in the immediate area to contact the relevant emergency personnel.
This could be the Emergency Services (Rescue 1122 etc) if an ambulance is necessary, Security
or Medical Officer
If you are not a trained First Aid Officer;
•
•
d.
Contact the relevant emergency personnel
This may be the emergency services if an ambulance is needed or contact the BBN Nominated
authorities
Personal Injury
In the event of personal injury,
•
•
•
•
If you are hurt and require first aid seek help from the Emergency Response Team Member of
your area
If you require medical attention, do so straight away by contacting the Dispensary/Medical
Room
Notify your immediate supervisor or manager as soon as possible
If you have had a work related injury/accident/incident/near-miss you are required to report
the incident
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e.
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The Factory Manager will contact the supervisor and have them investigate the
accident/incident
Chemical Spill
In case of spilling of acidic chemicals, immediately wash the affected area with a dilute solution of
Soda Ash or any other basic solution to neutralize the effects of acidic chemical otherwise wash the
area with diluted oxalic acid in case of basic chemical. The affected area is thoroughly flushed with
tap water.
In case of eye contact, wash the affected eye immediately with clean lukewarm for at least 20
minutes and hold the affected eye(s) open. Wash your hands with soap and water afterwards. Seek
medical attention if there are any burns caused by chemical.
In case of swallowing, rinse the mouth with cold water. If the victim is conscious, have them drink
lots of water to dilute the acid followed by a glass of milk or milk of magnesia in case of acid. Induce
vomiting any other common chemical is swallowed. Call 1122 for immediate medical assistance.
f.
Actions in case of oil spill
•
•
•
•
g.
In the event of oil spill, concerned worker instantly informs his supervisor and emergency
response team
Members of emergency response use the Spill Kit and instantly put sand around the spill so that
it may not spread further
Then, sand is put on the spill to make the surface dry and floor is dried by means of sand and
absorbing cloth
The sand is then collected and disposed of properly
Air Emissions
In case of any excessive emissions which are hazardous to health, safety or environment, the related
process is immediately shutdown to avoid the impacts of emissions. The emergency response team
of the area reviews the situation and decides whether to continue the process or not. If the situation
is severe the process is kept halted and immediately reported to Factory Manager, who takes further
appropriate actions to resolve the issue.
h.
Earthquake
If inside the building, get under a desk or table or stand in a doorway or corner. Stay clear of
windows, file cabinets, mirrors, and fireplaces. If possible, extinguish open flames/ignition sources.
If outside the building, stay in an open area away from trees, buildings, walls, and power lines. If
driving, pull over and stop. Avoid overpasses and power lines. Stay inside the vehicle until shaking
stops. If the earthquake was severe, do not attempt to cross damaged walls or buildings.
8.1.24. Associated Records
a. Emergency Response Team (ERT)
b. First Aid Kit Inspection Record
c. Emergency Drill Records
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d. HSE Guide
8.2. Requirements for products and services
8.2.1. Customer Communication
ABC Management has implemented effective communication with customers. Customer communicates with
ABC through telephonic conversation, letters, email, sale person visit etc.
8.2.2. Receipt and Review of Clients’ Inquiries
An initial inquiry from customer is received through phone, letter, fax, email or personal visit by Commercial
Officers for capability analysis before accepting the order or making a contract. After capability analysis,
following parameters are reviewed and discussed with customer.
a.
b.
c.
d.
e.
f.
g.
Price
Product specifications
Dummy Sample
Material availability
Filling requirements
Delivery requirements
Financial terms and conditions
8.2.3. Preparation and Review of Contract
After the approval of samples and finalization of terms & conditions, customer sends a confirmed Purchase
Order/Contract Document through phone, letter or email etc. List of customers is also maintained.
8.2.4. Legal and Regulatory Requirements
All legal and regulatory requirements that apply to company’s product are identified. ABC management take
care of all applicable regulatory requirements.
8.2.5. Customer Communication
Director, P&D Incharge or commercial officers communicates with customer regarding information related to
product specifications, order, contract requirements and customer feedback (including customer complaints).
Communication channel may be phone, fax, email or personal visits.
8.2.6. Customer Complaints
•
The Complaint Form must include, at a minimum name and affiliation of the complainant, name of
the individual logging the complaint, date the complaint was received and nature of the complaint.
•
Feedback/ Complaints from customers are statistically compiled by P&D Incharge. The complaint may
be related to but not limited to the following cases:
a.
b.
c.
d.
e.
