Virtual QcC audit for Suplier Certification-Copy

Questionnaire Audit
Supplier:
Date:
Client:
Quest Nr. Question Answers
A. General / Accreditation / Policies
PI - General management

1.1 IS09001? (quality standard)

ISO 9001 is a globally recognized standard for quality management systems (QMS) that helps organizations improve their performance and meet customer expectations
ISO 14001 is the principal management system standard which specifies the requirements for the formulation and maintenance of an EMS. This helps to control your environmental
1.2 IS014001? (environmental management)
aspects, reduce impacts and ensure legal compliance.
IS045001? (health & safety) ISO 45001 is an international standard for occupational health and safety management systems. It provides a framework for organizations to: Reduce workplace risks, Improve health
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and safety, Promote well-being at work, and Demonstrate compliance with health and safety law.
IS050001? (energy management) The ISO 50001 standard is designed to help companies develop a coherent energy strategy for the short, medium and long term. By establishing a structured framework, it enables
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precise action plans to be defined and energy efficiency initiatives to be prioritized.
1.5 Other accreditations?
B. Quality Assurance
P2 - Machine / Product Specs
Maintaining Machine Specifications involves the following steps :
1. Records: Maintain detailed machine specs and performance logs.
2. Inspections: Regularly check machines for compliance.
3. Maintenance: Perform scheduled preventive maintenance.
2.1 How are machine specifications maintained? 4. Calibration: Periodically calibrate for accuracy.
5. Updates: Keep software and controls updated.
6. Training: Train operators on machine specs and monitoring.
7. Monitoring: Use sensors for real-time performance tracking.
8. Corrections: Address and document deviations immediately.
1. Documentation: Maintain detailed, updated records of product specifications
2. Version Control: Use a system to track changes and revisions.
3. Approvals: Ensure all updates are reviewed and approved by relevant teams.
4. Distribution: Share updated specifications with production, QA, and stakeholders.
2.2 How are product technical specifications maintained?
5. Audits: Regularly audit specifications for accuracy and relevance.
6. Training: Train staff on changes to ensure compliance.
7. Storage: Secure specifications in a centralized, accessible system.
8. Review: Periodically review to align with market or regulatory changes.
1. Verification: Compare machine/product specifications against standards or design requirements.
2. Testing: Conduct functional and performance tests to ensure compliance.
3. Calibration: Validate machines with calibrated tools and reference standards.
2.3 How are machine & product specifications verified / authorized? 4. Inspection: Perform visual and dimensional checks on products.
5. Approvals: Obtain authorization from engineering or quality teams for specifications.
6. Documentation: Record verification results and approvals in a controlled system.
7. Audits: Periodically audit verification processes to maintain consistency.
1. Frequency: Reviews are conducted at regular intervals (e.g., monthly, quarterly, or annually) or after major changes.
2. Process:Compare specifications to current standards and requirements.Inspect and test machines/products to ensure compliance.Identify deviations and update specifications if
needed.
2.4 What is frequency of and process for review / checks of machine & product specification?
3. Approvals: Verified changes are reviewed and authorized by quality/engineering teams.
4. Documentation: All checks and updates are recorded for traceability.
5. Audits: Internal audits ensure adherence to the review schedule.

1. Daily Maintenance: Routine checks, cleaning, lubrication, and inspection of essential parts.
2. Preventive Maintenance: Scheduled maintenance (weekly/monthly) to replace wear parts, calibrate machines, and prevent breakdowns.
2.5 What is the maintenance schedule? (Preventive Maintenance, Daily Maintentance, etc.) 3. Predictive Maintenance: Monitor machine performance using sensors and data to address issues before failure.
4. Annual Maintenance: Comprehensive inspection and overhaul of machinery.
5. Emergency Maintenance: Unplanned repairs to fix breakdowns immediately.
6. Documentation: Maintain detailed logs of all maintenance activities.

