DORE QUALITY OPERATION PRESENTATION
DORE established, implemented and maintained a quality management system and continually improves its effectiveness in accordance with the requirements of International Standard, which aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
1. QUALITY POLICY
DORE's reputation for product quality is among its most valuable assets. Our commitment to product quality is an integral part of our design, manufacturing, testing and distribution processes, and is essential to the success of our business. Product reliability and customer satisfaction are our primary concern. We will meet or exceed legal requirements and industry standards for product quality. We strive every day to earn our consumers' trust through our dedication to quality, and to exceed the expectations of customers.
Employees have an obligation to immediately report any concerns about product quality to DORE's Quality Department.
2. ROLES AND RESPONSIBILITIES
Overall responsibility for product quality rests with the executive management, headed by the company Chief Executive Officer (CEO). He has the responsibility and authority for execution of the activities to assure that all necessary actions have been taken to assure product quality and to evaluate their effectiveness. He oversees that corrective actions are implemented as needed and has authority to suspend production or shipment of product or to call for a recall if necessary.
Chief Regulatory Officer (Management Representative) reports to the CEO. His role in the organization is to assure that products DORE makes meet the regulatory standards and requirements and that they are safe for customer to use. He works closely with the government sector, industry association and retail businesses to establish the product quality standards.
Quality Department Supervisor is responsible for manufacturing quality and implementation of good manufacturing principles in DORE operation. He manages the Manufacturing Quality organization, which assures that the products are manufactured and inspected according to the specified requirements and releases the products for distribution to the retail channels. He also supports vendor strategy by implementation of the vendor scorecard and ensures vendor accountability.
Corporate Responsibility Auditor performs internal audits to verify that DORE quality and regulatory requirements are being met and that principles of Corporate Responsibility are implemented throughout the corporation.
Quality Control (QC) organization is involved in every stage of the product life cycle, from concept, through manufacturing, to consumer. Its responsibility is to assure that DORE’s products are high quality and meet consumer’s expectations.
As a department, QC has committed to the following directives:
· No compliance = No shipment
· I shall understand and support our corporate direction without compromise
· We will re-establish trust through accreditation
· Partner with the brands while remembering my role
QC manages DORE’s Quality Management System (QMS) with the use of extensive Quality Operating Procedures and Quality Manufacturing Policies. The QC group actively participates in all areas of product development and manufacturing, and assures regulatory compliance through activities of the following organizations:
· Sample Quality Control Team
· Outsourcing Quality Control Team
· Incoming Quality Control Team
· In Process Quality Control Team
· Final Quality Control Team
· Corporate Responsibility Team
Virtually every organization in DORE has an impact on product quality:
Design and Development (D&D) develops products that are safe and reliable for customer, the most vulnerable segment of our society.
Procurement purchases raw materials and components according to specifications prescribed by the D&D and QC groups.
Manufacturing are responsible for producing finished products that meet all specified test and regulatory requirements.
Logistics inventories finished goods, protects them from any damage, and distributes them through retail channels. In the event of a recall, Logistics isolates the product such that it is not inadvertently shipped to the market place.
Consumer Relations reports the feedback from consumers to use for corrective actions on existing products or lessons learned for future products with similar features.
Training for New Employees
New Hire Orientation
New QC Employee Training
Continuing Education Training for QC employees
Employee Proficiency Testing
4. DESIGN REVIEW
At DORE, we build quality into every product. QC works very closely with the product development department throughout the product life cycle. Each product design must go through several reviews for potential failure during the design and development process before it is released to manufacturing.
Individual components including the materials, packaging and labeling are included in the quality review.
When evaluating a product design for potential failure, QC takes into consideration the identity of the intended user, their ability to use the product, and foreseeable use.
5. PURCHASED MATERIALS CONTROL
DORE views purchasing of raw materials and components of critical importance to assure that finished products will be safe and quality. It has procedures for the procurement groups at individual manufacturing locations and at vendors for purchasing of raw materials and components that will be used to manufacture and assemble finished goods.
Purchasing documents include the specifications and requirements purchased materials must meet. They reference Raw Material Specifications which specify the industry standards and regulatory requirements that raw materials and components must meet prior to purchase. Purchasing documents require that the supplier notify DORE of any changes in raw materials, raw material sources, engages in subcontracting, manufacturing processes and/or manufacturing location, so that an appropriate approval plan can be established if needed.
DORE has an extensive supplier certification program, and encourages all key suppliers to become certified. When a certified supplier is available for a specified material, we must use the certified source. Suppliers are categorized by the type of product purchased from them and the potential for safety infractions.
DORE’s policy is that all production operations must follow the Quality Operating Procedures to assure compliance to regulations and product requirement for our consumers.
