Control design procedure

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

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 control the design of the product in order to ensure that the specified requirements are met. 

This general requirement for procedures introduces uncertainty into what particular procedures are actually required. The standard does not require the design control procedures to address each requirement of this clause but were they not to, you would need to demonstrate that the absence of such procedures had no adverse affect on the quality of design. 

Create a procedure for controlling the allocation of work packages to various design groups and to subcontractors. 

You may only need one procedure that covers all the requirements but this is not always practical. The provisions you make for specific quality records should be included in the procedures for controlling the activity being recorded. For example, provisions for inspection records should be included in the inspection procedures, provisions for design review records should be included in the design review procedure. Within such procedures you should provide the forms (or content requirements for the records), the identification, collection/submission provisions, the indexing and filing provisions. It may be more practical to cover the storage, disposal, and retention provisions in separate procedures because they may not be type-dependent. Where each department retains its own records, these provisions may vary and therefore warrant separate procedures. 

I.I. The Traditional Safety Engineering (TSE) View The traditional safety engineering view is the most commonly held of these models in the CPI (and most other industries). As discussed in Chapter 1, this view assumes that human error is primarily controllable by the individual, in that people can choose to behave safely or otherwise. Unsafe behavior is assumed to be due to carelessness, negligence, and to the deliberate breaking of operating rules and procedures designed to protect the individual and the system from known risks. 

The human factors audit was part of a hazard analysis which was used to recommend the degree of automation required in blowdown situations. The results of the human factors audit were mainly in terms of major errors which could affect blowdown success likelihood, and causal factors such as procedures, training, control room design, team communications, and aspects of hardware equipment. The major emphasis of the study was on improving the human interaction with the blowdown system, whether manual or automatic. Two specific platform scenarios were investigated. One was a significant gas release in the molecular sieve module (MSM) on a relatively new platform, and the other a release in the separator module (SM) on an older generation platform. 

If a manufacturer has modified their own device they can avail of a special 510(k) procedure for declaring substantial equivalence to their existing device, provided that the intended use or the basic technology has not changed. They must apply design controls and risk analysis to the development process, but the advantage is that they can receive a faster review process. 

A method proposed by Schweder and Spjotvoll (1982) is based on a plot of the cumulative distribution of observed p values. Farrar and Crump (1988) have published a statistical procedure designed not only to control the probability of false positive findings, but also to combine the probabilities of a carcinogenic effect across tumor sites, sexes, and species. 

Sample pretreatment and varied experimental procedures designed to control or eliminate the effects of one or more of the aforementioned characteristics do not result in more than one order of magnitude change in the experimental dissolution rates. 

The Canadian Task Force categorized the quality of evidence based on the type of research study. The quality of evidence was organized into three classes Class I evidence comes from procedures having at least one randomized controlled study to support them. Class II is divided into three subclasses, where II-l involves a well-designed controlled study without randomization. Class II-2 evidence comes from well-designed cohort or case-control studies, preferably carried out at more than one research setting. Class II-3 involves uncontrolled research with dramatic results (e.g., penicillin trials in the 1940s). Class III evidence includes the opinions of experts and authorities in the field based on clinical... 

Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following ... 

To describe the design control procedure in accordance with clause 4.4 of ISO 9001 and corresponding clauses of international standard ISO 9001 2000. 

Modelling of solar radiation components (diffuse and direct) in clear sky conditions is necessary in many solar energy applications (systems design and simulation, radiometers accuracy control procedures, quality control of data, recovering of observational missing data, etc) as well as in routine procedures in engineering. 

The licensee shall establish and maintain a statistical control system including control charts and formal statistical procedures, designed to monitor the quality of each type of program measurement. Control chart limits shall be established to be equivalent to levels of (statistical) significance of 0.05 and 0.001. Whenever control data exceed the 0.05 control limits, the licensee shall investigate the condition and take corrective action in a timely manner. 

Since 1998, all medical devices marketed in Europe (EEA) must bear the CE mark, which signifies conformity to the essential requirements of the MDD. The MDD harmonized the European requirements along with device certification and the inspection procedures for manufacturers to ensure the highest degree of safety and product quality of the medical devices throughout the EC. Most important was the requirement for a full quality assurance system (Annex II of the MDD, 93/42/EEC), which included design controls for new medical device products. This was in line with the ISO 9000 series of standards established for quality systems by the International Organization for Standardization. 

Sets of instructions that detail the procedures designed to reduce errors occurring during analytical procedures and ensure accurate quantitations are found in the quality assurance (QA) and quality control (QC) manuals. Quality assurance procedures are used by the laboratory to detect and correct problems in analytical processes. As newer methods and instrumentation are added to the laboratory, older procedures must be modified or changed completely. Quality control procedures are used to maintain a measurement system (i.e., a gas chromatograph) in a statistically satisfactory state to ensure the production of accurate and reliable data. 

FDA warning letter citation Your firm failed to establish and maintain procedures... in order to ensure that specified design requirements are met. For example, the software designed by your firm was developed without design controls. ... 

This citation talks to a core concept of computer systems validation development procedures and system specifications. Note that the firm was not cited for lack of validation testing of the software but for lack of design controls. Effective design controls would have included written design procedures. Adherence to these procedures would have... 

According to 21 CFR 211.160(b), Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. ... 

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