This document summarizes the quality procedures for controlling documents, records, internal audits, non-conforming products, and corrective and preventive actions at NS Automotive Ltd. It establishes processes for document control, record retention, conducting internal audits, handling non-conforming products, and implementing corrective and preventive actions. Key responsibilities are assigned to ensure effective management of these quality system elements.
Hello guys i prepared QMS kick off meet PPT. Here I have shown how to start a project in any organization. What contents we need to discuss with top management at the time of start of QMS implementation. Kindly comment and share your views.
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Missing the Iceberg – avoiding project failure through killing or redefining it in time webinar
Tuesday 6 September 2022
APM Systems Thinking Specific Interest Group
Presented by panel members:
Hugh Buckley, Cesar Rendora, Tony Thornburn, Simon Tinling, Amanda Whittaker and Andrew Wright
The link to the write up page and resources of this webinar:
https://www.apm.org.uk/news/missing-the-iceberg-avoiding-project-failure-through-killing-or-redefining-it-in-time-webinar/
Content description:
Most project professionals have found themselves on a project where success looks unlikely, yet nobody does anything about it. Why is this? Flagging up that a project is heading for failure is typically a career limiting move - the messenger bringing the bad news get blamed.
This panel delivered webinar on Tuesday 6 September 2022 explored a simple approach to how we, as project professionals, can flag up the need for changes to projects (or even killing them), in a way that avoids being blamed personally.
This approach can be used in any context where stakeholders don’t want to hear changes are vital.
Getting commitment to reshaping or killing a failing project without the messenger being killed.
ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.
operational excellence ...an excersice of leadership, deals with the implementation of an op ex project, including the tactical part but also taking care of people througout the change process
QCC is one of the leading providers of training solutions in India for management systems, process improvement, business improvement and auditing. QCC helps companies understand, implement and manage business systems and processes through its training solutions in its endeavor to equip your staff with the confidence and expertise they need to attain their goal.Our training solutions are built on innovative experimental methodologies with global delivery capacity. Our presenters (trainers) are auditors, business improvement specialists, consultants, industry experts as well as trainers who have been exposed to a wide range of companies and industries in India and overseas. They develop and deliver courses for both public & in-house training, thus bringing along firsthand experience and knowledge to the delegates.
How to Introduce Operational Excellence in your Organisation?Tina Arora
This presentation will help you present to the management the need and benefits of introducing Operational Excellence as a department in your Organisation.
It can be modified to suit the advocacy in any industry - be it Financial services, BPO, LPO, KPO, Domestic call centres, Manufacturing, Consumer Goods, Retail, etc.
Materials contain the full scope of the requirements of the new version of the ISO 9001:2015 in the form of a 89 slide MS Power Point presentation. Presentation can be used as a basis for a 24 hour ISO 9001:2015 Training courses for staff and/or internal auditors. Pictures and diagrams from the Presentation will be a good illustration for your Quality Management System Documentation updated in accordance with the ISO 9001:2015.
Jim Watts, Principal Engineer held a presentation on Plastic Logic's colour electrophoretic displays, which are manufactured in the company's volume factory.
Hello guys i prepared QMS kick off meet PPT. Here I have shown how to start a project in any organization. What contents we need to discuss with top management at the time of start of QMS implementation. Kindly comment and share your views.
Kindly write your comment it will greatly help me to create new PPT and it will definitely motivate me.
Missing the Iceberg – avoiding project failure through killing or redefining it in time webinar
Tuesday 6 September 2022
APM Systems Thinking Specific Interest Group
Presented by panel members:
Hugh Buckley, Cesar Rendora, Tony Thornburn, Simon Tinling, Amanda Whittaker and Andrew Wright
The link to the write up page and resources of this webinar:
https://www.apm.org.uk/news/missing-the-iceberg-avoiding-project-failure-through-killing-or-redefining-it-in-time-webinar/
Content description:
Most project professionals have found themselves on a project where success looks unlikely, yet nobody does anything about it. Why is this? Flagging up that a project is heading for failure is typically a career limiting move - the messenger bringing the bad news get blamed.
