Should Quality Have Time Limits?

Where’s my coffee and a hot shower!

Anyone who has ever purchased merchandise from L.L. Bean is no doubt aware of this rock solid guarantee:
“Our products are guaranteed to give 100% satisfaction in every way. Return anything purchased from us at any time if it proves otherwise. We do not want you to have anything from L.L. Bean that is not completely satisfactory.... Of course, we want you to be the fair judge of quality. If you’re not satisfied with your purchase, we’ll replace it or give you your money back. It’s that simple”.

In my mind, this is the gold standard for how customers should be treated. I’m an L.L. Bean fan and have jackets, coats, fanny packs, and other outerwear that has never worn out. It should come as no surprise that L.L. Bean was just honored as being No. 1 in customer service by the National Retail Federation’s American Express Customers’ Choice survey. What is remarkable about L.L. Bean is that only rarely does one have to activate this guarantee, because merchandise from the company is first-class. If only other companies would adhere to this strong quality ethic. Let me give you an example of how some companies administer their own guarantees.


source : www.qualitydigest.com

What is ISO 9000 and Should I Care?

The ISO 9000 series of standards

ISO 9000 consists of a series of Quality Management System standards that are designed to facilitate the establishment of business processes aiming to ensure that customer requirements are met or exceeded. They can be applied in any manufacturing industry or service sector.

Why should an organization implement ISO 9001?
Without satisfied customers, an organization's future is at risk! To keep customers satisfied, the organization needs to meet and/or exceed their requirements. The ISO 9001 standard provides a universally recognized, tried and tested framework for taking a systematic approach to managing the organization's processes, so that they consistently turn out product that satisfies customers' expectations.

The 5 main clauses of ISO 9001:2008

* Quality Management System
* Management Responsibility
* Resource Management
* Product Realization
* Measurement, Analysis and Improvement

Industry specific variations of ISO 9000

A number of different industry sectors have adopted ISO 9001, added supplemental requirements which are specific to their own industry, and modified the title of the standard. The most notable of these are:

* ISO/TS 16949 - Automotive
* AS9100, 9110 and 9120 - Aerospace
* ISO 13485 - Medical Devices
* TL 9000 - Telecommunications

Application of the standards

The standards are not designed to tell you how to run your business, but rather to allow you to be compliant with the standard in a manner that best suits the way you decide to run your business. There are some “shalls” which are non-negotiable requirements if you wish to be certified by an independent certification body, also known as registrars.


source : www.qualitydigest.com

Four Essentials of Effective Work Instructions

Returning the focus to the worker

A work instruction is a tool provided to help someone do a job correctly. This simple statement implies that the purpose of the work instruction is quality and that the target user is the worker. Unfortunately, in many workplaces, today’s work instructions have little connection with this fundamental focus. Factories have encumbered work instructions with content that has been added to satisfy auditors, lawyers, engineers, accountants, and yes, even quality managers. We’ve piled on so much extraneous material that we’ve lost sight of the intended purpose of work instructions.

Instead of providing a simple tool to do a job right, we’ve buried the work instruction under a cascade of specifications, contract requirements, revision history, references, controls, licensing provisions, and engineering theory. The person who uses the work instruction has become an afterthought in favor of satisfying a licensing or certifying auditor.


Source : http://qmsforyou.blogspot.com/

EnterpriseIQ - EnterpriseIQ Quality Management System

he Quality Management System within EnterpriseIQ provides a systematic approach to meeting all your quality needs. It provides the tools and capabilities necessary to ensure customer satisfaction and compliance with the most stringent quality standards, including automotive (QS and TS), medical (21 CFR Part 11) and ISO standards. Electronic signatures, automatic Workflow, CAPA/CAR, APQP/PQ, SPC and Cost of Quality are all aspects of this package, written and designed by IQMS and tied directly into your complete ERP system - eliminating redundant data and increasing efficiency.

QMS is a truly embedded Quality Management System that was designed and written by IQMS, therefore, it ties directly into your complete ERP system. The result – increased efficiency and eliminating redundant data entry thus, saving time, reducing costly errors and improving communication.

The EnterpriseIQ Quality Management System is a comprehensive suite of applications including key features and functionality such as:

Advanced Product Quality Planning (APQP/PQ)
With QMS you can ensure that you are complying with ISO and FDA requirements through completely tracking of all the information required for process documentation and definition.

Corrective Action Request (CAR/CAPA)
Define, schedule, manage, assign and track Corrective Action Requests (CARs) in order to ensure compliance and meet supplier/customer requirements. This application helps you drive tighter cost control and avoid losing money due to your products or services being completed incorrectly the first time.

Device History Record (DHR) and Product Lifecycle Management (PLM)
This module gives you the ability to follow the product from the design and quoting process to the production stage and all the way through to the end of the life of the product. You will benefit from the open communication this application provides with your suppliers and customers through the use of web-based workflow tools and email.

Document Control
The Secure Document Control application helps you keep full control over your documents. It tracks the document from creation, through approval, implementation and obsolescence. Through electronic signatures and approvals, you will increase visibility of the record and enhance your reaction time all while keeping in line with the strictest quality requirements including automotive, ISO and medical standards.

Some additional functions of EnterpriseIQ QMS include:

• Material Review Board (MRB) module
  
• Repeatability and Reproducibility (R&R) Calibration module
  
• Statistical Process Control (SPC) modulde
  
• Engineering Change Order System module

Sourec : http://www.2020software.com

ISO 9001:2000 - Your Management Review

Just as every organization undertakes an annual ritual of financial review, forecasting, planning and budgeting, a similar approach is specified in the ISO 9001:2000 standard for quality management. In the ISO 9001 standard, this process is referred to as a Management Review. Typically, such reviews are held as regularly scheduled events within an organization, with top management convening to review the performance of its quality management system against organizational goals and objectives, and other criteria as specified within the standard.

Specifically, as stated within the ISO 9001 standard, the purpose of a management review is to review the Quality Management System to ensure its continuing adequacy, suitability and effectiveness. This should include an evaluation of the performance of the system based on existing data (review inputs), and should also address any decisions or actions necessary to improve the program and its related processes (review outputs).

To further define the concepts of adequacy, suitability and effectiveness:

1. Adequacy – Sufficient to satisfy a requirement or meet a need*. A quality management system should be capable of satisfying applicable requirements including those specified by the organization, the customer, and any applicable standards and/or regulations.

2. Suitability – The quality of having properties that are right for the specific purpose*. A quality management system should be able to sustain the current performance levels of the organization utilizing an acceptable amount of organizational resources.

3. Effectiveness – Adequate to accomplish a purpose; producing the intended or expected result*. A quality management system should enable the organization to meet its own needs, those of the customer and those of other interested parties.

*Random House Unabridged Dictionary, © Random House, Inc. 2006.

As a minimum, such reviews should be performed annually, although they may be performed on a more frequent basis, including quarterly or even monthly. I personally recommend that oganizations with “newer” systems perform this function on a more frequent basis, at least for the first 18-24 months.

Records of these reviews should be maintained in accordance with documented record control procedures. These records should include, as a minimum, the date of the review, participants in the review, criteria by which the system is measured, strengths and weaknesses of the system, and any decisions or actions that are required.

To assist the organization that is new to this process, I’ve attached the following management review template below. These topics should be considered as the “bare minimum” necessary, and this template should be further modified or expanded, as necessary, to address any additional issues or considerations that the organization may have.

Source : http://masquality.com