Wednesday, September 03, 2008

Common Sense Steps to Creating a Quality Controlled Document


Following are some ideas and comments when managing a Document Control System:

1. It all boils down to this phrase – “ Document What You Do and Do What You Document.”

2. Without a document all you have is an opinion, or at best a good idea.

3. When a document does not have standardization, approval, definition, scope and agreement then no one is responsible, and worse yet workers are doing their best in a wide and varied way.

4. Within each Quality Management System (i.e., ISO Series) there is a procedure for designing a document control structure. ISO Series for example does not provide a method for controlling a document. Most companies follow the traditional style that includes numbered sections and broken down paragraphs.

5. Do not sweat the format; spend time on defining the purpose of a document and the content that needs to be included. Just remember once you have gathered the information required, go ahead and write the procedure. If your not sure just ask yourself if the documents you are creating fulfill customer requirements.

6. How can you tell if a documented procedure, instructions, forms, records, etc… need to be controlled? Answering the following questions will help:
- The process owner and user(s) understand what to do?
- The work task is standardized and performed the same across the department (all shifts)?
- The output fulfills the requirements as stated in the input?
- There is a chance that variation is widespread among workers and the risk for producing defects is warranted?
- A new employee/temp/replacement would be able to do learn a work task from notes, manuals or other workers if the experienced worker cannot perform the job?
If the answer is no or not sure to any of those questions then a controlled document should be produced.

7. Controlled vs. Uncontrolled – the following must be present in order for a document to be controlled:
- The revision status must be known
- The authorization & approval must be evident (not signed, not authorized)
- The document must be protected from destruction, damage or carry an unauthorized revision
- Electronic Media documents must also be protected from corruption, spyware & viruses
- It must be protected from unintended use.

8. The quality manual or policy states the company’s intent and goals. If you were going on vacation this would be the document that tells you where you are going. The manual serves as your map.

9. Difference between a Procedure and Work Instructions? A controlled documented procedure covers the major functions and accurately describes the process that it controls. Work Instructions (SOPs), Tasks, Forms, Job Descriptions, training Guides, Drawings, etc. requires more detail than a procedure and is usually found at the worker(s) location. A procedure creates an umbrella like scenario encompassing a whole range of work instructions or tasks. For example, the procedure for conducting system application testing may require a number of work instructions or methods needed to complete the process.

10. There is a direct relationship between documents and records. Documents provide the definition of requirements. Records provide evidence of fulfilling those requirements. Documents relate to inputs; Records relate to outputs. Together they show an excellent example of the concept of process. You cannot generate a record if you do not have an output, which is the outcome of a process. You cannot have an outcome if you did not do anything. You cannot do anything if you do not know what you are supposed to do. You cannot know what you are supposed to do if you do not have a requirement – the input to your process. Therefore, it is impossible to create a record if you do not have a requirement to match it up against.

10. Documents are living: Records are dead. Documents can be revised: A record can be added to, but it cannot be revised (to do so means fraud).

11. Forms – Utilizing Forms that are well defined and capture the correct amount of information can two purposes when controlling documents. First, having the appropriate information about a process is an excellent way for documenting requirements. Second, Forms capture the extra benefit of incorporating the record of fulfillment.

12. External Documents (international standards, statutory & regulatory requirements, product standards, operating procedures) – always debated as to if they need to be controlled. Documents of this type are not created by the organization but define requirements that are necessary for fulfilling customer requirements. The accepted thought is that because the organization does not have control over the revisions (exists with the originator) nor can they be approved internally they do not need to be controlled. However, companies that use these type of documents must ensure their people understand and control the following:
- Access
- Preservation (including disposal)
- Status of Revisions
- Process that details how to obtain the latest revisions
- Making sure requirements from external documents flow seamlessly with requirements of internal created documents.

13. The most efficient way to ensure control of external documents is to create a matrix that identifies responsibility (i.e., ownership) and the location where the document can be found by all those who need to know (location also goes for internal documents.

14. Electronic Media (i.e., Software) – tracking changes, revisions and new versions is very important. The company must ensure sufficient control of electronic media. IT Managers must make sure IT documents integrate properly into the company‘s documentation if the process it relates to is being controlled.

15. The interdependency of your controlled documents should emulate the interdependency of your processes. The employees involved in these interrelations must set up modes of communication with one another. The responsibility of these documents is shared and should be noted in the approval process.

16. Users (technicians, service reps, operators, line workers, sales folks) – play a vital role in controlling documents. Users play an important part in creating and revising documents that need to be controlled, as well as sharing ownership for the documents contents.

17. Flowcharts – In the quality and information technology field a number of people use flowcharts to describe their processes. Know your user before settling on using just flowcharts, if not you will be needing to have associated (added cost) training. Flowcharts (also illustrations) can be stand-alone documents or integrated into work instructions.

18. Acronyms & Abbreviations - like flowcharts, do not use them if your audience does not understand their meanings. Some departments seem to talk in a foreign language when communicating with one another.
To see an example of a quality controlled document template go to my sky drive folder at:

1 comment:

Meredith said...

This is interesting information about document control . I'll have to save it for future reference.