This panel delivered webinar on Tuesday 6 September 2022 explored a simple approach to how we, as project professionals, can flag up the need for changes to projects (or even killing them), in a way that avoids being blamed personally.
This approach can be used in any context where stakeholders don’t want to hear changes are vital.
Getting commitment to reshaping or killing a failing project without the messenger being killed.
ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.
operational excellence ...an excersice of leadership, deals with the implementation of an op ex project, including the tactical part but also taking care of people througout the change process
QCC is one of the leading providers of training solutions in India for management systems, process improvement, business improvement and auditing. QCC helps companies understand, implement and manage business systems and processes through its training solutions in its endeavor to equip your staff with the confidence and expertise they need to attain their goal.Our training solutions are built on innovative experimental methodologies with global delivery capacity. Our presenters (trainers) are auditors, business improvement specialists, consultants, industry experts as well as trainers who have been exposed to a wide range of companies and industries in India and overseas. They develop and deliver courses for both public & in-house training, thus bringing along firsthand experience and knowledge to the delegates.
How to Introduce Operational Excellence in your Organisation?Tina Arora
This presentation will help you present to the management the need and benefits of introducing Operational Excellence as a department in your Organisation.
It can be modified to suit the advocacy in any industry - be it Financial services, BPO, LPO, KPO, Domestic call centres, Manufacturing, Consumer Goods, Retail, etc.
Materials contain the full scope of the requirements of the new version of the ISO 9001:2015 in the form of a 89 slide MS Power Point presentation. Presentation can be used as a basis for a 24 hour ISO 9001:2015 Training courses for staff and/or internal auditors. Pictures and diagrams from the Presentation will be a good illustration for your Quality Management System Documentation updated in accordance with the ISO 9001:2015.
Jim Watts, Principal Engineer held a presentation on Plastic Logic's colour electrophoretic displays, which are manufactured in the company's volume factory.
The future of health the emerging view 14 01 16Tim Jones
A short talk given in London in January 2016 highlighting some of the key health and healthcare related insights from the Future Agenda workshops. Mixing views from around the world it looks at public health issues, the increasing role of digital, changes to the healthcare system, the ageing challenge, financing health and where global answers may emerge from.
Webinar delivered in September 2012 featuring experts from Informatica Cloud and customers from Dolby and Actelion. For more information on Informatica Cloud integration applications and platform, please visit: http://www.informaticacloud.com/
Sample ISO 13485 Quality Manual & Procedures Package ComplianceOnline
This procedure describes Management Responsibilities for the Quality Management System (QMS) at Your Company.
For more Information please visit and copy paste in browser.
http://www.complianceonline.com/iso-13485-quality-manual-procedures-package-standards-10218-prdp
ISO 9001 is a process standard for a quality management system, known worldwide. This standard is suitable for any size company or organization that wants to meet its customers ’ and regulatory requirements and consistently improve.
Management review procedure for legal practicesVal Antoff
The management team must review the Quality Management System to ensure its continuing suitability, adequacy and effectiveness for achieving client and regulatory requirements in your legal practice. This is an example of a management review procedure.
1. QUALITY SYSTEM PROCEDURE
QSP 01
4.2.3
Effective Date
April 20, 2015
Revision Level
0
Page
1 of 3
Control of Documents
Uncontrolled copy if NS Automotive Ltd logo NOT in RED
Issued By: Quality Manager Approved By: CEO
PURPOSE
To establish a process that ensures appropriate documentation to support the QMS is
established, maintained, and controlled.
SCOPE
This procedure applies to all documentation used to support the quality system in NS
Automotive Ltd. facilities and affects all employees whose work impacts the realization
of the quality objectives stated in the organization’s Quality Manual.
RESPONSIBILITIES
The Quality Manager is responsible to develop, implement and maintain the QMS and
control related documents.
The NS Automotive Ltd. Management is responsible to review and approve the quality
system documentation.