•
Non-conforming product
Poor filling and shipment
Late delivery
Late response
Any other problem
After receiving the complaint from customer, it is forwarded to the Relevant department for detail
investigation through CPAR’s.
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•
After thorough analysis of complaint corrective action(s) is/are taken on complaint. If the action
taken is effective, efficient and satisfactorily completed or if further follow-up action is needed. If
follow-up action is needed, a follow-up date is determined and documented.
•
Customer is then reported to mitigate his dissatisfaction. Customer complaints data and customer
complaint log is maintained by marketing department.
•
Customer complaints data is statistically compiled and analyzed quarterly basis by the P&D
department. This analysis is submitted to Director for review. Based on this analysis, Director initiates
corrective actions or recommend preventive actions for improvement using the CPAR.
8.2.7. Customer Surveys / Feedback
•
Customer feedback other than complaints may be considered “continuous improvement”
suggestions. Customer feedback may include but is not limited to:
a. Suggestions for process changes that will improve efficiency or quality
b. Ideas for new products
c. Comments on recognition of high-quality work products or services
•
Activities associated with Customer Feedback should be documented on the Customer Feedback
form; Director monitors the progress of the customer feedback.
•
Customer Feedback Survey is conducted on bi-annual basis to monitor the customer satisfaction and
identify customer needs and expectations. It is done by using the following methods:
a. Designing surveys forms/questionnaires and circulating these forms to customers
b. Collecting feedback through phone calls and personal visits
c. Collecting feedback through participating in different events and exhibitions
Feedback from customers is statistically compiled and reported quarterly basis by the P&D
department. These survey results are presented as input in the management review and analyzed by
top management. Based on these analyses, corrective actions or preventive actions are initiated for
improvement in quality of products
8.2.8. Associated Records
a. Customer Feedback Form
b. Customer Complaint Form
c. Customer Complaint Log
d. Corrective/ Preventive Action Forms
8.3. Design and development of products and services
8.3.1. General
ABC Management has developed a system for design and development of new products
8.3.2. Design and development planning
In determining the stages and controls for design and development, the ABC Management consider:
a. the nature, duration and complexity of the design and development activities. P&D Manager
gives specification design taken from customer to ABC Designer. And as per specification
Factory Manager formulate product and perform test on it from ABC lab
b. the required process stages, including applicable design and development reviews conducted
by Factory Manager and Director;
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c. the required design and development verification and validation activities perform in QC lab
of ABC
d. the responsibilities and authorities involved in the design and development process. New
formulation by Factory Manager and Designing by P&D Department
e. the internal and external resource needs for the design and development of products and
services;
f. the involvement of customers and users in the design and development process by finalizing
sample product from customer;
g. the requirements for subsequent provision of products and services;
h. the level of control expected for the design and development process by customers and other
i. relevant interested parties;
j. the documented information needed to demonstrate that design and development
requirements have been met.
8.3.3. Design and development inputs
ABC Management has determined the requirements essential for the specific types of products and
services to be designed and developed. The ABC Manager consider:
a. Functional and performance requirements of ABC Packaging
b. Information derived from previous similar design and development activities that is available
in QC lab under supervision of Factory Manager
c. Statutory and regulatory requirements specifically related to trade mark of customers also
consider and Director give final approval on it
d. Standards or codes of practice that the ABC has committed to implement as per mutual
agreement with customer available in Director and Manager P&D
e. Potential consequences of failure due to the nature of the products and services also consider
during meeting with Director related to design and development
f. Conflicting design and development inputs also resolved after discussion with Director
ABC has retained all documented information on design and development inputs
8.3.4. Design and development controls
ABC Management has applied controls to the design and development process to ensure that:
a. the results to be achieved are defined; (Recipes)
b. reviews are conducted to evaluate the ability of the results of design and development to
meet requirements; (Director Meetings)
c. verification activities are conducted to ensure that the design and development outputs
meet the input requirements; (Test report on new batch)
d. validation activities are conducted to ensure that the resulting products and services meet
the requirements for the specified application or intended use; (QC Reports)
e. any necessary actions are taken on problems determined during the reviews, or verification
and validation activities; (Wastage record)
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All documented information of these activities is retained.
