1. SCOPE

The scope of this procedure is applicable to all customer orders and customer related processes.

2. PURPOSE

To define the methods for documenting and resolving customer complaints/concerns and to ensure that customer complaint is handled effectively.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,
3.2Customer Related Processes.
3.3 Procedure for Correction and Corrective Action.
3.3 Procedure for Control of Documented Information
3.4 Procedure for Manufacturing.
3.3 Procedure for QA
3.4 Procedure for Monitoring and Measurement of customer satisfaction.

4. TERMS & DEFINITIONS
4.1 Customer – is defined as the organization or its employee(s), regardless of the person’s title, who issued the order to our Company. This is also the organization that makes payments to our Company for services/products delivered.

5. RESPONSIBILITY AND AUTHORITY

The sales manager is responsible for recording, acting upon, and communicating to the customer on all complaints received. PROD, QA, PD, and all other concerned Depts are responsible to assist the sales Dept when required.

6. DETAILS OF PROCEDURE

6.1 General

6.1.1 The Sales and/or Quality Assurance Department personnel shall be responsible for documenting, tracking, and resolving Customer concerns/complaints or corrective action requests.
6.1.2 When a concern/complaint or corrective action is verbally or in writing communicated by the Customer, the Sales/Quality Assurance person records and/or attaches the submitted information to the Customer Complaint/Concern Record form and makes an entry into the Customer Complaint/Concern Log.
6.1.3 Each Customer concern/complaint is assigned a unique number (i.e. Year-XX or 06-01, 06-02, etc.)
6.1.4 When a Customer Complaint/Concern is received, the originator who prepared the Customer Complaint/Concern Record form shall distribute copies of it to the Production, Sales, Quality Assurance, and others as deemed necessary to resolve the issue. The original is retained in the Customer Complaint/Concern Logbook.

6.2 Customer Feedback/ Rating :

6.2.1 Customer response obtained from customers is reviewed to find out opportunities for improvements. These shall be obtained once a year. Quality rating feedback is also received from customers.
6.2.2 Level of customer satisfaction can be judged through the feedback/rating obtained, also reviewing customer’s perception captured during the visit by/to customers.
6.2.3 Wherever necessary, corrective/preventive actions shall be initiated to improve customer rating.

6.3  Addressing Concerns/Complaints

6.3.1 Sales /Quality Assurance and Other Functional Departments are responsible for addressing concerns/complaints. The goal is to have all issues addressed and closed by Sales/Quality Assurance personnel in less than 7 working days.
6.3.2 When Sales /Quality Assurance and other Functional Department personnel cannot resolve the concern/complaint within 7 working days, the issue is elevated to the Technical Director for resolution. This is accomplished via a written memo or email.
6.3.3 When deemed necessary by the Sales or Quality Assurance, a Corrective Action Request (CAR) may be issued to document, investigate, identify the root cause and obtain corrective action per procedure for Correction and Corrective Action.
6.3.4 Sales/Quality Assurance and Support Functions shall ensure Customer’s concerns/complaints are closed.
6.3.5 Summary of customer complaints shall be submitted for Management Review Meeting.
6.3.6 Sales /Quality assurance dept studies the nature of the complaint and takes action to redress the customer’s grievance, in consultation with Productions and other Depts where necessary.
6.3.7  Where necessary, a visit is made by the concerned Dept. to the customer’s premises to understand, analyze and decide the course of action.
6.3.8 In-house inspection test records at various stages are studied by QA if necessary to analyze/understand the complaint.
6.3.9 If the correction proposed involves a change of process/specifications, the customer’s concurrence is sought. If necessary a sample lot as per the revised process is made and tried at the customer’s end before the conclusion.
6.3.10 Products rejected and returned by the customer are identified and recorded and may be sorted out through one of the following methods
– Reworked, retested, and returned.
– Replacements are given.
6.3.11 After the complaint has been closed the customer is informed of the action taken.
6.3.12 When it is found that the complaint is incorrect, the customer is informed in a personal meeting or correspondence, explaining the correct situation.
6.3.13  Even if it is concluded that the complaint is not due to material/manufacturing defect covered under warranty, replacement may be given by sales at its discretion to maintain/improve goodwill.

6.4  Delivery Performance Monitoring

6.4.1 Summary of delivery performance shall be prepared monthly.
6.4.2 In case of delivery performance is below target reasons shall be identified.
6.4.3 Necessary actions for improving delivery performance shall be identified & follow up shall be done.

6.5 Quality Records

6.5.1 Customer concerns/complaints are considered quality records and shall be retained as per the Procedure for Control of Documented Information

6.6  Quality Assurance

6.6.1 Quality Assurance shall ensure this process is audited as scheduled per Procedure for Internal QMS Audit.

7. RETAINED DOCUMENTED INFORMATION

7.1 Summary of customer complaints ( QMS F 024)
7.2 Summary of delivery performance(QMS F 021)
7.3 Customer rating (QMS F 020)
7.4 Customer satisfaction survey (QMS F 026)
7.5 Customer complaints Record (QMS F 025)
7.6 Corrective Action Report(QMS F 023)
7.7 Customer Complaints Log( QMS F 022)

1. SCOPE

This procedure defines the actions and responsibilities of the maintenance manager in maintaining the Machinery & equipment in good working condition. This covers activities from receiving maintenance request up to a turnover of machine & equipment to the concerned unit

2. PURPOSE

To ensure sustenance of machine and equipment capability by periodic preventive maintenance.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,
3.2 Procedure for Manufacturing.
3.3 Work instructions for Preventive Maintenance
3.4 Procedure for Equipment Calibration and Maintenance

4. TERMS & DEFINITIONS
4.1 Preventive Maintenance –Preventive maintenance is maintenance that is regularly performed on a piece of Machinery or equipment to lessen the likelihood of it failing. It is performed while the equipment is still working so that it does not break down unexpectedly.

4.2 Breakdown Maintenace–Breakdown maintenance is maintenance performed on a piece of machinery or equipment that has broken down and is unusable. It is based on a breakdown maintenance trigger. It may be either planned or unplanned.

5. RESPONSIBILITY AND AUTHORITY

The maintenance manager is responsible to plan and carry out periodic preventive maintenance and ensure continued process capability. Also responsible for oil spillage, vibration, emission, and noise level.

6. DETAILS OF PROCEDURE

6.1 Based on conditions of use and experience, periodic maintenance work on machines is planned by maintenance dept. it is identified in relevant preventive maintenance work
instruction.
6.2 Maintenance is done based on the maintenance schedule.
6.3 Work instruction for daily maintenance like checking, filling of oil/grease of production machine is given to PROD for execution.
6.4 Scheduled and other maintenance plans are executed by maintenance dept personnel
and records are maintained in the respective machine file.
6.5 When breakdown occurs necessary repair/rectification work is carried out and records are maintained. Maintenance manager reviews the record and classifies the machine break down as either ‘Minor’ or ‘Major’ and maintains records of downtime hours, spares consumed and the approximate cost of spares/repair. Root cause analysis and corrective/preventive action records shall be maintained for all the major machine breakdowns, The records shall include details of breakdown experienced/attended, the effectiveness of action taken and preventive action if any.
6.6 If the root cause of machine break-down is due to normal wear and tear of the repaired/rectified parts then same shall be considered as ‘Minor’, but in case ‘Minor’ is repeated then it shall be considered as ‘Major’.
6.7 Machine Details like make, capacity, location and spares parts of the machine shall be maintained in the respective machine file.
6.8 Maintenance Manager plans to procure and stock essential spare parts to ensure maintenance with minimal downtime. List of critical spares and existing stock is maintained.
6.9 All the spares/accessories with shelf life shall be identified with the label containing details like Name, the location of use/application and date of receipt etc.
6.10 Breakdown hours reported in the machine breakdown report shall be analyzed for all production machines on a regular basis.
6.11 Maintenance of production draw dies, rolls & edge rollers are verified to ensure proper working condition. Records are maintained in respectively.
6.12 Maintenance department should check and maintain the record for Oil spillage, vibration, emission and noise in work area

7. RETAINED DOCUMENTED INFORMATION

7.1 Preventive Maintenance Schedule – (MAINT/F/01)
7.2 Maintenance History Card – (MAINT/F/02)
7.3 Corrective/Preventive action-for Major Breakdown – (MAINT/F/03)
7.4 Critical Spare Parts – (MAINT/F/04)
7.5 Maintenance Work Order – (MAINT/F/05)
7.6  Breakdown Analysis – (MAINT/F/05)
7.7 Oil spillage/Vibration/emission/Noise level – (MAINT/F/05)
7.8 Non-conformance Report (QC / QF/01)

1. SCOPE

The scope includes all projects including that of suppliers and subcontractors, that will ensure the compliance of all work in respect to the contractor-equipment, materials, workmanship, finish, functional performance, and identification.