Functional area managers are responsible for identifying appropriate needs for
document revision and hand over to Quality Manager for consideration.
All the users of documents are responsible to ensure that they are using the latest
versions of the documents as mentioned in Documentation Master List on form QF-
A1.
DEFINITIONS
QM Quality Manager
QMS Quality Management System
Document Information and its supporting medium
2. QUALITY SYSTEM PROCEDURE
QSP 01
4.2.3
Effective Date
April 20, 2015
Revision Level
0
Page
2 of 3
Control of Documents
Uncontrolled copy if NS Automotive Ltd logo NOT in RED
Issued By: Quality Manager Approved By: CEO
PROCEDURE
All system controlled documents (required by ISO 9001:2008) are identified by a
unique name, number, revision level and effective date to ensure that they are current
and up-to-date.
The Documentation Master List is maintained in form QF-A1 and made available to all
affected and users to ensure that the documents in use are the latest.
All QMS documents are created by the Quality Manager and approved by at least one
member of the Management Team. The creation of new documents and revision of
existing documents follow the same procedure. Any changes/revisions in the
documents are recorded on Document Change Log form QF-A2.
NS Automotive Ltd. Quality Manual, Quality System Procedures, and Work
Instructions have a red color logo of the organisation in the header as a means to
control to preclude the unauthorized use of photocopies. The colored logo does not
apply to system forms. Working copies of forms could be made by photocopying
and/or slight adjustments in the working space without affecting the main contents.
Computer generated documents are backed up once a month and computer software
is protected by anti-virus protection software.
Any changes to product specifications or drawings must be approved by the customer.
However, due to practical limitations and urgency of production priorities, sometimes,
the customer proposes and approves some changes on telephone. The Quality
Manager and the members of Management are authorized to sign and allow any
changes to any document on floor pending formal approval as per established
procedure.
All the users remove the obsolete documents from points of use and handover to the
Quality Manager. The Quality Manager then decides to retain for reference and/or
destroy them by any suitable means.
3. QUALITY SYSTEM PROCEDURE
QSP 01
4.2.3
Effective Date
April 20, 2015
Revision Level
0
Page
3 of 3
Control of Documents
Uncontrolled copy if NS Automotive Ltd logo NOT in RED
Issued By: Quality Manager Approved By: CEO
Obsolete and photocopied controlled documents may be retained for reference and
training purposes only.
QUALITY RECORDS
Documented Master List form QF-A1
Document Change Log form QF-A2
ASSOCIATED DOCUMENTS
ISO 9001:2008, Clause 4.2.3
NS Automotive Ltd. Quality Manual
4. QUALITY SYSTEM PROCEDURE
QSP 02
4.2.4
Effective Date
April 20, 2015
Revision Level
0
Page
1 of 2
Control of records
Uncontrolled copy if NS Automobile Ltd logo NOT in RED
Issued BY: Quality Manager Approved By: CEO
PURPOSE
To ensure that all records documenting the processes of the QMS are controlled in a
manner that ensures their retention and availability.
SCOPE
This procedure applies to all records identified in the QMS documentation as Quality
Records.
RESPONSIBILITIES
Quality Records are controlled by the functional areas generating the records or as
defined in QSP Manual.
All the employees are responsible for handing over current/obsolete records after
completion to Quality Manager for retention/destruction.
NS Automotive Ltd. Management is responsible for providing all necessary support to
Quality Manager in controlling of records.
DEFINITIONS
QMS Quality Management System
QSP Quality System Procedure
Quality Record Document stating results achieved or providing evidence of
activities performed
PROCEDURE
All Quality Records are identified and listed in Records Master List on form QF-A3.
All Quality Records are completed in pen and ink or computer-generated to ensure their
permanency.
5. QUALITY SYSTEM PROCEDURE
QSP 02
4.2.4
Effective Date
April 20, 2015
Revision Level
0
Page
2 of 2
Control of records
Uncontrolled copy if NS Automobile Ltd logo NOT in RED
Issued BY: Quality Manager Approved By: CEO
The integrity of Quality Records is ensured by:
Hard copy records:
Filing in cabinets designed to prevent damage and deterioration and with access
controlled.