8.3.5. Design and development outputs
ABC Management ensure that design and development outputs:
a. meet the input requirement of customer;
b. are adequate for the subsequent processes for the provision of products and services;
c. include or reference monitoring and measuring requirements, as appropriate, and acceptance
criteria;
d. specify the characteristics of the products and services that are essential for their intended
purpose and their safe and proper provision.
All such documents are retained in QC Lab/under supervision of Factory Manager
8.3.6. Design and development changes
ABC Management identify, review and control changes made during, or subsequent to, the design
and development of products and services, to the extent necessary to ensure that there is no adverse
impact on conformity to requirements. ABC retain documented information on:
a.
b.
c.
d.
design and development changes; (QC Lab)
the results of reviews; (QC Lab)
the authorization of the changes; (Director and Factory Manager)
the actions taken to prevent adverse impacts (Recommendation of Director and Factory
Manager)
8.4. Control of externally provided processes, products and services
ABC Packaging has defined a system for Control of Externally Provided, Products and Services as per
following criteria:
8.4.1.
Supplier Evaluation and Selection
ABC Packaging Industries (Pvt) Ltd evaluates its existing Suppliers minimum once in a year. Managers are
responsible for evaluation of the suppliers as per the defined criteria in Supplier Evaluation Form. The
minimum passing criteria is 6.
For the selection of a new Supplier, Supplier’s reputation/goodwill is accounted as well. Only Director has
the authority for the approval of a new Supplier.
8.4.2.
Material Issue and Purchase requisition
There are 2 types of Purchases at ABC Packaging Industries (Pvt) Ltd
•
•
International Purchase (Raw material “Grain”, equipment)
Local Purchase
Functional Incharge(s) raises demand, in form of a demand Note and forwards it to store. If the item is
available in store then it is issued to Functional Incharge. In case of unavailability of item, Store Keeper
informs Functional Manager of the unavailability of item.
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Functional Incharge forwards the demand to Manager who then takes it to Director for approval. After
the approval, demand is forwarded to Accounts & Finance department. Purchase order is sent to
concerned approved supplier from the List of Approved Supplier.
In-case of a new Supplier, quotations are requested from the potential suppliers and these suppliers are
evaluated as per the procedure in described in section 4.1.
8.4.3.
Receiving Inspection and Verification
On receiving, the items are extensively inspected by the respective Functional Incharge to verify that the
ordered item is as per the requirements.
Upon the successful inspection of item, the item is sent to store. The Store Keeper, updates his inventory
list and issues it accordingly. If the item does not conform to the requirements, the received item is sent
back to the supplier with the reason(s) of rejection.
8.4.4.
Storage
Items received after successful inspection are sent to Store. Store Keeper updates his inventory list and
issues them accordingly.
8.4.5.
a.
b.
c.
Associated Records
List of Approved Supplier
Supplier Evaluation form
Demand form
8.5. Production and service provision
8.5.1.
Control of production and service provision
ABC Management has planned & developed the processes needed for its service. Planning of product
realization is ensured to be consistent with the requirements of the other processes of the Integrated
management system and should meet the customer requirements. Records of planning are maintained.
This is achieved through effective development, implementation and monitoring the planned activities.
ABC has developed a comprehensive system for the monitoring of control measures throughout the
processing and in the events of nonconformities.
8.5.2.
a.
b.
Associated Documents
Business Analysis Reports
Supply Chain Reports
8.5.3.
Identification and traceability
ABC Packaging Pvt Ltd. has defined system for identification and traceability of every batch.
Production give batch number to product after passing from lab.
8.5.4.
Property belonging to customers or external providers
Property belonging to customer is applicable in ABC Packaging as it does not hold any customer property in
its premises. Stamp and printing design on customer product are also designed by ABC from its external
provider. It is maintained under control conditions.
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8.5.5.
Preservation
ABC Packaging preserves outputs from customers at offices in documented form and electronic ERP portal.
All new products or materials that purchase, it is maintain properly at Store under custody of Factory
Manager.
8.5.6.
Post-delivery activities
ABC Packaging meets the requirements for post-delivery activities associated with the products
and services. Post-delivery activities that are related to ABC Packaging are:
a. Statutory and regulatory requirements;
b. the potential undesired consequences associated with its products and services;
c. the nature, use and intended lifetime of its products and services;
d. Customer requirements;
e. Customer feedback;
f. Product Warranty provisions; etc.
Factory Manager take action on complaints received from customer and as per requirement. He also
visits customer after taking confirmation from Director where require.
8.5.7.
