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MANAGEMENT REVIEW
General
Top management shall review organization's quality management system, at planned
intervals, to ensure its continuing suitability, adequacy and effectiveness. This review
shall include assessing opportunities for improvement and the need for changes to the
quality management system, including the quality policy and quality objectives.
Records form management reviews shall be maintained
Review Input
The input to management review shall include information on
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and correction actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement.
Review output
The output from the management review shall include any decisions and' actions
related to
a) improvement of the effectiveness of the quality management system and its
processes,
b) improvement of product, related to customer requirements, and
c) resource needs
SSALManagement Review Checklist.xlsx
GLASS/PLASTIC BREAKAGE POLICY
To avoid contaminating food with glass or hard plastic materials other than
ordinary glass, porcelain and enamelware (e.g. stainless steel, toughened
plastic) are used wherever possible in areas where food is handled. (This
includes containers, mirrors and gauge covers). All fluorescent tubes are
fitted with diffusers or safety coated light strips.
In the event of a breakage the following procedure is to be followed:
1. Notify a responsible person (e.g. supervisor/manager/owner).
2. Stop food production where contamination of the product is possible until
restarted by a responsible person.
3. Examine all products near the breakage and, if contaminated (or
reasonably likely to have been contaminated) discard the product.
4. Carefully sweep up the glass/other fragments into a dustpan and transfer to
a suitable container (e.g. a cardboard box to be marked ‘Broken Glass –
Take Care’).
5. Wipe all areas (including equipment and floor) in the vicinity of the
breakage with a clean wet cloth.
6. The responsible person (supervisor/manager/owner) must inspect the
whole area carefully and declare it clear before production resumes.
7. Record all breakage incidents in the daily diary, including date, time, place,
and actions taken and which, if any, products were contaminated.
Approved by:
Name: Position:
Signed: Date: / /
CUSTOMER COMPLAINT AND RECALL POLICY
& PROCEDURE
Policy
Silver Spark Apparel Ltd welcomes the information and feedback from customers, which
will enable us to improve the quality of service provided. SSAL recognises the value in
complaints and will accept the complaint openly. The complaint is seen as an
opportunity to review and evaluate the service we deliver. The complaints procedure will
be clear for everyone to understand and will give SSAL customers the confidence that
the complaint will be treated confidentially and with no retribution.
Complaints & Recall procedure
 In the first instance complaints may be made in person, over the telephone or in
writing with photos as determined by the customer.
 Anonymous complaints will not be accepted.
 The Marketing & Merchandising staff member will notify the Quality Department
& Related Departments that a complaint has been made.
 The complaint is recorded as an E-mail soft copy and the action taken.
 All complaints will be treated seriously but will be dealt with at the lowest
operational level within the organisation with the aim to resolving the complaint
promptly.
 Customer affected by the complaint should be fully informed of all facts and given
the status of resolution.
 The staff member receiving will attempt to resolve the issue in the first instance.
If this does not resolve the issue for the customer, the process will proceed to the
GM Operations and then GM Marketing & Merchandising.
 The marketing staff member will advise the complainant of the complaints to the
GM Marketing &Merchandising,and will share the E-mail of the complainant and
advise them to they can speak to the GM Marketing & Merchandising on further
action
 At this stage team will attempt to resolve the issue within 3 days.
 13. The Customer will be informed of the outcome of their complaint and CAP will
be submitted for their confirmation on the complaints.
 If the issue is still not resolved to the Customer’s satisfaction, the Customer can
suggest & advice the change in process and procedure which will be
implemented within 15days and mocks of the same will be submitted to the
customer, copy of the same will be retain with the merchants.
 Effected shipped goods will be recalled, or appropriate support will be provide to
resolve the issue so customer quality standard will not be on stake.