1. Planning: Schedule preventive maintenance and monitor equipment health.

2. SOPs: Follow standard procedures and document all activities.
3. Work Orders: Assign tasks with clear timelines.
4. Inspections: Use checklists to identify defects early.
2.6 How is the maintenance and overhaul of production facilities / tools controlled? 5. Overhaul: Assess, clean, repair/replace parts, and test machinery.
6. Quality Control: Verify functionality and production output after maintenance.
7. Training: Equip staff with necessary skills and updates.
8. Spare Parts: Maintain inventory of critical components.
9. Monitoring: Track performance metrics like downtime and repair time.
10. Compliance: Ensure safety and industry standards are met.
P3 - Packaging

3.1 How is packaging chosen to ensure quality of the material? Packing is chosen based on material compatibility, ensuring it protects against moisture, dust, and impact while being durable and the right fit. It should preserve the product,
comply with standards, and be eco-friendly if possible. cost and also considered to ensure quality and customer satisfaction.
P4 - Quality Management

An organization in quality management ensures products or services meet customer expectations and regulatory standards. Its functions, responsibilities, and backup include.
4.1 What is the Organisation? Functions, responsibilities and back up with respect to Quality management. Functions: Set quality standards, monitor performance, and drive improvements.
Responsibilities: Top management sets goals, the quality team ensures compliance, and production follows processes.
Backup: Maintain SOPs, train staff, have contingency plans, and use redundant systems.
Incidents and Quality Issues Management:
Detection: Identify issues via inspections.
Quarantine: Isolate off-quality materials.
Root Cause: Investigate the cause.
4.2 How are Incidents and Quality issues managed? (off-quality material, quarantine, concessions etc.)
Corrective Action: Implement fixes.
Concessions: Allow limited use if acceptable.
Documentation: Record actions and resolutions.
Follow-Up: Verify effectiveness of fixes.

QC Procedures:
4.3 What are the QC procedures and status of reference standards? Sampling, Testing, Inspection, Documentation, Corrective Action.
Reference Standards:
Calibration, Validity Check, Proper Storage, Traceability.

Corrective & Preventive Actions:

Identification: Detect issues or potential risks.
Analysis: Find root causes and assess risks.
4.4 How are corrective & preventive actions manages ?
Action Plan: Implement fixes (corrective) or improvements (preventive).
Implementation: Apply actions and monitor effectiveness.
Documentation: Record actions and outcomes.
Review: Verify and review for recurrence prevention.
Continuous Improvement Systems:
Kaizen: Incremental improvements in all processes.
Six Sigma: Reducing defects and variation in processes.
4.5 What system of continuous improvement are used? For what processes? Lean: Eliminating waste and improving efficiency.
PDCA (Plan-Do-Check-Act): Iterative process for ongoing improvement.
5S: Organizing workspaces to improve productivity.
Used for:
Production processes, Quality control, Supply chain, Maintenance, Customer service.
Change Control: Formal approval process for changes (documents, forms).
Risk Assessment: Evaluate potential impacts of changes.
Authorization: Ensure changes are approved by relevant authorities.
4.6 What system are use for management of change(Authorisation,communication,etc.).
Communication: Notify all stakeholders through meetings, emails, or systems.
Documentation: Record all changes for traceability and future reference.
Training: Provide necessary training for affected personnel
Claims Procedure:
Communication: Notify relevant stakeholders (internal and external) about the claim.
Authorization: Obtain approval from authorized personnel before proceeding.
4.7 What is the procedure with respect to claimes (communication , authorization and financial rulings). Investigation: Assess the validity of the claim, gather evidence, and analyze.
Resolution: Decide on compensation, repair, or replacement based on findings.
Financial Rulings: Approve financial settlements or reimbursements following company policy.
Documentation: Record all claim details, actions, and outcomes for future reference.
B. Production / Supply chain
P5- Supply Chain Management
System for Selection & Approval of Key Suppliers:
Supplier Evaluation: Assess potential suppliers based on quality, reliability, cost, and capacity.
Audits/Inspections: Conduct on-site visits or audits to verify capabilities and compliance.
5.1 What is the system for Selection & Approval of key Raw Material / service suppliers? Approval Process: Review and approve suppliers based on set criteria and risk assessments.
Trial Orders: Place test orders to evaluate performance.
Contract & Terms: Formalize agreements detailing quality standards, delivery timelines, and payment terms.
Ongoing Monitoring: Continuously evaluate supplier performance through KPIs and regular reviews.
 System for Management of Key Suppliers:
Supplier Audits: Conduct regular audits to assess compliance with quality standards and regulations.
Supplier Assessment: Evaluate based on criteria like quality, delivery performance, and cost-effectiveness.
5.2 What is the system for management of key suppliers (audits, assessments, KPls etc.)? KPIs: Monitor key performance indicators like on-time delivery, defect rates, and responsiveness.
Performance Reviews: Regularly review supplier performance and hold meetings for feedback and improvements.
Corrective Actions: Implement corrective actions for underperforming suppliers, with timelines for improvement.
Continuous Improvement: Collaborate with suppliers to drive continuous improvement initiatives.
Incoming Materials Quality Assurance:
Supplier Certification: Verify suppliers' quality certifications (e.g., ISO).
Inspection: Perform visual and dimensional checks upon arrival.
5.3 How are incoming materials quality assured? Sampling: Random sampling and testing of materials for conformity.
Documentation: Review certificates of analysis (COA) and other relevant documents.
Non-Conformance: Quarantine and investigate any materials that don’t meet specifications.
Approval/Rejection: Approve materials that meet quality standards or reject non-compliant ones.
Incoming Goods Storage & Inventory Management:
Receiving: Inspect and verify goods upon arrival, checking for damage and discrepancies.
5.4 How are incoming goods stored and inventory managed? Quarantine: Store non-conforming or unverified goods separately until clearance.
Labeling: Properly label items with batch numbers, expiry dates, and other identifiers.
Storage: Store goods in designated areas, ensuring proper environmental conditions.
Stock Rotation: Implement FIFO (First In, First Out) or LIFO (Last In, First Out) to manage stock.
Control of Outsourced Processes:
Vendor Selection: Choose qualified vendors based on capability, reliability, and quality standards.
Contracts/Agreements: Define clear quality expectations, timelines, and responsibilities in formal contracts.
5.5 If any processes are outsourced, how are these processes controlled? KPIs: Monitor key performance indicators (e.g., delivery times, quality, costs) to track supplier performance.
Communication: Maintain regular communication with suppliers for updates and issue resolution.
Documentation: Keep records of outsourced processes, including quality reports and corrective actions.
Review & Feedback: Regularly review outsourced processes and provide feedback for improvement
Risk Management & Business Continuity Controls:
Risk Identification: Identify potential risks (e.g., supply chain disruptions, equipment failure, natural disasters).
Risk Assessment: Evaluate the likelihood and impact of risks on operations.
What processes of Risk management, business continuity controls, including safety stock where applicable, are Mitigation Strategies: Develop strategies to reduce or eliminate risks (e.g., supplier diversification, preventive maintenance).
5.6
used? Business Continuity Plan (BCP): Create and maintain a BCP outlining steps to continue operations during disruptions.
Safety Stock: Maintain extra inventory of critical materials to buffer against supply chain disruptions or unexpected demand.
Contingency Planning: Develop and test backup plans for key processes (e.g., alternate suppliers, emergency response).
Regular Reviews: Continuously assess and update risk management and continuity plans based on changing conditions
P6 - Process / Production
1 Process Input
Identification, Approval, Storage, and Transport of Incoming Materials:
Identification: Label materials with unique identifiers (e.g., batch number, SKU, or lot number) upon arrival.
6.1.2 How are incoming materials suitably identified/ approved / stored / transported? Approval: Inspect materials for quality, verify certificates of analysis (COA), and test samples before approval.
Storage: Store materials in designated, controlled areas, ensuring proper environmental conditions .
Transportation: Use proper packaging to protect materials during transit, and ensure secure handling to prevent damage.
Documentation: Maintain records of receipts, approvals, and storage locations for traceability.

Tracking and Documenting Changes to Product or Process:

Change Control System: Use a formal change control process to request, approve, and implement changes.
6.1.3 How are changes to the product or process tracked and documented? Documentation: Record all changes in change request forms, including details of the change, reasons, and impact analysis.
Approval: Obtain approval from relevant authorities before implementing changes.
Traceability: Link changes to production batches or process runs for traceability.
Communication: Notify all relevant teams (e.g., production, quality) of the changes and ensure proper training if needed.
2 Process Sequence

Measuring and Documenting Key Production and Test/Inspection Parameters:

Measurement: Use calibrated instruments (e.g., gauges, calipers,measuring tapes,gloss meter , power puck, etc.) to measure key parameters (e.g., dimensions,Gloss, intensity,etc.).
Standard Operating Procedures (SOPs): Follow predefined SOPs for each parameter to ensure consistency.
6.2.1 How are key production and test/inspection parameters measured and documented?
Real-Time Monitoring: monitoring the machine parameters during production and testing.
Documentation: Record measurements in batch records, test logs for traceability.
Data Analysis: Analyze recorded data for trends, outliers, or deviations from the set standards.
Quality Control: Include pass/fail criteria and corrective actions for out-of-spec measurements.
Checking, Approving, and Controlling Production Operations:
Planning: Set clear production schedules, goals, and quality standards.
Inspection: Perform in-process checks (e.g., visual, dimensional, functional) during production.
Approval: Ensure approval from supervisors or quality control before moving to the next stage.
6.2.2 How are production operations checked , approved , and controlled?
Documentation: Maintain production logs and quality records for traceability.
Process Control: Use control charts, monitoring systems, and regular audits to ensure consistency.
Corrective Actions: Implement corrective actions for any deviations or non-conformities.
Post-Production Review: Conduct final inspections and approvals before product release.
 Managing Scrap, Rework, and Setting Parts:
Separation: Designate separate areas for scrap, rework, downgrade materials to avoid mixing.
Labeling: Clearly label each category with tags (e.g., "Scrap", "Rework", "B-Grade") to identify them easily.
6.2.3 How are scrap, rework and setting parts kept separate and identified?
Documentation: Record quantities and reasons for scrap and rework in logs or tracking systems.
Inspection: Inspect rework parts to ensure they meet quality standards before returning to production.
Tracking: Use inventory control systems to monitor scrap rates, rework actions, and setting part usage.
Recycles: Define processes for scrap disposal or recycling, and ensure reworked parts are reapproved before reuse.
3 Personnel Support
Training and Qualification of Operators:
Initial Training: Provide onboarding training on safety, equipment operation, and quality standards.
Job-Specific Training: Offer hands-on training for specific tasks or machines, including SOPs and troubleshooting.
6.3.1 How are the operators trained and qualified? Ongoing Training: Conduct regular refresher courses and update training on new processes or technologies.
Competency Evaluation: Assess operator skills through tests, performance reviews, and practical assessments.
Documentation: Maintain records of training sessions, certifications, and evaluations for each operator.
Mentorship: Assign experienced operators to mentor new hires for practical learning.
4 Process effectiveness level
Measuring and Communicating Process Efficiency, Productivity, and Quality:
1. Process Efficiency:
Measured by cycle time, throughput, and utilization rates.Tracked through performance monitoring systems or manual logs.
2. Productivity:
Measured by output per unit of time or labor (e.g., units produced per hour).Compared against target goals for continuous improvement.
6.5.1 How is process effiency, productivity, and quality measured and communicated to operators?
3. Quality:
Measured by defect rates, first-pass yield, and customer complaints.Monitored through in-process and final inspections.
4. Communication to Operators:
Display real-time performance data via dashboards or visual boards.Provide regular feedback through daily/weekly meetings or reports.Use performance indicators (KPIs) to highlight
areas for improvement.Offer training and support to maintain and improve performance.
Auditing Processes and Products:
Processes: Audited with checklists for SOP and quality compliance.
6.5.2 How are processes and products audited? What is time schedule? Products: Inspected for conformity to specifications.
Schedule: Regular audits (quarterly/annually for processes, per batch/shift for products).
Follow-up: Implement corrective actions and document results.

Root Cause Analysis & Corrective Actions:

Analysis: Use 5 Whys or Fishbone Diagram to find the cause.
6.5.3 In the case of deviations, how are the root causes analysed and the corrective actions managed? Actions: Develop and implement corrective plans.
Management: Assign tasks, set deadlines, and track progress.
Documentation: Record deviation, actions, and results.
Verification: Monitor effectiveness of actions.
P7 Customer reports/ Customer Satisfaction/ Services

Customer Service and Planning Processes:

7.1 What are customer service and planning processes? Customer Service: Involves handling customer inquiries, complaints, and feedback, ensuring timely delivery, and maintaining communication throughout the process.
Planning: Includes demand forecasting, production scheduling, inventory management, and ensuring resources are available to meet customer needs. Both processes focus on
ensuring customer satisfaction, meeting deadlines, and resolving issues promptly.