2. PURPOSE

This procedure has been established for all projects to provide the necessary supervision, control phases, and tests of all items of work, including that of suppliers and subcontractors, that will ensure the compliance of all work with the applicable specifications and drawings in respect with the contractor-equipment, materials, workmanship, finish functional performance, and identification.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,
3.2 Procedure for Equipment Calibration and Maintenance

4. TERMS & DEFINITIONS
4.1 Quality Control Checks – Periodic confirmation of the reliability of equipment, instrumentation, and/or reagents.
4.2 Reference Standard – Material or substance one or more of whose property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials.
4.3 Traceability – The linking of measurement standards and/or measuring instruments to relevant national or international standards through an unbroken chain of comparisons.
4.4 Performance Verification – The confirmation of the reliability of a previously validated method(s) or equipment.

5. RESPONSIBILITY AND AUTHORITY

The QC Manager is responsible for implementation and management of this procedure.

6. DETAILS OF PROCEDURE

6.1 Control of On-site

The Quality Control Manager will perform sufficient control phases and tests of all work, including that of subcontractors to ensure conformance to applicable specifications and drawings with respect to the materials, workmanship, finish functional performance and identification. The Quality Control will perform three phases of control for all definable features of work

6.1.1  Preparatory Meetings

Preparatory Meetings shall be performed prior to the beginning of any major definable feature of work. A meeting shall be held for all crew performing such feature of work or when members of the crew change. Preparatory Meetings shall be conducted by the Quality Control Manager and/or his designee after a complete review of all applicable specifications, shop drawings, and related submittals. A Preparatory Meeting Agenda shall be prepared for each definable feature of work and distributed at the meetings. At the Preparatory Meeting, the Site Supervisor (involved in this phase of construction) shall coordinate with Quality Assurance, Quality Control, and Safety personnel and shall introduce their plan for accomplishing the work. The following items shall be discussed at such meetings:

• Review of the applicable specifications.
• Review of shop drawings.
• Review of related submittals and a check that all related submittals, shop drawings and materials have been submitted and approved.
• Review of the detailed sequence of the execution of work.
• Discuss required testing and its frequency.
• Review provisions to ensure controlled inspection and testing.
• Examination of the work area to ensure that all required preliminary work has been completed and is in compliance with the contract.
• Examination of the related material, review of the Receiving Inspection Reports and verification that the items received are in compliance with the contract and are properly stored.
• Review of the Activity Hazard Analysis Report to ensure that all safety precautions are met and the required safety equipment has been purchased and is available.
• Review and document the workmanship expected for the definable feature of work.
• Meeting Minutes shall be recorded and distributed within 48 hours of the conclusion of the meeting.

6.1.2  Initial Inspections

Initial Inspections shall be conducted on the day of the start of any definable feature of work and must be repeated at any time new workmen or new crews are assigned to the work or if the required standard of work is not being met. The same person who attended the Preparatory Meeting shall also attend the Initial Inspection. This should include the Site Supervisor, Safety Personnel, and Quality Control Personnel. The following shall be accomplished during such meetings;

• Review the minutes of the Preparatory Meeting and verify that the work complies with the design documents; i.e., submittals, specifications, shop drawings.
• Resolve all differences.
• Verify adequacy of inspection and testing.
• Establish a level of workmanship and verify that it meets the requirements.
• Check Safety and review the Activity Hazard Analysis Reports.
• Provide documentation of the previous inspection of the work area.
• Re-examine the work area for compliance.
• Meeting minutes shall be recorded and distributed within 48 hours of the conclusion of the meeting.

6.1.3  Follow-Up Phase Inspections

Follow-Up Inspections shall be performed daily to ensure that the control established during the Preparatory Meeting and Initial Inspection continues to provide a product that conforms to the contractual requirements.

• All activities shall be inspected by Quality Control in accordance with Quality Control Procedures. Forms for various activities shall be filed and attached to the Contractor’s Quality Control Report.
• Installation and testing activities which do not comply with the requirements shall be documented on a Non-Conformance Report (NCR),
• Modifications, repairs and/or replacement of materials and/or parts performed subsequent to Final Inspection shall require re-inspection and/or retest to verify acceptability. Inspection and testing documents shall be filed and maintained. Reports and Records shall be available for review by the client.

6.2 Receiving & Warehousing

Inspection of Raw materials received will be performed by the Quality Control Manager or his designate. A visual inspection will be made for the following:

• Identification
• Damage
• Completeness
• Evidence of compliance with approvals
• Proper Documentation

6.3 Off-site Control

Facilities of offsite fabricators and suppliers will be surveyed as required to assure that all requirements of the contract drawings and specifications are met and maintained and to assure delivery of quality products. The results of each survey will be recorded. The fabricator or supplier will be notified of any deficiencies and will be required to submit a report of corrective actions taken.

6.4 Documentation

The Quality Control Manager will maintain current records of all control activities and tests. These will include factual evidence that the required control phases and tests have been performed, including the number and results; the nature of defects causes for rejection, etc.; proposed remedial action; corrective actions are taken; contractor’s records will cover both conforming and defective features and will include a statement that all supplies and materials incorporated in the work are in full compliance with the terms of the contract.

6.5 Workmanship Inspection

Items that will be embedded in the concrete placements or areas which will be covered up by the following operation will be inspected by the Quality Control Manager or his designate. The Quality Control Manager shall verify by signature that all items installed are in accordance with the contract drawings and specifications prior to the placement of concrete or covering. Any corrective action required will be recorded.

6.6 Daily Quality Control Report (DQCR)

A Daily Quality Control Report which includes the following shall be submitted to the QC Manager.

• QC activities performed each day
• Resources on site
• Activities that took place for each DFW
• Materials received on site and the result of receipt inspections
• Submittal activity summary
• Off-site surveillance activities
• Safety activities and observations
• Preparatory meeting details(if any)
• Initial phase meeting details(if any)

The report is a precise, factual, legible, and objective document. Copies of the supporting documentation, such as checklists, test reports, and meeting minutes shall also be attached. DQCRs are prepared, signed, and dated by the QC representative on site.

6.7 Quality Control Testing and Verifications

6.7.1 Testing

A list of tests required, to verify that control measures are adequate, shall be delineated in the specifications and/or determined upon the completion of the design. The list shall include the test name, specification paragraph, feature of work to be tested, the test frequency, and the organization that will perform the test. The QC representative on-site shall witness the test with the appropriate organization and/or individual qualified to perform the designated test(s).

These entire tests will be performed under the supervision of the Quality Control Manager or his designate and the result will be submitted to the client for review and further action. Test plans, forms, and checklists shall also be prepared and submitted.

1. The Contractor Quality Control Manager and/or staff member shall review the testing requirements to ensure that the planned test is in accordance with the design documents: i.e., plans, specifications, shop drawings, and/or other documents.

2. Instruments used for testing shall be calibrated in accordance with established calibration procedures. Specialists experienced in such work shall perform the calibration.

3. Technicians performing tests shall provide copies of calibration certificates and their field notes and reports to the Contractor Quality Control Manager.
4. Quality Control shall witness all required tests delineated in the design documents (blueprints, specifications, shop drawings, etc.).

5. The client shall be notified in advance of all scheduled tests.

Test reports, when completed, shall be attached to the  Quality Control Report

6.7.2 Failed Testing

Failing tests shall be cleared by one of the following methods:

1. Retest – Retest if there is any doubt that the first test was not adequate.
2. Rework – Re-inspect and retest.
3. Failed Material- Remove, replace re-inspect and retest.

6.8 Document Storage and Retention

1. Records shall be stored in areas that shall protect them from damage, deterioration, and/or loss at the Contractor Quality Control site office during the construction period. Records shall be accessible to the client.
2. Records shall be stored for a period of time as determined by the contractual documents. Records, designated for storage, shall not be destroyed or otherwise disposed of within that period of time. Control and final disposition of subcontractor and supplier records, both onsite and offsite, shall be in accordance with the contractual documents.