Computer-generated records:
Maintaining back-up copies of all the data files (once a month) with access controlled to
prevent unauthorized changes.
Quality Records clearly identify the process or product they are traceable to.
The retention times for Quality Records are mentioned in Records Master List QF-A3.
Obsolete Quality Records, when they are due for disposal, are handed over to Quality
Manager for destruction by shredding or any other suitable means.
Once the data is fed into computer and/or records are maintained electronically, there is
no need to save hard copies. Hard copies may be destroyed, or saved for reference only.
QUALITY RECORDS
Records Master List on form QF-A3
ASSOCIATED DOCUMENTS
ISO 9001:2008, Clause 4.2.4
NS Automotive Ltd. Quality Manual
6. QUALITY SYSTEM PROCEDURE
QSP 03
8.2.2
Effective Date
April 20, 2015
Revision Level
0
Page
1 of 4
Internal Quality Audits
Uncontrolled copy if NS Automotive Ltd logo NOT in RED
Issued BY: Quality Manager Approved By: CEO
PURPOSE
To ensure that internal quality management system audits are planned, scheduled,
and concluded thoroughly and effectively.
SCOPE
This procedure applies to all internal quality management system audit activities.
RESPONSIBILITIES
The Quality Manager is responsible for planning, scheduling, and conducting the
internal audits.
The Quality Manager is responsible for leading the internal audit activities with
assistance from functional area staff where required.
Where functional area personnel are part of the audit team, the Quality Manager is
responsible for training them in internal auditing techniques and ensuring that they are
independent from the area being audited.
All the employees are responsible for cooperating with the audit team for required
activities.
The Management team is responsible for extending full support to the audit team and
provides necessary resources in conducting internal audits.
The Quality Manager is responsible for advising the Management Team of audit
findings and plans for their resolution.
DEFINITIONS
CAR Corrective Action Request
PROCEDURE
The following process map and table give details of the steps in conducting the internal
audits.
7. QUALITY SYSTEM PROCEDURE
QSP 03
8.2.2
Effective Date
April 20, 2015
Revision Level
0
Page
2 of 4
Internal Quality Audits
Uncontrolled copy if NS Automotive Ltd logo NOT in RED
Issued BY: Quality Manager Approved By: CEO
Process Map for Internal Audit
Internal Audit
Team
Requirements
Train Audit
Team
Notify
Functional
Area
Develop Audit
Checklist
Brief Audit
Team
Conduct
Internal Audit
Generate CAR
Produce Audit
Report
Distribute
Audit Report
Audit Follow-
Up
8. QUALITY SYSTEM PROCEDURE
QSP 03
8.2.2
Effective Date
April 20, 2015
Revision Level
0
Page
3 of 4
Internal Quality Audits
Uncontrolled copy if NS Automotive Ltd logo NOT in RED
Issued BY: Quality Manager Approved By: CEO
Steps Action
Internal Audit
Team
Requirements
The Quality Manager determines the makeup of audit team based on:
Impact on the overall quality system
Corrective Action history
Results of previous audits
Customer Feedback
Train Audit
Team
The Quality Manager conducts audit team training:
For training internal auditors
Refresher training only (4 Hours)
For new internal auditors
Full internal audit training (8 Hours)
Notify
Functional
Area
The Quality Manager notifies the functional are to be audited 5 working
days in advance before the scheduled audit. This notice includes:
Date and time of audit
Scope of audit
Audit team membership
Any special resources required
Develop Audit
Checklist
The Quality Manager develops audit checklist based on:
ISO requirements
Customer and regulatory requirements
Previous audit findings
New process implemented
Brief Audit
Team
The Quality Manager holds audit team briefing meeting to review audit
