WE ARE DEDICATED TO MAKE SURE YOUR PROGRAM IS SUCCESSFUL!
Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. Having a simplified process doesn’t mean the audit won’t be robust – it will. Our reputations and integrity depend on it.
However, we guarantee that you will find us easy to work with because we are;
- Responsive from your first contact;
- Flexible in meeting your needs;
- Our auditors are pragmatic and will add value to your business.
Our key differentiator is that you will have one point of contact through a dedicated client manager who will work with you to achieve positive outcomes. Your client manager will handle quotes, audit scheduling, liaising with your auditor and will answer any question you have.
Use us only as needed our services are listed below.
Quality Program and Manufacturing Solutions
Contact us for a prompt response to meet your quality program as well as consulting on manufacturing practices and regulatory issues – Aerospace, Military, Distribution, and Medical Components.
Our Approach:
Every Job Shop / Machine Shop or OEM Manufacturer have unique needs and methodology towards their quality system.
We define measure, analyze, improve and control the quality methods to meet each client’s business practices….
No overnight promises, we will work with employees to improve on their strength and draft clear documented practices that staff can use and be accountable.
Benefit of professional quality implementation:
Creating a quality manual, work instructions, process flow charts, forms, training, data analysis programs could be confusing. We set-up your quality processes and help in getting the company quality program started. We will get your company ready for certification by a reputable accredited certifying body.
We have the expertise to get your company to the next level.
We will create documents that meet your processes and train employees in understanding their roles in the quality implementation efforts.
Implementing the quality system is confusing and as consultants we will work with your management and quality department to insure effective and efficient approach to creating the system that meets your size of company and your industry…
TYPICAL IMPLEMENTATION OR UPGRADE (TRANSITION) OF QUALITY SYSTEM
- Identify Company Resources and Capacity
- Review existing quality process
- Develop process structure and layouts
- Identify record retention and regulatory requirements
- Develop procedures to meet applicable Quality System ( AS9100, ISO9001, ISO13485)
- Review and approve procedures and work instructions
- Create job descriptions and training requirements
- Implement quality system and generate records for data analysis
What we offer for MAINTENANCE of your Quality System
Monthly:
Quality System
- Create DCNs for document, quality manual or procedural changes
- Update Procedures and Work Instructions
- Revise Quality Manual as necessary
- Maintain distribution of documents
- Document, follow-up and investigate NCR and Corrective Actions – internally and external
- Initiate Preventive Action – for continuous improvement – if necessary
- Collect data analysis pertaining to production.
Employees
- Technical support on forms and Quality Management requirements to employees
- Train employees on quality standards
- Maintain training database
- Update employee matrix as necessary.
Equipment
- Review Maintenance Log
- Update Equipment Maintenance database
- Review Calibration database
Suppliers
- Coordinate Supplier Questionnaire
- Evaluate and process Questionnaire
- Update & Maintain Approved Supplier List – remove or add vendors
- Initiate and complete evaluation of supplier corrective actions
- Verify that all requirements flow down to suppliers per standard
- Collect data analysis pertaining to suppliers
Customers
- Complete customer audit surveys
- Follow-up and answer Corrective Actions
- Represent the company for on-site audits
- Communicate with customer regarding any findings
- Verify contracts for quality clauses,
- Collect data analysis pertaining to customer focus
Annually:
- Create reports and chart all areas of data analysis
- Initiate Management Review and record minutes
- Create Management Review report
- Conduct Internal Audit
- Create Internal Audit report
- Facilitate meeting with management to review reports
- Coordinate Equipment Calibration database
- Prepare for annual Registrar visit
- Complete review of Quality Management System of the company
- Update quality objectives and policy