Measuring, Maintaining, and Improving Customer Service Quality:

Quality: Measured through customer feedback, satisfaction surveys, and service audits.
How is quality of customer service (quality, delivery, reporting, and service) measured, maintained, and
7.2 Delivery: Monitored by tracking on-time deliveries, order accuracy, and response time.
improved?
Reporting: Regular reporting on KPIs like response time, issue resolution rate, and customer satisfaction scores.
Service: Assessed through issue resolution effectiveness, customer retention rates, and service level agreements (SLAs).
Improvement: Regular training for customer service teams, process optimizations, and addressing customer feedback for continuous improvement.
 Questions Response

Please provide process map / flow chart of manufacturing process Attatached Last Page

Traceability for Materials and Products:

1. Incoming Materials:
Each batch or lot is assigned a unique identifier (e.g., lot number or batch code) to track its source, supplier, and quality history.Inspection results are recorded, ensuring materials
meet specifications before use.
2. Films:
Traceable through supplier details, batch numbers, and specific film rolls used in production.Documented in inventory records and production logs for easy tracking.
3. Wear Layers:
How do you manage different Batches/Lots? Different print films? Different key materials?
Each wear layer is tagged with batch/lot numbers to ensure consistency and quality.Production data (e.g., usage and quality checks) is recorded for traceability.
4. Cores:
Core materials are identified by batch codes and tracked through the production process for consistency in the final product.
5. Finished Product:
Finished goods are tracked by batch numbers, order no which are recorded in excel.Complete product history, including inspections and tests, is recorded for traceability to
customers.Each stage of the process ensures that all materials and products are traceable back to their source, with relevant records maintained for quality control and regulatory
compliance.

1. Material Identification: Scrap material is identified and separated from other waste during production.
2. Segregation: The scrap material is collected and stored for reuse in the mixer.
3. Grinding Process: The scrap is ground into smaller pieces in the mixer, with IXPE removed to be reused in the production of new SPC tiles.
Description of how manage and incorporate recycled content? 4. Quality Control: The recycled material is inspected for consistency and quality before being reintroduced into the production process.
5. Blending: Recycled material is blended with fresh raw materials as per the required specifications for new SPC tiles.
6. Tracking: The amount of recycled scrap used in production is documented and tracked for traceability.
7. Compliance: Ensure that the reuse of scrap material complies with relevant environmental and industry standards.
8. Continuous Improvement: Regularly assess the process to improve efficiency and quality of recycled material usage.

Monitoring Critical Process Parameters and Controls:

Where in Process: Critical parameters are monitored at key stages, such as raw material handling, production, quality checks, and final inspection.
How are critical process parameters and controls monitored? Where in process? What frequency? What to Monitor: Parameters may include, speed, moisture levels, dimensions, and material quality.
Frequency:Continuous monitoring in real-time for critical parameters.Periodic checks during production (e.g., every batch, shift, or hour) for non-continuous parameters.End-of-line
inspections for finished products.
Controls: Manual checks are used to ensure parameters remain within specified limits. Any deviations trigger corrective actions.

Testing Protocols, Testing Cycle, and Data Availability:

Testing protocols, testing cycle, availability of their data on our product spec. Internal & inline capabilities & are they Testing Protocols: Defined procedures for testing parameters like strength, dimensions, and quality. These are based on product specifications and industry standards.
maintaining run chart? Testing Cycle: Tests are performed at specified stages, including raw material inspection, in-process checks, and final product testing. Frequency varies based on the process,
typically every batch, shift, or after significant changes.
Data Availability: Test results are recorded and made available for reference in product specifications and quality documentation for traceability.
Internal & Inline Capabilities:
Internal Capabilities: In-house laboratories and testing equipment are used for regular checks, including mechanical, chemical, and physical tests.
Inline Capabilities: Manual checks integrated into production lines for real-time monitoring and adjustments.
Maintenance: Run charts are maintained for critical parameters to track trends and performance over time, helping identify deviations and improving process control.

Product Conformance Verification:

Pre-Shipment Inspection: Final inspection and testing are done to ensure product meets specifications (e.g., dimensions, quality, functionality).
Sampling: Random sampling may be performed to verify batch conformity.
How do they verify product conformance prior to shipping, what is their COA process?
COA Process (Certificate of Analysis):
Generation: A COA is issued after testing, confirming that the product meets all required specifications and standards.
Contents: It includes test results, material lot numbers, and compliance with relevant regulations.
Approval: The COA is reviewed and signed by quality control or relevant authorities before shipment.
Documentation: The COA is included with the product shipment for customer verification.
 Traceability for Materials and Products:
1. Incoming Materials:
Each batch or lot is assigned a unique identifier (e.g., lot number or batch code) to track its source, supplier, and quality history.Inspection results are recorded, ensuring materials
meet specifications before use.
2. Films:
What is their traceability?As it relates to: Incoming materials, films, wear layers, cores, and finished product? Traceable through supplier details, batch numbers,design code and specific film rolls used in production.Documented in inventory records and production logs for easy tracking.
3. Wear Layers:
Each wear layer is tagged with batch/lot numbers to ensure consistency and quality.Production data (e.g., usage and quality checks) is recorded for traceability.
4. Cores:
Core materials are identified by batch codes and tracked through the production process for consistency in the final product.
5. Finished Product:
Finished goods are tracked by order numbers, batch numbers or other identifiers linking them to raw materials used.Complete product history, including inspections and tests, is
recorded for traceability to customers.
Each stage of the process ensures that all materials and products are traceable back to their source, with relevant records maintained for quality control and regulatory compliance.
Process for Controlling Nonconforming Product with Customers:
1. Identification:
Upon detecting nonconformance, the product is flagged and segregated to prevent further use or shipment.
2. Assessment:
The nonconformance is evaluated to determine its severity, impact on functionality, and whether it can be reworked or replaced.
3. Communication:
Inform the customer immediately about the issue, providing details about the nonconformance and potential impact.
4. Corrective Actions:
Process for controlling nonconforming product with customers? Develop and implement corrective actions, such as reworking, replacing, or issuing credits.
5. Approval:
Gain customer approval for any corrective action plan (e.g., replacement product, refund, or rework).
6. Documentation:
Document the nonconformance, assessment, corrective actions taken, and customer communication for traceability.
7. Root Cause Analysis:
Conduct root cause analysis to prevent recurrence of the nonconformance.
8. Follow-Up:
Monitor the effectiveness of corrective actions and maintain ongoing communication with the customer to ensure satisfaction.

Certification of Incoming Raw Materials:

1. Supplier Certification:
Ensure that suppliers provide certificates of analysis (COA) for each batch of raw materials, confirming compliance with specified standards.
2. Inspection and Testing:
Conduct initial inspection and quality tests upon receipt to verify the material's conformity to the required specifications (e.g., physical, chemical properties).
Certification of incoming raw materials? 3. Documentation:
Maintain records of COAs, inspection results, and test reports for traceability and compliance
4. Approval/Rejection:
Approve materials that meet specifications; reject those that don't meet quality or regulatory standards.
5. Storage and Traceability:
Store materials with clear labeling, including COA information, to ensure traceability throughout production.
6. Ongoing Monitoring:
Continuously monitor raw materials throughout the production process for quality control.
Change Management Process (Communication of Changes):
1. Change Identification:
Changes can be related to raw materials, processes, equipment, specifications, or regulatory requirements. The change is identified by either internal teams or suppliers.
2. Impact Assessment:
Assess the potential impact of the change on quality, production, compliance, and customer requirements.
3. Notification:
Suppliers or internal teams must notify the relevant stakeholders (including customers) of any changes, typically through formal communication channels such as emails, change
notifications, or updated documentation (e.g., COAs, process changes).
4. Documentation:
Document the change, including the reason, scope, and any necessary adjustments in production or quality processes.
Change management process (communication to us on changes?
5. Approval:
The change is reviewed and approved by designated authorities (e.g., quality control, production managers) to ensure it meets specifications and does not compromise product
quality.
6. Implementation:
Once approved, the change is implemented in production or operations, with new procedures or materials integrated as needed.
7. Feedback and Monitoring:
After implementation, monitor the results and provide feedback to ensure the change is effective and doesn't negatively impact the product.
8. Customer Communication:
If the change impacts customer products or delivery, inform customers promptly with all relevant details and any actions they need to take.This process ensures that any changes are
effectively communicated, documented, and evaluated for their impact on quality and compliance.
 Run Charts for CTQs (Critical to Quality) for a Current Product:
1. Data Collection:
Collect data on the Critical to Quality (CTQ) parameters, such as dimensions, weight, strength, appearance, or any other key product characteristic.
2. Frequency:
Gather data at regular intervals (e.g., hourly, per shift, or per batch) during the production process.
3. Chart Creation:
Plot the collected data on a run chart, with time (or production batch) on the x-axis and the CTQ parameter on the y-axis.
Run charts of CTQ's if the product is a current product for vendor? 4. Analysis:
Observe trends, shifts, or patterns that could indicate potential issues with the production process or product consistency.
Monitor if the CTQ values stay within the defined acceptable limits.
5. Action:
If the data shows any outliers or trends outside the acceptable range, investigate the root cause and implement corrective actions.
6. Communication:
Share run charts with relevant stakeholders (e.g., quality control, production teams, suppliers) for awareness and decision-making.
By using run charts, you can visually track CTQs and ensure that the product continues to meet quality standards over time.

