More Training?

So you’ve written your quality manual and your required procedures.   You’ve reviewed ISO 9001, and determined what additional work instructions you needed, and you’ve written them (Hopefully most of these work instructions are pictures or flow charts).

What’s next? Train!  Wait a minute, you say.  Didn’t we already do that? Well, yes, but there’s more to do.  Some organizations have a habit of writing well intended documents, but never doing the training that employees need to implement them.  The rule should be:  If it was important enough to write a document, it’s important enough to train in the document.

One company I worked with did a great job writing its procedures and work instructions.  Every employee had a handbook of the procedures he or she was to follow.  But a quick audit of the employees’ handbooks revealed all sorts of mark ups to the procedures, hand written by the employee, indicating to me that the procedures were not being followed as written.  Worse still, different employees doing the same job, had different mark ups.  Either document control was failing, or training was failing.  More likely both were failing.

You’ve trained in ISO 9001, but successful implementation requires that the procedures and work instructions you’ve created to implement the standard are followed.  Someday an auditor is going to arrive and he or she is going to audit against those procedures and work instructions.  Writing procedures is of little benefit if the workforce doesn’t know about them, or doesn’t know their responsibilities, which you’ve described in those documents.

Using the plan-do-check-act philosophy of ISO 9001, before training starts, there should be a training plan.  The training plan should outline what training is required for each job title or each employee.  The plan could be a training database (many commercial products of modest cost are available) or a collection of spreadsheets.  A record of the training plan(s) and the training completed should be available during the external audit.

Well trained employees are often more productive.  Training has side benefits.  In addition to informing the employees of their responsibilities, good training allows for two way communication between the employees and the trainer.  Employees will often know the work they do better than the author of the document that describes that work.  Training is an excellent way to get feedback from the employees doing the work.  That feedback will help the author improve the document, or correct employees’ misconceptions of what they are expected to do.

Some think training consumes valuable time on unproductive activity.  In fact the opposite is often the case.   For more information see www.rosehillsystems.com
 

Quality Manual and Associated Documents

ISO 9001 requires the organization to create a quality manual.  The quality manual pulls together the quality management system (QMS) into one document.  This document is an overview of the quality management system.  It references other documents that describe elements of the QMS in more detail as needed.

If you search for quality manuals, you will discover many companies that sell canned quality manuals, and quality manual templates.  I recommend that companies write their own manual with the guidance of a quality management consultant, It is not that difficult to write one and it gives the organization ownership of the document.

A key component of the quality manual is the scope.  Here the organization describes the nature of the company's business, the elements of the business that the QMS applies to, and the elements of the standard that are being excluded.  As an example of an element exclusion,  if the organization does not design its own products, then it would exclude section 7.3 Design and development.

The quality manual should address each section of the ISO 9001 standard.  While not required, it is recommended that the mumbering of  the sections of the manual coincide with the section numbers in the standard, and that they be in the same order as the standard.  This helps with gap analysis, and makes it easier for the external auditor to understand your QMS.

In addition to the quality manual, ISO 9001 requires the organization to write some procedures.  The specific required procedures are:

• Document control
• Control of records
• Internal audits
• Control of nonconforming product
• Corrective action
• Preventive action

The quality manual will not detail these procedures but will merely make reference to them.

No other procedures are required, unless the absence of those procedures would affect the quality of the product or service provided by the organization.  In general, organization find it necessary to write a few more procedures to assure that the quality system is effectively implemented and the organization properly trained.

With a well written quality manual, and a few documented procedures, the organization is well on its way to certification.

Implementation Team

Once a commitment is made to proceed with ISO 9000 implementation, a team and a team leader should be selected.  A 'management representative' must also be appointed (often the team leader).  The 'management representative' is the person in the company who, independent of other duties, has responsibility for implementation and management of the quality management system (QMS).  We'll talk more about the responsibilities of this position in a later post.

An implementation team is not required.  In fact, my first implementation was done without a team, the team only being formed when we were close to implementation and most of the work was done.  But there is a lot to do, and a lot of buy in required by the various departments in the organization.  If others are involved, the implementation will go much easier.  More hands on the work will shorten the the implementation cycle.

The members of the team should be decision makers.  Since the members will be involved with implementation of the processes developed, middle management members are a good choice.

Remember that team members have other full time work to do.  To keep the implementation on track, it is best to have regular meetings with meeting minutes, including action items, assignees and due dates.  Keep meetings to a defined amount of time.   Start and end the meetings on time. 

In keeping with ISO 9000's plan-do-check-act model, the first order of business of the team is the implementation plan.  There are many ways to implement ISO 9000, so there is no one best plan.  Whatever plan is adopted, document and monitor the plan at each meeting.  A gantt chart is a good choice for reporting progress of the plan, and many tools, such as Microsoft Project are available.

With a well formed committed team, a good plan, and the advice of an experienced consultant, a successful certification experience is likely.  Contact Rosehill Systems for guidance.

Getting Started

Implementing ISO 9000 must be a company decision.  The person responsible for quality may see the benefits of ISO 9000 certification, but unless the management team is on board, implementation may not be successful.

The senior executive must decide that ISO 9000 certification is an important company objective.  Implementation requires not only the efforts of the quality organization, but the efforts of a cross functional team of decision makers.  Implementation will require effort from a number of organizations, and without their support, implementation will not succeed.

In addition to the effort involved, there is cost.  Cost includes the cost of the time of individuals involved and required to do work in addition to their normal work, the cost of a consultant, and the cost of a certification body.  Finally, once certification is accomplished, there is the recurring cost of external audits.

Certificatin is no small task.  It requires a lot of work from many people.  So, when a company becomes certified, it normally advertises this accomplishment to its suppliers, and, in particular, its customers.  A company which becomes certified and later decides to de-certify its quality system, may put itself in a poor light with its customers.  So, the decision to become certified should not be taken lightly.

Once the senior executive decides to proceed with certification, it is important that all members of the company become informed.  All employees involved with products of services will be affected in some way.  It is important that they be aware of the company's decision, and  their involvement.

Successful implementation requires a committed management team, an involved leader, and professional guidance.  For more information see www.rosehillsystems.com

Overview

ISO 9000 is a quality system standard which has been adopted throughout the world. Started by the EEU, it became popular in the US in part because the EEU made ISO 9000 compliance a requirement for doing business with the European economic community.

The standard was first published in 1987 and is based on the Brittish standard BS 5750, but its linneage goes back even further to the US Department of Defense's MIL-Q-9858.

As quality system standards go, and there are many, it does not satisfy all the needs of all industries. It has been written to be general in nature so that it can be applied to almost any industry. Having said that, there are some industries for which ISO 9000 compliance is not sufficient. For example the nuclear industry has it's own standards (10CFR50 Appendix B, being the most common, developed by the Nuclear Regulatory Commission).

Some industries start with ISO 9000 as a base and enhance it to meet special needs of that industry. An example is the aerospace industry. It's standard AS 9100 is similar to ISO 9000, but has additional requirements important to the industry.

Today ISO 9000 is the most ubiquitious quality system standard in the world. It has been adopted by most countries and industries. For the company looking to develop a consistent approach to quality ISO 9000 is a good start. While implementation can seem daunting to the uninitiated, with the guidance of a knowledgable consultant implementation should not be difficult for a well run company