Procedural Noncompliance

Workers do not always follow procedures (Dekker, 2003). One of the most prominent problems associated with the use of procedures is operator noncompliance. Violations of procedures are a significant cause of industrial accidents and are a frequent cause of production losses, poor quality, and unreliable maintenance (HSE, 1995). According to Dekker (2003), there is a history of industrial disasters where a lack of procedural compliance played a role. Procedural noncompliance can take the form of unintentional noncompliance, where the operator unknowingly deviates from a procedure due to factors such as memory lapses or misinterpretation, or intentional noncompliance, where the operator knowingly ignores a procedure, often due to a perception that following the procedure offers more drawbacks than benefits (Ockerman and Pritchett, 2001). 

Procedural noncompliance is related to the complex error category that is known as violations (Reason, 1990), which are categorized as any behavior that deviates from accepted procedures, standards, and rules. Violations can be either deliberate or erroneous (Reason 1997). Deliberate violations occur when an actor deliberately deviates from set rules or procedures for example, a driver who is consciously exceeding the speed limit is committing a deliberate violation. Erroneous or unintentional violations, however, occur when an actor unintentionally deviates from a set of rules or procedures for example, a driver who unintentionally exceeds the speed limit, due to either not comprehending the speed of the vehicle or not being aware of the current speed limit, is committing an erroneous or unintentional violation. 

Embrey (1989) suggested that a large portion of accidents involve operators intentionally ignoring known procedures (Cox and Cox, 1996). Embrey (1989) outlined the following four reasons why operators may opt not to follow procedures  

The procedures in question do not correspond to the way in which the task is actually undertaken. 

The information within the procedures, despite being correct, is not presented in a usable form. 

---

The HSE (2007) suggested that procedural noncompliance occurs for a variety of reasons The procedures may be incorrect or out of date, they are difficult to use or follow, they are not readily available, or there are easier ways to undertake the task in question. Also, noncompliance may be due to peer pressure, a failure to understand the risks involved, or perceived pressure from management to get the job done. 

The definition of nonconformity in ISO 8402 states that it is the nonfulfillment of specified requirements therefore a nonconforming product is one that does not conform to the specified requirements. Specified requirements are either requirements prescribed by the customer and agreed by the supplier in a contract for products or services, or are requirements prescribed by the supplier which are perceived as satisfying a market need. This limits the term nonconformity to situations where you have failed to meet customer requirements. However, ISO 8402 1987 suggests that nonconformity also applies to the absence of one or more quality system elements, but clearly the requirements of clause 4.13 cannot be applied to nonconformity with quality s /stem requirements. Both ISO 9001 and ISO 9004 only address nonconformity in the context of products, processes, and services and when addressing quality system elements the term deficiencies is used. Some auditors use the term nonconformity to describe a departure from the requirements of ISO 9001 but it would be preferable if they chose the term noncompliance to avoid any confusion. The requirements of clause 4.13 therefore only apply to products, processes, and services and not to activities, quality system elements, or procedures. 

Where an effective informal system exists and is followed, the issue is one of style, not substance. A facility or unit may have a strong safety culture and sound safety practices, but its managers lack the habit of form documentation, or simply don t think it is important. Assuming that safety performance meets applicable standards, you will probably assign cases like these a relatively low priority, compared with other noncompliance situations. Cases like these are also often the easiest to fix since the fundamentals are already in place, what s required is simply to formalize the informal system by preparing and implementing documentation procedures. 

The regulations require that IRBs must follow the written procedures that are set out in the assurances they have filed with HHS, review proposed research at convened meetings at which a majority of the IRB members are present, vote approval by a majority of members present at the meeting, and be responsible for reporting to the appropriate institutional official and the Secretary of HHS ... any serious or continuing noncompliance by investigators with the requirements and determination of the IRB. ... 

Consent decrees typically involve a defendant agreeing to address the areas of noncompliance in a manner satisfactory to the FDA within a certain amount of time. It can also provide for the hiring of an expert consultant to certify in detailed reports that the manufacturing facility, at periodic dates, is in full compliance with the cGMPs, and has adequate adverse-event controls, adequate training, and adequate recall procedures. It may also require the payment of money to the U.S. Treasury such as under the equitable remedy of disgorgement, as described in Figure 8. 

