Written Inspection Reports

Written inspection reports should be designed to record hazards found during the inspection. One individual or team should be responsible for developing an action plan, and tracking hazards to completion. Refer to Appendix C for a sample report. 

Written records are important because these documents will help to make sure that the following has been completed  

Written reports will be helpful if they are reviewed by someone knowledgeable in the inspection process. This report can provide top management with a summary of safety issues. Use in-house expertise [2]. 

---

The QAU must then write an Inspection Report and send it to the Project Manager. The written Inspection Report should be complete and objective. Suggested content is given in Table IV. 

The Durham Humphrey Amendment (1951) defined the kinds of drugs that required medical supervision for safe use and restricted them to sale by prescription. Two years later, in 1953, the US Public Health Service issued a policy document entitled Group Consideration of Clinical Research Procedures Deviating from Accepted Medical Practice or Involving Unusual Hazard. This policy stated that the potential risks of clinical studies must be carefully assessed and that informed consent was essential. Ethical review of research proposals was also suggested. In this same year, the Factory Inspection Amendment was passed, requiring the FDA to give written inspection reports to manufacturers. 

Presenting a written inspection report to management after each inspection. Ensuring that the deviations reported are rectified by ongoing follow-up. Attending meetings of the health and safety committee and also accepting nomination on this committee. 

If the inspection uncovers one or more violations, the OSHA compliance officer provides an explanation on a written inspection report. The types of violations include the following ... 

Written inspection reports document hazards identified, the assignment of responsibility for correction, and when corrective actions were completed. A well-designed format will help to ensure that ... 

For small businesses that do not use written inspection reports or written employee reports of hazards, this system provides important documentation that otherwise might not exist. The weakness in this system is much the same as for tracking by committee there is always a possibility that incorrect or incomplete information will be transferred or that a correction... 

At the end of the audit, a Final Report Narrative is written by the QAU to the Project Manager. The format of the Narrative is similar to that of the Inspection Report. Once again the Project Manager responds in writing, thus establishing a loop the completed Narrative is then forwarded to upper management. 

Another general distinction between FDA and EU inspections relates to the disclosure of certain information obtained during an inspection. In the United States, anyone can submit a written request to FDA, pursuant to the Freedom of Information Act (FOIA), to obtain a copy of an FD-483 issued to a company (i.e., a listing of observations by an FDA investigator of a facility s potential noncompliance), the company s response, the establishment inspection report (i.e., the investigator s diary of the inspection), and any resulting enforcement action, such as the issuance of a warning letter. 

Periodic inspection of equipment or plant for detection and monitoring corrosion should be followed by a written report, detailing all the observations and the necessary actions to be taken in future maintenance so that unexpected premature failures can be avoided. It is also necessary that all personnel involved are aware of the observations in the periodic inspection report on corrosion detection and monitoring in order to avoid future premature failures. 

The Inspection Response Team will normally conduct an internal debriefing immediately after the inspector has left the site. A more formal Inspection Report should be written soon afterward. The... 

The procurement agency should follow a written procedure to collate the outcomes of the evaluation of product information, laboratory results for samples analysed and inspection reports. 

There shall be written evaluation and inspection reports for every product evaluated, and every manufacturing site inspected. 

When a Test Facility Inspection or Study Audit has been completed, the Inspector should be prepared to discuss his findings with representatives of the test facility at a Closing Conference and should prepare a written report, i.e., the Inspection Report.. 

The Canadian fabricator, packager/labeller, distributor or importer obtains copies of inspection reports of the health authority responsible for the inspection of the contractor. A written evaluation of the report is made by the fabricator, packager/labeller, distributor or importer, stating that from a review by a technically qualified person, the contractor is in conformance or non-conformance with the GMP Division of the Regulations. The evaluation is signed and dated by the person that undertook the review. The health authority report is considered insufficient to ascertain conformance or nonconformance if ... 

In 1998, the BOOS health unit did receive a report on an MOE inspection of the Walkerton water system that showed some serious problems did exist. When the local Walkerton public health inspector read the report, he filed it, assuming that the MOE would ensure that the problems identified were properly addressed. Note the coordination problems here in an area of overlapping control. Both the MOE and the local public health inspector should have followed up on the 1998 inspection report, but there was no written protocol instructing the public health inspector on how to respond to adverse water quality or water system inspection reports. The MOE also lacked such protocols. Once again, the local public health authorities received no feedback that indicated water system operations were problematic. 

No written protocol provided to local public health inspector on how to respond to adverse water quality or inspection reports. Coordination ... 

Depending on practices in the States concerned, inspection reports should be written for each team inspection, each special inspection and each site visit by nonresident site inspectors or, for example, for weekly inspection activities carried out by resident inspectors. 

Equipment Provided by Motor Carrier — A written vehicle inspection report must be prepared and signed by the driver at the completion if each da/s work on each vehicle operated. The report must cover at least the following parts and accessories ... 

If inspection reports are written, do they show that inspections are done on a regular basis Do the hazards found indicate a good ability to recognize hazards typical of this industry Are hazards found during inspections tracked to complete correction What is the relationship between hazards uncovered during inspections and those implicated in injuries or illness ... 

D6. Do the written routine inspection reports clearly indicate what needs to be corrected, by whom, and by when ... 

All crawler, truck, or locomotive cranes in use shall meet the applicable requirements for design, inspection, construction, testing, maintenance and operation as prescribed in the ANSI B30.5-1968, Safety Code for Crawler, Locomotive and Truck Cranes. However, the written, dated, and signed inspection reports and records of the monthly inspection of critical items prescribed in section 5-2.1.5 of the ANSI B30.5-1968 standard are not required. Instead, the employer shall prepare a certification record which includes the date the crane items were inspected the signature of the person who inspected the crane items and a serial number. 

The success or failure of inspection programs is determined by the quality of follow-up and the action planning. If corrective actions cannot be accomplished immediately after a hazard is identified, the inspection report should include interim measures that have been taken, as discussed previously, and should not be considered completed until the final action plan has been signed off. A written tracking system will improve your inspection program. Refer to Appendix C for methods of tracking hazards. 

The QAU must periodically submit to management and the study director written status reports on each study, noting any problems found and the corrective actions taken. Issuing each inspection report with the corrective actions taken to both the study director and study director s management satisfies the requirement for periodic reports. 

Are there one or more written programs which involve top-level management in safety and health activities For example, top management can receive and sign off on inspection reports either after each inspection... 

K inspection reports are written, do they show that inspections are done on a regular basis ... 

Although written reports are the inspecting authority s end product they by no means comprise the whole of the professional service that is supplied or is available on request. The authority s quality assurance objective is likely to be on the lines of client satisfaction allied to compliance with contractual obligations . Although reports are almost certainly monitored, they are a poor indicator of the quality of the examination, and the authority s quality control will rely less on report... 

The QA unit should have written procedures (SOPs) for the conduct of inspections and audits. These procedures should incorporate all considerations for the review of electronic data systems. The QA unit SOPs should address the role and responsibilities of the QA unit in software development, purchase, and validation activities, in-process audit procedures for data collected on line, procedures for on-line review of data (i.e., what will be verified and how much data will be reviewed), and the procedure for auditing reports using on-line data. 

---