Quality Management-Quality Manual for Multi-Location Enterprises

May 11, 2012 · Posted in Business · Comment 

Since introduction of ISO 9001 Standard for quality management systems the market has developed numerous practical models of quality manuals for organizations with single sites. At the same time, formats for management system structures for multi-facility businesses are limited at best in technical publications. This paper discusses a model for structuring a top-level documentation that allows an organization with multiple sites to use common ISO 9001 quality management system manual. Discussed approach noticeably improves consistency of the organization’s quality policies.

Through my work as a Lead Auditor with major registrars, I observed dozens of large multi-location companies struggling with connecting their corporate ISO 9001 quality manuals with the supporting, location-specific, documents. To develop a quality manual for a company with numerous facilities, organizations take two routes. Some organizations create site-specific quality manuals as copies of the corporate manual; others create site-specific ISO 9001 quality manuals that are entirely different from the corporate manual.

In practice, neither one of these approaches result in a consistent result. In the 1st instance when a modified quality manual is used for a location, methods for updating local quality manuals are not defined. This disconnect arises from the fact that the corporate office manuals are controlled by the home office, while local quality manuals are facilities’ responsibility.

In the case of companies choosing their facilities to develop their own ISO 9001 manuals, discrepancies in numerous quality manuals result in visible differences between the home office and facilities’ quality manuals.

From the corporate identity and simply business consistency points of view, an organization should not find itself in a position of having different or conflicting commitments of its facilities to quality, customer satisfaction, design approaches and other requirements of ISO 9001 standard.

One of our large customers demonstrated this point well. The corporate ISO 9001 quality manual addressed majority of the requirements of the standard and referenced appropriate regulations. At the same time, one of their US locations did not reference required ISO 13485 standard, Mexico facility missed a commitment to compliance with regulatory requirements, yet Costa Rica site failed to document their ISO 9001 quality policy all together!

Summarizing my consulting experiences, I am convinced that these approaches to design of the corporate quality manual and sites’ manuals do not provide a solid consistent way to document organization’s quality manuals.

If a business wishes to establish a quality manual that will serve all its facilities, we need to consider a different route. Let’s start from an example of a clause 5.4.1, Planning, Quality objectives. This clause may state: ABC Corporation’s Management Team ensures that quality objectives, including those needed to meet requirements for product, are established for relevant functions and levels within the organization per the Management Review Procedure and the Quality Objectives Matrix.

The same method will also work for a multi-site organization for those documents that are used at all locations. For example, such processes as Management Review, NC-CAPA Procedure, Documentation Management Procedure, Audit Procedure, and others may be the same for all locations and therefore be referenced in the quality manual as shown above.

While references to common procedures in an ISO 9001 quality manual are clear, we still have to address those documents that are specific to particular locations such as incoming inspection, org charts, product verification and others. When we wish to maintain just one quality manual, we need to reference in it supporting procedures for all sites which may easily clutter the manual. To solve this problem we will examine how a common quality manual can efficiently reference facility-specific procedures to address statements of the organization’s ISO 9001 quality manual.

As with a single-location company, a business can still use the same reference structure if the number of locations or sites is small; let’s say not to exceed three. For example, element 8.5.1 Continual improvement, may read: Yellow Submarine Company has established and maintains documented procedures to continually improve its QMS through the use of its Quality Policy, Quality objectives per the Quality Objectives Matrix HO and the Quality Objectives Matrix BA This example references the common Quality Policy and site-specific Quality Objectives Matrix HO (Home Office) and Quality Objectives Matrix BA (Buenos Ares). This model serves well quality management systems with limited number of facilities, but it becomes ineffective when the number of company’s locations increases.

When an enterprise has significant number of facilities and needs to reference in its manual numerous procedures including those controlled by its sites, we have another choice. We can develop a matrix to connect our quality manual elements with the location-specific supporting documents. We will title this document a Manual Reference Matrix and establish the following documentation reference structure.

Corporate ISO 9001 Quality Manual clause

Manual Reference Matrix Table of Contents (ToC)

Location Manual Reference Matrix

Corresponding site-specific document

Our Manual Reference Matrix ToC is simply a list of company’s locations or sites’ Manual Reference Matrixes, as shown in the illustration below:

Manual Reference Matrix Table of Contents

Corporate Office (Salt Lake City, UT USA)

Ontario (Canada)

Cleveland, OH (USA)

Buenos Aires, (Argentina)

Los Angeles, CA, USA


To illustrate this model, let’s document element 5.5.1 of our corporate ISO 9001 quality manual with references to site-specific organizational charts: QW Enterprises, LLP’s Management Team ensures that the responsibilities and authorities are defined and communicated within the organization per the Resource Management Procedure and site-specific Organizational Charts per the Manual Reference Matrix ToC. This statement tells us that the company uses common Resources Management Procedure and site-specific organizational charts. To locate a site-specific organizational chart, we need to refer to the Manual Reference Matrix Table of Contents (ToC).