CUSTOMER COMPLAINTS HANDLING FLOWCHART& RECALL PROCESS
Marketing Manager or relevant staff member is notified
Complaint is recorded in the E-mail format soft copy
Customer is reminded of complaints verbally and in writing by merchants
Relevant staff member attempts resolution with customer
Action Taken Yes
Customer Satisfied?
No
Manager investigates complaint; makes judgement about its reasonableness and determines
appropriateness of further action
Complaint reasonable, pass to GM Further action taken
Not reasonable No further action taken
Customer makes a complaint
End the
process
Customer not satisfied
Report & Response sent to CEO for informationCustomer
Action Taken on the problem in process & Recall of the shipment
Customer satisfied
End the
process
INTERNAL AUDIT
The organization shall conduct internal audits at planned intervals to determine whether
the quality management system
a) Conforms to the planned arrangement to the requirements of the International
Standard and to the quality management system requirements established by the
organization, and
b) Is effectively implemented and maintained.
An audit program shall be planned, taking into consideration the status and importance
of the processes and areas to be audited, as well as the results of previous audits. The
audit criteria, scope, frequency and methods shall be defined. Selection of auditors and
conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors
shall not audit their own work.
A documented procedure shall be established to define the responsibilities and
requirements for planning and conducting audits, establishing records and reporting
results.
Records of the audits and their results shall be maintained
The management responsible for the area being audited shall ensure that any
necessary corrections and corrective actions are taken without undue delay to eliminate
detected nonconformity and their causes.
Follow-up activities shall include the verification of the action taken and the reporting of
verification results
 K:FINALinternal auditsaudit procedure.docx
 K:FINALinternal auditsAudit Process Matrix.xlsx
 K:FINALinternal auditsInternal Audit.docx
 K:FINALinternal auditsInternal Audit Process Map.docx
 K:FINALinternal auditsPre Audit Checklist.docx
BROKEN NEEDLE CONTROL PROCEDURES
 When a needle is broken during sewing; every effort must be made to locate ALL
fragments of the broken needle in the garment(s); machinery must be checked,
including such areas as the sewing machine throat plate, feed dogs and bobbin
case. Use of magnet to locate / search all fragments of the broken needle is
recommended.
 Any breakage must be recorded in the broken needle log immediately and the
broken fragments attached (kept) in the Log; entries into the
 Log must be completed in full. This log should be kept in the plant supervisor’s
office. The QA or Product Safety Specialist will review this log during their site
visits.
 If all fragments cannot be found, then the bundle of garments on which the
operator is sewing, and any bundles in close proximity must be taken to a
separate bin in the plant for further examination. A metal detection unit can be
used to help locate the needle fragments.
 Unauthorized access to the bin must be forbidden. The bin may be painted in
RED for identification.
 Under management supervision, all garments in the bin should be re-passed
again through the needle detector.
 Garments not rejected again may be accepted.
 Garments rejected again must be searched for metal contamination. If nothing is
found, pass the garment bundles once more through the needle detector. If no
contamination is detected, the garment bundle may be returned to the sewing
floor.
 All needles must be accounted for at the end of each shift by tallying used
quantity against issued quantity.
K:FINALmaintainanceneedles, sharp tools
CORRECTIVE MAINTAINANCE (SOP)
8D steps
The 8D (Eight discipline) resolution approach to root-cause corrective action includes
these steps:
1. Detection of problem
The operator working on the machine may detect the problem by facing
unusual situation while performing his/her operation.
2. Call the maintenance team
The operator will inform the team leader/supervisor/line manager, whoever
can be approached fastest and tell him/her the problem and ask him to call
the maintenance team. Then, the maintenance team will be informed about
the problem, the machine and the location of the machine.
3. Team approach
The maintenance team will approach with the tools as per requirement of the
particular machine as described to him/her while informing.
4. Describe the Problem
The operator working on the machine will describe the problem occurring in
the operation. If he gets to know the issue of the machine, he will describe it
to the maintenance team.
