Example of Procedure for Analysis of Data

1.0 PURPOSE

The purpose of the procedure is to establish a system for the identification, collection, and analysis of data to demonstrate the suitability and effectiveness of the quality management system. At XXX, Data analysis includes data generated from monitoring and measurement, internal audits, management reviews, and other relevant sources.

2.0 SCOPE

This procedure is applicable to all the following systems and standards

• ISO 9001: 2020/ API Spec Q1, 9th edition
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3.0 RESPONSIBILITY

• Management Representative
• Quality Systems Manager
• All concerned process heads

4.0 INPUT

• Customer satisfaction Feedback
• Customer Complaints
• Audit Results
• Conformity to product requirements.
• Nonconformities and product failures identified after delivery or use.
• External provider/Suppliers Performance
• Quality objectives

5.0 RESOURCES

Competent Manpower, Computers, Printer & Internet connection, Stationaries, XXX Procedures

6.0 PROCEDURE

• Management Representative reviews the data collected like customer complaints and identifies the statistical techniques for establishing, controlling and verifying process capability, product characteristics.
• As soon as suitable technique is identified, it is used in the relevant area.
• The analysis of data provides information relating to;
  • Customer satisfaction
  • Customer Complaints
  • Self – Assessment
  • Audit Results
  • Conformity to product requirements.
  • Nonconformities and product failures identified after delivery or use, provided the product or documented evidence is available to facilitate the determination of the cause
  • Characteristics and trends of process and products including opportunities for preventive action.
  • Suppliers Performance
  • Information on Quality objectives
• Corrective actions taken are to ensure their effectives.
• The Data Analysis record is maintained.
• The data from the above is analyzed periodically (at least once in 3 months) and statistical report is prepared and submitted to the top management (CHAIRMAN) for information and necessary follow-up for the corrective action and continual improvement of the system/area. 
• Summary of the statistical analysis is produced in the Management Review Meeting.

6.1 CUSTOMER FEED BACK

Customer Satisfaction is detailed in procedure for Customer Satisfaction

6.2 CUSTOMER COMPLAINT

1. All customer complaints received within XXX are recorded in the customer complaint Record.
2. It is the responsibility of all managers and staff to report in case of receipt of any customer complaints to the Quality Systems Manager and Management Representative by forwarding such written complaints received from the client. In case of verbal complaints the concerned personnel records such complaint in the customer complaint Record or send a written note to the Management Representative.
3. The customer complaint is used as a tool for the verification of customer satisfaction. All customer complaints within XXX are logged in the customer complaint record and are subject to the verification of Management Representative, and a review of customer complaints is carried out periodically.
4. All personnel in XXX have the responsibility to inform the Management for any customer complaints reported verbally or in written format.
5. Each customer complaint is treated as Non-conformities within XXX and necessary corrective and preventive actions taken accordingly.
6. No of customer complaints/ or the frequency of customer complaints are monitored in weekly basis and the trend of NCs are reviewed accordingly.
7. Management Representative summarizes the above with the status of corrective and preventive action and furnish the same for the Management Review.

6.3 VERIFICATION OF CONFORMITY TO PRODUCT REQUIREMENT

1. XXX realize that the product conformance are the results of using right personnel on right job, using right material, machinery, tools etc., and well understanding of customer requirements. All personnel performing product manufacturing or providing services are trained to carry out their task in order to meet the product service requirements.
2. This requirement is being monitored during various stages of the manufacturing process or service by the supervisors and Inspection personnel.
3. Training needs and records are verified during Management Review Meetings once in 12 months.
4. All production equipments are checked periodically and monitored for its fitness for the intended use. All measuring equipments are calibrated, validated and checked prior to use. Records are maintained for historical review.
5. Deviations and non-conformities, trends of NCs, reasons, occurrence and recurrence are recorded and verified periodically, and necessary corrective action and opportunities for preventive measures are verified accordingly.

6.4 SUPPLIER OR SUB-CONTRACTOR VERIFICATION

1. In order to maintain the product/service quality, XXX has to be aware of the performance of the vendor/supplier/ sub-contractor that can be managed within this Quality Management System.
2. XXX follows an approved vendor/subcontractor list and the suppliers and sub-contractors are reviewed once in 12 months.
3. Data pertaining to each supplier or subcontractor are maintained in the Procurement Department.

7.0 OUTPUT

Analysis of Customer feedback, analysis of Supplier performance, Quality objectives status, Analysis of Audit Results, Conformity to product requirements.

8.0 KEY PERFORMANCE INDICATOR

All analysis done and related action plans & corrective actions

9.0 ASSOCIATED DOCUMENTS & RECORDS

DESCRIPTION	FORMAT NUMBER	RESPONSIBILITY
Master List of Quality Objectives	XXX / MR / D07	Management Representative
Nonconformance Report	XXX / MR / 09	Management Representative
QHSE Performance Analysis	XXX / MR / 22	Management Representative
Customer feedback form	XXX / COM / 04	Commercial Officer
Annual Customer Evaluation	XXX / COM / 09	Commercial Officer
Production Monitoring & Delivery Status	XXX / COM / 10	Commercial Officer
Supplier Evaluation Form	XXX / PRO / 04	Procurement Engineer
Vendor Rating	XXX / PRO / 06	Procurement Engineer
Customer Complaint Record	XXX / QA / 14	QA/QC Engineer
Nonconformance Product Report	XXX / QA / 42	QA/QC Engineer