The validation integrity of LIMS must be periodically reviewed to ensure that ongoing support systems are effective. The review process should be designed to identify trends that may indicate noncompliance with support procedures or weakness in the original validation exercise. The review should further examine the original test data sets to determine their applicability to the current computer system configuration and duty. The review shall determine if there is a need for further validation of the cnrrent LIMS installation. 

Inadequate supplemental physical procedures Inadequate patient immune system response Patient noncompliance... 

Laboratory tests are affected by many factors, such as recent intake of food, alcohol, or drugs, and by smoking, exercise, stress, sleep, posture during specimen collection, and other variables (see Chapter 17). Proper patient preparation is essential for the test results to be meaningful. Although responsibility for this usually resides with personnel outside the laboratory, the laboratory must define the instructions and procedures for patient preparation and specimen acquisition. These procedures should be included in hospital procedure manuals and should be transmitted to patients in both oral and written instructions. Compliance with these instructions is monitored directly when the laboratory employs its own phlebotomists. Specific inquiry should be made regarding patient preparation before specimens are collected, and efforts should be made to correct noncompli-ance. For tests in which standardization of the collection is very important (such as for plasma catecholamines), specimens should be collected in a controlled environment, such as a clinical testing unit. 

A statement of the circumstances under which the patient will be withdrawn from the study (e.g. noncompliance with test procedures). 

QA s task to identify noncompliance with regulatory requirements, the trial protocol and internal procedures such as SOPs is not always an easy job. Communicating deficiencies and highlighting inadequate procedures is certainly a benefit for the company as a whole, but the individual may not appreciate being confronted with audit findings (Winchell, 2004). In order to be efficient and effective in QA, the following should be observed. 

Systems audits focus on the verification of quality control steps incorporated in the procedures, on interfaces between different functions and departments and on relationship to external providers. While noncompliance may be detected in systems audits, such audits aim to assess the capability of a system to deliver a quality output. 

Another type of noncompliance is the subjects adherence to the protocol procedures and schedules. It is the role of the investigator to make sure that the protocol is adhered to. Lack of adherence to the protocol complicates the analysis and may make the result difficult to interpret. 

Information and instruction are distinguished by the ability of instruction to change behavior. Behavior change, in turn, is the one proven method that lowers the risk of noncompliance by aligning employee behavior with mandated work procedures. Instruction is an engineered activity, specifically designed to meet identified learning... 

It may seem that the noncompliance procedure under the climate change regime is less stringent than those in other recent international environmental agreements. Although Article 13 of the Framework Convention calls for the consideration of a multilateral consultative process for questions regarding implementation and Article 10 of the Framework Convention establishes a Subsidiary Body for Implementation, the functions of the latter are limited. The Subsidiary Body is called upon to . . . assist the Conference of Parties in the assessment review of the Convention. .. and thus lacks the competence to deal with individual cases. Equally, the mandate of the Conference of Parties to establish a noncompliance system is limited. The parties are only called upon to . . . consider the establishment of a multilateral consultative process, available to Parties on their request for the resolution of questions regarding the implementation of the Convention. . . . This mandate lacks the focus on the noncompliance of individual states parties which is characteristic of the Montreal Protocol and the Second Sulphur Protocol. 

Disaster Recovery. SOPs must be developed to ensure that it is possible to recover from system failures in a controlled manner to a known state. Such procedures will cover backup, archive and restoration, check-pointing and so on. In addition to being able to recover to a known state, it is also necessary to consider backup processes to ensure GMP compliance during the period of system outage and also to assess and address potential noncompliance arising from the failure. 

Were there regular procedures, including internal or external compliance and management audits, to evaluate, detect, prevent, and remedy circumstances like those that led to the noncompliance ... 

Audits should be scheduled (although imannoimced audits can be carried out), preplanned, structured, independent, objective, competent, completed on time, and reported. Any noncompliances found by the audits will be reported and a review of the processes and procedures will be carried out and any amendments made. 

Regulations that govern procedures in proceedings to determine whether a motor carrier, property broker or freight forwarder, its agent, employee, or any other person subject to the jurisdiction of the Federal Motor Carrier Safety Administration (FMCSA) has comphed with all regulations. If noncompliance has been determined, actions must be taken to ensure future compliance with the statute or regrdation, assess a civil penalty, or both. 

In cases where NIH proposes to suspend, limit, or terminate financial assistance becauseof noncompliance with the NIH Guidelines, applicable DHHS and Public Health Service procedures shall govern. 

---