5. Root Cause Verification
The maintenance team will check the machine and find the actual problem
occurring.
6. Implement Corrective Action
The maintenance team will take actions to the rectification of the machine, if
on-site corrective action is possible. If there is major problem, the machine
will either be replaced or taken to the maintenance department for resolving
the issue.
7. Verify Corrective Action
After the problem is resolved, the maintenance team will verify the working of
the machine.
8. Prevent Recurrence
The maintenance team will also make sure that the problem does not occur
again. He may change certain parts or lubricate certain parts as per
requirement.
PREVENTIVE MAINTAINANCE (Planning)
Preventive maintenance is planned as per the machines.
K:FINALmaintainancePREVENTIVE MAINTAINANCE (Planning).docx
K:FINALmaintainancepreventive maintainance (soft copy).xlsx
CONTROL OF NONCONFORMING PRODUCT
The organization shall ensure that product which does not conform to product
requirements is identified and controlled to prevent its unintended use or delivery. A
documented procedure shall be established to define the controls and related
responsibilities and authorities for dealing with nonconforming product.
The organization shall deal with nonconforming product by one or more of the following
ways;
a) By taking action to eliminate the detected nonconformity;
b) By authorizing its use, release or acceptance under concession by a relevant
authority and, where applicable, by the customer;
c) By taking action to preclude its original intended use or application;
d) By taking action appropriate to the effects, or potential effects, of the
nonconformity when nonconforming product is detected after delivery or use has
started.
Control of reworked product
Rework instructions including re-inspection requirements shall be accessible & used by
appropriate personnel
Customer Information
Notify customers promptly if nonconforming product has been shipped
Customer Waiver
When your product or manufacturing process is different from that currently approved,
then you shall obtain a customer concession or deviation permit prior to further
processing.
 Keep a record of expiry date & quantity authorized by each concession or permit
 Revert back to compliance with the original or superseding specification, when
the customer authorization expires
 Properly identify each container of material shipped on an authorization. This
also applies to purchased product
 Approve any requests from your suppliers before submission to your customers
Key Explanation Points and Tips:
 Nonconforming product is defined as product that does not conform to customer
requirements; applicable regulatory requirements or your own organization
requirements. The definition may also apply to nonconforming processes and
services. Nonconformities may relate to suppliers and outsourced work; your own
organizational activities or product shipped to customers. Also review specific
nonconforming product requirements at OEM customer or IATF websites.
 The controls under clause focus on eliminating the nonconformity, but not the
cause. Your documented procedure for nonconforming product must include
controls and responsibilities to – identify; contain it, (i.e. prevent further
processing or use); keep records of the nature and other details of the
nonconformity; notify appropriate personnel and customers, where appropriate;
evaluate what disposition action needs to be taken; carry out timely disposition;
determine policies for release for further processing or shipment to the customer;
obtain customer concessions and deviation permits; rework and re-verification;
waivers and approvals of supplier materials, etc.
 Product or material found with no identification or its quality status is not known,
must be treated as nonconforming product and controlled by the above
procedure.
 If you find that nonconforming product has been shipped, without a customer
concession, notify the customer immediately and use your procedure, to
effectively contain and resolve the situation to your customer’s satisfaction.
Where required, use the customer prescribed form for recording and controlling
nonconforming product.
 An authorization refers to written permission (number or code) to ship or
manufacture nonconforming product. The permission is usually very specific
about product, quantity and time frame during which nonconforming product can
be shipped. The authorization number or code must identify each container
shipped under the authorization.
 A concession authorization allows you to ship nonconforming product, under
controlled conditions. A deviation authorization allows you to manufacture
product different from the original specification, under controlled conditions.
 Ensure that all rework has evidence of re-inspection after the rework has been
done and that the personnel doing the rework and re-inspection have been
trained (keep records of training) and are using the rework instructions.
 All customer-oriented processes must show the interaction with your process for
nonconforming product.
