iso 9000:2005 Archives -

Defining Qualification, Verification, and Validation

Q: I understand the hierarchy, but I would be hard pressed, if asked, to give a clear definition of the terms: qualification, verification, and validation. Can one of the experts help explain these terms? Thank you.

A: This is a great question and I hope I’ll be able to help you.

To begin, I refer you to ISO 9000:2005 Quality management systems – Fundamentals and vocabulary. As you may already know, this document is used to define/describe many terms used in the ISO 9000 series, including the three words you question.

In 9000:2005, under clause 3.8 Terms relating to examination, we find:

3.8.4 verification
Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled
NOTE 1 The term “verified” is used to designate the corresponding status.
NOTE 2 Confirmation can comprise activities such as
–          performing alternative calculations,
–          comparing a new design specification with a similar proven design specification,
–          undertaking tests and demonstrations, and
–          reviewing documents prior to issue.

3.8.5 validation
Confirmation, through the provision of objective evidence, that the specified requirements for a specific intended use or application have been fulfilled
NOTE 1 The term “validated” is used to designate the corresponding status.
NOTE 2 The use conditions for validation can be real or simulated.

Validation definition, as provided by ASQ's Quality Glossary.

3.8.6 qualification process
Process to demonstrate the ability fulfill specified requirements
NOTE 1 The term “qualified” is used to designate the corresponding status.
NOTE 2 Qualification can concern person, products, processes or systems.
EXAMPLE Auditor qualification process, material qualification process.

I’ll try to expand on these definitions in hopes of making things a bit more clear. Keep in mind that qualification, verification, and validation are individual processes, but the explanations below (from Boston Scientific) should help you recognize their individuality as well as their interdependence.

Validation is an act, process, or instance to support or collaborate something on a sound authoritative basis.

Verification is the act or process of establishing the truth or reality of something.

Qualification is an act or process to assure something complies with some condition, standard, or specific requirements.

For example:

A design verification verifies that a frozen (static) design meets top level product specifications.

A process validation validates that the on-going (dynamic) manufacturing process produces product that meets product/print specifications and consist of installation qualifications, operational qualifications, process performance qualifications, a product performance qualification and perhaps process verifications.

An installation qualification qualifies that equipment was installed correctly and are a subset of a process validation (or possibly a test method validation).

Validation Examples:
• Design validation, sterilization validation, test method validation, software validation, and process validation.

Verification Examples:
• Design verification and process verification.

Qualification Examples:
• Installation qualification, operational qualification, process performance qualification, product performance qualification, and supplied material qualification.

After reading all of this, I am confident you would be able to explain qualification. An old and trusty phrase to help summarize the other two is: Validation – Are we producing the right product?; Verification – Are we producing the product right?

Bud Salsbury
ASQ Senior Member, CQT, CQI

ISO 9001 Clause 7.5.1 Work Instructions

Mr. Pareto Head and standard work

Q: Within my organization there has been much debate on what a work instruction is. The term work instruction is not defined in the ISO 9001-2008 Quality management systems—Requirements standard (appears in clause 7.5.1).

Our question is that if the organization is providing services such as maintenance and repair of the customer’s equipment, and the customer provides maintenance and repair manuals and publications for this equipment to the organization, would this literature satisfy the requirements of ISO 9001:2008 as work instructions? Any assistance provided would be greatly appreciated.

A: You are correct when you state that “work instructions” is not defined in ISO 9001:2008, nor is it in ISO 9000:2005 Quality management systems–Fundamentals and vocabulary.

Terms are not defined by the Technical Advisory Group (the standard developers) when it is felt that the general accepted usage is clear and unambiguous. Such is the case with this term. A work instruction is simply what the name implies, instructions to do work. Written instructions might not be necessary and so the phrase “as necessary” is in the text of the standard. It depends on your specific situation.

The challenge to comply with the requirements of clause 7.5.1 is not in the definition (or lack of definition) of work instructions. It is planning and carrying out production and service work under controlled conditions.

