Saturday, November 13, 2010

Why Does ISO 9000 Emphasis On Document Control?


Why Does ISO 9000 Emphasis On Document Control?

Think of the Document Control Procedure as ‘evidence’ that an established process or procedure was adhered to in order to satisfy customer requirements. Both Registrars and Internal Auditors will always focus on the quality, continuity and flow of documentation; inconsistencies in this flow of information will indicate a problem and generate a non-conformance.

It is vital that your organization implements and maintains a robust document and record management system pursuant to Clause 4.2. of ISO 9001:2008.

Terms and definitions

To better understand the difference between a document and a record, the following terms and definitions are taken from ISO 9000:2005:

Term, Clause and Definition

Document, 3.7.2, Information and its supporting medium

Record, 3.7.6, A document stating results achieved or providing evidence of activities performed Control of Documents (4.2.3)

Implementing a quality management system might mean that you will be generating new documents and keeping some records that you might not be already keeping. Some of this documentation may seem burdensome until you become more familiar with the quality standard. In general though, the organization must:

- Approve documents before your distribute them
- Provide the correct version of documents at points of use
- Review and re-approve documents whenever you update them
- Specify the current revision status of your documents
- Monitor documents that come from external sources
- Prevent the accidental use of obsolete documents
- Preserve the usability of your quality documents

In order for any organization to demonstrate the effective implementation of its quality management system, it may be necessary to develop documents other than documented procedures. However, the only documents specifically required by ISO 9001:2008 are:

- Quality policy (4.2.1.a)
- Quality objectives (4.2.1.a)
- Quality manual (4.2.1.b)
- Control of Records (4.2.4)

A record is a document that provides traceability; it declares results or presents evidence that the activities undertaken met customer requirements. It is important to identify relevant quality records as you progress your documentation and ensure that records are defined within a procedure or by a system and that it exists and is controlled.

Types of Records required by ISO 9001:2008 Document Control Procedure

5.6.1 Management reviews
6.2.2 e) Education, training, skills and experience
7.1 d) Evidence that the realization processes and resulting product fulfil requirements
7.2.2 Results of the review of requirements related to the product and actions arising from the review
7.3.2 Design and development inputs relating to product requirements
7.3.4 Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any actions
7.4.1 Results of supplier evaluations and any actions arising from the evaluations
7.5.2 d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement
7.5.3 The unique identification of the product, where traceability is a requirement
7.5.4 Customer property that is lost, damaged or otherwise unsuitable for use
7.6 a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
7.6 Results of calibration and verification of measuring equipment
8.2.2 Internal audit results and follow-up actions
8.2.4 Indication of the person(s) authorizing release of product.
8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2 e) Results of corrective action
8.5.3 d) Results of preventive action

Document Control Procedure Summary

Remember that you are in control of the documents and records and not vice versa. Only document and record what is necessary – the fewer documents and records you keep, the fewer things that will be audited, and the more time you will have to actually run your business.

ISO 9000 Standards Certification and Registration


ISO 9000 Standards Certification and Registration

The International Standards Organization is responsible for two major sets of requirements that relate to an overall quality management system to be used by businesses. The ISO 9000 family of standards is the primary set of requirements for most businesses.

Quality management by definition address that the organization does certain things to “fulfill the customer’s quality requirements and applicable regulatory requirements while aiming to enhance customer satisfaction, and achieve continual improvement of its performance in pursuit of these objectives”.
ISO 14000 address the environmental management to minimize harmful effects to the environment. Again, it is a quality management system designed to “achieve continual improvement of its environmental performance.

ISO certification 9000 is the most common. So, let’s take a look at what ISO certification entails and what it means. To become certified, a quality management system must be in place that meets the requirements of the ISO standard. This begins with the business recognizes the requirements and developing a quality system to meet their needs at the same time they meet the requirements.

ISO 9000 certification and ISO 9000 registration are two different entities, though they are often used interchangeably. To achieve ISO certification 9001 , an independent registrar is hired to audit the quality system for thoroughness and compliance to all the standards. When this is accomplished, the business is offered a certificate stating that the quality system conforms to standards within the particular standard.