 Performance indicators to measure the effectiveness of control of nonconforming
product may include – reduction in cycle time to evaluate and dispose of
nonconforming product; reduced errors in preventing unintended use or delivery;
improved alternate use of nonconforming product and cost recovery; etc.
K:FINALnon conforming productsNonconformance control Procedure.doc
K:FINALnon conforming productsNonconforming Product.doc
TRAINING MODULE AND EXERCISE FORMAT
K:FINALtraining moduleExercise Format.docx
K:FINALtraining moduleTraining Modue.docx
CONTROL OF DOCUMENTS
Documents required by the quality management system shall be controlled. Records
are a special type of document and shall be controlled according to the requirements
given.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are
identified,
d) to ensure that relevant versions of applicable documents are available at points
of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin determined by the organization to be
necessary for the planning and operation of the quality management system are
identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable
identification to them if they are retained for any purpose.
CONTROL OF RECORDS
Records established to provide evidence of conformity to requirements and of the
effective operation of quality management system shall be controlled.
The organization shall establish a documented procedure to define the controls needed
for the identification, storage, protection, retrieval, retention and disposition of records.
Records shall remain legible, readily identifiable and retrievable.
CUSTOMER FOCUS
Top management shall ensure that customer requirements are determined and
are met with the aim of enhancing customer satisfaction.
COMPETENCE, TRAINING AND AWARENESS
The organization shall
a) determine the necessary competence for personnel performing work affecting
conformity to product requirements,
b) where applicable, provide training or take other actions to achieve the
necessary competence,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their
activities and how they contribute to the achievement of the quality objectives,
and
e) maintain appropriate records of education, training, skills and experience
PRODUCT REALIZATION
Planning of Product Realization
The organization shall plan and develop the processes needed for product realization.
Planning of product realization shall be consistent with the requirement of the other
processes of the quality management system .
In planning product realization, the organization shall determine the following, as
appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes, documents, and provide resources specific to
the product;
c) required verification, validation, monitoring, measurement, inspection and test
activities specific to the product and criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting
product meet
requirements
The output of this planning shall be in a form suitable for the organization's method of
operations
NOTE 1 A document specifying the processes of the quality management system,
(including the product realization processes) and the resources to be
applied to a specific product project or contract can be referred to as a
quality plan
NOTE 2 The organization may also apply the requirements given to the
development of product realization processes
SUPPLIER PERFORMANCE CONTROL
 A Collaborative communication is required for continuous supplier performance
improvement
 Enhance supplier knowledge (of manufacturer needs)
 Build supplier affective commitment (toward the manufacturer).
 Establish capability control to enhance the positive effects of both supplier
knowledge and supplier affective commitment on continuous supplier
performance improvement, whereas process control undermines the effect of
supplier knowledge on the outcome.
 Emphasize capability control
 Emphasize process control to foster continuous supplier performance
improvement.

