Quality Engineering and Management Services

Quality cannot be stand-alone, it must be embedded in the processes

Quality Engineering and Management Services

Quality management can be considered to have three main components: quality control, quality assurance and quality improvement. Quality management is focused not only on product quality, but also the means to achieve it. Quality management therefore uses quality assurance and control of processes as well as products to achieve more consistent quality.

 

POPULAR STANDARDS, METHODS AND TECHNIQUES USED FOR QUALITY MANAGEMENT & IMPROVEMENT

There are many methods for quality improvement. They cover product improvement, process improvement and people based improvement. In the following list are methods of quality management and techniques that incorporate and drive quality improvement:

ISO 9004:2008 — Guidelines for performance improvement.

ISO 15504-4: 2005 — Information technology — process assessment — Part 4: Guidance on use for process improvement and process capability determination.

QFD — Quality Function Deployment, also known as the house of quality approach.

Kaizen — Japanese for change for the better; the common English term is continuous improvement.

Zero Defect Program — Created by NEC Corporation of Japan, based upon statistical process control and one of the inputs for the inventors of Six Sigma.

Six Sigma — Six Sigma combines established methods such as statistical process control, design of experiments and FMEA in an overall framework.

PDCA — Plan, Do, Check, Act cycle for quality control purposes. (Six Sigma's DMAIC method “define, measure, analyze, improve, control” may be viewed as a particular implementation of this.)

Quality Circle — A group (people oriented) approach to improvement.

Taguchi Methods — Statistical oriented methods including quality robustness, quality loss function, and target specifications.

The Toyota Production System — Reworked in the west into lean manufacturing.

Kansei Engineering — An approach that focuses on capturing customer emotional feedback about products to drive improvement.

TQM — Total Quality Management is a management strategy aimed at embedding awareness of quality in all organizational processes. First promoted in Japan with the Deming prize which was adopted and adapted in USA as the Malcolm Baldrige National Quality Award and in Europe as the European Foundation for Quality Management award (each with their own variations).

TRIZ — Meaning "Theory of Inventive Problem Solving"

BPR — Business Process Reengineering, a management approach aiming at 'clean slate' improvements (That is, ignoring existing practices).

OQM — Object Oriented Quality Management, a model for quality management.

 

Proponents of each approach have sought to improve them as well as apply them for gains. Simple one is Process Approach, which forms the basis of ISO 9001:2008 Quality Management System standard, duly driven from the 'Eight principles of Quality managagement', process approach being one of them. On the other hand, the more complex Quality improvement tools are tailored for enterprise types not originally targeted. For example, Six Sigma was designed for manufacturing but has spread to service enterprises.

 

Some of the common differentiators between success and failure include commitment, knowledge and expertise to guide improvement, scope of change/improvement desired (Big Bang type changes tend to fail more often compared to smaller changes) and adaption to enterprise cultures. For example, quality circles do not work well in every enterprise (and are even discouraged by some managers), and relatively few TQM-participating enterprises have won the national quality awards. Therefore, enterprises need to consider carefully which quality improvement methods to adopt, and certainly should not adopt all those listed here. It is important not to underestimate the people factors, such as culture and habits, in selecting a quality improvement approach. Any improvement (change) takes time to implement, gain acceptance and stabilize as accepted practice. Improvements must allow pauses between implementing new changes so that the change is stabilized and assessed as a real improvement, before the next improvement is made. Improvements that change the culture take longer as they have to overcome greater resistance to change. It is easier and often more effective to work within the existing cultural boundaries and make small improvements (that is Kaizen) than to make major transformational changes. Use of Kaizen in Japan was a major reason for the creation of Japanese industrial and economic strength. On the other hand, transformational change works best when an enterprise faces a crisis and needs to make major changes in order to survive. In Japan, the land of Kaizen, Carlos Ghosn led a transformational change at Nissan Motor Company which was in a financial and operational crisis. Well organized quality improvement programs take all these factors into account when selecting the quality improvement methods.

 

QUALITY STANDARDS IN USE TODAY

The International Organization for Standardization (ISO) created the Quality Management System (QMS) standards in 1987. They were the ISO 9000:1987 series of standards comprising ISO 9001:1987, ISO 9002:1987 and ISO 9003:1987; which were applicable in different types of industries, based on the type of activity or process: designing, production or service delivery.

 

The standards are reviewed every few years by the International Organization for Standardization. The version in 1994 was called the ISO 9000:1994 series; comprising of the ISO 9001:1994, 9002:1994 and 9003:1994 versions.

 

Then a major revision was in the year 2008 and the series was called ISO 9000:2000 series. The ISO 9002 and 9003 standards were integrated into one single certifiable standard: ISO 9001:2008. After December 2003, organizations holding ISO 9002 or 9003 standards had to complete a transition to the new standard.