Control of changes
The ABC Management review and control changes for production or service provision, where
necessary to ensure continuing conformity with requirements. Manager P&D consult with director and
Factory Manager if any requirements are changes.
All such documents that has information related to changes are maintained. Approval of all such changes,
are authorized by Director.
8.6. Release of products and services
ABC Packaging has criteria for release of product. Prior to release of product; Quality Control lab of ABC
perform testing on product and prepare report of testing activity. Factory Manager verify the report and
test sample and lab person paste batch number on pass product. After finalization, Factory Manager
approves the report and pass the batch.
8.7. Control of nonconforming outputs
ABC manages and controls the nonconforming outputs as per procedure for Corrective Actions in Section
10. P&D and Production department deal non-conforming product.
8.7.1.
Associated Record
a. Customer Service Complains Record
9. Performance evaluation
9.1. Monitoring, measurement, analysis and evaluation
9.1.1. General
ABC uses the management system to improve its processes, products and services. Such
improvements aim to address the needs and expectations of customers as well as other interested
parties, to the extent possible.
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Management of ABC periodically (before every MRM) evaluates compliance with applicable legal
requirements and monitor customers’ perceptions of the degree to which their needs and
expectations have been fulfilled.
Following are the inputs while considering improvements for the system:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
Review of System Documentation
Up gradation of existing equipment
Suggestion for better utilization of existing resources
CPA Forms
Internal Audit Reports
External Audit Reports
Previous Management Reviews (unfinished objectives and missed target dates)
Customer Complaints
Supplier Evaluations
Training Evaluations
The results of analysis are used to evaluate:
a.
b.
c.
d.
e.
f.
conformity of services
the degree of customer satisfaction
the performance and effectiveness of the management system
the effectiveness of actions taken to address risks and opportunities
the performance of external providers
other improvements to the management system
9.1.2. Customer Satisfaction
ABC Management monitor customers’ perceptions of the degree to which their needs and
expectations have been fulfilled as per procedure mention in section 8.2
9.1.3. Analysis and Evaluation
ABC Management analyze and evaluate appropriate data and information arising from monitoring
and measurement.
The results of analysis are used to evaluate:
a. conformity of products and services; (Lab Data)
b. the degree of customer satisfaction; (Number of Complaints and Feedback)
c. the performance and effectiveness of the integrated management system; (No. of NCs)
d. if planning has been implemented effectively; (Production Plan, Job Cards)
e. the effectiveness of actions taken to address risks and opportunities; (Risk Assessment
violations, accidents/near miss etc.)
f. the performance of external providers; (Purchase Inspection record)
g. the need for improvements to the integrated management system (MRM, CPA records)
9.2. Internal audit
ABC Management has defined system for Audit Planning and Execution as following:
9.2.1. Audit Team
ABC has developed an Internal Audit Team for conducting internal audits on regular basis and Factory
Manager maintains the list of internal auditors. Internal Auditors are selected from different functions
within the company based on their experience and professional skills. They are then trained on
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auditing skills by sending them to seminars and/or conducting internal training sessions. Training
record/certificate copies of the auditors is maintained.
9.2.2. Audit Frequency and Planning
Annual Audit Program is prepared at the start of each year. This program shows all the departments
of the company and month in which audit is planned. In this program, each cell, against each year and
department, is split in to four (4) cells. Each cell representing a step of audit cycle as explained below.
Box 1 represents planning, when the ABC has to start the planning of the audit of any concerned
department/ section. Box 2 is for planned audit execution when audit actually is to be performed. Box
3 represents that when the ABC has to take the corrective actions against the nonconformities found
during the audit. And Box 4 represents that when the follow up of the corrective actions that are to
be taken as a result of non-conformance, is required to check the compliance level.
If all 4 activities i.e. Audit Planning, Audit Performance, Corrective Actions and Follow Up of the
corrective action taken, is complete for all departments, it completes one audit cycle. It is compulsory
to complete one audit cycle each year.
9.2.3. Audit Frequency and Planning
Factory Manager is responsible for planning and scheduling the internal audits. Factory Manager
prepares the yearly audit schedule on Annual Audit Program normally at the beginning of the year.
Director approves the Annual Audit Program. The internal audits are carried at least once in year.
A Week before the proposed audit date, Factory Manager in consultation with the Auditors prepares
the Audit Plan. The audit plan lists all the activities corresponding to the Integrated Management
System, identifies locations where these activities are taking place, and time of audit for each activity.
