Document control

The EPCM contractor s document control system will be operative from start to finish embracing all phases of the project. The site document control system will be as it were an extension of the over all project system. The latter normally includes the following features  

The site document control function is sometimes treated as an administrative matter, but it is much better if it is under the authority of the site engineer. This function needs the necessary procedmes, staff, computing facilities and suitably equipped and furnished offices. Responsibilities 

It is important for a company to have a document control system. This system is a formal system that controls how documents are updated so that there is always a record of how designs or operations evolve over time. The document control system is the company s primary document control system and is not just for safety information management. That is covered in the next section. 

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The EPA publishes Series Methods that describe the exact procedures to be followed with respect to sample receipt and handling, analytical methods, data reporting, and document control. These guidelines must be followed closely to ensure accuracy, reproducibility, and reliability within and among the contract laboratories. 

The quahty manual should be organized to faciUtate referral to the quahty system standard. It should be brief and refer to other documentation for more detail. The manual should be under document control, ie, each page is uniquely identified as to date or revision number and its preparer. It is common practice to offer customers a copy of the manual upon request, ie, the manual should not be proprietary. 

Environmental management system documentation Document control Operational control Emergency preparedness and response Checking and corrective action... 

If you are making a voluntary revision to a previous Form R submission, enter Voluntary Revision" in the space marked This space for your optional use" on aHfive pages of the form. If you have obtained the Document Control Number (DCN) of the original submission from EPA, enter that number also in this space. Enter the revised data to the Form R and circle it in red ink. Sign the certification and provide a current date. 

The standard does not require you to document how you maintain your quality policy but the requirements of clause 4.5.1 place the quality policy into the category of documents which need to be governed by documented control procedures and hence all changes must be reviewed and approved. 

It should be noted that the business plan is a document that relates to the requirements of the standard and therefore should be under document control (although your controls may be different to those used for controlling other types of documents). 

These elements of ISQ/TS 16949 are linked together as shown in Figure 2.1. In the figure, document control and management are functions common to other elements of the business, and the education and training process is shown separately as it operates in both the implementation and the design phase. 

To determine the procedures you need you should design the system from the top down. Some requirements will apply to many operations such as document control, corrective action, and quality records whereas other requirements may apply to only one operation, such as auditing and management review. A matrix showing this relationship is given in Appendix D. 

The verification plan should be approved by the designers and those performing the verification activities. Following approval the document should be brought under document control. Design verification is often a very costly activity and so any changes in the... 

In the world of documents there are two categories those that are controlled and those that are not controlled. A controlled document is one where requirements have been specified for its development, approval, issue, revision, distribution, maintenance, use, storage, security, obsolescence, or disposal. You do not need to exercise control over each of these elements for a document to be designated a controlled document. Controlling documents may be limited to controlling their revision. On the other hand, you cannot control the revision of national standards but you can control their use, their storage, their obsolescence, etc. Even memoranda can become controlled documents if you impose a security classification upon them. 

Figure 5.4 Clause relationships with the document control element...

The principal elements of document control are illustrated in Figure 5.5. This process provides for bringing existing documents under control, for controlling the preparation of new documents and for changing approved and issued documents. Each process could represent a procedure or a form. The processes may differ depending on the type of documents and organizations involved in its preparation, approval, publication, and use. One procedure may cater for all the processes but you may need several. 

The aspects you should cover in your document control procedures are as follows, some of which are addressed further in this chapter ... 

All data should be examined before use, otherwise you may inadvertently introduce errors into your work. The standard does not require that data controls be the same as document controls so you are at liberty to pitch the degree of control appropriate to the consequences of failure. 

If you do not have a means of readily distinguishing the correct version of a document, amendment instructions should require that the version being replaced is destroyed or returned to the document controller. If you allow uncontrolled copies to be taken, removal of obsolete documents becomes more difficult. However, providing you have a... 

Processes in this context means those series of related activities that turn inputs into outputs of added value. They include design, procurement, manufacture, packing, delivery, installation, maintenance, operations, disposal as well as the processes which serve these primary processes such as calibration, training, inspection, test, document control, etc. 

Throughout the standard, various clauses reference the clause on quality records. To avoid repetition, the common requirements for quality records are assembled under one heading. The requirements, however, are not limited to those clauses in which this requirement is referenced as many other clauses refer to records. However, as all clauses will generate some documentary evidence it should not be assumed that all such documents are quality records. The requirements, however, apply only to original records and not to any copies other than those taken for security reasons or copies of subcontractor records. There are several types of document used in a quality system and only some are classified as quality records. As quality records are documents it might be assumed that the requirements of clause 4.5 on document and data control apply to quality records. As clause 4.16 is not cross referenced in clause 4.5 (except for clause 4.5.2.2), there is clearly no requirement for you to apply the requirements for document control to quality records. (See also Part 2 Chapter 5.) Figure 5.2 illustrates the difference between quality records and documents. 

Quality Management system priorities to consider are management responsibility, quality system principles, auditing, contract review, design control, corrective action, document control, quality records, training, product safety and liability, and statistical techniques, because these are critical aspects of the Quality Management system where Xmple Inc. already has some systems in place. 

A document control function is required to regulate the authorisation and circulation of such documents. This involves the sign-off on a master copy of the document by authorized personnel, followed by a recorded circulation of official copies to relevant departments. If a document needs to be updated, the revised version should be reviewed and approved by the same functions that approved the original. The revised version is then issued with a new version number and date, and all copies of the obsolete version should be destroyed other than the obsolete master, which may be kept for historical traceability. 

Documentation requirements - Create quality policy, quality manual, procedures, and document control and distribution function. Retain records for the expected lifetime of the device or a minimum of 2 years... 

Sec. 820.40 Document controls - Establish procedures for document approval, revision and distribution... 

Is there a SOP for archive requirements and retention policies (Is the archived material indexed, is there document control and is it secure )... 

Data analysis should focus on the development or refinement of the conceptual site model by analyzing data on source characteristics, the nature and extent of contamination, the contaminants transport pathways and fate, and the effects on human health and the environment. All field activities, sample management and tracking, and document control and inventory should be well managed and documented to ensure their quality, validity, and consistency. 

U.S. EPA, Supplemental Technical Development Document for Effluent Limitations Guidelines and Standards for the Pulp, Paper, and Paperboard Category Subpart B (Bleached Papergrade Kraft and Soda) and Subpart E (Papergrade Sulfite), U.S. EPA, Document Control 14487, Washington, October 15, 1997. 

EPA. 1980b. 8E Substantial risk report Symptoms of all employees who had some contact with exotherm, follow up study of EPA document control no. 8EHQ-0480-0338. Submitted to the U.S. Environmental Protection Agency, Office of Pesticides and Toxic Substances, Washington, DC, by the Lockheed Missiles Space Company, Inc. EPA/OPTS 8EHQ-0980-0338. Fiche no. OTS0200599. 

EPA. 1996a. Bioavailability of lead in soil samples from the Jasper County, Missouri Superfund Site. U.S. Environmental Protection Agency Region 8. Document Control No. 04800-030-0161. 

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