Friday, June 29, 2012

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
 

Saturday, June 2, 2012

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.