Documentation procedures

The general purpose of an audit may be to determine if the toller has management systems and documented procedures in place to ensure process safety, environmental responsibility, product quality and traceability of materials. The need to audit could be to evaluate compliance with regulations or accordance with client requirements related to specific performance elements. A subjective rating system for ranking management systems audit results is often used. An example of one that might be appropriate is shown below ... 

Is there a documented procedure for retaining product samples How long ... 

Documented procedures are often necessary to ensure consistency and correctness for any type of transaction. This section refers to the overall system of communicating, updating, and approving procedures. The procedures pertinent to the implementation of the quality assurance/improvement process should be compiled in a quality manual, the quality manual should be communicated throughout the organization. 

A JHA documents procedures that can be used to review job methods and uncover hazards that may exist in the workplace. JHAs can also be used to document changes in work tasks. Some solutions to potential hazards may be physical changes that eliminate or control the hazard or a modified job procedure that will help eliminate or minimize the hazard. 

Requirement for documented procedures to develop and verify the design... 

Are tenders, contracts, and subsequent amendments reviewed in accordance with documented procedures prior to submission or acceptance as appropriate ... 

Is product design controlled in accordance with documented procedures ... 

Are all internal and external documents that relate to the requirements of ISO 9001 controlled in accordance with documented procedures ... 

Are the required inspections and tests and the records to be produced detailed in documented procedures or quality plans ... 

Are documented procedures employed to prevent the inadvertent use or installation of nonconforming products ... 

Are documented procedures employed to determine the cause of nonconformities in products, processes, and the quality system and to prevent their recurrence ... 

Are documented procedures employed to detect and eliminate potential causes of nonconformance and prevent their occurrence ... 

It is not mandatory that you have documented procedures for forming the quality policy and the quality objectives, defining the responsibility of personnel, identifying resources, or conducting management reviews. However, section 4 of the standard is titled Quality s /stem requirements and section 4.2 requires that a quality manual be prepared covering the requirements of the standard. It follows therefore that you need to address the requirements of section 4.1 in your quality manual. You have a choice of how you address the requirements providing they are documented. 

You need an improvement system that causes improvement opportunities to be identified. Relying on chance encounters will not create the conditions needed for continuous improvement. The data that needs to be analyzed will be generated by a particular process and this process governed by particular documented procedures. By having already placed instructions in these procedures for certain data to be transmitted to your data analysts, you can cause opportunities to be identified. Other opportunities that are less dependent on product or process data may arise from the audit process and particular projects such as benchmarking, customer and supplier surveys. 

Although there is no requirement for you to have a documented procedure for management review, you need to ensure that certain information is brought before the review and the review produces certain results. As you are going to conduct these reviews frequently you may want to ensure they follow a repeatable process and an obvious way to achieve this is through a documented procedure. 

The standard requires the supplier to prepare documented procedures consistent with the requirements of this international standard and the supplier s stated quality policy. 

It follows therefore that the idea of calling documents procedures when they only apply to interdepartmental activities and calling documents work instructions when they apply to departmental activities is ill-conceived. Both types of documents are in fact procedures. In both cases work instructions may be needed to initiate work and procedures may be needed to define the sequence in which the work is to be executed, where the instructions alone are insufficient. 

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 to develop and verify the design of processes used for product realization. 

You should develop a documented procedure for the facility planning activity that will ensure the provision of adequate information on which to base plant design decisions. The procedures should provide for a separate development plan with allocation of responsibilities for the various tasks to be undertaken and should cover the layout, specification, procurement, installation, and commissioning of the new or revised plant. 

The standard requires firstly that the supplier establishes and maintains documented procedures for contract review. 

The standard requires that the supplier establishes documented procedures for coordinating contract review activities. 

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