The audit plan is approved by the Director and is then distributed to all the concerned departments/
sections covered under the scope of audit.
9.2.4. Audit Execution
Before starting an audit, the auditors ensure the possession of;
a.
b.
c.
d.
Audit Plan
Internal Audit Report
Copies of Integrated System Manual and Integrated System Procedures
Audit Checklist
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The audit begins with a briefing to the management on the methodology of the audit, its scope and
any administrative arrangements required.
While conducting the audit, the auditors seek to:
a. Determine whether documented procedures and instructions meet the requirements
of the standards
b. Verify whether procedures and instructions are being implemented. For this, the data
and records generated as evidence of activities are examined for compliance with
specified procedures. In addition, the auditors make it a point to talk to personnel
actually performing various tasks to ascertain whether they understand the procedures
and instructions, and are following these. Auditors observe tasks being carried out, to
see whether these conform to specified norms and procedures of Integrated
Management System
c. When an auditor observes non-conformity in the system, all relevant information is
examined carefully and full details of nonconformance are recorded so that corrective
action can be taken. The responsible department head is associated with such
observations. Evidence of non-conformity and the department head concurrence is
recorded on the observation sheet to avoid controversy
d. On completion of the audit, a closing meeting is arranged with the management to
review findings and to obtain clarifications if required. Appropriate corrective measures
are also discussed
After the completion of audit, auditors compile all these findings and prepare Audit Report. It includes
the summary of the audit and audit non-conformities and observations observed. Audit report
normally contains the following information;
a. Report title, number and the relevant information
b. Particulars and compositions of the audit team
c. Background information, such as the auditor’s objective, scope, dates and
procedures used
d. Brief description of the activities and departments audited
e. Summary of findings and observations
9.2.5. Corrective Action and Follow up
Factory Manager initiates the Corrective / Preventive Action Requests (CPARs) on the nonconformities observed in the audit and gives it to the concerned departmental / section heads.
The concerned departmental / section head investigates the cause of the problem, proposes a
corrective action to be taken and indicates the date by which the corrective action will be fully
implemented.
9.2.6. Input to Management Review Meetings
Results of internal audit are submitted in Management Review Meeting by Factory Manager as input.
9.2.7. Associated Records
a. Annual Audit Program
b. Internal Audit Plan
c. Audit Checklist
d. Internal Audit Report
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9.3. Management review
ABC Management has defined system for Management Review Meeting. It is conducted following:
9.3.1. MRM Frequency
Management Review Meetings (MRM) are carried out to regularly evaluate the level of compliance
related to IMS. It is conducted on biannually basis; however unscheduled meetings can be called at
any time on the direction of Top Management/Director.
9.3.2. Attendance
The Management Review Meeting is chaired by the Director or his deputed representative (in case of
absence) and attended by the following members;
a.
b.
c.
d.
Director (Chairs the MRM)
Factory Manager (FM)
All HODs
Other members of Emergency Response Team -ERT (Optional)
9.3.3. Inputs/ Agenda to Management Review Meeting (MRM)
The agenda of the MRM is prepared by the Factory Manager in consultation with Managers. It is
distributed well in advance at least 7 working days in advance. Following are the inputs of
Management Review Meetings;
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.
l.
m.
n.
o.
p.
Adequacy of QHSE policy
QHSE objectives and management program
Results of internal and external audit
Relevant communication(s) from external interested parties, including complaints and feedbacks
Performance of external provider
Resources adequacy
Process performance and product conformity
Status of Status of incident investigations and preventive & corrective actions
Action taken to address risk assessment
Follow-up actions from previous management reviews
Evaluation of compliance with legal requirements
Emergency situations, accidents and product withdrawals
Reviewing results of system-updating activities
Any changes in IMS
Recommendations and action taken for improvements
Any other matter that require attention of management
9.3.4. Output of the Management Review Meetings
The minutes of the MRM are prepared by the Factory Manager and then distributed to the members
preferably within 3 working days.
The minutes may include decisions related to;
a. Effectiveness of QHSE policy, objectives and targets
b. Improvement of effectiveness of IMS management system
c. Improvement of product related to customer requirements
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d. Resources required for the improvement of integrated management system
e. Other elements of the Integrated Management System
9.3.5. Follow Up of the Meeting
FM is responsible for the follow up of the decisions taken in the meeting to ensure that the decisions
are implemented in the specified time frame.
