In God we trust! all others require a review.
In a direct relation to the issue of documents control, I will discuss the records control requirements. The ISO 9001 Standard presents guide lines for identification and maintenance of records included in the quality management system and are necessary for the realization of the product.
Documents control defines a document and requires method for managing it from various aspects: versions control, editions, distribution, elimination etc. Now we must define which records are included under the quality management system and how shall we handle with them throughout the realization processes.
TYPES OF RECORDS The Documentation that combine a quality management system includes the next elements:
The classification of documentation is specified with the next pyramid:
- Quality guide and policy
- Quality procedures – documents describing the procedures within the quality management system.
- Process diagrams, procedures and work instructions - a definite method to perform activity or a process.
- Specifications – documents that specify requirements for product realization.
- Quality plans – documents which define the procedures and resources required to accomplish a project, a product a process or an agreement.
- A record – a document that declares results or present evidence for activities taken.
This pyramid was drawn using Smart Draw software. Now I know it is not the perfect pyramid that you ever laid your eyes on, but it took us just five minutes to do it. When you need to document your organization's QMS - it sometimes takes hours with the conventional tool (MS tools - including Visio). We know because we have been there. This software is really making our quality managers life much easier. Give it a try. They have a free trial: Smartdraw.com.
Back to business.
A SHORT EXPLANATION ABOUT THE RELATION BETWEEN RECORDS AND THE QUALITY SYSTEM Why is it so important to define which records need to be controlled? Let's presume that tomorrow's morning one of your customers will complain about a product he purchased or service that you provided - not so far away from our daily reality. In order to examine if he is right or not, and to review the events that occurred during the communication with him (interaction between the organization and the customer) you must approach your records and investigate. The records are our statement of defense. Let's just wish that we would never have to use it. But still, if tomorrow morning we find ourselves in a situation where questions are being presented, the records would be our savior. From this explanation I drive the next conclusion – the record is evidence.
But how on earth, from all the records that lay around the organization, you would know what is relevant to your quality management system? Well, the relation can be measured in various levels:
Any record that answers the definitions mentioned above would be considered as a quality record and therefore must be controlled according to the ISO 9001 Standard requirements of records control. What are the requirements? Nothing special. Actually the requirements are pretty much standard:
- The first rule is easy. You must distinguish whether a record takes part in the realization of a product. If there are records in the organization that do not participate in the product realization process – they are not considered as part of the quality management system. Plain as that.
- Whether the record provides any aspect of product (or service) designing, developing or planning - it is part of the quality management system. For example – specifications, plans and product portfolio. These are outputs of quality plans. A record which defines the procedures and resources required to accomplish a project, a product, a process or an agreement.
- Outputs of a working process. For example, quality measurements of product or a review of equipment installation. The ISO 9001 Standard does not require preservation of all forms or records but it is recommended to examine for every record of any working process, if recording and archiving it in necessary. Again, you must not preserve any record, but think twice before you dismiss records.
- The record provides evidence for a requirement. Every record that documented a performance for a requirement. In other words evidence for achieving the quality plans. Any document that answers the definitions mentioned above, would be considered as a quality record and therefore must be recorded and must achieve the ISO 9001 Standard requirements of records control. What are the requirements? Nothing special. Actually the requirements are pretty much standard:
- Identification of records. It will be possible to attribute a record to its origins. How to attribute? It depends on your organization. You must develop a method for identification of records according to their properties and use.
- Legible records. It will be possible to read and understand the information recorded at any time.
- Retrieval of records. It will be possible to trace back records at any given moment. That means to preserve the record and to develop a method for tracing. Preservation time is determined according to customer requirements or legal requirements. In any case it would be preserved for a minimum of one year time.
- Handling the records. The method for controlling records shall include how they are to stored, archived and when needed, disposed.
The ISO 9001 Standard requires that all the definitions above would be documented within a procedure. Again, this is not a recommendation but a requirement. You must maintain a procedure to define what how records are being controlled according to the point mentioned above.
All these requirements can be hard to handle in large organizations where a large number of employees are producing records of all kinds and sorts. As if it is not complicated enough, the ISO 9001 Standard requires that you record evidence of specific standard requirements. Say again? You must maintain records of specific quality processes presented in the standard with the control suggested above: you must plan, maintain, fill out, and preserve (not in this order). Which requirements? But as I promised I would try to make it easier on you and make a list of all requirements for records:
I will make a list but before that I would like to give you a valuable advice. If you would brows through the ISO 9001 Standard you would notice a note that repeats constantly: see 4.2.4. This note actually directs you to paragraph 4.2.4 of the ISO 9001 standard: Control of records. Still obscured? Any paragraph that ends with that note means that you must maintain a record of this specific requirement.
Yes folks, for any quality processes mentioned above (assuming you have not excluded it) you must maintain a record.
- Management review outputs must be recorded – paragraph 5.6
- Employees appropriate education training and skills must be recorded – paragraph 6.2.2
- The planning of product realization must be recorded – paragraph 7.1
- Review of requirements related to product Record – paragraph 7.2.2
- Design and development inputs must be recorded – paragraph 7.3.2
- Design and development review must be recorded - paragraph 7.3.4
- Design and development verification must be recorded – paragraph 7.3.5
- Design and development validation must be recorded – paragraph 7.3.6
- Design and development change control must be recorded – paragraph 7.3.7
- Suppliers evaluation results must be recorded – paragraph 7.4.1
- Validation of process must be recorded – paragraph 7.5.2
- Identification and traceability of products or service provision must be recorded – paragraph 7.5.3
- Customer notifications regarding his property must be recorded – paragraph 7.5.4
- The control of Monitoring and measurements devices must be recorded – paragraph 7.6
- The results of internal audits must be recorded – paragraph 8.2.2
- Monitoring and measurement of product (or service) must be recorded – paragraph 8.2.4
- Evidence for nonconforming products and actions taken to eliminate must be recorded – paragraph 8.3
- Evidence for corrective actions taken must be recorded – paragraph 8.5.2.
- Evidence for preventive actions taken must be recorded – paragraph 8.5.3
- The ISO 9001 Standard require that you define which records we must control and are considered as part of your quality system.
- Quality records include: process diagrams, outputs of processes, outputs of quality processes specifications, quality plans and results or evidences for activities taken.
- Any record must be maintained according to the ISO 9001 Standard: legible, identified and retrievable. Handling the records will be specified as well.
- You must maintain a documented procedure which defines which records are to preserve and the methods for controlling and handling the records.
- The ISO 9001 Standard requires records of some of its requirements for quality processes. You must maintain evidence for these requirements. In fact, any paragraph that ends with the note - see 4.2.4 is a process that must be recorded.