ISO registration means that the certification has been recorded in its client register. Because most companies have been certified and in turn registered, the terms are offed interchanged in general use. While the term “certification” is the most widely used, “registration” used in North America. Both are completely acceptable, because the business has fulfilled the requirements set forth by ISO.

Risk Management In ISO 9000 Standard


Risk Management In ISO 9000 Standard

In each human endeavour there is an element of risk; personal, project or financial, or a combination of them all. The job of the responsible individual is to identify the risk and act accordingly. We all do these ‘risky’ things, almost daily, aware that we are taking a risk. Rather than staying away from the risk we become adept at identifying it and having a strategy for dealing with it if the risk materialises. This is what risk management is about, and is an ability that is important in virtually every endeavour.

The popular misconception that risk management is difficult or complicated stems from the bureaucratic methodology of some system-oriented organisations and managers. It is neither complicated or bureaucratic, and need not be. Risk management is basically a simple proposition with a complexity dictated by the nature of the situation to which it applies – usually a project, and the parties involved. In its basic form risk management involves:

1. Identifying risk – Looking for anything that threatens the successful completion of the project against the original requirement. Risks can be environmental, organisational, technical, legal, economic or commercial.

2. Counteracting risk – Taking action to remove or reduce the probability of a risk being realised. The response depends on the nature or seriousness of the risk.

3. Acting when the risk event occurs – Invoking whatever contingency measures were devised for the risk that has materialised.

And for this to happen needs:

4. Monitoring at all stages – This typically means documenting a risk assessment in a profile that identifies the risk, the probability of its occurrence, and the impact if it does materialise. Factors that score paramount are those that require the greatest attention and monitoring. A good risk manager will devise contingency plans that reduce either the probability or the impact of these occurrences, and so remove them from the scene.

Working within a formal structured management system similar to that defined by ISO 9000 requires the application of risk assessment practices to satisfy the requirements of the Standard. Auditors of such systems may not find specific references to risk management in these areas even though the identification of potential failure (8.5.3) is wholly concerned with a topic that is nothing less than risk management.

Well managed risk taking is an essential feature of any forward thinking enterprise, since risk is an element of any progression or advancement. It is the adoption of effective risk management in conjunction with the continuing need to drive forward from a comfortable position that leads to progress and advancement. Doing what we always do purely because the risks appear to be negligible or are well known is to be ‘risk averse’, and for progressive organisations cannot be acceptable. Neither is it acceptable to pursue new ideas without an understanding of their potential benefit, proper planning, a clear idea of the threats to these benefits being achieved , and a strategy for dealing with them should they materialise. We need to manage in a manner that is neither predictable or reckless. Risk assessment is an essential tool to support this strategy.

ISO 9000 Document Management Software System


ISO 9000 Document Management Software System

Today’s manufacturing companies that seek ISO 9001 compliance-(regardless of their motivation to do so) probably don’t find it that difficult to create intelligent documentation. After all, a few days with a good consultant or a quality manager can take care of document creation. The problem lies in the gap between what employees are doing and what employees are supposed to be doing (in terms of adhering to documentation) and the gap between the manner in which processes are being implemented and the manner in which they should be implemented ( in accordance with documentation). In other words, the problem lies in the way processes are strategized and applied and in the way employees commit to standards when compared against existing documentation. How can a company overcome these issues? The answers may be simpler than you think.

Automation is the Answer for ISO Control
If your underlying processes are poorly strategized then an automated document management software system won’t be of much use. However, once the processes have been effectively planned (and applied) a document management software system can speed process-to-process management by leaps and bounds. Companies that automate not only to comply with ISO standards but to generate more revenue by performing less administrative labor save weeks and even years worth of time just by automating their processes and documentation control with a document management software system.

Making Amends
The right document management software system and ISO document control would also allow companies to find deviations and nonconformance events faster and move those events to resolution phases in a small fraction of the time they were originally routed—if they were routed at all. Some ISO 9000 document management software systems may even be combined with a CAPA QMS solution. This is especially valuable when determining the root cause of major to minor deviations.