6.9 Tracking Deficiencies

6.9.1 Non-Conforming Items

1. Non-conforming items are those conditions that deviate from the requirements delineated in the specifications, blueprints, and/or shop drawings. The Quality Control Manager shall be responsible for the control and documentation of non-conforming items.
2. The Quality Control Manager shall prevent non-conforming items from being installed.
3. Minor non-conforming items, which are corrected on the same day, shall be documented in the “Daily Quality Control Report”.
4. All other non-conformances shall be documented on a Non-Conformance Report prepared by a Quality Control staff and shall be sequentially numbered and dated and shall include the following information, as appropriate:
   1. Description of the non-conformance including relevant details of the occurrence.
   2. Identification of the material, component, or system by part number, blueprint, shop drawing and/or specification number, and intended installation location.
   3. Source of material or item (name of the supplier, owner, or subcontractor).
   4. Current status or item in shop, warehouse, lay-down yard, or structure.
   5. Individuals and organizations detected the non-conformance.
   6. Recommendation for corrective action: including sketches, test data, and/or repair procedures necessary to substantiate the recommendation.
   7. Cause of the non-conformance and steps are taken to prevent reoccurrence indicating the action taken, positions or titles of persons contacted, letters written, and/procedural changes proposed.
5. The Quality Control Manager and/or designee shall sign and forward the Non- Conformance Report to the Project Manager.
6. Each Non-Conformance Report shall be entered into the Non-Conformance Report Log. The Non-Conformance Report (original) shall be filed and copies distributed accordingly.
7. Action to be taken shall be entered into the Non-Conformance Report Log. The QC Staff, or designated representative, shall initiate the disposition necessary to clear the item.
8. Verification of “Corrective Action” (e.g., completion of repairs) shall be by Quality Control after the work in question has been re-inspected and/or retested. Entries shall be made in the NCR Log indicating the Final Disposition of the NCR.
9. Non-Conformance Reports, logs, and documents shall be filed and maintained.

6.9.2 Punch-Out Inspection

The QC Report should report the punch list (deficiencies) throughout the life of the project and demonstrate that the QC Staff is correcting the deficiency in a timely manner. XXX will not wait until the job is finished to develop a punch list. The Punch List shall be submitted to the Project Manager for corrective action. Corrections shall be accomplished within the time stated. The Quality Control Department shall perform Follow-Up Inspections to ensure the deficiencies have been corrected before notifying the client of a Pre-final Inspection.

6.10 Inspection, Testing and Commissioning

6.10.1 Pre-Final Inspection

After the completion of the Punch-Out Inspection, the Quality Control Manager and the client representatives shall perform a Pre-Final Inspection and develop a joint “Punch List” of noted deficiencies. The Punch List shall be formally documented along with the estimated date by which the deficiencies will be corrected. BLK Quality Control shall perform Follow-Up inspections to ensure that all deficiencies have been corrected before notifying the client of a request for Final Inspection.

6.10.2 Final Inspection

Upon completion of the items listed in the Pre-Final Inspection “Punch List”, Quality Control shall notify the client 14 days prior to the Final Inspection (or as agreed to) with the assurance that all items listed in the Pre-Final Inspection and all other remaining work has been completed and shall be acceptable by the date of the Final Inspection.

6.10.3 Commissioning

After completing the work, XXX demonstrates that the systems fully satisfy the functions for which the systems have been planned: (1) HVAC, (2) Electrical, (3) Plumbing, and (4) Fire Alarm. The commissioning shall include appropriate tests, the operation of the system, control checks, and other system checks as necessary.

7. RETAINED DOCUMENTED INFORMATION

7.1 Non-conformance Report (QC / QF/01)
7.2 Daily Quality Control Report(QC / QF/02)
7.3 Final Inspection Report (QC / QF/03)
7.4 Initial Phase checklist (QC / QF/04)
7.5 Material Inspection Report (QC / QF/05)
7.6 O&M Data for Equipment (QC / QF/06)
7.7 Operation and Maintenance Training Validation Certificate (QC / QF/07)
7.8 Preparatory Phase Meeting Checklist (QC / QF/08)
7.9 QC Test Plan (QC / QF/09)
7.10 Request for Information (QC / QF/10)
7.11 Request for Inspection(QC / QF/11)
7.12 Meeting Sign-in Sheet(QC / QF/12)
7.13 PEB Inspection Checklist(Internal)  (QC / QF/13)
7.14 PEB Inspection Checklist  (QC / QF/14)

Instrument calibration and maintenance are an integral part of any operation in manufacturing/ laboratory. and are vital for data quality assurance. Accurate and reliable monitoring results are crucial for data analysis, particularly when the monitoring results are to be compared with the relevant standards or guidelines for compliance purposes, or for population exposure and health risk assessments. Where such analyses lead to air quality policy formulation and the quality of the original data is especially important. This Procedure outlines the basic requirements for the calibration and maintenance of monitoring instruments based primarily on standard monitoring methods.  Monitoring agencies should develop their own detailed calibration and maintenance programs appropriate to their data quality assurance goals. 

Examples of Procedure for Equipment Calibration and Maintenance

1. SCOPE

This procedure applies to the laboratory equipment used by the Laboratory of XXX.

2. PURPOSE

This procedure specifies the schedule and requirements for calibration, performance verification, and maintenance of Laboratory testing instruments and equipment.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,
3.2 Procedure for Quality Control

4. TERMS & DEFINITIONS

4.1 Calibration – Adjustment or standardization of the accuracy of a measuring instrument, usually by comparison with a certified reference or standard.
4.2 Certified Reference Material (CRM) – A reference material whose property values are certified by a technically valid procedure and accompanied by or traceable to a certificate or documentation issued by a certifying organization.
4.3 Critical Laboratory Equipment – Analytical instrumentation and equipment affecting the accuracy or precision of a test method.
4.4 Quality Control Checks – Periodic confirmation of the reliability of equipment, instrumentation, and/or reagents.
4.5 Reference Standard – Material or substance one or more of whose property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials.
4.6 Traceability – The linking of measurement standards and/or measuring instruments to relevant national or international standards through an unbroken chain of comparisons.
4.7 Performance Verification – The confirmation of the reliability of a previously validated method(s) or equipment.

5. RESPONSIBILITY AND AUTHORITY

5.1 Quality Assurance – is responsible for preparing, implementing and maintaining this procedure. In addition, QA is assigned Calibration Administration responsibilities as defined in this procedure
5.2 Calibration Administrator/Operations – is responsible for following the procedure defined in this document.

6. DETAILS OF PROCEDURE

6.1 General Equipment Requirements

6.1.1 The QA Manager or designee shall maintain an equipment inventory that shall include the following information:

• Item, including software and version.
• Manufacturer and model.
• Serial number or other unique identification.
• Location.

6.1.2 All equipment in the equipment inventory system shall be identified uniquely (e.g., DOJ bar code number).
6.1.3 All equipment shall be maintained in good operating order and according to the manufacturer and/or Section maintenance requirements.
6.1.4 All critical equipment shall be calibrated or verified before use.

6.2. Reference Standards

6.2.1 Whenever possible, reference standards traceable to SI units (International System of Units) shall be used. In situations where SI units cannot be used, certified reference material provided by a competent supplier shall be used if available.
6.2.2 Reference standards shall be calibrated by an accredited organization or vendor that can provide proof of traceability. These typically would include, but not be limited to, ISO 17025-certified companies.
6.2.3 Reference standards shall only be handled by employees authorized by the QA Manager/Supervisor and shall be stored to prevent contamination and/or deterioration. Reference standards shall be calibrated before and after any adjustment. All reference standards, certified reference materials, or reference materials used for calibration shall be uniquely identified. A certificate of traceability, if applicable, shall be retained to ensure traceability.

