Internal Audit Check List
The purpose of the Internal Audit chdck list and
Procedures Operating Manual is to provide a
written summary of the audit processes
employed by the Internal Auditor. It provides guidance
for the planning, execution, reporting and
follow up procedures performed by the Internal Auditor. uuu
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Quality System
- Is a Quality Manual documented. ffff
- Does the Quality Manual contain reference to implementing procedures and outline the documentation of the Quality System.
- Quality System Procedures
- Are procedures documented for the Quality System.
- Are the procedures consistent with ISO requirements.
- Are procedures effectively implemented
- Quality Planning
- Are Quality Plans or procedures documented that address the following as appropriate for products, projects, or contracts:
- Preparation of Quality Plans
- The identification of any controls, processes, equipment,fixtures, resources, and skills that may be needed to achieve the required quality
- Ensure the capability of activities and documentation
- Updating of inspection & test techniques
- Identification of measurements that exceed the capability of measuring instruments
- Identification of verification at suitable steps in the processes
- Clarification of standards for acceptability of the product or service
- Identification and preparation of Quality Records
Contract Review
- General Internal Audit
- Are documented procedures implemented
- Reviews
- Are reviews conducted of:
- Request for Quotes
- Contracts, Purchase Orders from customer
- Does the contract review address the following:
- Requirements adequately defined
- Order requirements agreed upon, including verbal orders
- Differences are resolved
- Supplier can meet the contract requirements
- Amendment to a Contract
- Do methods exits for amendments to the contract.
- Records
- Are Quality Records maintained for contract review.
- Other Questions
Design Control
- Document and Data Control
- General
- Documented procedures to control all documents and data that relate to:
- ISO Requirements Standards
- Customer Drawings External Documents
- Document & Data Approval & Issue
- Are documents and data reviewed and approved prior to issue.
- Is a master list used or equivalent document control procedure used to identify the current revision of documents to preclude the use of invalid and/or obsolete documents.
- Document and Data changes
- Are changes reviewed & approved by same functions as the original review & approval
- The reviewers shall have access to background information
- Where practicable, the nature of the change shall be identified in the document or in the appropriate attachments
Purchasing
- General
- Are documented procedures implemented to ensure purchase products meets requirements
- Evaluation of subcontractors
- Evaluate and select bases on:
- Ability to meet requirements
- Quality System implemented
- Specific QA requirements
- Define the type and extent of controls. Depends on:
- Type of product
- Impact of item/service on the final product
- Where applicable apply Quality Audits Reports and/or Quality
- Records on previous demonstrated capability and performance of subcontractors.
- Quality Records of acceptable subcontractors are maintained.
- Purchasing Data
- Purchasing document shall contain data clearly describing the product ordered, including where applicable:
- Type, grade, class or other precise identification
- Tittle or positive identification, applicable issues of specifications, drawings, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment and personnel.
- Review/approve purchasing documents for adequacy of specified requirements prior to release.
- Supplier Verification at subcontractor’s premises
- Where verify at subcontractors premises, shall specify:
- Verification arrangements
- Method of product release in purchasing document.
- Customer Verification of subcontracted product
- Must be specified in contract
- Verification can not be used as evidence of effective Quality
- Verification does not remove the responsibility for acceptable product
- Verification does not stop rejection of item by the customer
- Other Questions
Customer Supplied Product
- Establish and maintain documented procedures for :
- Verification
- Storage
- Maintenance
- Product that is:
- Lost
- Damaged
- Otherwise unsuitable
- Shall be recorded and reported to the customer.
- Verification by the supplier does not absolve the responsibility to provide acceptable product.
Product Identification and Traceability:
Establish and maintain identification by suitable means from receipt to delivery. Maintain identification as required/specified and have Quality Records for this case.Process Control
Identify and plan activities, production, installation, and servicing activities that affect Quality. Activities carried out by controlled conditions shall include:- Procedures where absence could adversely affect Quality
- Use of suitable equipment and environment
- Compliance with reference standards/codes, quality plans, documented procedures
- Monitoring/control of process parameters and product characteristics.
- Approval of processes and equipment as applicable.
- Criteria for workmanship
- Suitable maintenance of equipment to ensure continuing process capability.
- Process that can not be verified by subsequent inspection and test require:
- Qualified operators and/or
- Continuous monitoring
- Control of process parameters to ensure that specified requirements are met.
- Requirements of qualified operators and equipment shall be specified and records shall be maintained.
Inspection and Testing
Establish and maintain documented procedures/Quality Plans. Required test and records shall be detailed in Quality Plans or documented procedures and implemented.- Receiving Inspection and Testing
- All incoming product is inspected or tested or otherwise verified before use.
- Determination of the amount and nature of receiving inspection is based upon amount of control at subcontractors premises and recorded evidence of conformance provided.
- Where product is released for urgent production, product is identified and recorded (QA Record) in order to permit immediate recall and replacement in event of nonconformity.
- In process Inspection and Testing
- Inspect and test product as required
- Hold product until required inspection and testing have been completed/documented/verified except for
- Final Inspection/Testing
- Implement inspection and test to complete evidence of conformance of finished product to specified requirements.
- Quality Plan/Procedure require all final inspection/test accomplished and results meets specified requirements. No product dispatched until all activities have been satisfactorily completed and associated data/documentation are available and authorized.