Clicking the hyperlink Ontario (Canada), for example, we will find a site-specific Manual Reference Matrix. Locating a specific element in the location’s Manual Reference Matrix, we will find a particular, location-specific document that corresponds with this clause of out ISO 9001 quality manual.

Our experience shows that a Manual Reference Matrix works well as a 3-column form with the 1st column titled Corp. Manual section, the 2nd column Corp. References, and the 3rd column called Site References. For the element 6.2.1, for example, the St. Petersburg’s Matrix indicates that manual references Training Procedure HO for the home office and Training Procedure SP for the St. Petersburg site.

Looking for samples of a quality Manual Reference Matrix for ISO 9001 QMS? Check links below.

If you are developing an ISO 9001 Quality Manual for a large corporation and wish to keep your documentation simple, check our Quality Assurance Manual Reference Matrix. If you need help with implementation of your Corporate Manual, check our Quality Management ISO 9001 consulting services

Lean Six Sigma, Phases: Analyze, Improve, Control

April 1, 2012 · Posted in Business · Comment 

As the team looks at the information collected through the Measure Phase, they may elect to adjust the data collecting method to incorporate additional facts. This goes on as the group examines both the information and also the process in an attempt to narrow down and verify the root reasons of waste and problems. What is your data revealing to you? This phase is usually interweaved with the Measure Phase. While information is compiled, the group may include individuals which will collect distinctive sets of data or additional data.

Thoroughly look at the process

Subsequent to making, verifying and looking at detailed process maps created in the Measure Phase, the group will be able to catalog concerns or pain issues while in the process. This enables the team to make the most of the combined wisdom of process members. Subsequently, the team can decide the value of every single step by carrying out “Process Analysis” which includes: 1) “Time Analysis”: is focused on the actual time work being done in the process in as opposed to the time that is wasted waiting around. The thing groups find out is that although individuals are 99% busy, “things” are 99% idle. 2) “Value Added Analysis”: brings one more aspect of discovery by looking at the process via the eyes of the client to find out about the price of doing business. 3) “Value Stream Mapping”: merges process data with a map of the value-adding steps to assist in establishing where Waste can be eradicated.

Inspect the Data Visually

After the collection of data, the group will be able to exhibit the data by means of charts and graphs for visual indications for concerns inside the process. The shift of numbers into visuals lets the group to readily express their determinations to management and other process participants.

Come up with probable cause(s) of the problem

Groups can easily formulate ideas around likely reasons behind the problem by thinking together. With a tool known as the “Cause & Effect Diagram”, the groups are able to carry out arranged thinking that will help them focus on the essential few factors behind lost time, flaws and waste in the process.

Validate the reason(s) of the issue

Ahead of moving to the next phase (called Improve), the group will need to affirm the proposed root cause is the reason behind the problem by validating their data through process investigation, data analysis, process observation and comparative analysis.

Revamp your Project Charter

Once your group has additionally looked at the information, they will have further details about process performance and the prospect of advancement. The team can easily update their Charter with the extra data so they possess a more precise depiction of the project status.

The Fourth Phase Of Lean Six Sigma Is Improve

The group is likely gathering development tips through the entire project, but a structured improvement undertaking can bring about innovative and well-designed solutions. How would you resolve the issue? The moment the project teams are pleased with their data and have decided that more analysis will not add to their understanding of the problem, it’s the perfect time to start working on development of a solution.

Generate remedies that will deal with the issue

The team’s labors at this point are to produce as much ideas as they can as per the idea that from Quantity, will come Quality. Imaginative concept generation is made up of a host of tactics designed to guide the group to out-of-the-box solutions.

Select the practical answers

More often than not, a project team can implement a list of changes to their processes, but once they’re required to select among contradicting choices, there are tools including the “Weighted Criteria Matrix”, which will help your group to make the optimum choice.

Formulate maps of processes that are based upon diverse solutions

These maps are useful in driving the team’s endeavours towards the new process, and might be used as a reference for new personnel while they are educated regarding the new process. With solutions under consideration to reduce rework loops, waste and wait times, the group should draw an enhanced map of the process, often called “To-Be Maps.”

