Inspections - facility

There are many individual items to evaluate in a warehouse. 

To help in the evaluations, custom-made inspection forms should be developed. The safety committee in the warehouse could easily create a comprehensive list by walking through the various departments and observing. Both employees and supervisors can assist in this process. 

A consultant or someone from another department or facility can complete the inspection. A new pair of eyes may spot specific conditions that could be missed by local personnel. The written reports from programmed inspections are usually more detailed and more specific. 

The collection of miscellaneous items listed in the various departments are recommendations and reminders of what to inspect for in a warehouse. There may be additional unmentioned items that should be a part of a specific inspection checklist. Checklists should be designed to be specific for a particular department and should not include items that do not exist in the area. Develop the checklist based upon knowledge of what, where, and how unsafe conditions have occurred in the past. An evaluation of departmental injury reports also provides a good source of ideas about which items require regular inspection. Employees are also helpful in recommending items that should be on the inspection list. When looking at a tool, machine, structure, or piece of equipment, direct the attention to those parts that are subject to developing unsafe conditions. 

Another element of the inspection process is to decide and specify exactly which unsafe conditions are to be checked. Give a brief description of a defective condition, using words such as broken, cracked, loose, leaking, protruding, unstable, sharp-edged, frayed, crooked, or deteriorated. Comments such as these could also be used on the reverse side of the inspection form for items not covered in the checklist. 

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Facility inspection safety, ergonomics, and mechanical completion... 

This means that parts must be ordered in advance for the turnaround and other work must be planned so that the whole operation may proceed smoothly and without holdups that could have been foreseen. This usually means close collaboration with the manufacturer or consultant and the OEM (or specialty service shop) so that handling facilities, service men, parts, cleaning facilities, inspection facilities, chrome plating and/or metaliz-ing facilities, balancing facilities, and some cases even heat treatment facilities, are available and will be open for production at the proper time required. This is the planning, which must be done in detail before the shutdown with sufficient lead-time available in order to have replacement parts available at the job site. 

Computerized systems should be included in facility inspections of field sites and analytical laboratories. Items discussed previously, such as computer maintenance records and personnel training records, can be reviewed more thoroughly during the facility inspection. 

The facility inspection should include a review of the computer systems and software to ensure they have been validated. There may be differences between how network systems are validated in contrast to stand-alone systems. The records, procedures, and SOPs for the different systems should be reviewed as part of the facility inspection. If validation reports have not previously been reviewed by the QA unit, the facility inspection may provide an opportunity to review these reports and data. 

ATSDR believes that one way to ensure that the system continues to operate in a manner consistent with operating conditions specified in the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) contract15 is for U.S. EPA to conduct frequent, random, unannounced facility inspections and to routinely provide the results to the public. Under some circumstances, permanent on-site inspectors might be advisable. 

The incident investigation team should consult legal counsel to determine other activities that will assist in preparing for facility inspections or investigations and document preparation depending on the incident. 

It also comprises reporting and internal market (= mutual acceptance of data) requirements. The directive requires that the OECD Revised Guides for Comphance Monitoring Procedures for GLP and the OECD Guidance for the Conduct of Test Facility Inspections and Study Audits must be followed during laboratory inspections and study audits. 

The Aimex I of the Directive 2004/9/EC consists of two parts Part A (Guides for compliance monitoring procedures for good laboratory practice) and Part B (Guidance for the conduct of test facility inspections and study audits). The provisions for the inspection and verification of GLP which are contained in Parts A and B are those contained in Annexes I and II respectively of the OECD Council Decision-Recommendation on comphance with principles of good laboratoiy practice. 

Guidance for the conduct of test facility inspections and study audits... 

Part B of Annex 1, provides guidance for the conduct of test facility inspections and study audits which would be mutually acceptable to OECD member countries. It is principally concerned with test facility inspections, an activity which occupies much of the time of GLP inspectors. Test facility inspections are conducted to determine the... 

To ensure safety, the FDA continues to oversee the production of vaccines after the vaccine and the manufacturing processes are approved. After licensure, monitoring of the product and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the product. If requested by the FDA, manufacturers are required to submit the results Continued on next page)... 

Use of the medical grade gas is by prescription only, and regulated by the FDA. Compressed medical gas suppliers must register with FDA, and are subjected to facility inspections from FDA at least once every two years. Licenses required to purchase and administer nitrous oxide in the healthcare setting is regulated on a state level. 

At the end of the facilities inspection and data audit, the inspector will present the laboratory with a Receipt for Samples form. This form lists all of the copies of documents, samples, etc., the inspection team collected for use in documenting the findings of the audit in their report. The laboratory will be given a closing session in which the auditors and the Inspector will discuss their findings. Frequently, this conference also provides a time for a question and answer session or an exchange of ideas. 

Upon completion of the review, a written evaluation of the product is prepared in a review document and the comments of the various reviewers are reconciled and reviewed by the division director. The results of the decisions are communicated to the applicant in an approvable or not-approvable letter. In some cases, if the questions have been satisfactorily addressed during the review process, the agency may proceed directly to an approval letter. The scientific review divisions are independent from the district offices that conduct field facility inspections. The review division will wait for assurance that the preapproval inspections are completed satisfactorily prior to issuing... 

The procedures and strategies for on-site sampling and analysis are also discussed. In connection with the verification activities of the OPCW onsite, samples may be taken, for example, during a facility inspection for subsequent on-site analysis. The possibility to send the samples for analysis offsite also exists. 

V Perry. FDA facility inspection. Paper presented at the RAPS annual conference, Washington, DC, September 1997. 

In this context, one needs to recall the objectives of the multilateral verification system. Traditionally, two aspects were emphasized confidence-building and deterrence of treaty violation. In the CWC case, confidence-building relates to the confirmation (a) that the declared CW stockpiles and production capabilities are actually being destroyed, and (b) that chemical activities in those facilities inspected under Article VI are legitimate. The deterrence effect of the CWC verification system relies essentially on two interconnected factors the probability that an Article VI inspection can actually detect a violation (and, relatedly, that the inspection system is optimized in such a way that it induces compliance and maximizes the selection of relevant facilities ), and the confidence of States Parties in the OPCW s ability to conduct an effective and conclusive challenge inspection should it be requested to do so. 

Facility Type Facilities Inspection type Inspections PDI PDI per facility... 

Good Laboratory Practice Compliance Facility Inspection 21 CFR Part 58... 

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