 

The ISO 9004:2000 document gives guidelines for performance improvement over and above the basic standard (ISO 9001:2000). This standard provides a measurement framework for improved quality management, similar to and based upon the measurement framework for process assessment.

 

The Quality Management System standards created by ISO are meant to certify the processes and the system of an organization, not the product or service itself. ISO 9000 standards do not certify the quality of the product or service. To give you a simple example, you could be manufacturing life vests made of lead metal and still be ISO 9000 certified, as long as you manufacture the life vests consistently, keep records and document the processes well and comply with the standard’s all requirements. Again, to repeat, a Quality Management System standard certification is meant to certify the processes and the system of an organization.

 

ISO has released standards for other industries too. For example Technical Standard TS 16949 defines requirements in addition to those in ISO 9001:2008 specifically for the automotive industry.

 

ISO has a number of standards that support quality management. One group describes processes (including ISO 12207 & ISO 15288) and another describes process assessment and improvement (ISO 15504).

 

On the other hand, The Software Engineering Institute has its own process assessment and improvement methods, called CMMi (Capability Maturity Model — integrated) and IDEAL respectively.

 

OUR QUALITY ENGINEERING & MANAGEMENT SERVICES

A robust quality system is essential to ongoing regulatory and standards compliance and smooth inspections and audits. AGS-Engineering is fully equipped to serve as an outsourced quality department, creating and implementing a customized quality system for our clients. Below is a list of some services we are competent in:

  • Quality Management System Development & Implementation

  • Quality Core Tools

  • Total Quality Management (TQM)

  • Quality Function Deployment (QFD)

  • 5S (Workplace Organization)

  • Design Control

  • Control Plan

  • Production Part Approval Process (PPAP) Review

  • Corrective action recommendations\ 8D

  • Preventive Action

  • Error proofing recommendations

  • Virtual Document Control and Record Management

  • Paperless Environment Migration for Quality & Production

  • Design Verification and Validation

  • Project Management

  • Risk Management

  • Post Production Services

  • Personalized consulting services to highly regulated industries such as the medical devices industry, chemicals, pharmaceutical industries

  • Unique Device Identification (UDI)

  • Regulatory Affairs Services

  • Quality System Training

  • Audit Services (Internal and Supplier Audits, ASQ Certified Quality Auditors or Exemplar Global Lead Auditors)

  • Supplier Development

  • Supplier Quality

  • Supply Chain Management

  • Statistical Process Control (SPC) Implementation and Training

  • Implementation of Design of Experiments (DOE) and Taguchi Methods

  • Capability study review and validation

  • Root Cause Analysis (RCA)

  • Process Failure Mode Effects Analysis (PFMEA)

  • Design Failure Mode Effects Analysis (DFMEA)

  • Design Review Based on Failure Modes (DRBFM)

  • Design Verification Plan & Report (DVP&R)

  • Failure Mode & Effects Criticality Analysis (FMECA)

  • Failure Mode Avoidance (FMA)

  • Fault Tree Analysis (FTA)

  • Launching of Containment Systems

  • Parts Sorting and Containment

  • Consulting and implementation of Quality related Software and Simulation Programs, Customization and Custom Software Development, other tools such as Bar Coding & Tracking System

  • Six Sigma

  • Advanced Product Quality Planning (APQP)

  • Design for Manufacturing & Assembly (DFM/A)

  • Design for Six Sigma (DFSS)

  • Functional Safety (ISO 26262)

  • Gauge Repeatability & Reproducibility (GR&R)

  • Geometric Dimensioning & Tolerancing (GD&T)

  • Kaizen

  • Lean Enterprise

  • Measurement Systems Analysis (MSA)

  • New Product Introduction (NPI)

  • Reliability & Maintainability (R&M)

  • Reliability Calculations

  • Reliability Engineering

  • Systems Engineering

  • Value Stream Mapping

  • Cost of Quality (COQ)

  • Product / Service Liability

  • Expert Witness and Litigation Services

  • Customer & Supplier Representation

  • Implementation of Customer Care and Feedback Surveys and Analysis of Results

  • Voice of the Customer (VoC)

  • Weibull Analysis

 

OUR QUALITY ASSURANCE SERVICES

  • QA Process Assessments and Consulting

  • Establishment of Permanent and Managed QA Function      

  • Test Program Management

  • QA for Mergers and Acquisitions             

  • Quality Assurance Audit Services

 

Quality engineering and management can apply to all companies, organizations, educational institutions, banks, …and more. If you are not sure how we can adapt our services to your case, please contact us and let us find out what we can do together.

AGS-ENGINEERING

Fax: (505) 814-5778 (USA)

Physical Address: 6565 Americas Parkway NE, Suite 200, Albuquerque, NM 87110, USA

Mailing Address: PO Box 4457, Albuquerque, NM 87196 USA

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