Change Management Process:

1. Change Identification:
Any change in product, process, materials, equipment, or regulations is identified by internal teams or suppliers.
2. Impact Analysis:
The potential impact of the change on quality, production, and customer requirements is assessed.
3. Documentation:
The change is formally documented, including the reason for change, the scope, and the anticipated effects.
4. Approval:
What is your Change Management Process? How/when are process changes communicated to us? Changes are reviewed and approved by designated authorities (e.g., quality control, engineering, management) before implementation.
5. Implementation:
Once approved, the change is implemented in the production process, product design, or operational procedure.
6. Monitoring:
The effectiveness of the change is monitored to ensure it achieves the desired outcomes without compromising product quality.
7. Communication:
When: Process changes are communicated to you in advance of implementation, typically when the change is finalized, or when it affects production.
How: Communication is done through formal notifications, emails, updated documentation (e.g., specifications, process flows), or meetings.
8. Customer Feedback:
If the change impacts customer products, you will be notified of any necessary actions on your part (e.g., new product batches, approvals).This structured process ensures
transparency and allows all stakeholders, including customers, to be informed and aligned with any process changes.
Procedure for Outside Inspection Before Shipment:
1. Inspection Request:
The customer or a third-party inspection agency requests an inspection prior to shipment, or it may be scheduled as part of the standard process.
2. Documentation Review:
Inspectors review product specifications, certificates of analysis (COA), and quality control documents to ensure compliance with agreed standards.
3. Product Sampling:
A sample of the finished products is selected for inspection based on a defined sampling plan, often according to international standards.
4. Inspection Criteria:
Inspectors check key product parameters such as dimensions, appearance, functionality, and compliance with the specifications.
What is the procedure for outside inspection before shipment? 5. Testing (if required):
If necessary, additional tests (e.g., strength,durability,impact testing) are conducted to verify the product's quality.
6. Report Generation:
After the inspection, the inspector generates a detailed report outlining the findings, including any non-conformance or issues detected.
7. Approval or Rejection:
Based on the inspection report, the product is either approved for shipment or requires corrective action (e.g., rework, replacement).
8. Customer Notification:
If required, the customer is notified of the inspection results and any actions taken (rework or shipment delay).
9. Shipment:
Upon approval, the product is cleared for shipment with proper documentation, including the inspection certificate and other quality records.
 The expected claim rates and types for a product depend on various factors, including the product's complexity, industry standards, customer expectations, and historical data.
However, for typical manufacturing products, the claims can generally fall into the following categories:
Expected Claim Rates:
1. Low Claim Rate:
For high-quality products with well-established processes, claim rates are usually low (typically 1-3% of the total orders).
This could be influenced by factors like good quality control, preventive maintenance, and customer satisfaction.
2. Moderate Claim Rate:
For moderately complex products or those with occasional quality issues, claims may range from 3-10%.
Frequent issues may include minor defects or delivery delays
3. High Claim Rate:
For new products, products with known quality challenges, or products involving complex supply chains, claims could be higher (10%+).
Claims may be more frequent in industries with stricter standards or for new suppliers who are still improving processes.
What are the expected claim rates and types on this type of product? Types of Claims:
1. Defective Product Claims:
Customers report defects in the product, such as functional issues, physical damage, or non-compliance with specifications.
2. Delivery or Shipping Issues:
Claims due to delays, incorrect quantities, or damage during transport.
3. Quality or Performance Failure:
Claims related to the product not performing as expected, such as issue during installing, breakage,etc.
4. Non-Conformance to Specifications:
Products that do not meet agreed-upon specifications, such as color, dimensions, or material properties.
5. Product Recall Claims:
Rare but possible in industries where safety or compliance issues are detected post-shipment, leading to product recalls.
6. Warranty Claims:
Claims related to defects covered under warranty, often for repair, replacement, or refunds.
Tracking and addressing claims is vital for improving quality and customer satisfaction, while also identifying opportunities for process improvements.

Do you have local inspection process in the US, Canada, EU?

Who is the technical resource for product and installation questions? Is there local US assistance?