6.3 Equipment Calibration and Verification

6.3.1 QA Managers/Supervisors shall include procedures for calibration and/or performance verification of new equipment in Section technical procedures.
6.3.2 Calibration procedures shall be appropriate for the intended use of the equipment and shall provide criteria for determining if calibration is satisfactory.
6.3.3 Manufacturer operating manuals shall be consulted to determine the correct calibration interval. Equipment that requires calibration shall not be used if satisfactory calibration cannot be achieved or the calibration date has passed. Equipment used infrequently, such that the manufacturers’ recommendations cannot be followed, shall have calibration verified prior to use. Prior to being used in testing, new equipment (or any piece of equipment which leaves the control of the Laboratory) shall undergo calibration procedures or performance verification.
6.3.4 Calibration records shall be maintained and associated with the unique identifier of each piece of equipment. These records shall include:

• the identity of the item of equipment and software.
• Name of manufacturer.
• Serial number or unique identifier.
• Date of calibration.
• Current location.
• Manufacturer’s instructions or a reference to location.
• The reference standard certified reference material or reference material used for calibration.
• Copies of all reports, results of calibration, and/or certificates of calibration.
• A maintenance plan and due date for the next calibration.
• The identity of the individual performing calibration.

6.3.5 When external calibrations are performed, service providers that demonstrate competence, measurement capability, and traceability shall be used. Calibration certificates from these providers shall contain the measurement results, including the measurement uncertainty and/or a statement of compliance with an identified metrological specification. When possible, providers accredited to ISO 17025 shall be used. Copies of the provider’s accreditation documentation shall be maintained by the Quality Manager (QM).
6.3.6 If calibrations are performed by an outside vendor, the Section document control custodian shall maintain the original calibration records provided by the vendor and a copy of the relevant records shall be readily available.
6.3.7 Laboratory equipment requiring calibration shall be labeled or coded to indicate the calibration status, including the date when last calibrated and the due date for recalibration (or expiration criteria for when recalibration is due).

6.4 Equipment Maintenance

6.4.1 Equipment shall be maintained as specified in the technical procedure.
6.4.2 Critical equipment shall have documented procedures for the maintenance process. Maintenance procedures and frequencies, either in the form of vendors’ manuals or in-house procedures, shall be available for each piece of equipment. The operating and maintenance manuals shall be readily available to the operator. In the absence of the manufacturer’s instructions, instructions shall be provided in the technical procedure.
4.3.3 Preventative maintenance procedures (other than basic cleaning) for each equipment item shall be developed by each Section unless already described elsewhere (e.g., the equipment manual) and shall be performed according to a regular, predetermined schedule. Preventive maintenance shall be documented in the maintenance records.

6.5 Maintenance Records

6.5.1 Maintenance records shall be maintained and shall include:

• Type of equipment.
• Equipment serial number or unique identifier.
• Date of maintenance.
• Adjustments or repairs made.
• The identity of the individual performing maintenance.

6.5.2 If maintenance is performed by an outside vendor on a lab-wide basis (e.g., microscope maintenance), the QA Manager or designee shall retain the original maintenance records provided by the vendor.
6.5.3 When a piece of equipment is retired from service, maintenance, and repair records shall be incorporated into the Section archives by the Forensic Scientist Manager or designee.

6.6  Out of Service Equipment

6.6.1 Equipment that has been subjected to overloading or mishandling, gives suspect results or has been shown to be defective or outside specified limits, shall be taken out of service. It shall be isolated and/or clearly labeled (Out of Service – Do Not Use) to prevent use until repaired and shown by calibration or test to perform correctly.
6.6.2 Prior to returning a piece of equipment to use (out of service for any reason – e.g., maintenance, malfunction, leaving the direct control of the Laboratory), the correct operation shall be demonstrated by calibration or performance verification. Laboratory personnel shall examine the effect(s), if any, of a malfunction on analysis results and implement the Procedure for Corrective Action as required.
6.6.3 An exception may be made if the equipment failure is not directly related to its analytical function, such as a problem with peripheral equipment.

6.7 Quality Control Checks

Quality control checks may be carried out at appropriate intervals to verify that equipment is functioning as expected. The procedures for quality control checks shall be included in the technical procedure for which the equipment is being used.

6.8 Correction Factors

Where calibrations give rise to a set of correction factors, the Section shall ensure that software is updated with these correction factors.

6.9 Safeguards

The QA Manager/Supervisor shall designate the personnel (Equipment Monitor) responsible for equipment calibration, maintenance (including outside vendors used for these services).

7. RETAINED DOCUMENTED INFORMATION

7.1 Listing of critical equipment requiring calibration and/or maintenance (QMS F 60)
7.2 List of authorized equipment service providers (QMS F 61)
7.3 Calibration, maintenance, and verification records(QMS F 62)
7.4 Service and repair records(QMS F 63)
7.5 Certificates of traceability for reference standards Employee Evaluation Record (QMS F 64)

1. SCOPE

This procedure is applicable to all the employees of XXX.

2. PURPOSE

The purpose of this procedure is to define the requirements for positions in the company affecting quality, for hiring and training employees to ensure these requirements are met, and for evaluating the effectiveness of training provided.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,
3.2 Procedure for HR and Administration

4. TERMS & DEFINITIONS
HR – Human Resource
PA-Performance Appraisal
OJT- On Job Training

5. RESPONSIBILITY AND AUTHORITY

The HR Manager is responsible for implementation and management of this procedure.

6. DETAILS OF PROCEDURE

6.1 OVERVIEW

6.1.1 XXX employees are selected, trained and evaluated to ensure that those personnel performing work affecting product quality are competent on the basis of four primary criteria:

• education
• training
• skills
• experience

6.1.2 Job requirements have been developed for each position in the company affecting the quality and documented in an applicable Job Description. These define the desired minimum requirements for each position, including the four criteria listed above.

6.1.3 HR Assistant shall include applicable statutory or regulatory requirements for the position defined.

6.2 CANDIDATE SCREENING

6.2.1 All XXX personnel are hired on the basis of their ability to perform acceptable work. This is done by comparing the candidate’s resume, experience, application, etc. against the job description requirements.

6.2.1 It is not mandatory that candidates meet all requirements if the company can provide subsequent training or other actions to bring the candidate up to the requirements eventually.

6.3 NEW HIRES

6.3.1 New employees for the XXX undergo employee orientation, which includes Company Work policies and practices, ISO 9001 and Health & Safety training, and training on the Quality, Health & Safety Policy. Orientation training shall be completed within 15 days of the employee’s start date.

6.3.2 Orientation shall include discussing with the employee the relevance and importance of that person meeting customer and company MS requirements, and how their work will affect quality objectives.

6.3.3 A record of the completion of the orientation shall be maintained in the employee’s training file.

6.4 SUBSEQUENT TRAINING / OJT

6.4.1 Subsequent training, including on-the-job training (“OJT”), is performed to ensure each employee is knowledgeable in their job function and their role within the company.

6.4.2 The Competency Matrix lists applicable task-specific requirements for the positions/roles/designations; for employees hired in these positions, the HR Manager will update this matrix as training is conducted for these tasks.

6.4.3 On the Competency Matrix, an employee is considered qualified if the task is marked off as completed; the employee may train others if this is indicated.

6.4.4 Training records are maintained for training course conducted as per Training Attendance Form and individually in Employee Training Record and should indicate the following:

• Type of training
• Method of training
• Duration of training
• Date of completion
• Location of training
• The name of the instructor or individual who conducted the training

6.4.5 Personnel undergoing third-party training and receiving a certificate of training by the training provider may retain this certificate as a training record in lieu of an Employee training record.

6.4.6 All training records are to be maintained in the employee training file. Copies may be given to the employee for their personal retention or posting in their work areas.

6.5 TRAINING EVALUATION

6.5.1 Management periodically reviews and re-certifies employees for operations where recertification is required or beneficial. Personnel evaluations are performed as per Training Evaluation Form to assess the effectiveness of training. Employee evaluations shall include goals for continual improvement of the employee’s competency and abilities, as well as their growth within the company, as applicable.

6.5.2 Where appropriate, some training programs will include a test or other means of verifying the effectiveness of training. In such cases, work instructions will define the minimum passing grade and actions to be taken when an employee does not pass.

6.5.3 If problems, weaknesses, or concerns are discovered during an evaluation or otherwise reported for any other reason (including customer complaints), the HR Manager shall be completed to identify the weaknesses and develop a plan of improvement for that employee;.

6.5.4 For some tasks, tests may be developed and given to assess training effectiveness. In case a candidate fails to pass the test, he/she may under asked to undergo retraining. Repetitive failure may lead to Job reallocation or termination.

