Documented procedures meaning

The standard requires documented procedures to be prepared consistent with the requirements of this international standard, but what does this mean Preparing procedures consistent with the requirements of the standard means preparing those procedures where the standard requires them. Outside ISO 9001, ISO/TS 16949 does not use the same wording to require procedures. In some clauses it requires a process and in others it requires methods or a methodology or a system. Although systems are not procedures, procedures are not processes and methods are not necessarily procedures, systems, or processes. Some methods, however, will inevitable need one or more procedures. By including systems, methods, and processes, the standard now requires 43 documented procedures directly. 

The standard doesn t require a procedure for Management Review and while it does require procedures for Design Control it does not specify that a Design Review Procedure is required. The phrases consistent with and in accordance with have the same meaning as both imply compatibility and agreement. If you restrict yourself to a literal interpretation of the standard, you need produce no more than 43 documented procedures - possibly less if some aspects do not apply to your business. You can combine several procedures in one document, the size of which depends on the complexity of your business. The more complex the business the greater the number of quality system documents. The more variations in the ways that work is executed, the larger the quality system will need to be. If you have a small business and only one way of carry-... 

The standard requires the supplier to establish and maintain documented procedures where appropriate for identifying the product bp suitable means from receipt and during all stages of production, delivery, and installation. 

Note that in ISO/TS 16949 documented procedures are needed where the product identity is not inherently obvious - the where appropriate condition has been removed. If products are so dissimilar that inadvertent mixing would be unlikely to occur, a means of identifying the products is probably unnecessary. Inherently obvious in this context means that the physical differences are large enough to be visible to the untrained eye. Therefore functional differences, no matter how significant - as well as slight differences in physical characteristics, such as color, size, weight, appearance - would constitute an appropriate situation for documented identification procedures. 

In a manufacturing environment, this requirement applies to the process plant, machinery, and any other equipment upon which process capability depends. The requirement for documented procedures in 4.9a implies that you will need procedures for maintaining this equipment and this means that you will need ... 

In continuous production, product is inspected by taking samples from the line which are then examined while the line continues producing product. In such cases you will need a means of holding product produced between sampling points until the results of the tests and inspections are available. You will also need a means of releasing product when the results indicate that the product is acceptable. So a Product Release Procedure or Held Product Procedure may be necessary. The standard implies, however, that if you have released product under positive recall procedures you do not need to hold product while in-process inspection and tests are performed. The reference to clause 4.10.3(a) is also ambiguous because the inspections and tests carried out in accordance with the quality plan or documented procedures may not cover those necessary to verify product on receipt into the plant. It would be wise to hold any product until you have... 

To accomplish this, you need to specify either in the quality plan or the documented procedures, the inspections and tests you intend to carry out to verify that the product meets specified requirements. In Part 2 Chapter 4 there is a description of a Design Verification Plan and this includes a specification of the tests and inspections to be performed on each production item as a means of ensuring that the qualified design standard is being maintained. This requires that you produce something like an Acceptance Test Plan which contains, as appropriate, some or all of the following ... 

The objective of vendor qualification is to get assurance that the vendor s products development and manufacturing practices meet the requirements of the user s firm. For software development this usually means that the software is developed and validated following documented procedures. The requirements usually vary between user firms and, within companies,... 

Standard Operating Procedures (SOPs) means documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines. 

Equipment used to process, store, or handle highly hazardous chemicals must be designed constructed, installed and maintained to minimize the risk of release. A systematic, scheduled, test and maintenance program is preferred over "breakdown" maintenance " that could compromise safety. Elements of a mechanical integrity program include 1) identification and categorization of equipment and instrumentation, 2) documentation of manufacturer data on mean time to failure, 3 ) test and inspection frequencies, 4) maintenance procedures, 5) training of maintenance personnel, 6) test criteria, and 7) documentation of test and inspection results. 

Are the means used to ensure that product conforms to specified requirements documented in the form of a quality manual and quality system procedures ... 

While the term adequacy is a little vague it should be taken as meaning that the document is fit for its purpose. If the objective is stated in the document, does it fulfill that objective If it is stated that the document applies to a certain equipment, area, or activity, does it cover that equipment, area, or activity to the depth expected for such a document One of the difficulties in soliciting comments to documents is that you will gather comments on what you have written but not on what you have omitted. One useful method is to ensure that the procedures requiring the document specify the required content so that the reviewers can check the document against an agreed standard. 

Timely review means days, not weeks or months - therefore immediately a new customer document is received, it should be routed to a person authorized through procedures to carry out a review. It would be advantageous to set up an interface with your customers so that their documents are always routed to the same position in your company. The review should establish the applicability of the document and its impact on the contract. Any changed documents should be treated as an amendment to the contract and processed accordingly. 

To limit the potential for deficiencies to escape detection before the product is released, special processes should be documented in the form of procedures and specifications that will ensure the suitability of all equipment, personnel, and facilities, and prevent varying conditions, activities, or operations. Qualification in the context of special processes means that you need to conduct a thorough assessment of the processes to determine their capability to maintain or detect the conditions needed to produce conforming product consistently. The limits of capability need to be determined and the processes only applied within these limits. In qualifying the processes you need to qualify the personnel using them by training and examination as well as the materials, equipment, and facilities employed. It is the combination of personnel, materials, equipment, and facilities which ensure qualified processes. 

An inventory management system should be established - meaning set up on a permanent basis to meet defined inventory policies and objectives approved by executive management. It should be documented - meaning that there should be a description of the system, how it works, the assignment of responsibilities, the codification of best practice, procedures, and instructions. The system should be planned, organized, and controlled in order that it achieves its purpose. A person should therefore be appointed with responsibility for the inventory management system and the responsibilities of those who work the system should be defined and documented. Records should be created and maintained that show how order quantities have been calculated in order that the calculations can be verified and repeated if necessary with new data. The records should also provide adequate data for continual improvement initiatives to be effective. 

You will also need a means of determining when the retention time has expired so that if necessary you can dispose of the records. The retention time doesn t mean that you must dispose of the records when the time expires - only that you must retain the records for at least that stated period. Records will need to be dated, the files that contain the records dated, and, if stored in an archive, the shelves or drawers dated. It is for this reason that all documents should carry a date of origin and this requirement needs to be specified in the procedures that describe the records. If you can rely on the selection process, a simple method is to store the records in bins or on computer disks that carry the date of disposal. 

If reviewers of completed forms are not the preparer, they need to be trained in procedures to audit the quality of the collected information and documentation files. This training may include means to check the completeness and credibility of the collected data by cross checking the data against other reference files, such as maintenance files or operating logs. 

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