9.3.6. Associated Records
a. Minutes of Management Review Meeting
b. Management Review Meeting Intimation Form
10.Improvement
10.1.
Nonconformity and corrective action
ABC has established a Procedure to identify non-conformance and corrective action that specify
appropriate actions to identify and eliminate the cause of detected nonconformities, to prevent
recurrence, and to bring the process or system back into control after nonconformity is encountered.
10.1.1. Initiating Corrective Actions
Corrective actions are taken to eliminate the causes of non-conformities to prevent their recurrence.
Anyone working at ABC Packaging can identify non-conforming work, areas of improvement by
initiating CPA Request related to but not limited to following:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
System / process non-conformities and problems
Product non-conformity
Environmental issues such as air emissions, effluents etc.
Health & Safety issues such as accidents, incidents, hazards etc.
Quality Management System issues
Non-compliance identified during an internal or external audit
Technical issues
Customer feedback including customer complaints
Supplier Performance
Non-conforming deliveries from suppliers
10.1.2. Requesting and Processing CPA
a. Any person in the company can initiate corrective actions form (CPA Form). CPA forms MUST be
available at the work place preferably CPA Boxes are to be placed at various locations so that
everyone has access to this.
b. Once CPA form is filled, it is either put in CPA Box or sent to the related section Incharge. The
initiator of CPA MUST mentioned his / her contact (Name, Section & Signatures) otherwise CPA
will not be entertained (any unnamed CPA will be discarded for no further action)
c. The request contains a description of the unsatisfactory condition that needs to be corrected and
are addressed to the person who is responsible for the area where condition occurred.
d. Section Incharge check the validity of this CPA and forward to concerned person for root cause
analysis and corrective action suggestion
e. The assignee investigates the causes of the problem that initiated in the CPA. The investigation
process includes:
i. Interviewing the concerned personnel and gather their views about the possible
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Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
causes of non-conformities
ii. Observing and examining the concerned processes and related records
iii. Examining the supplier and his supplies (where required)
iv. If appropriate, make use of scientific techniques (like cause and effect, SPC, Pareto
etc.) to determine root causes
f.
The assignee, then, proposes a corrective action to be taken and indicates the date by which the
corrective action shall be fully implemented.
10.1.3. Implementation of Corrective Action
When a corrective action is decided upon, it is implemented and the results are closely monitored.
Further measures or changes in the measures may have to be made until satisfactory results are
attained. The magnitude of corrective action depends on the nature of non-conformity and its effect
on the quality of product / process.
10.1.4. Verification of Corrective Action
Immediately after, the due date of implementation of a corrective action, Section Incharges/Managers
take follows up to determine if the corrective action has been implemented and if it is effective. When
there is objective evidence that the corrective action is effective, the CPA can be closed out. If more
work is needed to fully implement the action, a new follow up date is agreed upon.
When the corrective measures are found to be effective, they are incorporated in the integrated
management system by making suitable changes in the relevant documents such as specifications,
operating procedures, work instructions and integrated system procedures.
10.1.5. Management Review meetings
Status of corrective actions is presented as input to management review meetings. Concern
department head compiles the status of corrective actions in the report and submits it in the
management review.
10.1.6. Suggestions/Improvement from Employees
All personnel are encouraged to identify opportunities for improvement in the integrated
management system related to his work function. The improvements may be identified in the
following manner;
i.
ii.
iii.
iv.
v.
Quality, Environmental, Health & Safety performance improvements
Initiating corrective actions on problems/NCs
Initiating corrective actions on potential non-conformities/problems
Giving suggestions for any other improvements
Customer complaints
In case the suggestion is rejected, the reason for its rejection is given on the CPAR form and the
suggested person is informed by the concerned head. In case the suggestion is approved by the
Director/Factory Manager, it is intimated to concerned HOD / Section Incharge for compliance.
After approval of suggestion, the concerned head assigns the responsible person and target date for
implementation of suggestion. Respective section Incharge is responsible for follow up of
implementation of suggestion. When it is verified that the suggestion has been effectively
implemented, it is closed out in the CPA Log.
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Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
Issue date: 1st July 2019
Rev # 00
10.1.7. Control of Nonconformance
Any nonconformance related to Quality Health Safety & Environment (QHSE) is also dealt with
appropriate corrective action through this procedure.