All materials, work-in-process, and finished goods must conform to the latest revision of the Product Requirement Document (PRD). Work instructions using text, diagrams, or approved visual samples are developed for the factory workers to follow. They help to minimize the variation in the assembly process and assure consistency of the visual attributes of the product. They are accessible in the work areas so that workers can easily refer to them as needed.
In general, production lines have an initial production start check and approval by plant QC and then periodic inspection and test as required for specific products, to assure that the product manufactured will meet all the requirements and be free of potential failure. QC determine when statistical control charts need to be maintained for testing/inspection of the product characteristics that affect product quality. Test and inspection records are maintained by the QC department at each manufacturing facility, documenting the test and inspection results, so that appropriate evaluations can be performed prior to product release to the marketplace.
Any product not meeting the specified requirements is placed on “Hold” by attaching a “Hold Tag” and is segregated to prevent the possibility of inadvertent release into the market. If product is dispositioned to be reworked, the reworked product must meet all requirements of the original design prior to the release to the market. Reworked product must pass all the required tests and inspections prior to the QC acceptance.
7. QUALITY CONTROL
At DORE, quality is designed and built into the product. QC participates in the product design reviews and participates in all stages of the development process.
The manufacturing Quality Control organization is responsible for inspecting the product from initial qualification through finished product audits to assure that it meets design requirements, industry standards, and customer and consumer expectations. They inspect incoming raw materials, perform in-process inspection, and finished product inspection as required by the PRDs and/or applicable customer requirements. Unless otherwise specified, standard sampling tables such as ANSI Z1.4 are used to determine the sample size and the acceptance criteria.
Manufacturing QC issue an inspection sheet for each product, it calls out characteristics to be inspected, frequency of inspection, and the tolerances of gauges to be used; it also calls out the sampling plan, classifies defects as critical, major and minor, and spells out their acceptance levels. QC Inspectors pull random samples from the production lot and perform inspections and/or tests as specified on the inspection sheet. They record the results in the check sheets or in the computer database depending on the facility’s systems so that the data are available for evaluation prior to product release. Any product that fails the inspection must be identified with red “reject” tags and isolated in the area designated for non-conformant product, until disposition is reached and the product is either determined to be acceptable as is and released, reworked to meet the requirements, or scrapped.
8. CORRECTIVE AND PREVENTIVE ACTIONS
DORE has a Corrective and Preventative Action (CAPA) process for identifying, documenting, analyzing and implementing corrective and preventative actions to correct discrepancies while focusing efforts to prevent their recurrence. It consists of the eight step problem solving process, and includes a Root Cause Analysis to determine root cause of the problem so that appropriate actions can be taken to prevent occurrence of the problem. The process defines sources of nonconformities, categorizes them as Zero Tolerance, Critical, Major and Minor, and spells out timing requirements for completion of corrective actions for each category.
EIGHT STEP CAPA PROCESS
Establish the Team
Use a team approach as needed
Describe the problem
Evaluate the magnitude of the problem and potential impact on the company
Implement Interim Containment
Isolate the effects of the problem from any internal and/or external customer until Permanent Corrective
Action can be implemented
Identify Root Cause
Perform a thorough analysis of the problem with appropriate documentations, including list of all possible causes and results of the data collection containing test results, records, processes etc.
Chose Permanent Corrective Action
Create an action plan listing all of the action tasks that must be completed to correct and/prevent the problem including following:
Actions to be completed and target dates
Person responsible for completing each task
Process, procedure or system changes
Implement Permanent Corrective Action
Implement the plan, and maintain the record of all the actions taken
Evaluate potential areas that may contribute to the problem and implement preventative actions to prevent a similar problem in the future
Follow up with Verification
Follow up with Verification of the completion of all of the tasks and asses effectiveness of the actions taken
Verify completion of all the changes, controls training
Results: Evaluate the effectiveness of the corrective actions and absence of any adverse effects
The supervisor of QC department is responsible for the CAPA through all of the steps of the process. DORE vendors are required to get approval for the action plan from designated DORE personnel prior to its implementation.
9. INTERNAL QUALITY SYSTEM AUDIT
DORE’s Corporate Responsibility Audit organization performs internal audits throughout the DORE Corporation and its vendor base, to verify that the quality operating policies and procedures are followed throughout the corporation.
Quality Management System (QMS) Audits are performed by DORE Auditors at DORE owned and operated plants, vendors and subcontractors. QMS Audits are based on assessments against the sustainability policies and procedures.
Audit reports are issued using a scoring system, and distributed to the appropriate leadership in corporate responsibility and the operations organizations as well as to certain corporate and executive management. The operations organization and /or vendor management is responsible for the development and execution of a corrective action plan. A follow-up audit is scheduled to verify the corrective actions were implemented and effective. Zero tolerance findings are handled swiftly and require immediate corrective action or disqualification of the vendor. Audit findings are used for analysis and reports to management to inform them of the trends in the audit findings and point out any areas of concern that need special attention.