Document Control Number

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. 

Jacobs Engineering. 2000. Modified Baseline Pueblo Chemical Agent Disposal Facility Basis of Design, Rev. B, October. Prepared for the Science Applications International Corporation by Jacobs Engineering. Document Control Number AFC-J23-35P22786-P6-0001. Oak Ridge, Tenn. Jacobs Engineering. 

Significant deficiencies regarding documentation controls were reported. Documents were either not dated, lacked a documentation control number, were missing, were reported in pencil on uncontrolled pages, or dates were crossed out without initials, dates, or explanation. [FDA Warning Letter, 2001]... 

The test report generated from these activities lacked a document control number. [FDA 483, 2000]... 

General test plans lack a document control number and lack approval by the Quality Unit. 

The report generated from these activities lacked a document control number, was not approved by the Quality Unit. Additionally, this report conunits to correct errors identified in XXXXXX during this testing. The original commitment in this report is for corrective actions to be delivered by March 31, 1998. Subsequently this plan was updated to have corrections delivered by March 31,1999. The firm produced no report, which addresses the corrections made in response to this report. [FDA 483, 2000]... 

The ninety day review period starts when the EPA receives a complete PMN form. The EPA assigns a receipt number, acknowledges receipt of the PMN, and informs the submitter of the date the PMN was received. If the information is not complete then the ninety day review period does not begin until the gaps are filled.If another person is supplying confidential information then the review period begins when the EPA receives all the necessary information.A Document Control Number is assigned if the PMN is complete. ... 

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. 

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. 

A system of document control, including restricting unofficial copying, is required, in order to ensure that only authorized methods are used and that these are the latest revisions. This requires attention to details, such as revision number, who authorized the method, who has amended it, issue date, date of next revision, number of copies and who owns them, etc. A variety of documentation formats are available, but a standard format for method documentation is provided in ISO 78-2 1999 and a layout based on this Standard is provided in the Appendix to this chapter [18]. 

Quality System shall provide for control of material and product identification during all stages of production and delivery. Identification is based on applicable drawings, specifications, or other documents. When required or specified, complete traceability of material or product shall be maintained by issuing unique or batch control numbers and/or markings. The identification and trace-ability procedure shall be fully documented to provide objective evidence of compliance with this Code in accordance with this requirement. 

What does document control system mean Every document must be clearly identifiable. This includes a unique number and revision status to show if this document has been revised. It could be useful to include the type of document into the number to ease the operation of the system. This is demonstrated on the slide with an SOP as example. 

This guidance document is intended to provide instruction on how to submit a request for a meeting or teleconference in electronic format to ONADE at the CVM (or the Center). The guidance was revised to update the phone number for the Electronic Document Control Unit and to replace the Web site to submit electronic comments. 

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, [[Page 29516]] OMB, Attn FDA Desk Officer, FAX 202-395-6974. All comments should be identified with the OMB control number 0910-0167. Also include the FDA docket number found in brackets in the heading of this document. 

Instrument application design is one of the most extensive activities, in terms of the number of types of instrument and the associated paperwork, and requires a logical, carefully controlled approach. A change to an instrument tag number or the addition/deletion of an instrument can affect up to ten different documents. However, with good document control, it is possible to produce a system of documentation that will allow instrument applications, both simple and complex, to be validated and easily maintained. This case study has described the instrument application design process commonly used in the industry and how this can be used to support validation. 

Many drug companies are using electronic means of verifying component names or item codes, receiving and control numbers, weights, or measures, and even the verification of component addition to a batch. There is a range of acceptability on the part of the FDA of electronic means of verification and batch documentation however, the validation of such... 

Management data It is important to document the number of staff, their position and responsibilities, performance records, administrative instruction, occupational and safety procedures, quality assurance, and quality control procedures. 

Referencing vendor manuals is a choice that maintenance managers can use to keep numbers of procedures manageable, but it imphes another level of document control. If you reference vendor manuals in maintenance procedures, your site must possess these documents and ensure they are accessible, up to date, and accurate. 

A hybrid method, bisecting K-means, combines the divisive hierarchical and K-means methods to produce a controlled number of hierarchical document clusters. It has been shown to perform as good as or better than hierarchical methods while retaining the performance of the K-means approach [32]. The process of this method involves bisecting a selected cluster of documents (biggest or poorest quality) into two smaller clusters but optimizing the centroids to obtain new clusters with the best possible quality. An example of an implementation of this type of method is the Oracle Text hierarchical K-means algorithm. 

Specific information about each endoscope (i.e., manufacturer, diameter, length, tip angle, depart-ment/unit, control number, and operator), the reason for the test (i.e., quality control, pre/post repair, etc.), and any problems associated with the scope are also documented through the electronic record. In addition, all the quantitative measurements from each test are automatically appended to the electronic record for life-cycle performance analysis. 

The reports must include in a separate, detachable part the exposed individual s name. Social Security Number, and birth date. The reports are to be sent to the U.S. NRC Document Control Desk, Washington, D.C., 20555, with a copy to the regional administrator. 

Title Page. Includes the words systems engineering management plan, the docmnent control number for the project, organization involved, and the document title and/or applicable system. Figure B.l provides an example of a title page with the necessary information identified. 

UN document ID number ST/NAR/31. Recommended Methods for the Detection and Assay of Lysergide (LSD), Phencyclidine (PCP) and Methaqualone in Biological Specimens United Nations Drug Control Programme, 1999, http //www.unodc.org... 

A document control system, including standard practices for numbering documents, their filing, the system of document approval and authorization of issue, distribution control, revision control, and archiving. 

The project time schedule control (or planning) system. Generally the same remarks apply as for cost control. Numbering needs are less exacting than for cost control, because roll-ups of like items are not applicable. Generally the numbering systems employed for equipment and documentation are adequate. 

The nature of the work is repetitive and easily codified in a procedure. The number of documents to be processed is predictable, and the timing is more or less predictable. The work can and must be planned, and adequate resources made available, on pain of losing control of the project when, for instance, it takes a week to circulate a batch of vendor drawings because they must first be renumbered in the project system, but the document controller is overloaded. And the delay may only be recognized when the time has been irretrievably lost. 

In conclusion then, at the outset of a project it is essential to have a well-thought-out document control procedure and numbering system that meets the needs of all users before and after project completion, and obviates any subsequent need for renumbering. 

---