A Document Management Software System and Employee Training
ISO standards do not require any type of automation but ISO standards lend themselves to automation in a way that’s quite remarkable. Take for instance the following document management requirements from the official ISO 9001 International Standard.

ISO 9001 Section 4.2.3
ISO standards make it clear that ISO 9001 “approved” companies must define (i.e., document) how they will approve documentation, how they will identify documentation changes, how they will update/reapprove revised documentation, how external documentation will be managed and how assurance will be provided that documentation will be available when it is required. 1 And that’s only a shadow of things to come! A document management software system designed for strict compliance can automate the approval of documentation, the identification of document changes, updates and reapproval notifications, external documentation management and high-level document security. Some solutions also integrate training and online exams as well.

How Much Could You Save?
Chances are high that automation will save you thousands, tens of thousands or even hundreds of thousands of dollars annually depending on the size of your company. Just foregoing a typical document routing process (a manual process) can save many employees fruitless trips back and forth from one office to another. Who wouldn’t want to avoid those time consuming searches through 3-ring binders and lost documentation due to employee absence or neglect?

Conclusion
Regulation and control are the future for manufacturing. Gone are the days of free experimentation and a blind eye toward material waste. Today is the day of premeditated design, quality assurance and web-based automation. If your company plans to be, or already is, compliant with ISO 9001 standards why not consider automating those ISO 9001 controls with a document management software system.