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qms

  • 1. MANAGEMENT REVIEW General Top management shall review organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records form management reviews shall be maintained Review Input The input to management review shall include information on a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and correction actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality management system, and g) recommendations for improvement. Review output The output from the management review shall include any decisions and' actions related to a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product, related to customer requirements, and
  • 2. c) resource needs SSALManagement Review Checklist.xlsx
  • 3. GLASS/PLASTIC BREAKAGE POLICY To avoid contaminating food with glass or hard plastic materials other than ordinary glass, porcelain and enamelware (e.g. stainless steel, toughened plastic) are used wherever possible in areas where food is handled. (This includes containers, mirrors and gauge covers). All fluorescent tubes are fitted with diffusers or safety coated light strips. In the event of a breakage the following procedure is to be followed: 1. Notify a responsible person (e.g. supervisor/manager/owner). 2. Stop food production where contamination of the product is possible until restarted by a responsible person. 3. Examine all products near the breakage and, if contaminated (or reasonably likely to have been contaminated) discard the product. 4. Carefully sweep up the glass/other fragments into a dustpan and transfer to a suitable container (e.g. a cardboard box to be marked ‘Broken Glass – Take Care’). 5. Wipe all areas (including equipment and floor) in the vicinity of the breakage with a clean wet cloth. 6. The responsible person (supervisor/manager/owner) must inspect the whole area carefully and declare it clear before production resumes. 7. Record all breakage incidents in the daily diary, including date, time, place, and actions taken and which, if any, products were contaminated. Approved by: Name: Position: Signed: Date: / /
  • 4. CUSTOMER COMPLAINT AND RECALL POLICY & PROCEDURE Policy Silver Spark Apparel Ltd welcomes the information and feedback from customers, which will enable us to improve the quality of service provided. SSAL recognises the value in complaints and will accept the complaint openly. The complaint is seen as an opportunity to review and evaluate the service we deliver. The complaints procedure will be clear for everyone to understand and will give SSAL customers the confidence that the complaint will be treated confidentially and with no retribution. Complaints & Recall procedure  In the first instance complaints may be made in person, over the telephone or in writing with photos as determined by the customer.  Anonymous complaints will not be accepted.  The Marketing & Merchandising staff member will notify the Quality Department & Related Departments that a complaint has been made.  The complaint is recorded as an E-mail soft copy and the action taken.  All complaints will be treated seriously but will be dealt with at the lowest operational level within the organisation with the aim to resolving the complaint promptly.  Customer affected by the complaint should be fully informed of all facts and given the status of resolution.  The staff member receiving will attempt to resolve the issue in the first instance. If this does not resolve the issue for the customer, the process will proceed to the GM Operations and then GM Marketing & Merchandising.  The marketing staff member will advise the complainant of the complaints to the GM Marketing &Merchandising,and will share the E-mail of the complainant and advise them to they can speak to the GM Marketing & Merchandising on further action
  • 5.  At this stage team will attempt to resolve the issue within 3 days.  13. The Customer will be informed of the outcome of their complaint and CAP will be submitted for their confirmation on the complaints.  If the issue is still not resolved to the Customer’s satisfaction, the Customer can suggest & advice the change in process and procedure which will be implemented within 15days and mocks of the same will be submitted to the customer, copy of the same will be retain with the merchants.  Effected shipped goods will be recalled, or appropriate support will be provide to resolve the issue so customer quality standard will not be on stake. CUSTOMER COMPLAINTS HANDLING FLOWCHART& RECALL PROCESS Marketing Manager or relevant staff member is notified Complaint is recorded in the E-mail format soft copy Customer is reminded of complaints verbally and in writing by merchants Relevant staff member attempts resolution with customer Action Taken Yes Customer Satisfied? No Manager investigates complaint; makes judgement about its reasonableness and determines appropriateness of further action Complaint reasonable, pass to GM Further action taken Not reasonable No further action taken Customer makes a complaint End the process
  • 6. Customer not satisfied Report & Response sent to CEO for informationCustomer Action Taken on the problem in process & Recall of the shipment Customer satisfied End the process
  • 7. INTERNAL AUDIT The organization shall conduct internal audits at planned intervals to determine whether the quality management system a) Conforms to the planned arrangement to the requirements of the International Standard and to the quality management system requirements established by the organization, and b) Is effectively implemented and maintained. An audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work. A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. Records of the audits and their results shall be maintained The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformity and their causes. Follow-up activities shall include the verification of the action taken and the reporting of verification results  K:FINALinternal auditsaudit procedure.docx  K:FINALinternal auditsAudit Process Matrix.xlsx  K:FINALinternal auditsInternal Audit.docx  K:FINALinternal auditsInternal Audit Process Map.docx
  • 8.  K:FINALinternal auditsPre Audit Checklist.docx
  • 9. BROKEN NEEDLE CONTROL PROCEDURES  When a needle is broken during sewing; every effort must be made to locate ALL fragments of the broken needle in the garment(s); machinery must be checked, including such areas as the sewing machine throat plate, feed dogs and bobbin case. Use of magnet to locate / search all fragments of the broken needle is recommended.  Any breakage must be recorded in the broken needle log immediately and the broken fragments attached (kept) in the Log; entries into the  Log must be completed in full. This log should be kept in the plant supervisor’s office. The QA or Product Safety Specialist will review this log during their site visits.  If all fragments cannot be found, then the bundle of garments on which the operator is sewing, and any bundles in close proximity must be taken to a separate bin in the plant for further examination. A metal detection unit can be used to help locate the needle fragments.  Unauthorized access to the bin must be forbidden. The bin may be painted in RED for identification.  Under management supervision, all garments in the bin should be re-passed again through the needle detector.  Garments not rejected again may be accepted.