7. RETAINED DOCUMENTED INFORMATION

1) Employee Evaluation Record (HR / QF/02)
2) Employee Training Record (HR / QF/04)
3) Position Description (HR / QF/05)
4) List of Employees (HR / QF/06)
5) Training Attendance Form(HR / QF/07)
6) Competency Matrix (HR / QF/08)
7) Training plan(HR / QF/09)
8)Training Evaluation Form (HR / QF/10)

1. SCOPE

This procedure is applicable to all the employees of XXX.

2. PURPOSE

The purpose of this procedure is to define the HR guidelines prior, during, and after employment.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,
3.2 Procedure for Training

4. TERMS & DEFINITIONS

HR – Human Resource
PA-Performance Apprisal
DA- Disciplinary Action

5. RESPONSIBILITY AND AUTHORITY

The HR Manager is responsible for implementation and management of this procedure.

6. DETAILS OF PROCEDURE

6.1  EMPLOYEE ENROLLMENT

6.1.1. As an employee joins the XXX, Employment Contract is prepared and approved by DGM
6.1. 2. An employee file is opened as soon as the visa is processed.
6.1.3. Information of employment is given to Finance Department & a copy is maintained in the employee file.
6.1.4. Advance payment is given to the employee.
6.1.5. Issue employee number once the visa is issued.
6.1.6. For payroll purposes, employee details are maintained in the system.
6.1.7. Get bank account details from the employee in case the employee is local and keep a copy of Bank a/c in the employee file.
6.1.8. In case of newly appointed overseas employee arrangements are made for advance payments for settling on arrival, uniform from Stores, Medical checks, Fingerprint, and all the details are recorded in System.
6.1.9. Based on the Project on which the employee is taken as decided by the Concerned Department Head, the Work Commencement Form is filled in.

6.2 RECRUITMENT

6.2.1. After the contract with the customer is signed, the Operations Manager advises of no. of employees in Employee Request required as per respective contract.
6.2.2. Check the minimum competency requirements for the vacancy specified. Check for any other specifications.
6.2.3. Choose the mode of recruitment (existing data, advertisement & through personal contacts).
6.2.4. Recruitments are also done through overseas approved agencies and employee requirements are sent to them.
6.2.5. In overseas, the agency collects the CVs from the existing data bank and Scrutinize the CV as per the specification of the Job Description & request made.
6.2.6. Prepare the shortlist for 1st level interview.
6.2.7. Call the applicants for the interview (if available locally), otherwise, arrange a Technical Interview over the phone by the concerned Manager or the consultant in case of the overseas candidate.
6.2.8. In some cases, the HR Manager and Operations manager travel overseas for the interview, salary negotiation, and contract period.
6.2.9. For selected candidates, an overseas agency fills in the Job Application of the selected applicant. Manpower evaluation sheet if filled by the interviewer. The agency then fills in the Acceptance letter (initial contract).
6.2.10. Before processing on visa, the selected employee’s pre-medical report is sent by the agency.
6.2.11. If all these above formalities are complete and the employee arrives, the Employment contract is prepared and signed by DGM.
6.2.12. Get Work Commencement Form when an employee starts work.
6.2.13. All XXX personnel are hired on the basis of their ability to perform acceptable work. This is done by comparing the candidate’s resume, experience, application, etc. against the Competency requirements.
6.2.14. It is not mandatory that candidates meet all requirements if the company can provide subsequent training or other actions to bring the candidate up to the requirements eventually.

6.3 ANNUAL LEAVE

6.3.1. Receive the Leave Request application signed by the employee, his/her department head ideally the Operations Mgr.
6.3.2. Check leave balance from system & update leave application by the HR Assistant
6.3.3. Check the reason for the unpaid leave if any.
6.3.4. Leaves calculated automatically through the HRMS system. In some cases, the manual calculation is done for cross-verification.
6.3.5. Enter leave days in the system & mention them in the Leave Request application.
6.3.6. Keep a copy in the file, send the original to the Finance department. Then, get DGM approval.

6.4. SICK LEAVE and SPECIAL LEAVES

6.4.1. Receive a Sick leave application from an employee/from the site and the Project manager approves. On application, comments are entered by the clinic/doctor.
6.4.2. Calculate rest days.
6.4.3. Enter sick leave in the System by the HR Assistant attached with the timesheet at end of the month.
6.4.4. Late Permission Request needs to be maintained for special leaves.

6.5 LEAVE RESUMPTION

6.5.1. Get Leave Return Form from department and updated Leave application.
6.5.2. Check the resumption date & reason if any delay.
6.5.3. Mention late resumption action for delay & send an original to Finance department.
6.5.4. Enter resumption date in system by the HR Assistant.
6.5.5. Keep a resumption copy in employee file.

6.6  EMPLOYEE PERFORMANCE APPRAISAL

6.6 1. Send Request for Employee Evaluation to concerned dept. on yearly basis.
6.6 2. Get the Employee Performance Appraisal by dept. Then reviewed and approved by DGM.
6.6. 3. File it to the Remuneration portion of the employee file.

6.7. DISCIPLINARY ACTION

6.7.1. Check for disciplinary actions as per Kuwait Labor Law.
6.7.2. Prepare employee warning notice as Disciplinary Action Form as per concerned department’s instructions/sent from site.
6.7.3. Keep a warning notice copy in file, one original to employee and one copy to Payroll.

6.8  EMPLOYEE RESIGNATION / TERMINATION/ EXIT

6.8.1. Get an employee resignation prepared by the employee.
6.8.2. Approval by concerned division/department head as well as DGM is needed on Resignation Acceptance Form.
6.8.3. Halt the employee salary. Pay salary till last working day and hold indemnity till visa transfer/or pay all dues when return to the home country.
6.8.4. Prepare a resignation memo
6.8.5. Check for other clearances from the employee file
6.8.6. Prepare final settlement based on Final Settlement Form.
6.8.7. Approval on Clearance Certificate needs to be obtained from HODs.
6.8.8. Keep a copy in file & send a copy to Finance & Admin department to proceed final settlement
6.8.9. Removing Passport from serial in case of Resignation/Termination.
6.8.10. Dues to be settled within 45 days from resignation acceptance after visa transfer.

6.9 PASSPORT REQUEST

6.9.1. Receive the Passport Request Form from the employee.
6.9.2. Prepare a memo for information & send it to the employee.
6.9.3. When the employee returns the passport then maintain the details in the system.

7. RETAINED DOCUMENTED INFORMATION

7.1Work Commencement letter (QMS F 30)
7.2 Employee Option Survey (QMS F 31)
7.3 Application Form (QMS F 32)
7.4 Disciplinary Action Form (QMS F 33)
7.5 Settlement and Clearance Statement (QMS F 34)
7.6 Late permission (QMS F 35)
7.7 Leave Request form (QMS F 36)
7.8 Leave Return form (QMS F 37)
7.9 Letter of Acceptance (QMS F 38)
7.10 Passport Request Form (QMS F 39)
7.11 Resignation Acceptance letter(QMS F 40)
7.12 Customer complaints (QMS F 10)

1. SCOPE

1.1. This procedure covers all roles, responsibilities, and authorities related to Business Development and Marketing at XXX

2. PURPOSE

2.1. The purpose of this procedure is to ensure that performed Business Development and Market Process is clearly identified and supports the work needs in XXX.
2.2. Applicable for all business development-related activities and concerned statutory & regulatory requirements.
2.3. Identifying a proper methodology to be adopted by the Business Development & Marketing department to deal with potential clients, starting from marketing.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,
3.2 Business Plan
3.3 Sales Procedure

4. TERMS & DEFINITIONS

4.1. Business Development: Business development entails tasks and processes to develop and implement growth opportunities within and between organizations.
4.2. Marketing: Marketing is the activity and processes for creating, communicating, delivering, and exchanging offerings that have value for customers, clients, partners, and society at large.
4.3. Client: any entity which the company provides with products or services, including showroom customers, retailers, and companies handling projects.

5. RESPONSIBILITY AND AUTHORITY

5.1 MARKETING HEAD

5.1.1 Oversees responsibility of the Supersonic Marketing Program
5.1.2 Provides Support for the following Programs/Activities and /or Managers

1. Website Coordination
2. Marketing Campaigns
3. Marketing Strategies

5.2 MARKETING STAFF

5.2.1 Support program executive’s activities with project wise or use of advertising materials for event promotion. Responsibilities & Advertising materials include the following:

1. Follow up with the customer on various stages
2. Able to manage
3. Responsible for checking the leads from all marketing portals
4. The executive should be available within office hours & available on mobile 24X6
5. Responding to the leads, follow up with the Lead, Customer
6. Maintain dress code
7. Ability to handle two to three marketing executives
8. Good Communication Skills is mandatory

6. DETAILS OF PROCEDURE

6.1 Business Development

To develop a new business/project, there has to be an idea about a product or service for which there is a market. The first thing is to assess whether the basics of the idea will hold. Briefly sketch the product, outline the potential market, define the business concept and estimate the initial funding.