Select the most beneficial answer

To assure the suitable selection is made, the team can utilize mini screening cycles named “PDCA” or Plan Do Check Act, which will help refine the ideas while gathering precious stakeholder feed back. These rounds are a good way to learn if smallish improvements are sensible in a prompt and minimum impact way.

Employ the answer(s)

The more time the team invests on preparing, the quicker they reach complete implementation to the improvements by their process members. Completing successful execution calls for meticulous preparation. The team should take into consideration logistics, teaching, paperwork and correspondence plans.

Gauge Once the team is ready to reveal that the solution has resulted in quantifiable progression, consequently the group can move on to the Control Phase.

The Fifth Phase Of Lean Six Sigma Is Control

The Control phase is a mini version of process management. The team has been establishing a type of infrastructure throughout the lifetime of the project, and through the Control Phase they will begin to document precisely how they wish to pass that arrangement on to the employees who operate within the process.

Consistently make improvements to the process employing Lean standards

While Continuous Improvement teams pass on the effects of every project, they should support efforts to encourage this concentration to the personnel by using the recently enhanced process. The 4 points of Value, Flow, Pull and Perfection ought to keep on being a consistent emphasis for almost every business. The process can indefinitely be enhanced.

1) Value – Evaluate which approaches are essential (are of “Value”) for the customer; 2) Flow – Clear away Waste in the system to enhance the process to perform at a more stable tempo; 3) Pull – Be sure the process responds to a customer’s needs (“Pull” = want); 4) Perfection – Continuously chase “Perfection” inside the process.

Make sure the process is being handled and closely watched thoroughly

In an effort to retain this emphasis, the team ought to focus on the crucial few readings they wish to maintain for on-going observation of the performance of the procedure. This supervision is coupled with a reaction plan describing the extremes of which the process ought to function and how to handle it in the event that the process should exceed those amounts. This leads to continuing process refinement.

Enlarge the enhanced process throughout the company

At this moment, the team must update documentation: process maps, document checklists, cheat sheets, and so on. The more appropriate their finalized documentation, the simpler it will be for process individuals to support the latest way of getting the job finished.

Employ new understanding to various other processes in the company

A proven way to increase the strength and value of Lean Six Sigma endeavors is to push the results from one project into other locations inside of the business. This transfer of improvement strategies can come from large and small endeavours but very quickly increases the impact for every single organization.

Recommend and rejoice in your achievements

The promotion of project success brings about increased momentum of transformation in the company. Even if your project cannot be moved to other departments, there are certainly pieces of it that can be customized and shared. The promotion and publicizing of each success improves the rate through which upcoming improvements can be realized. Lean Six Sigma results drives even more success.

Learning Lean Six Sigma doesn’t need to be difficult. A Lean Six Sigma Simulation could be the key and helps organizations all around the world kick-start their process improvement projects.

The Various Applications of Video Calls

February 3, 2012 · Posted in Internet · Comment 

Did you know that online video meeting is likewise referred to as video collaboration? During interactive video, attendees have to have these particular devices personal computer, microphone, web cam and broadband internet connectivity in order to participate.

Did you know the reason why interactive video is a very convenient mode of connecting? This saves time and money. With this efficiency users can easily carry out different transactions and meetings anywhere from far and close by without ever transporting out of their offices. When talking about video chat the primary things needed are certainly delay, synchronization along with broadcast. Using these, members can have the opportunity of taking a look at their fellow participants and this could have been very unlikely.

Think of how much several people would have paid to travel, lodge and feed all in the bid to attend a meeting, conduct seminars, and interviews. With video conferencing all these can be done with ease and without hazards or the spending of much money. With recent technology such as mobile app developments such as Android and iPhone apps it makes it all much easier.

Are you aware that there are generally three systems of video conferencing? These systems are computer-based system, desktop system and studio-based system. Out of these three the cheapest is the computer based due to the fact that it has a restricted field of view. What is video conferencing, if not a technology that allows anyone anywhere to see and hear another party in real time? However, to set the system you will require a web cam, microphone, speaker, a computer and video conferencing software.

Interactive video devices are at this point budget friendly, are you aware of that? This fact has recently generated the technology a household equipment in many countries around the world nowadays.

For organizations to fully utilize video conferencing facilities, they must include a camera that allows participants to view themselves. With the unprecedented boost and expansion the business industry is gaining more grounds these days, video conferencing is propping the industry by providing suitable means of communication to facilitate this development. The presence of any company can be felt today anywhere in the world.

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