  • 10.  Garments rejected again must be searched for metal contamination. If nothing is found, pass the garment bundles once more through the needle detector. If no contamination is detected, the garment bundle may be returned to the sewing floor.  All needles must be accounted for at the end of each shift by tallying used quantity against issued quantity. K:FINALmaintainanceneedles, sharp tools
  • 11. CORRECTIVE MAINTAINANCE (SOP) 8D steps The 8D (Eight discipline) resolution approach to root-cause corrective action includes these steps: 1. Detection of problem The operator working on the machine may detect the problem by facing unusual situation while performing his/her operation. 2. Call the maintenance team The operator will inform the team leader/supervisor/line manager, whoever can be approached fastest and tell him/her the problem and ask him to call the maintenance team. Then, the maintenance team will be informed about the problem, the machine and the location of the machine. 3. Team approach The maintenance team will approach with the tools as per requirement of the particular machine as described to him/her while informing. 4. Describe the Problem The operator working on the machine will describe the problem occurring in the operation. If he gets to know the issue of the machine, he will describe it to the maintenance team.
  • 12. 5. Root Cause Verification The maintenance team will check the machine and find the actual problem occurring. 6. Implement Corrective Action The maintenance team will take actions to the rectification of the machine, if on-site corrective action is possible. If there is major problem, the machine will either be replaced or taken to the maintenance department for resolving the issue. 7. Verify Corrective Action After the problem is resolved, the maintenance team will verify the working of the machine. 8. Prevent Recurrence The maintenance team will also make sure that the problem does not occur again. He may change certain parts or lubricate certain parts as per requirement.
  • 13. PREVENTIVE MAINTAINANCE (Planning) Preventive maintenance is planned as per the machines. K:FINALmaintainancePREVENTIVE MAINTAINANCE (Planning).docx K:FINALmaintainancepreventive maintainance (soft copy).xlsx
  • 14. CONTROL OF NONCONFORMING PRODUCT The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product. The organization shall deal with nonconforming product by one or more of the following ways; a) By taking action to eliminate the detected nonconformity; b) By authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; c) By taking action to preclude its original intended use or application; d) By taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started. Control of reworked product Rework instructions including re-inspection requirements shall be accessible & used by appropriate personnel Customer Information Notify customers promptly if nonconforming product has been shipped
  • 15. Customer Waiver When your product or manufacturing process is different from that currently approved, then you shall obtain a customer concession or deviation permit prior to further processing.  Keep a record of expiry date & quantity authorized by each concession or permit  Revert back to compliance with the original or superseding specification, when the customer authorization expires  Properly identify each container of material shipped on an authorization. This also applies to purchased product  Approve any requests from your suppliers before submission to your customers Key Explanation Points and Tips:  Nonconforming product is defined as product that does not conform to customer requirements; applicable regulatory requirements or your own organization requirements. The definition may also apply to nonconforming processes and services. Nonconformities may relate to suppliers and outsourced work; your own organizational activities or product shipped to customers. Also review specific nonconforming product requirements at OEM customer or IATF websites.  The controls under clause focus on eliminating the nonconformity, but not the cause. Your documented procedure for nonconforming product must include controls and responsibilities to – identify; contain it, (i.e. prevent further processing or use); keep records of the nature and other details of the nonconformity; notify appropriate personnel and customers, where appropriate; evaluate what disposition action needs to be taken; carry out timely disposition; determine policies for release for further processing or shipment to the customer; obtain customer concessions and deviation permits; rework and re-verification; waivers and approvals of supplier materials, etc.