6.2 Prepare a Project Brief.

6.2.1 A Business plan for 4-5 years is developed by business development. It is derived based on the initial market research conducted by the organization and the organization’s vision and strategy.

6.2.1 The annual plan is derived from the annual sales plan, project data, and customer data. It essentially describes the type of projects and products, the organization will look out for for possible development. The same is aligned with the expansion plan for a year. Based on the annual plan a project brief will be prepared.

6.3 Conduct Proactive Internal and Market Research

6.3.1 The internal research team will conduct market research in the target market to identify high potential areas for future development. Research on competitor’s strategy, customer demographics, psychographics, adequacy of public services, facilities available, accessibility of transportation, retail stores in the area, etc. will be carried out.

6.3.2 The customer database will be checked for the potential database. A pan will be developed and regular updates from dealers will be received. The dealers include the ones registered with the company dealing in a targeted locality or the set of dealers having name & experience in dealing in target locality. Information received from dealers will be captured in a dealer form.

6.3.3 The BD team will collect proposals from different sources like advertisements in newspapers and trade journals, government body notifications/ local authorities will be approached. This approach is an informal approach whereby Local authorities of destined locality like office, registration office, city survey office, etc will be approached. The required information will be gathered on a one-to-one basis through interaction.

6.4 Competitive Analysis

6.4.1 The Marketing Manager will conduct the competition research. The Department will learn about the competition in order to understand where the organization stands in the market. This will also help to determine the desired market positioning. The following steps will be done in order to assess the competition:

1. Determine the company´s top competitors (4-6 competitors).
2. Set up criteria or mechanism of comparison; choose different variables to use in order to compare, such as strengths/ weaknesses, price, product quality, exposure, brand reputation, etc.
3. Find out what projects competitors are targeting within the market segment; assess if the organization can develop an offering that can take clients away from them.
4. Use the organization’s advantage: visit the competitors´ showrooms (if they have any) anonymously, like any regular customer, and collect valuable input to use in your research.

6.5 Capture of Requirements

6.5.1 During the Contracting Sales procedure/Trading sales procedures, customer requirements are captured and recorded.

6.5.2 The Business Development Manager will also ensure that XXX has suitable access to all applicable statutory and regulatory requirements which may apply to the work.

6.5.3 The Business Development Manager will also document any requirements not specified by the customer, but for which XXX Knows will apply to the work.

6.6 Review of Requirements

6.6.1 The BD Manager will oversee the review of incoming requirements, to ensure XXX has the capability to meet those requirements. This must occur before any commitment made to the customer.

6.6.2 The review of requirements may require a formal risk assessment, at the discretion of management. If so, the risk assessment shall define the expected risks associated with the work, as well as a mitigation plan for each identified risk. If useful, risks may be ranked by likelihood of occurrence and severity of the impact of the risk, if it does occur. Management may elect to accept certain risks as a function of doing business, but if so, this must also be indicated. When a risk assessment is conducted, this will be filed with the appropriate requirements information where?.

6.6.3 If a formal quotation is to be prepared for the customer, this shall be developed by the Sales Executive with input from all proper departments and staff, and released to the customer after reviewed and approved by the Sales Manager.

6.6.4 When a contract or purchase agreement is subsequently received, it shall be reviewed by the Sales Manager to ensure there are no differences between it and any previously submitted quotations. If there are differences, the Sales manager shall resolve these with the customer before the contract is accepted.

6.6.5 Acceptance of a contract or purchase agreement is to be done by the Sales manager and recorded in the Purchase order.

6.7 Changes of Requirements

6.7.1 Where the customer requests changes to active work, the changes must also be captured, reviewed, and approved prior to committing to the change.

6.7.2 The change will consider the impact on work already delivered, work underway, and planned work. Problems or concerns over implementing the change will be communicated by [who?] with the customer. Such changes may require the renegotiation of contracts.

6.7.3 If changes are agreed upon, the Sales Manager will work with the affected departments to implement the change. The disposition of existing work shall be determined by management, along with input from the customer.

6.7.4 Where changes are required by XXX, these will be negotiated with the customer before implementation, and a record of the customer’s acceptance maintained.

6.8 Marketing

6.8.1 Essentially marketing is about anticipating and meeting the needs of the client in a manner consistent with the organization’s objectives, such as being profitable. Perhaps the best way to explain the breadth and scope of marketing is to look at the concept of the 7Ps – seven integral components of marketing.

People	The profile of potential clients and customers
Planning	Research, analysis, objectives, and strategies
Positioning	The position a product or service should have in the market relative to competing products
Product	The service or product you are selling
Price	The value of the product or service as determined by demand and perceptions of quality and value
Place	Where the product or service is delivered or distributed
Promotion	Techniques used to sell or position the product or service

6.9 Marketing Plan.

Sr. No.	Input	Activity	Output
1	Business Plan	Interaction with / visit to the market and customer	Market / Customer Information / data
2	Customer data	Collection of Enquiry	Enquiry
3	Customer Enquiry	Logging of New Enquiry	Enquiry Register (ER)
4	Customer Enquiry	Preliminary Assessment of Enquires	Preliminary Assessment Report, Risk Assessment Form
5	Enquiry Register, Preliminary Assessment Report	Sending enquiry to Design & receiving Technical Feasibility Report (TFR)	TFR
6	TFR	Preparation of Quality System Requirement Review Checklist (QSRRCL) and sending of the quotation, if the enquiry is feasible & updating of ER	Cost Estimate, Quotation, updated enquiry Register QSRRCL
7	Feasibility Report	Sending of regret letter, if the enquiry is not feasible	Regret letter
8	Customer Purchase Order	Receipt & Review of Purchase Order	Contract Review Checklist (CRC)
9	CRC	Release on Development Clearance Memo (DCM) to Design along with QSRRCL for development.	D C M.

7. RETAINED DOCUMENTED INFORMATION

7.1 Marketing Weekly Report (QMS F 26)
7.2 Marketing Monthly Report(QMS F 27)
7.3 Marketing Payment Report(QMS F 28)
7.4 Customer Log(QMS F 29)
7.5 Customer Complaints(QMS F 30)
7.6 Customer Feedback(QMS F 31)

1. SCOPE

This procedure applies to all the activities within the scope of the XXX Quality Management System.

2. PURPOSE

2.1 To ensure that top management systematically reviews the QMS and its performance in accordance with the established operating procedures.

2.2 To review the adequacy. suitability. and effectiveness of previous corrective and preventive actions including those related to outsourced service and supplier performance.

3.3 To identify strengths and opportunities for improvement and make recommendations for continual improvement.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,
3.2Procedure for Internal QMS Audit.
3.3 Procedure for Correction & Corrective Action
3.4 ISO 19011:2018 standard

4. TERMS & DEFINITIONS

4.1 Management Review: cross-functional review by an organization’s top management which takes place at regular intervals aimed to assess the organization’s success at achieving objectives established thus ensuring its continued suitability, adequacy, and effectiveness and to take action to correct it when necessary.

4.2 Quality Objective: A statement describes what should be achieved within the time frame and available resources. It shall be consistent with the evidence-based practice and the visions that the institution creates itself to achieve.

4.3 Audit: A systematic, independent, and documented process for obtaining audit evidence (records, statements of fact, or other information which are relevant and verifiable) and evaluating it objectively to determine the extent to which the audit criteria (set of policies. procedures, or requirements) are fulfilled.

5. RESPONSIBILITY AND AUTHORITY

The following will be responsible for the process of preparing for the Management Review Meeting :
5.1 CEO :
5.1.1 Assure the implementation of the MR policy
5.1.2 Chair the MR meeting
5.1.3 Invite members of the top management to the meeting
5.1.4 invite other categories of staff as per necessity (e.g. quality focal points, internal auditors)
5.2 Director/ Head and Staff of department:
5.2.1 Set in coordination with the Director, the date and time of the meeting.
5.2.2 Prepare and present the agenda of the meeting according to the agenda stated above.
5.2.3 Take the list of attendance.
5.2.4 Make minutes of the meeting that includes discussion points raised with the suggestions as well as the decisions that have made during the output session.
5.2.5 Follow-up the decisions that have been taken during the output discussion.
5.2.6 Follow-up the implementation of the MR.