- Inspection/Test Record
- Establish and maintain records for product that has been inspected/tested. Records shall show:
- Product passed/failed to defined acceptance/rejection criteria
- If fail, apply procedures for nonconformance
- Shall identify the inspection authority responsible for release of product
Inspection, Measuring, Test Equipment
Establish and maintain procedures for inspection and test equipment and test software used to demonstrate product conformance. Test equipment used to:- I a manner which ensures that the measurement uncertainty is known and
- Consistent with the required measurement capability.
- When test software/comparative references are suitable forms of inspection they shall be:
- Checked to prove capable of verification
- Rechecked of prescribed intervals and
- Recorded and maintained as evidence of control
- When calibration data is required, data is made available to customer.
Control Procedure
- Determine measurements to be made
- Accuracy required
- Select appropriate equipment
- That is capable of necessary accuracy and precision
- Identify all equipment
- Calibrate/adjust at prescribed intervals or prior to use
- Traceable to NIST or industry standard
- If no standard exists, basis for calibration is documented
- Define calibration process including:
- Equipment type
- Unique identification
- Location
- Frequency of checks
- Check method
- Acceptance criteria
- Action taken when out of calibration
- Identify equipment by suitable indicator or approved identification record to show calibration status.
- Maintain calibration records
- Assess and document validity of previous inspection/test equipment out of calibration.
- Ensure suitable environmental condition for use of equipment
- Ensure handling, preservation and storage is such that accuracy and fitness for use are maintained
- Safeguard equipment and test software from adjustments which invalidate the calibration setting.
Inspection and Test Status
Status identified by suitable means that indicates conformance/nonconformance throughout the production, installation, and servicing of product.Control of Nonconforming Product
Establish and maintain documented procedures to ensure that product that does not conform to specified requirements is prevented from unintended use or installation. Controls provide for:Identification, documentation, evaluation, segregation (when practical), disposition, and notification
Review and Disposition: Responsibility for review, authority for disposition shall be defined. Product reviewed in accordance with documented procedures. Product may be:
- Reworked to meet specified requirements
- Accepted with/without repair by concession
- Regraded for alternative application
- Rejected or scrapped
Corrective and Preventive Action
Establish and maintain documented procedures. Corrective/Preventive action shall be to degree appropriate to the magnitude of the problem and commensurate with risk encountered.Shall implement and record any changes to documented procedures resulting from corrective/preventive action.
Corrective Action: Procedures shall include:
- Customer complaints, product nonconformity
- Cause, recording of results (Quality Record)
- Determination of corrective action to eliminate cause
- Application of controls to ensure action is taken and effective
Preventive Action: Procedures shall include:
- Use of appropriate source of information:
- Process and work operations
- Concessions
- Audit results
- Quality Records
- Service reports
- Customer complaints
- Ensuring that revelant information or actions is submitted for management review.
Handling, Storage, Packaging, Preservation, and Delivery
General: Establish and maintain documented proceduresHandling: Provide methods of handling product that prevents damage or deterioration.
Storage: Use designated storage areas or stock rooms to
Prevent Damage: Deterioration of product pending use or delivery Appropriate methods for authorizing receipt to and dispatch from such areas shall be stipulated.In order to detect deterioration of the condition of the product in stock, the condition shall be assessed at intervals
Packaging Control
Packaging: Marking Processes including material used to ensure conformance to specified requirements
Preservation: Use appropriate methods for
- Preservation
- Segregation when under supplier control
- Delivery
Control of Quality Records
Maintained to demonstrate conformance to specified requirements and effective operation of the Quality System. Subcontractors records are included. Documented procedures for:- Identification
- Collection
- Indexing
- Access
- Filling
- Storage
- Maintenance
- Disposition
- Quality Records shall be Legible
- Quality Records shall be Stored/retained-readily retrievable
- Quality Records shall be Facilities provide suitable environment to prevent damage or loss or deterioration
- Quality Records shall be Retention time established/recorded
- Quality Records shall be Contractually required-records are available to the customer or customer representative.
- Quality Records are required for Management Review
- Quality Records are required for Contract Review
- Quality Records are required for Design Review
- Quality Records are required for Design Verification
- Quality Records are required for Acceptable Subcontractors
- Nonconforming Customer Supplied Product
- Quality Records are required for Product Identification
- Quality Records are required for Inspection and Test
- Quality Records are required for Calibration
- Inspection authority for release of product
- Investigation of cause for Corrective Action
- Results of Internal Audits
- Follow-up for Internal Audits
- Quality Records are required for Training Records
Internal Quality Audits
Follow-up audit activities shall verify and record the implementation and effectiveness of the corrective action taken. (Quality Record)Documented procedures for- Planning
- Implementing
- Verify whether Quality activities and related results comply with planned arrangements
- Determine effectiveness of Quality System
- Audits shall Be scheduled on the basis of status/importance
- Audits shall Carried out by independent personnel
- Results of audits Recorded (Quality Records)
- Results of audits Brought to the attention of personnel having responsibility in the area audited.
- Results of audits Management take timely corrective action
Training
Documented procedures for:- Identifying training needs
- Provide training
- Personnel performing specific assigned tasks shall be qualified as appropriate by:
- Education
- Training and/or experience
- Quality Records are maintained
Servicing
Warranty activities may be considered as servicing or may be addressed as nonconforming product/Corrective & Preventive Action. Documented procedures for:
- Performing
- Verifying
- Reporting of Top 85 Required Documents for Tesco Technical Audit
- That the servicing meets the specified requirements
Statistical Techniques
Identification of Need: Identify need for statistical techniques for:- Establishing
- Controlling
- Verifying
- Process capability and product characteristics
- Procedures of Internal Audit
- Procedures to implement and control the application of statistical techniques identified
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