Controlled documents

Fan noise is demanding and receiving much attention because of environmental laws. The basic control document is the federal OSHA limitation of 90 dB(A) at an operator s work place for 8-h exposure. There are other limitations on entire plant noise at the boundary of new plants from local ordinances which are typically more severe than the OSHA limitation. 

Produces internal control documentation and wemmentally required reports. Manifest printing from files containing information on approved transporters and disposers, waste materials, and historical data. 

One person in a unit retrieved a two-year-old shutdown procedure from his locker and tried to use it. The old procedure was significantly different from the updated procedure. If the old procedure were followed exactly, there would be more risk. If the two procedures were intermingled, there would be high temperature and catastrophic corrosion. The unit management team tore up the bootleg procedure and added the updated shutdown procedure to the controlled document system used for ISO 9002 (ISO 9000, 1994). In this document system, only the current procedure is available. Alternate systems may use an expiration date or require periodic reconfirmation. 

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. 

There are three types of controlled documents, as illustrated in Figure 5.1 ... 

Figure 5.3 shows some examples of the different classes of documents and their relationship. All the controlled documents except records are governed by clause 4.5 of the standard. Records are governed by clause 4.16 of the standard. 

The standard requires the supplier to establish and maintain documented procedures to control documents of external origin such as standards and customer drawings. 

Customer engineering standards and specifications are external documents. Therefore your procedure for controlling external documents should also cover these documents. Where ISO/TS 16949 differs from ISO 9001 on this topic is that ISO 9001 does not require external documents to be reviewed or implemented. However, any external document received or procured for the organization should be reviewed for its applicability before it is brought under control, otherwise resources could be wasted on controlling documents that have no practical use in the organization. This requirement could be placed under Contract rev/ew since any documents issued by customers form part of the contract and should go through contract review before acceptance and implementation. 

As with all controlled documents, a distribution list for customer documents should be maintained so that copies can be withdrawn, replaced, or amended when required. 

Specify appropriate requirements for each of the controlled documents. 

Produce procedures for preparing, reviewing, approving, issuing, and changing controlled documents. 

Determine who will review and who will approve the controlled documents. 

Create a formal change request mechanism for initiating changes to controlled documents. 

How do you control documents and data that relate to the requirements of ISOATS 16949 ... 

Don t put the distribution list on controlled documents - keep it separate. 

Don t change a controlled document without an approved change notice. 

Do review controlled documents periodically to determine whether they remain relevant. 

You will need a documented procedure for generating the AVL, adding new subcontractors, changing data, and removing subcontractors that no longer meet your criteria. Whether in paper form or in a computer database, treat it as a controlled document or controlled data and apply the document/data controls developed to meet element 4.5 of ISO 9001. 

Product specification documents and analytical test methods—In preclinical development, these are important documents and they evolve along with the development phases. Drug substances and products for clinical trials are tested based on these documents, and so are the stability samples. It is critical to ensure that the analyst will perform the right tests against the right specifications with the correct version of the test method. Therefore a mechanism must be in place to control these documents. This can be done manually or with TIMS. A manually controlled system would require the analyst to sign out hard copies of the documents from a central location. After the testing is done, the analyst would have to return these controlled documents to the... 

Draft Guidance for Industry-Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls Documentation, Nov. 13, 1998. 

To have a basic knowledge of the factors to include in controlled documents. 

Controlled documents held All documents should be current versions... 

Process control documents (PCDs), 26 745 Process control languages (PCL), 20 672 Process control system, 20 730-731 Process cut-offs, in life cycle assessment, 24 813... 

The responsibilities are best laid out in a controlled document that includes clear statements of what needs to be done, when, how, how often, and by whom. Procedures and job descriptions may specify some of these responsibilities for an existing facility. Development of a management system will be most effective with broad input from the persons who will be given the designated responsibilities and be held accountable to fulfill them. 

Documentation comprises procedures, instructions, test methods,batch records, and so on that are documented and controlled. Documentation is prepared, reviewed, and approved by qualified personnel. Approved copies of documents are distributed to relevant departments and superseded copies are retrieved and archived. The retention period for each type of document is specified. Documents are issued with document and version numbers for ease of identification and reference. Master copies of documents are filed at secured locations with authorized access. Master copies stored in electronic media require validation in accordance with FDA regulation 21 CFR Part 11 (see Section 9.6.3) to assess the security of access and data integrity. Operators are trained and retrained to only apply the latest approved documents. 

Guidance for Industry, Analytical Procedures and Method Validation Chemistry, Manufacturing and Controls Documentation, Draft, August 2000, Center for Drug Evaluation and Research, Center for Biologies Evaluation and Research, FDA, Department of Health and Human Services, 2000. 

Guidance for Industry, Analytical Procedures and Methods Validation, Chemistry Manufacturing and Controls Documentation, Draft Guidance, FDA, August 2000. 

Currently, there are closure Resource Conservation Recovery Act (RCRA) permit modifications awaiting ERA approval. To date, there have been no delays due to approval of permit modifications, but they could occur in the future. Permit modifications need to be identified sufficiently early to allow time for regulatory reviews, public comment, resolution of comments, and incorporation of changes into the applicable engineering change proposals (ECPs), work orders, or other management control documents. 

A record of software acceptance testing and software maintenance or change control documents also ensures future software integrity. 

Guidance for industry, container closure systems for packaging human drugs and biologies, chemistry, manufacturing and control documentation, Food and Drug Administration, 1999. 

U.S. Food and Drug Administration (FDA) (2000), Guidance for industry, Analytical procedures and methods validation—Chemistry, manufacturing, and controls documentation, FDA, Rockville, MD. 

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