checklist and any potential area of conflict
Conduct
Internal Audit
The Audit team conducts internal audit using checklist
Notes are made during the audit for findings with objective evidence as
well as opportunities for improvement
Generate CAR
Audit team generates CAR
Opportunities for improvement are not subject to CAR process
9. QUALITY SYSTEM PROCEDURE
QSP 03
8.2.2
Effective Date
April 20, 2015
Revision Level
0
Page
4 of 4
Internal Quality Audits
Uncontrolled copy if NS Automotive Ltd logo NOT in RED
Issued BY: Quality Manager Approved By: CEO
Produce Audit
Report
The Quality Manager produces the audit report with assistance from audit
team, including:
Date and time of audit
Scope of audit
Audit team members and lead auditor
CAR raised
Observations for improvement
Distribute
Audit Report
The Quality Manager processes the completes CAR and distributes the
audit report:
One copy for Quality record
One copy for concerned functional are audited
Audit Follow-
up
The Quality Manager follows up with functional areas to ensure that CAR
are promptly acted upon
QUALITY RECORDS
Internal Audit Plan on form QF 15a
Internal Audit Checklist on form QF 15b
Internal Audit Nonconformity Report on form QF 15c
Internal Audit Summary on form QF 15d
ASSOCIATED DOCUMENTS
ISO 9001:2008, Clause 8.2.2
NS Automotive Ltd. Quality Manual
10. QUALITY SYSTEM PROCEDDURE
QSP 04
8.3
Effective Date
April 20, 2015
Revision Level
0
Page
1 of 3
Control of Non-Conforming Product
Uncontrolled copy if NS Automotive LTD. logo NOT in RED
Issued By: Quality Manager Approved By: CEO
PURPOSE
To ensure the integrity of products is maintained by identifying and controlling
nonconforming products.
SCOPE
This procedure applies to all nonconforming products.
RESPONSIBILITIES
Quality Control and production personnel are responsible for identifying
nonconforming products in their inspections.
Purchasing Manager is responsible for identifying nonconforming products/parts
purchased from suppliers.
Quality Manager and NS Automotive Ltd. Management are responsible for final
disposal of nonconforming product.
DEFINITIONS
Nonconforming Product Products that do not meet the specified requirements
Reuse Use the product with customer approval again
Rework Action on a nonconforming product to make it conform to
the requirements
Repair Action on a nonconforming product to make it acceptable
for intended use
Scrap Action on a nonconforming product to preclude its
originally intended use
11. QUALITY SYSTEM PROCEDDURE
QSP 04
8.3
Effective Date
April 20, 2015
Revision Level
0
Page
2 of 3
Control of Non-Conforming Product
Uncontrolled copy if NS Automotive LTD. logo NOT in RED
Issued By: Quality Manager Approved By: CEO
PROCEDURE
Quality Inspector identifies all nonconforming products from in-house production.
A red tag is issued to nonconforming products bearing job #, part #, quantity affected,
date, and suspected nonconformity. A yellow tag may be issued in case of any
ambiguity or when the product requires re-inspection.
Nonconforming products are kept in segregated quarantine area to preclude its
misuse.
Quality Manager logs the details on form QF 10. He then records the details of the
discrepant condition on quality form QF 18. In the event of non-availability of Quality
Manager, any member of the Management takes care of his responsibilities.
Quality Manager, in consultation with a member of Management decides the action to
be taken for disposition of the nonconforming product that may be:
Reuse
Rework
Repair
Scrap
Customer approval may be necessary of it affects them. A new tag is issued to the
product after a disposition decision is taken stating the status of the product. Green
tag may be issued if the product has been approved for use. Corrective action request
may have to be initiated, if necessary.