6. DETAILS OF PROCEDURE

6.1 Attendants:

6.1.1 Top management review meeting shall be held twice a year (first week of July and last week of December). The meeting is allocated a maximum of 2:30 hours. The distribution is according to the following:

1 hour: presenting the review input.
30 minutes: questions and answers
1 hour: review output (it is recommended that this section is attended by the CEO, directors, and  heads of departments)

6.1.2 The Management review meeting to be chaired by CEO

6.2 Agenda of MR:

6.2.1 Review Input: this part of the review shall include information on:

1. Results of audits. By reporting the results of audits carried during the previous period (internal and external). It should include the presentation of data analysis showing strengths and opportunities for improvement in the system.
2. Customer feedback. Through analysis of reporting results of customer feedback that have been collected through various channels such as satisfaction surveys and compliments and complaints system. It is simply referring to what do your customers think of you and your organization. The reporting should look closely at both the negative and positive feedback.
3. Changes in external and internal issues that are relevant to the quality management system.
4. The result of the Incident Reporting System and analysis.
5. Process and result of performance conformity. This refers to reporting whether the institution is reaching and/or maintaining performance targets.
6. Status of preventive and corrective actions. This refers to reporting of steps that have been taken to manage failures detected as well as steps to avoid the occurrence of any potential problems that are likely to rise.
7. Follow-up actions from previous management reviews. This refers to all issues raised or resolved since the last review to make sure problems are being resolved properly. and to look for trends in the data.
8. The effectiveness of actions taken to address risks and opportunities:
9. Changes that could affect the quality management system. This refers to reporting any changes to standards. regulations, technology, competition. staffing. and other business activities that could affect the quality system in either a positive or negative manner.
10. Recommendations for improvement. This refers to proposing corrective and preventative actions to be taken based on the outcome of the review of the system carried out since the last MR in order to improve the quality of services.

6.2.2 Review Output: This part of the review shall be allocated to discuss and decide on actions to be taken to improve the management system, services/ processes. and resource needed. The output shall include any decisions and actions related to:

1. Improvement of the effectiveness of the quality management system and its processes. This refers to the fact that based on the information that has been discussed whether there are areas where worthwhile improvements can be made.
2. Improvement of services related to customer requirements. This refers to whether there are any improvements that can be made to the processes and products.
3. Resource needs. This refers to listing the resources (Human — current adequacy and future needs. competency and training; material resources — adequacy. suitability and maintenance of equipment and building, work environment, and services) that are needed to achieve the improvements stated above. Here comes the importance of Top Management attending these reviews as they control the resources.
4. Any need for change in QMS

6.3 Forms and records of the review:

The record of the review will be maintained by the QM department and a summary report of the meeting will be sent to the Management Representative.

7. RETAINED DOCUMENTED INFORMATION

7.1 Management Review record (QMS F027)
7.2 Data analysis reports. (QMS F028)
7.3 Management review agenda and minutes(QMS F029)

1. SCOPE

To ensure that the documented information. including all documents of internal & external origin, is controlled with respect to approval, distribution, change, etc.

2. PURPOSE

To establish a consistent process for controlling the documented information required to maintain XXX’s quality management system.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,
3.2 Document Master List with Revision History
3.3 External Document Control List
3.4 Quality Plan

4. TERMS & DEFINITIONS
Documented Information- Records and Documents
Maintained Documented Information- Document
Retained Documented Information- Record
WI- Work Instruction
F- Format
QM – Quality Manual
QMS- Quality Management System
SOP- Standard Operating System

5. RESPONSIBILITY AND AUTHORITY

5.1 The Management Representative (MR) and HOD’s of all departments are responsible for the effective implementation of this procedure.
5.2 President gives final approval on all XXX’s quality system documents
5.3 Quality Assurance Manager/MR

• Ensure that XXX quality system documents are formatted, identified, and issued per the requirements of this operating procedure.
• Ensure that revisions to quality system documents are reviewed and approved by the same functions that performed the original review and approval.
• Ensure that the necessary documents are accessible to appropriate personnel.
• Prevent the use of obsolete or invalid documents.
  Maintain the computer system and files on the online server.

5.4 Document Owners

• Draft, review, and update quality system documents applicable to their areas of expertise and process ownership.
• Work with the Quality Assurance Manager or designee to ensure that their documents are up to date and accurately logged within the Document Master List
• Control of Documented Information

5.5 IT Manager

• Work with the Quality Assurance Manager/MR to ensure that documented information is available as necessary through XXX’s computer network.
• Assist the Quality Assurance Manager/MR in setting up an appropriate network and file security features, as well as maintaining necessary data backups.

6. DETAILS OF PROCEDURE

6.1. General Document Control Policies

6.1.1  XXX’s quality management system includes the documented information required by ISO 9001 as well as the documented information determined by XXX as being necessary for the effectiveness of our quality management system.
6.1.2 Examples of XXX’s documented information are:

• Quality Manual
• Operating Procedures
• Work Instructions
• Forms and Quality Records

6.1.3. XXX’s Quality Manual and our operating procedures are maintained as pdf files and hosted at xxx.com/ iso 9001 for the convenience of our employees, customers, and other interested parties. These files can be accessed through any standard web browser, such as Internet Explorer, Chrome, Safari, or Firefox. They can be opened and viewed with the Adobe Acrobat browser plug-in or standalone application.
6.1.4. XXX’s work instructions are maintained as pdf files and made available throughout XXX’s internal computer network. Work instructions are generally not posted on the internet.
6.1.5. XXX’s forms are generated in a variety of formats appropriate to the nature of the information to be captured. The format for generating any given form, and the media required (paper or electronic) is documented in the Document Master List.
6.1.6. This documented information is made accessible through computer stations and mobile devices located throughout XXX’s factory and office. Controlled paper copies of documents may be issued in areas where it is not practical to maintain computer equipment.
6.1.7. XXX’s quality system documents are protected from unauthorized or unintended changes by passwords, restricted read/write privileges, and saved backup files.
6.1.8. XXX’s quality system documents are written in English.

6.2 Document Identification/Numbering

6.2.1 The documents required for our QMS are assigned code numbers by the Quality Assurance Manager.

6.2.2 SAMPLE OPERATING PROCEDURE IDENTIFICATION:

The following shows the sections of a sample XXX document number QMS F 015:

QMS – the Management system
F- Document Code prefix
15- Document identification number

6.2.3. Document Code Prefixes – The following list of prefixes is used to identify the quality documents maintained by XXX and generate the Document Code Prefix section of the Document Number.

QM- Quality Manual
WI- Work Instruction
SOP-Standard Operation Procedure
F- Format

6.2.4 To ensure that all XXX documents are uniquely identified, Document Numbers are further distinguished by sequential Document Identification Numbers. e.g. 01, 02, 03. The Document Master List, QMS F 22 should be reviewed as appropriate to ensure that document numbers are not duplicated.

6.3 Document Formatting

6.3.1. Quality system operating procedures have the following information in the header:

• Document Identification Number
• Document Title
• Revision
• Effective Date
• Document owner/originator name, position and date of approval
• Management name, position, and date of approval
• Printed copies of this document are for information purposes only and are uncontrolled. Printed copies are not valid after the date of printing.

6.3.2. Operating procedures shall have a Print Date Stamp in the footer that indicates the print date of paper copies. (Note: the Print Date Stamp is a dynamic element added to the pdf version of the operating procedure.)
6.3.3 The body of each operating procedure should address these main topics, as applicable. The table below identifies the title of the heading and a description of the content.

Item	Heading Title	Content Description
1	PURPOSE	This section states the intended purpose or needs for generating the document.
2	RESPONSIBILITIES	This section identifies the personnel, department, and/or authority in the organization that is responsible for maintaining, and/or implementing the steps within the document.
3	APPLICABLE FORMS OR REFERENCES	This section provides a list of the operating procedures, work instructions, forms or external documents referenced in the document.
4	POLICIES	Statements of principle that apply to the document as a whole.
5	PROCEDURES	Where appropriate, step-by-step flowcharts should illustrate the procedures.
6	RECORDS/OBJECTIVE EVIDENCE	This section directs users to the QMS F 22 Document Master List for the retention duration of records referenced in the procedure.
7	REVISION HISTORY	This section records the history for each procedure and should be noted in the document with the following or similar text: “Revision, approved date, effective date and a document change summary are available QMS F 22 Document Master List with Revision History.”