The characteristics of quality Classification of products and services


If we group products and services (entities) by type, category, class and grade
we can use the subdivision to make comparisons on an equitable basis. But
when we compare entities we must be careful not to claim one is of better
quality than the other unless they are of the same grade. Entities of the same
type have at least one attribute in common. Entities of the same grade have
been designed for the same functional use and therefore comparisons are valid.
Comparisons on quality between entities of different grades, classes, categories
or types are invalid because they have been designed for a different use or
purpose.
Let us look at some examples to illustrate the point. Food is a type of entity.
Transport is another entity. Putting aside the fact that in the food industry the
terms class and grade are used to denote the condition of post-production
product, comparisons between types is like comparing fruit and trucks – there
are no common attributes. Comparisons between categories are like comparing
fruit and vegetables. Comparisons between classes are like comparing apples
and oranges. Comparisons between grades is like comparing eating apples and
cooking apples.
Now let us take another example. Transport is a type of entity. There are
different categories of transport such as airliners, ships, automobiles and trains;
they are all modes of transport but each has many different attributes.
Differences between categories of transport are therefore differences in modes of
transport. Within each category there are differences in class. For manufactured
products, differences between classes imply differences in purpose. Luxury cars,
large family cars, small family cars, vans, trucks, four-wheel drive vehicles etc.
fall within the same category of transport but each was designed for a different
purpose. Family cars are in a different class to luxury cars; they were not
designed for the same purpose. It is therefore inappropriate to compare a
Cadillac with a Chevrolet or a Rolls Royce Silver Shadow with a Ford Mondeo.
Entities designed for the same purpose but having different specifications are
of different grades. A Ford Mondeo GTX is a different grade to a Mondeo LX.
They were both designed for the same purpose but differ in their performance
and features.
Now let us take an example from the service industry: accommodation. There
are various categories, such as rented, leased and purchased. In the rented
category there are hotels, inns, guesthouses, apartments etc. It would be inappropriate
to compare hotels with guesthouses or apartments with inns. They are
each in a different class. Hotels are a class of accommodation within which are
grades such as 5 star, 4 star, 3 star etc., indicating the facilities offered.
You can legitimately compare the quality of entities if comparing entities of
the same grade. If a low-grade service meets the needs for which it was
designed, it is of the requisite quality. If a high-grade product or service fails to
meet the requirements for which it was designed, it is of poor quality,
regardless of it still meeting the requirements for the lower grade. There is a
market for such differences in products and services but should customer
expectations change then what was once acceptable for a particular grade may
no longer be acceptable and regrading may have to occur.
Where manufacturing processes are prone to uncontrollable variation it is
not uncommon to grade products as a method of selection. The product that is
free of imperfections would be the highest grade and would therefore
command the highest price. Any product with imperfections would be
downgraded and sold at a correspondingly lower price. Examples of such
practice arise in the fruit and vegetables trade and the ceramics, glass and
textile industries. In the electronic component industry, grading is a common
practice to select devices that operate between certain temperature ranges. In
ideal conditions all devices would meet the higher specification but due to
manufacturing variation only a few may actually reach full performance. The
remainder of the devices has a degraded performance but still offer all the
functions of the top-grade component at lower temperatures. To say that these
differences are not differences in quality would be misleading, because the
products were all designed to fulfil the higher specification. As there is a
market for such products it is expedient to exploit it. There is a range over
which product quality can vary and still create satisfied customers. Outside the
lower end of this range the product is considered to be of poor quality.
If we group products and services (entities) by type, category, class and grade
we can use the subdivision to make comparisons on an equitable basis. But
when we compare entities we must be careful not to claim one is of better
quality than the other unless they are of the same grade. Entities of the same
type have at least one attribute in common. Entities of the same grade have
been designed for the same functional use and therefore comparisons are valid.
Comparisons on quality between entities of different grades, classes, categories
or types are invalid because they have been designed for a different use or
purpose.
Let us look at some examples to illustrate the point. Food is a type of entity.
Transport is another entity. Putting aside the fact that in the food industry the
terms class and grade are used to denote the condition of post-production
product, comparisons between types is like comparing fruit and trucks – there
are no common attributes. Comparisons between categories are like comparing
fruit and vegetables. Comparisons between classes are like comparing apples
and oranges. Comparisons between grades is like comparing eating apples and
cooking apples.
Now let us take another example. Transport is a type of entity. There are
different categories of transport such as airliners, ships, automobiles and trains;
they are all modes of transport but each has many different attributes.
Differences between categories of transport are therefore differences in modes of
transport. Within each category there are differences in class. For manufactured
products, differences between classes imply differences in purpose. Luxury cars,
large family cars, small family cars, vans, trucks, four-wheel drive vehicles etc.
fall within the same category of transport but each was designed for a different
purpose. Family cars are in a different class to luxury cars; they were not
designed for the same purpose. It is therefore inappropriate to compare a
Cadillac with a Chevrolet or a Rolls Royce Silver Shadow with a Ford Mondeo.
Entities designed for the same purpose but having different specifications are
of different grades. A Ford Mondeo GTX is a different grade to a Mondeo LX.
They were both designed for the same purpose but differ in their performance
and features.
Now let us take an example from the service industry: accommodation. There
are various categories, such as rented, leased and purchased. In the rented
category there are hotels, inns, guesthouses, apartments etc. It would be inappropriate
to compare hotels with guesthouses or apartments with inns. They are
each in a different class. Hotels are a class of accommodation within which are
grades such as 5 star, 4 star, 3 star etc., indicating the facilities offered.
You can legitimately compare the quality of entities if comparing entities of
the same grade. If a low-grade service meets the needs for which it was
designed, it is of the requisite quality. If a high-grade product or service fails to
meet the requirements for which it was designed, it is of poor quality,
regardless of it still meeting the requirements for the lower grade. There is a
market for such differences in products and services but should customer
expectations change then what was once acceptable for a particular grade may
no longer be acceptable and regrading may have to occur.
Where manufacturing processes are prone to uncontrollable variation it is
not uncommon to grade products as a method of selection. The product that is
free of imperfections would be the highest grade and would therefore
command the highest price. Any product with imperfections would be
downgraded and sold at a correspondingly lower price. Examples of such
practice arise in the fruit and vegetables trade and the ceramics, glass and
textile industries. In the electronic component industry, grading is a common
practice to select devices that operate between certain temperature ranges. In
ideal conditions all devices would meet the higher specification but due to
manufacturing variation only a few may actually reach full performance. The
remainder of the devices has a degraded performance but still offer all the
functions of the top-grade component at lower temperatures. To say that these
differences are not differences in quality would be misleading, because the
products were all designed to fulfil the higher specification. As there is a
market for such products it is expedient to exploit it. There is a range over
which product quality can vary and still create satisfied customers. Outside the
lower end of this range the product is considered to be of poor quality.