The activities are recorded on CAR by the Quality Manager who finally closes CAR
after its completion
QUALITY RECORDS
12. QUALITY SYSTEM PROCEDDURE
QSP 04
8.3
Effective Date
April 20, 2015
Revision Level
0
Page
3 of 3
Control of Non-Conforming Product
Uncontrolled copy if NS Automotive LTD. logo NOT in RED
Issued By: Quality Manager Approved By: CEO
Corrective Action Request on form QF 18
NCR Log form QF 10
ASSOCIATED DOCUMENTS
ISO 9001:2008, Clause 8.2.2
NS Automotive Ltd. Quality Manual
13. QUALITY SYSTEM PROCEDURE
QSP 05
8.5
Effective Date
April 20, 2015
Revision Level
0
Page
1 of 4
Corrective and Preventive Actions
Uncontrolled copy if NS Automotive LTD. logo NOT in RED
Issued By: Quality Manager Approved By: CEO
PURPOSE`
To establish a process that promptly identifies the root cause of nonconformities so
that corrective and preventive actions could be taken to prevent recurrence of the
problem.
SCOPE
This procedure applies to all elements of the QMS and the applicable functional
departments.
RESPONSIBILITIES
The Quality Manager is responsible for coordination, recording, and verification of
corrective and preventive actions related to the QMS.
Functional area management is responsible for providing appropriate technical
expertise in the analysis and execution of corrective and preventive actions in a prompt
and efficient manner.
NS Automotive Ltd. Management is responsible for extending full support to the
Quality Manager in ensuring prompt and effective corrective and preventive actions.
DEFINITIONS
QMS Quality Management System
CAR Corrective Action Request
Root Cause The fundamental reason for the nonconformity that, if
corrected, would prevent recurrence
Corrective Action Action to eliminate the cause of a detected nonconformity
Preventive Action Action to eliminate the cause of a potential nonconformity
Nonconformity Non-fulfillment of a requirement
14. QUALITY SYSTEM PROCEDURE
QSP 05
8.5
Effective Date
April 20, 2015
Revision Level
0
Page
2 of 4
Corrective and Preventive Actions
Uncontrolled copy if NS Automotive LTD. logo NOT in RED
Issued By: Quality Manager Approved By: CEO
PROCEDURE
The following process map and table give details of the steps for corrective and
preventive actions.
Identify
Nonconformity
Evaluate
Nonconformity
Analyse for
Root Causes
Determine
Appropriate
Corrective/
Preventive
Action
Monitor
Corrective/
Preventive
Action
Dispose
Nonconformin
g Product
15. QUALITY SYSTEM PROCEDURE
QSP 05
8.5
Effective Date
April 20, 2015
Revision Level
0
Page
3 of 4
Corrective and Preventive Actions
Uncontrolled copy if NS Automotive LTD. logo NOT in RED
Issued By: Quality Manager Approved By: CEO
Steps Action
Identify
Nonconformity
Quality related nonconformities are identified through:
Internal Audits
Customer complaints/concerns
Inspections
Quality Manager logs identified nonconformities on NCR
Log form QF 10
Evaluate
Nonconformity
Non-conformance are evaluated by Quality Manager and
affected functional area personnel for impact on:
Performance
Customer satisfaction
Application requirements
Analyze for Root
Causes
Quality Manager, with inputs from functional area, analyzes
for root causes and enters on CAR form QF 18
Determine
Appropriate
Corrective/Preventive
Action
Functional area management with assistance from Quality
Manager develops corrective and preventive actions
Monitor
Corrective/Preventive
Action
Quality Manager monitors the corrective and preventive
actions
Dispose
Nonconforming
Product
Nonconforming product is disposed in accordance with
QSP 04(8.3)
16. QUALITY SYSTEM PROCEDURE
QSP 05
8.5
Effective Date
April 20, 2015
Revision Level
0
Page
4 of 4
Corrective and Preventive Actions
Uncontrolled copy if NS Automotive LTD. logo NOT in RED
Issued By: Quality Manager Approved By: CEO
QUALITY RECORDS
Corrective Action Request on form QF 18
Preventive Action Report on form QF 19
NCR Log on form QF 10
ASSOCIATED DOCUMENTS
ISO 9000:2005, Clause 3.6
ISO 9001:2008, Clause 8.5
NS Automotive Ltd. Quality Manual
NS Automotive Ltd. Quality System Procedure QSP 04 (8.3)