[Note: Nonconformance/Nonconformity is defined as non-fulfillment of a requirement on any
deviation from relevant work standards, practices, procedures, legal requirements, QHSE management
system requirements, etc.]
Any nonconformance occurs in the system must be identified, controlled and appropriate actions
should be taken to eliminate the impact of nonconformance. Any nonconformance identified in the
system must be reported on CPA form and processed as defined in this procedure.
10.1.8. Identification and Action on Non-Conforming Product
Non-conformance can be identified during in-process operation, finished product and raw/packaging
materials.
The concerned head of department is responsible to identify and segregation of the non-conforming
product(s), in such a manner to avoid any mix up of the products / materials as per direction of quality
department.
Factory Manager evaluates the nature of nonconformance with Manager P&D and takes immediate
action in consultation with the Director, in-case of rework Director suggest the rework (as defined
above in section 4.2, 4.3 and 4.4)
10.1.9. Associated Records
a. Corrective Action (CPA) Form
b. Corrective and Preventive Action Log
10.2.
Continual improvement
ABC Packaging continually improves the suitability, adequacy and effectiveness of the ISO. ABC
considers the results of analysis and evaluation, and the outputs from management review, to
determine if there are needs or opportunities that shall be addressed as part of continual
improvement.
End of Manual
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Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
Annexure: List of Annexures
Sr.
Code
1
MGT/FRM 1.01
2
MGT/FRM 1.02
3
MGT/FRM 1.03
4
MGT/FRM 2.01
5
MGT/FRM 2.02
6
MGT/FRM 3.01
7
MGT/FRM 3.02
8
MGT/FRM 3.03
9
MGT/FRM 4.01
10 MGT/FRM 4.02
11 MGT/FRM 6.01
12 MGT/FRM 6.02
13 MGT/FRM 6.03
14 MGT/FRM 7.01
15 MGT/FRM 7.02
16 MGT/FRM 7.03
17 MGT/FRM 8.01
18 MGT/FRM 8.02
19 MGT/FRM 8.03
20 MGT/FRM 8.04
21 MGT/FRM 8.05
22 MGT/FRM 8.06
23 MGT/FRM 8.07
24 MGT/FRM 8.08
25 MGT/FRM 8.09
26 MGT/FRM 8.10
27 MGT/FRM 8.11
28 MGT/FRM 8.12
29 MGT/FRM 9.01
30 MGT/FRM 9.02
31 MGT/FRM 9.03
32 MGT/FRM 9.04
33 MGT/FRM 10.01
34 MGT/FRM 10.02
35 MGT/FRM 11.01
36 MGT/FRM 11.02
37 MGT/FRM 12.01
38 MGT/FRM 12.02
39 MGT/FRM 12.03
40 MGT/FRM 12.04
41 MGT/FRM 13.01
42 MGT/FRM 14.01
43 MGT/FRM 17.01
44 MGT/FRM 17.02
45 MGT/FRM 17.03
46 MGT/FRM 17.04
Issue date: 1st July 2019
Rev # 00
Title
Master List of Documents & Records
Master List of Files/Folder and Register
Document Change Request
Stakeholder Analysis Sheet
Internal and External Issues
Environment Risk Assessment
Occupational Health and Safety Risk Assessment
Quality Risk Assessment
Summary of Departmental Objective
Management Program for Objective
List of Approved Suppliers
Supplier Evaluation Form
Material Requisition Form
Training Attendance & Evaluation Form
Training Need Assessment & Plan Form
Leave form
Master List of Equipment
Machine Maintenance and Inspection Form
Housekeeping Sheet
Visitor Register
Lavatory Inspection Sheet
Environment Monitoring form
Security Roster
Security Report
Asset Log
Assets Issuance and Return Form
Applicable Legal Requirements
Work Permit Request
Internal Audit Program
Internal Audit Plan
Audit Checklist
Internal Audit Report
Meeting Intimation Form
Management Review Meeting Minutes
Corrective Action Request
Corrective Action Log
Customer Feedback Form
Customer Complaint Form
Customer Complaint Log
Customer Feedback Analysis
Compliance Evaluation form
Incident Investigation Report
Emergency Response Team
Safety Equipment Inspection Sheet
Emergency Drill Report
Emergency Contact Number
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Doc. # MGT/ISM-01
Integrated Management System
Manual
Based on ISO 9001, 14001 & 45001
Page 48 of 48
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Issue date: 1st July 2019
Rev # 00