6.4  Approval and Issue of Quality System Documentation

6.4.1. Prior to the issue, the Document Owner and the President shall review and approve controlled documents. Records of the approval process shall be maintained within the Document Master List, QMS F 22.
6.4.2 Revisions to existing documents are reviewed and approved by the same functions that performed the original review and approval.
6.4.3  Digital formatting is the preferred method for maintaining quality system documents. Computers shall be protected by the use of virus protection software, regular data backups, and off-site storage when appropriate.
6.4.4. Uncontrolled documents are not valid after the date of printing. Printed work instructions that are made available at the point of use are controlled by the document owner and unauthorized copies should not be made.
6.5.5. Obsolete printed copies of internal documents retained for legal and/or knowledge preservation shall be marked “OBSOLETE” and/or held in a binder/folder marked “OBSOLETE”.
6.4.6. Superseded/Obsolete Documents are moved to a segregated location and made inaccessible to prevent unintended use. The Quality Assurance Manager should be contacted for access to obsoleted documents.
6.4.7. The current revision for any quality system document can be verified through the Document Master List, QMS F 22. Unless otherwise specified, the current revision of a quality system document should be referenced or followed.

6.5 Control of Customer Supplied Information

6.5.1. Examples of customer-supplied information are blueprints, art files, sketches, samples, purchase orders, and emailed correspondences.
6.5.2. A printed copy of a blueprint and any relevant customer-supplied information should travel with quote requests and shop orders. If the electronic file is later accessed to generate artwork or be reprinted, the contents of the file should be checked to verify that it matches the customer’s current requirements.
6.5.3. Typically, the current revision for a blueprint or other customer-supplied information can be verified by referencing a current purchase order, a customer’s supplier portal, or checking with the customer’s purchasing or quality representative.
6.5.4. Obsolete blueprints and other customer-supplied information that is retained for legal and/or knowledge preservation shall be marked “OBSOLETE” or held in a binder/folder marked “OBSOLETE”. It should not be assumed that blueprints or other customer-supplied information stored within closed shop orders represent the current revision.

6.6  Control of External Documents

6.6.1. External documents are defined as documents whose origin and control is by a body outside XXX. Examples:

• Equipment manuals regarding the operation, safety, repair or maintenance of equipment used by XXX in the processing of customer orders.
• Supplier manuals, specifications, or standards from customers that are provided to XXX, which contain customer requirements that are not part specific.
• Documents necessary for the planning and operation of the quality system.
• International Quality Standards, example: ISO 9001: 2015.

6.6.2. External documents are maintained as digital files whenever possible. When practical, external documents that are readily available on the internet should not be maintained at XXX. The External Document Control List, QMS F 24 is able to store a link to the online location of the document.
6.6.3. Printed copies of obsolete, external documents that are retained for legal and/or knowledge preservation shall be marked “OBSOLETE” and/or held in a binder/folder marked “OBSOLETE”.
6.6.4. Electronic files of obsolete, external documents that are retained for legal and/or knowledge preservation shall be overwritten with notes to indicate that the file is obsolete. If the contents of the file are write-protected, the file name shall be appended with “OBSOLETE”.
6.6.5. The personnel responsible for periodically verifying that XXX has access to the current revision of an external document is identified in the External Document Control List, QMS F 24. When appropriate, the schedule, method for verification, and other means for control shall be recorded there as well.
6.6.6. The Customer Master List Database can be used to save files and URL links to customer-specific external documents. External documents saved in the Customer Master List Database are considered “For Reference Only”

6.7. Control of Quality Records

6.7.1. Quality records at XXX consist of those documents that describe the results of some activity. Examples of quality records include inspections, tests, reviews, audits, measurements, training records, meeting minutes. The control of quality records refers to the originals.
6.7.2. The Document Master List with Revision History, QMS F 22, lists for each quality record;

• The document code and title,
• The current revision and issue date,
• A description of revision changes,
• The index for sorting or filing the records,
• The location of active records and the personnel responsible for maintaining them,
• The active retention time for records, and the total retention time for archived records,
• The means for retrieving records,
• The methods for disposing of the records, when their total retention time is up and they are no longer useful.
• Additional notes regarding access, distribution, use and risk as applicable

6.7.3. XXX quality records are maintained to demonstrate product quality, the effectiveness of the quality system, and/or conformance to specified requirements.
6.7.4 XXX personnel involved with filling out forms and storing company-related records are to ensure that the records are:

• Filled out properly, accurately, and completely
• Documented in ink or other permanent marker
• Signed or initialed and dated, when appropriate
• Legible when hand written
• Printed through all copies of multiple carbons
• Stored in a clean, dry area in such a manner as to prevent damage or deterioration to prevent loss or unintended alterations
• Stored either on paper (hard copy) or stored on the computer (electronic media) for the proper retention period
• Made available to the customer or regulatory authority upon request, when required by the contract.

6.7.5. Quality records are generated internally within XXX and externally from customers, suppliers, and subcontractors.
6.7.6. Typically, XXX asks that suppliers provide all necessary quality records so they may be retained and controlled internally. When a XXX supplier is required to maintain quality records, the means for retaining and controlling the records are specified on purchasing documents. When required, XXX suppliers should maintain quality records to the same standards as referenced in Policy Note 4 of this procedure.

6.8. Making corrections on quality records

Pens with permanent ink should be used to make corrections or changes to the quality records. White-out or pencil should not be used to make corrections or changes to quality records. Follow the steps in the table below to make corrections to a quality record. Corrections to quality, records are to be made so that traceability and any significant history are maintained. Corrections are to be made in ink.

STEP 1:
ASK: Will corrections made to this document be clear and legible?
If “No”, create a new record.
If “Yes”, go to Step 2.
STEP 2:
Cross out what is to be changed with a single line.
STEP 3:
Initial and date what has been crossed out.
STEP 4:
Make the change required.

6.9  Maintaining Quality Records

The table below identifies the type of quality records maintained at XXX and how each is maintained.

Item	Type of Quality Record	How it is maintained
1	PAPER	Protect the record from becoming dirty or soiled. Keep records away from sources of contamination. Use a plastic sleeve if appropriate.
2	ELECTRONIC MEDIA (Computer)	Use virus protection practices. Backup data on a regular basis. Maintain backups off-site if appropriate.

6.10  Identifying quality record retention requirements

Quality record retention requirements are specified in Document Master List with Revision History, QMS F 22. Specified retention requirements are established in accordance with the:

• Duration of the contract
• Life of the product, and
• Requirements of applicable standards, and
• The government, customer, legislative, statutory, regulatory, and/or contract requirements.

6.11. Archiving quality records

Authorized personnel uses the steps in the table below to properly archive quality records. Currently, outside storage services are not used to archive quality records.

Step	Task	Action
1	Labeling the box	Indicate the names of the records being archived. Indicate the period covered by the records being archived. Example: From (the date of the first record ) to (date of the last record) Indicate the date the box is being archived.
2	Storing the box	Place the records in a designated archive storage area that will: Protect the record from becoming dirty or soiled. Keep records away from sources of contamination.

6.12. Disposition of original quality records

Authorized personnel uses the steps in the table below to assure the proper disposal of original quality records.

STEP 1:

Review the records to be disposed of.
STEP 2:
Ask: Has the useful life of the records ended?
If “No”, do not dispose of the records.
If “Yes”, go to Step 3.
STEP 3:
Ask: Have the contractual requirements of the records been satisfied?
If “No”, do not dispose of the records.
If “Yes”, go to Step 4.

STEP 4:
Dispose of quality records. XXX Management determines disposal methods for quality records based on the type of quality record, data contained in the record, and/or security requirements. Records are shredded when appropriate.

7.0 RETAINED DOCUMENTED INFORMATION

7.1 Master copies of all Documents of Internal Origin(QMS F 22)
7.2 Master list of Documents of Internal Origin(QMS F 23)
7.3 Master list of Documents of External Origin(QMS F 24)
7.4 Master copies of Documents of External Origin(QMS F 25)