Are your work processes controlled? This clause identifies six elements that need to be considered. Work instructions are one of the six elements. Do your operators know what to do? Are they trained? Do they need written instructions? In general, you must make this call, not an auditor. If you are challenged by an auditor, you need to be able to defend you position. But there is no hard and fast rule here.

Let me note that telltale signs of lack of control are frequent errors, defects and rejects. This indicates to an auditor that you don’t have a controlled process. You need to tighten things down including addressing those of the six elements that are at the root cause of your process failures. You might need work instructions or improved work instructions based on process performance.

You mention that your organization maintains customer equipment and that the customer provides manuals. These manuals might be adequate. They might not. Let’s say that part of your maintenance is changing the oil on a gasoline engine. The manual, hopefully, states when this needs to occur. It might not. You probably need to establish a maintenance schedule for changing the oil and lubricating the machine, recording when this is done. Do you need a detailed work instruction on how to change the oil? Probably not. However, the machine might be complicated and have many lubrication points, a number of them not at all obvious. In such a case, a simple work instruction might be useful.

The key is to control your process and use whatever is needed to do so.

Joe Tsiakals
Voting member of the U.S. TAG to ISO/TC 176 (ASQ)
Voting member of the U.S. TAG to ISO/TC 210 (AAMI)

For more on this topic, visit ASQ’s website.

ISO Documentation Practices; Difference Between Record and Document

ISO documentation practices, requirements

Q: Is there a published ISO standard for good documentation practices (e.g., crossing out an error with a single line and initialing and dating; striking through a blank space)?

Thank you.

A: Your question has two parts:

1) Is there a standard?

2) Does it cover the specific practice you cited?

The answers are “yes” and “no.” 🙂

About a decade ago, the ISO Technical Committee (TC) 176 on Quality Management and Quality Assurance started work on a documentation standard. There was (and still is) much confusion in the world about what kind of documents were expected and what should go into them. Of course, most didn’t want to take the time and energy to understand the purpose of documents, much less describe their practices in a site-specific manual. How sad. The output of the ISO/TC 176 work was a Technical Report: ISO/TR 10013:2001 – Guidelines for quality management system documentation. Frankly, however, I do not think it will address your question.

First of all, documents and records are often confused. Even though the ISO terms and definitions standard (ANSI/ISO/ASQ 9000:2005 Quality management systems — Fundamentals and vocabulary) parks them both under the word document, it is good practice to always think document=before, and record=after.

In other words, a document tells us what to do. A record tells us what was done. Many people, not understanding this principle, have actually tried to place records under configuration control!

The record-keeping practices you cited — crossing out an error and marking in a blank space — have their origin in the early military practices of the 1950s! Back then, there were no computers, internet or even ISO standards. There was also much more falsification of information back then, as we treated the workers with little or no respect.

The practices you cite were attempts to make sure that the data entered on a record wasn’t changed. Those practices just kind of hung on for half a century. In my 40 years in the quality profession, I have never seen these “rules” written down in an external document, like a regulation or standard or policy. Sure, individual organizations have required these practices through their local Standard Operating Procedures, but I am pretty sure they are not published in higher-level documents.

With automation and networking, records are becoming much more virtual. Paper records are becoming a thing of the past. Security and protection of those electronic records is a much bigger problem than when they were all on dead trees.

Follow-up from expert: Doing some further research (for an upcoming class), I discovered that ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories, contains a clause about records correction, 4.13.2.3. In general, the clause says all alterations must be visible (not erased, blacked out, or deleted), and all changes must be signed or initialed by the person making the change. Equivalent measures should be taken in the case of electronic records.

I don’t know why I didn’t think of this standard earlier, however, my earlier remarks about this coming from the 1950s practices B.C. (before computers) still stand.

Dennis Arter
ASQ Fellow
The Audit Guy
Columbia Audit Resources
Kennewick, WA
http://auditguy.net

For more about this topic, please visit ASQ’s website.