  • 16.  Product or material found with no identification or its quality status is not known, must be treated as nonconforming product and controlled by the above procedure.  If you find that nonconforming product has been shipped, without a customer concession, notify the customer immediately and use your procedure, to effectively contain and resolve the situation to your customer’s satisfaction. Where required, use the customer prescribed form for recording and controlling nonconforming product.  An authorization refers to written permission (number or code) to ship or manufacture nonconforming product. The permission is usually very specific about product, quantity and time frame during which nonconforming product can be shipped. The authorization number or code must identify each container shipped under the authorization.  A concession authorization allows you to ship nonconforming product, under controlled conditions. A deviation authorization allows you to manufacture product different from the original specification, under controlled conditions.  Ensure that all rework has evidence of re-inspection after the rework has been done and that the personnel doing the rework and re-inspection have been trained (keep records of training) and are using the rework instructions.  All customer-oriented processes must show the interaction with your process for nonconforming product.  Performance indicators to measure the effectiveness of control of nonconforming product may include – reduction in cycle time to evaluate and dispose of nonconforming product; reduced errors in preventing unintended use or delivery; improved alternate use of nonconforming product and cost recovery; etc. K:FINALnon conforming productsNonconformance control Procedure.doc K:FINALnon conforming productsNonconforming Product.doc
  • 17. TRAINING MODULE AND EXERCISE FORMAT K:FINALtraining moduleExercise Format.docx K:FINALtraining moduleTraining Modue.docx
  • 18. CONTROL OF DOCUMENTS Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given. A documented procedure shall be established to define the controls needed a) to approve documents for adequacy prior to issue, b) to review and update as necessary and re-approve documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use, e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
  • 19. CONTROL OF RECORDS Records established to provide evidence of conformity to requirements and of the effective operation of quality management system shall be controlled. The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records. Records shall remain legible, readily identifiable and retrievable.
  • 20. CUSTOMER FOCUS Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction.
  • 21. COMPETENCE, TRAINING AND AWARENESS The organization shall a) determine the necessary competence for personnel performing work affecting conformity to product requirements, b) where applicable, provide training or take other actions to achieve the necessary competence, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) maintain appropriate records of education, training, skills and experience
  • 22. PRODUCT REALIZATION Planning of Product Realization The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirement of the other processes of the quality management system . In planning product realization, the organization shall determine the following, as appropriate: a) quality objectives and requirements for the product; b) the need to establish processes, documents, and provide resources specific to the product; c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and criteria for product acceptance; d) records needed to provide evidence that the realization processes and resulting product meet requirements The output of this planning shall be in a form suitable for the organization's method of operations NOTE 1 A document specifying the processes of the quality management system, (including the product realization processes) and the resources to be applied to a specific product project or contract can be referred to as a quality plan NOTE 2 The organization may also apply the requirements given to the development of product realization processes
  • 23. SUPPLIER PERFORMANCE CONTROL  A Collaborative communication is required for continuous supplier performance improvement  Enhance supplier knowledge (of manufacturer needs)  Build supplier affective commitment (toward the manufacturer).  Establish capability control to enhance the positive effects of both supplier knowledge and supplier affective commitment on continuous supplier performance improvement, whereas process control undermines the effect of supplier knowledge on the outcome.  Emphasize capability control  Emphasize process control to foster continuous supplier performance improvement.