Written policies

This note applies to roadhaulage only. Haulers may subcontract the haulage, or employ independent traction (driver/tractor) or employ interim drivers. A written policy is expected, detailing what criteria have to be met in such cases, and at what stage the client is to be informed about the use of subcontractors. 

Every job has constraints surrounding it - without written policies people would be left to discover them by trial and error, the organization would become a disorganized mess, its managers lacking any means to direct and harmonize their staff s activities. 

Policies enable managers to determine whether a subordinate s action or decision was simply poor judgement or an infringement of the rules. If no rule exists, subordinates cannot be criticized for using their judgement, however poorly it is used. If a rule exists, one has to establish whether it was accidentally or deliberately broken, for the latter is a disciplinary offence. Without written policy no one knows where they stand and any decision may create an unwanted precedent. 

In many organizations, the existing PSM and ESH systems may be partially or almost completely informal. It is essential that this informality is eliminated in the integrated system. An informal system exists when there are few written policies, procedures or standards, or written requirements are not enforced or followed. Informal systems almost invariably contain internal inconsistencies which can lead to breakdowns in PSM and ESH management. Different departments and locations will have different systems. Part of the team s work will be to formalize these informal PSM and ESH management during the integration process. 

Establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures... 

If the site or corporation has a written policy statement for incident investigation, it typically appears here. 

Attention should also be directed to facihty security, particularly in laboratories in which controversial animal testing is involved. Visitor identification and restriction in accordance with written policy is appropriate as a protection of both the data that are the focus of Part 11 and of equipment and animal subjects. 

The amount of internal standard added should be similar to the amount of analyte contained in the sample. In fact, errors are minimized when the relative responses for analyte and internal standard are comparable. If a wide concentration range is to be measured, the amount of internal standard should be selected to maximize precision where it is critically important. As a general rule, with a six-level calibration curve, the internal standard concentration, should be between the second and third calibration standard concentration depending on the relative instrument response for analyte and internal standard and precision at the LLOQ level (i.e., internal standard should be closer to LLOQ if the precision of the LLOQ is low). Many bioanalytical laboratories use a written policy for rejecting sample with low internal standard even though it is not suggested by the 2000 Washington conference final report. 

Laboratory operations will have a written policy defining how three-year reviews and New Supervisor Reviews will be conducted. 

Software development standards Written policies or procedures that describe practices a programmer or software developer should follow in creating, debugging, and verifying software. 

As mentioned earlier, the expectation of the FDA is not only that the applicable regulations from 21CFRwill be complied with during the course of clinical trials, but also that pharmaceutical companies will develop adequate written policies and procedures to describe how the conduct their clinical research processes in compliance with the regulations. Table 2 provides a list of some procedures that Parts 50,56, and 312 require in writing. 

One final comment about things to do in industry. If management is not made accountable for the success of the organization s people, you will not see women rising through the ranks. I think one of the first bullets ought to be a written policy in which senior managers are made accountable for the retention of women and underrepresented minorities on the staff. 

Internal written policies and procedures must be developed to define the scope of QA activities within the company. These policies and procedures should encompass those areas within the company that, after an assessment of risk, provide the most assurance that safety and integrity are designed into the drug development process. 

Establish written policies and procedures for rapid specimen identification and electronic reporting of results. 

Does the orgaifization follow a written policy for both the development and maintenance of computer systems ... 

Is there a written policy that guides the estabhshment and management of multidisci-phned teams ... 

Is there a written policy that makes it clear that individuals are fully accountable and responsible for actions initiated under their electronic signatures in the same way as for their hand-written signatures and has this policy been communicated 11.10 ... 

Responses. Of the respondents, 97 percent have written environmental policies, but only 40 percent have a written policy on sustainability - only human rights was less frequently addressed at 34 percent (Fig. 8.5). 

Initial Observation Sustainability Policies Lagging. Owing to prolonged industrywide focus on the subject, most companies have environmental policies. Sustainability, however, is not clearly defined by many companies, and written policies do not yet exist. Also, many areas covered under most definitions of sustainability may be perceived to be addressed already by existing policies, negating the need for a separate sustainability policy. 

Figure 8.5. Does your company have a written policy that specifically addresses the following areas (Check all that apply.) (Question 2). (Source PricewaterhouseCoopers, LLP.)...

Within federal services and agencies, such as the Armed Services, Indian Health Service (IHS), and the Veterans Administration (VA), there may exist directives or regulations that confer the authority to prescribe on certain classes of practitioners. Federal facilities require that their health care professionals be licensed by at least one state, but the scope of practice of these professionals may be broadened or limited by written policies. 

A written policy should govern safety and health of chemical warehouse employees. The policy should include ... 

Develop a written policy and effectively communicate it to employees. The components of a PPE program should be contained in a company s safety policy as outlined in Section 4.2. 

Decriminalization and depenalization strate es. Most of the strategies in this section are in r ard to marijuana. The most well-known innovation regarding marijuana use is in the Netherlands. The Amsterdam coffee shops that sell marijuana are famous and many people believe that marijuana is legal in the Netherlands. However, that is not the case. The production and distribution of marijuana is iUegal. There is a formal, written policy of nonenforcement of possession and sale of up to 30 grams of marijuana and tolerance of the sale of small amounts of marijuana in coffee shops. Cities in the Netherlands can determine whether or not to allow coffee shops and most do not. The amount that can be sold to a customer and the quantity of marijuana that is kept on the premises is controlled and a person must be 18 or older to buy. The coffee shop cannot advertise the product and no other drugs can be sold. ... 

At a systems level, human resource policies such as recruiting, onboarding, succession planning, high potential identification, leadership development, work-life balance, accommodations for differently abled employees, benefits, rewards and recognition, and performance systems all need to support the goal of inclusion, and many organizations written policies do so today. 

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