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Lean ISO 9001 Quality Management Systems – Other QMS Documents
In the two previous articles of this series we discussed two important aspects of a Lean ISO 9001 Quality Management System: a Lean Quality Manual and Lean Quality Management System (QMS) Procedures. But what about other documentation that may be needed? Some may argue that it is not following Lean principles if you are adding documents that are not required. The goal, however, is not only to comply to the standard, but to add value to your organization and start on the path of continual improvement. Any document that aids the organization in meeting its goals and provides value in the goal of effective and efficient operations is a document that is needed.
Determining Needed Documents
What are some of these potentially needed documents? Here is a table that lists documents you may want to consider making part of your QMS. (Referring to the ISO 9001 Standard might make some of the descriptions more clear.) Frequently particular documents may not be required by the ISO 9001 Standard, however, creating a document may be the easiest way to comply with the intent of the standard.
|
Document |
Clause Number |
Rationale |
| A flow chart or process diagram to identify the sequence and interaction of required QMS processes | Clause 4.1a | Strongly Implied. (Many Registrar’s now require this document). |
| Outsourced Process Control Plan. | Clause 4.1 | Required, but there are various means to meet the requirement. |
| Quality Policy | Clause 4.2a and 5.3 | Required |
| Quality Objectives | Clause 4.2a and 5.4.1 | Required |
| Management Commitment Statement | Clause 5.1a | Optional, but supports the “shall” statement |
| Organization Chart | Clause 5.5.1 | Optional, but is an easy means to fulfill the requirement |
| Management Representative Identification Memo | Clause 5.5.2 | Optional, but is an easy means to fulfill the requirement. |
| Annual Management Review Meeting Schedule. | Clause 5.6 | Optional, but helps to ensure timely completion of the meeting (s). |
| Annual Employee Competency Memo. | Clause 6.2.2 | Implied and is easier to audit than confidential individual performance evaluations. |
| Annual Employee Training Needs Assessment (at least for management and key personnel). | Clause 6.2.2a | Strongly implied. |
| Grandfather Listing | Clause 6.2.2e | Optional. This is only used one time, when the QMS is initially developed. It can take the place of many records and helps the organization identify what tasks are important. |
| Quality Plan | Clause 7.1 | Strongly Implied. Helps to organize activity from the customer’s viewpoint. |
| Supplier Selection Criteria. | Clause 7.4.1 | Strongly Implied. |
| Approved Supplier List | Clause 7.4.1 | Optional. Helps to ensure that only approved suppliers are used in the procurement process. |
| Work Instructions | Clause 7.5.1b and 4.2d | Simple procedural documents that can be used in any area of the organization to facilitate a task or process. |
| Annual Internal Audit Schedule or Calendar | Clause 8.2.2 | Strongly Implied. Partial means to fulfill the audit planning requirement. |
| A specific Audit Plan for each audit or group of similar Audits. | Clause 8.2.2 | Strongly Implied. Along with an Audit Calendar, will fulfill the audit planning requirement. |
| Product or Service Release Criteria. | Clause 8.2.4 | Strongly Implied. |
| Non-conforming Product Log. | Clause 8.3 | Optional, but makes this process easy to audit and can be used to fulfill the record requirement |
| Performance Charts | Clause 8.4 | Optional, but makes sense. Charts or graphics are an easy means to prove analysis. Also provides an easy means to share the data with employees or other parties. |
What a list! It doesn’t seem very “lean,” does it?
Lean Means Value – Not Small
Some of the listed documents are required, so there is no choice. The goal it to keep the required document simple, thus ensuring that it provides value. (As I attempted to convey in the two previous articles in this series.)
For the documents listed as “Strongly Implied” in the table above, there may not be an actual document requirement in ISO 9001:2000, but it may be the easiest way to meet the requirements in the standard, as opposed to verbal explanations. In addition, the items listed as “Strongly Implied” there is also value in having a document that is actually useful for the organization. An example would be the Approved Supplier List.
For the documents categorized as “Implied” or “Optional,” an organization needs to focus on the rationale for these items to see the value. For example, ISO 9001 clause 5.5.1 states, “Top Management shall ensure that responsibilities and authorities and defined and communicated within the organization.” An Organizational Chart goes a long way to effectively communicate the responsibilities and authorities. Try substituting a few paragraphs of text for an Organizational Chart and one can see the value of a simple graphic. In some organizations, this is all that is needed to meet the 5.5.1 “shall” statement.
Overall, if an organization maintained all or most of these documents in a simple value-added format, then their Registrar Compliance Audits will go much smoother. As anyone who has been through the audit process knows, anything that will help the auditor facilitate a swift completion of the audit is a big plus.
Creating Your Lean System
I hope this series will assist those who with a Quality Management System, whether it is to comply with ISO 9001, AS 9100, TS 16949, or other standards. The time savings in using a Lean approach to QMS documentation can be dramatic, as well as the value of saving paper. The greatest value, however, lies in having a document that is actually used and aids the organization by providing value, rather than a wasted document that never really used and only exists to be brought out at audit time.
For those who are just starting their journey to ISO registration to a Quality Standard, I hope that I have at least put a few holes in the “documentation nightmare” myth. As you go through your journey, first examine if the document is required. If it is, then ensure that when complete it is adding value to your organization. If the document is not required, but desired, absolutely ensure there is value and not added bureaucracy to your QMS.
A simple matrix listing required documents and non-required documents, and the value non-required documents add may help you decide which documents are needed to meet the needs of your organization and QMS.
Best of luck to all of you changing your paradigm and instituting a Lean ISO 9001 Quality Management System
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December 22nd, 2008 at 7:46 am
What exactly is a Annual Employee Competency Memo?
December 29th, 2008 at 12:14 pm
An “Annual Employee Competency Memo” is really formal memo written by a department head, etc…, that states that a certain individual has the education and experience to fill a position, perform certain functions, have certain responsibilities. It is just a simple way to demonstrate competence.
January 18th, 2009 at 9:23 am
What is meant by ‘grandfather listing’, and ‘product/service release critiera’ please?
January 19th, 2009 at 2:18 pm
An example of a Grandfather listing in terms of Clause 6.2.2 would be the people who have been doing a great job in their position for a number of years. They are not suddenly unqualified because you are putting a ISO 9001 Quality Management System in place and you do not have documented evidence of competence for them. Creating a Grandfather list for them is an easy way to document their competence.
The Product/Service Release Criteria are the standards you have in place for a product that need to be verified before released to a customer. Clause 8.2.4 states “evidence of conformity with the acceptance criteria shall be maintained.” It is difficult to have evidence of conformity if you don’t have established criteria. This criteria typically comes from performance specifications, customer requirements, contracts, etc…