Compliance verifying

Introduction Review and audit processes are used in the chemical process industry to evaluate, examine, and verify the design of process equipment, operating procedures, and management systems. These processes assure compliance with company standards and guidelines as well as government regulations. Reviews and audits can encompass the areas of process and personnel safety, environmental and industrial hygiene protection, quality assurance, maintenance procedures, and so on. 

The extent to which documents are reviewed will depend upon the results of the initial questionnaire responses, the interviews, and facility walk-around. In general, documents should be reviewed to verify good practice compliance, and a sampling will usually suffice. 

Provide an explanation of the method(s) used by the site to verify that the control device(s) are operating as designed and m compliance with all regulatory requirements. 

Type tests These are conducted on a finished voltage or current transformer, one of each design and type, to verify their compliance with the design data and relevant Standards. 

These agencies have developed specific test procedures which must be used to verify compliance with the established limits. 

Compliance with the written program can be verified during the walkaround by personal observation and employee interviews. If respirators are required to be worn in the workplace or respirators other than dust masks are worn by voluntary users, a written program is required. An overexposure is not required to cite. Discrepancies between the written program and implemented work practices at the worksite should be cited. Use of a elastomeric or supplied-air respirator, even when voluntary on the part of the employee, will require the employer to include all elements in a written program that will make sure that there is proper use of these respirators so that they do not create a hazard. 

A checklist analysis (CCPS, 1992) verifies the status of a system. It is versatile, easy and applicable at any life-cycle stage of a process. It is primarily used to show compliance with standards and practices by cost-effectively identifying hazards, chlorine Tar> <- liccklists provide commonality for management K.-, icw of hazard assessments. It may be used for controlling a proces.s from development to decommissioning. Approvals by appropriate authorities Cl i( V each stage of a project. 

Conformance with ISO/TS 16949 for third party certification shall be based on objective evidence of meeting each applicable requirement including customer-specific requirements at the time of the audit. The auditor needs to determine specific customer requirements that apply and verify compliance with each requirement - not a sample. If the supplier has several different customers then compliance with the requirements of each customer has to be demonstrated. 

The implication is that the audit should focus on performance and not on conformance. It is therefore not sufficient to verify conformity with a supplier s documented policies and practices. The auditor should examine the documented system for compliance with all requirements and examine operations to verify the results achieved are those required by the policies and practices and by the standard. 

What your customer wants to be verified to meet the need for confidence. (The customer may not demand you demonstrate compliance with all customer requirements, only those which he/she judges as critical.)... 

In order to verify that the products or services meet the specified requirements you will need to carry out tests, inspections, assessments, etc. and these need to be performed against unambiguous standards of acceptability. You need to establish for each requirement that there are adequate criteria forjudging compliance. You need to establish how reliable is reliable , how safe is safe , how clean is clean , how good is good quality . Specifications often contain subjective statements such as good commercial quality, smooth finish, etc., and require further clarification in order that an acceptable standard can be attained. The secret is to read the statement then ask yourself if you can verify it. If not, select a standard that is attainable, unambiguous, and acceptable to both customer and supplier. 

The techniques of design verification identified in clause 4.4.7 can be used to verify that the design output meets the design input requirements. However, design verification is often an iterative process. As features are determined, their compliance with the require-... 

A situation where staff operate under self control is for telephone orders where there is little documentary evidence that a transaction has taken place. There may be an entry on a computer database showing that an order has been placed with a particular supplier. So how would you verify compliance with the requirements of this clause in such circumstances ... 

If the subsequent discovery of a nonconformity will cause major design, production, installation, or operational problems, you should subject the item to a complete test to verify compliance with all prescribed requirements. An example of this would be an electronic unit. 

All audits should be conducted against a standard for the performance being measured. Examinations without such a standard are surveys, not audits. Audits can also be conducted against contracts, project plans, specifications - in fact any document with which the organization has declared it will comply. The standard now requires system audits to be conducted to verify compliance with ISO/TS 16949 and any other system requirements. 

For each regulatory study, a written plan must exist prior to initiation of the study. The study plan must be approved by dated signature of the Study Director and verified for GLP compliance by QA personnel. 

An additional requirement not noted in Table 1 is compliance with GLP7 These practices establish a paper trail for all procedures involved in the determination of residues. With regard to immunoassays, GLPs require calibration of measurement devices such as adjustable pipettors and dedicated spectrophotometers. Computer software output, as noted above, must be verified prior to use. This process can be simplified by limiting the application of specialized software to the operation of an instrument and carrying out the residue calculations in a broadly available spreadsheet such as Excel. On a positive note, in recent years, the software accompanying most microtiter plate readers has become generally easier to use and usually incorporates internal spreadsheets that are compatible with external systems. 

During operation, the owner/operator of an incinerator must conduct sufficient waste analyses to verify that the waste feed is within the physical and chemical composition limits specified in the permit. This analysis may include a determination of a waste s heat value, viscosity, and content of hazardous constituents, including POHCs. Waste analysis also comprises part of the trial burn permit application. U.S. EPA stresses the importance of proper waste analysis to ensure compliance with emission limits. 

IMPORTANT LEGAL NOTICE Neither the CEC or the IPCS nor any person acting on behalf of the CEC or the IPCS is responsible for the use which might be made of this information. This card contains the collective views of the IPCS Peer Review Committee and may not reflect in all cases all the detailed requirements included in national legislation on the subject. The user should verify compliance of the cards with the relevant legislation in the country of use. 

Inspector (owner s) responsible for verifying that all required quality examinations, NDE, inspections, and testing are complete and that all certifications and records have been completed to the extent necessary to satisfy compliance to the requirements of this Code, the engineering design, and the construction organization s quality systems program. 

---