Signatures and Approvals

Upon completion of the JSA, the JSA team members sign the document in the spaces provided (first page of the JSA form) to indicate their concurrence with the 

Prior to implementing the JSA, it is recommended that the appropriate company safety representative review the completed JSA form. If circumstances warrant, a safety representative may have also been a member of the JSA team, in which case their signatures as a team member also indicates their approval of the completed JSA form. 

Attachments to the JSA can include any permits or documents necessary to control the hazards specified within the JSA (e.g.. Confined Space Entry Permits, Excavation and Trenching Permits). 

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Other signatures may also be required. Eor example, if there are sub-eontraetors who will be performing site work, a representative from the subeontraeting firm should review and approve the plan. If the site has oversight eontraetors present, is eomplieated, large in size, or ineludes work that is projeeted to take plaee over a long period of time, there will likely be additional approvals required. 

The term issue in the context of documents means that copies of the document are distributed. You will of course wish to issue draft documents for comment but obviously they cannot be reviewed and approved beforehand. The sole purpose of issuing draft documents is to solicit comments. The requirement should be that the documents are reviewed and approved prior to use. Some organizations insist that even drafts are approved for issue. Others go further and insist that copies cannot be taken from unapproved documents. This is nonsense and not what is intended by the standard. Your draft documents need to look different from the approved versions either by using letter issue notation (a common convention) or by printing on colored or watermark paper. If the approved document would carry signatures, the absence of any signature indicates that the document is not approved. 

The inspection authority for a document is the person who approved it. There may be other personnel in the chain such as the issuing authority or the publishing authority, but the person who verified the content is normally the approval authority. With documents that carry signatures you have less protection from prying users and so here is a good reason for excluding the name of the author or approver from the finished document if it is to be used externally. Separate document development records can be used to trace authors and approvers to specific documents. 

But we in the military were not alone in undertaking experiments without specific high level review and approval. In civilian academic institutions, the proposals were often relatively concise, and usually went forward with little more than a signature by the department chairman, perhaps accompanied by a pro forma countersignature by the dean or his designated chief of research. 

A docirmented, properly maintained and approved (by dated signature) Plan of the Laboratory Activities, has to be in place and made available to laboratory and quality assttrance persormel. The director of the laboratory is responsible for the overall conduct of the laboratory activities and the approval of the final reports. 

Validation protocols are required to describe the objective, methodology, and acceptance criteria for installation, operational, and performance qualifications. They are written to ensure test methods, and acceptance criteria are reviewed and approved before qualification of protocols. In practical terms, there are several stages for the production of protocols. First, an acceptable format needs to be agreed. No universal format exists for protocols, but to some extent, the type of equipment, the size of the project, and the personal preferences will dictate the protocol style. However, some norms have been established. Like other controlled documents, protocols are assigned unique reference numbers and revision numbers. They are titled and numbered on every page and have a particular place for approval signatures. Other common elements in protocols tend to be brief descriptions of the item being qualified and a clear statement of responsibilities. 

Operational Qualification The OQ document certifies that the equipment works as desired and defined by the manufacturer and the purchaser. An example is the acquisition of a new high-shear mixer/granulator where the paddle is put on rotation with a real calibrated rotation speed tester and, if the value obtained meets the specifications, the mixer paddle rotation passes the OQ test. If not, additional requalification must be performed. All the test results must be introduced and verified in the OQ report that is approved by the company at the end. The OQ document must describe several tests and related specifications to perform on the equipment in order to evaluate if it is working well, and the test to be performed must be described and approved by the manufacturer and the purchaser. Therefore, tests must be performed on the equipment, and for each one a description and signature of who performed and verified the test are required. Usually the tests are performed by the manufacturer and verified by the purchaser. These tests usually consist of evaluating if the mechanical and electric components of the equipment are working as desired. 

Approved by Each page of the quality manual has a space to provide the name, title, and department of the person in the quality assurance unit or the management representative approving the manual with signatures and the date. 

Where the results of a process cannot be fully verified by subsequent inspection and tests, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented. 

Approval with names, titles, date, and signature of those responsible for the review and approval of the analytical test procedure. 

An efficient document management and control system is essential for minimizing the costs of a process validation effort. Detailed discussion of document management is beyond the scope of this chapter however, one suggestion is offered that has proven particularly successful. Efficiency of the document review and approval process can be greatly enhanced by a policy that defines the purpose of each signature required (e.g., technical correctness, regulatory compliance, compliance with other corporate documents, and authority to pro-... 

Procedural controls (1) Measures taken to ensure the trustworthiness of records and signatures established through the implementation of standard operating procedures (SOPs). (2) Written and approved procedures providing appropriate instmctions for each aspect of the development, operations, maintenance, and security applicable to computer technologies. In the context of regulated operations, procedural controls should have QA/QC controls equivalent to the applicable predicate regulations. 

As part of the action of signing an electronic record, the purpose of the signature must be identified and be an element of each signed record. In the drag CGMP arena, there are relatively few purposes for a signature and these include authored by, reviewed by, and approved by The execution of an action such as a production step does not require an electronic signature, and can be documented via the audit trail. 

Shorten approval processes—The time required to secure approvals of validation documents should be kept to a minimum. One way to accomplish this is to minimize the number of review and approval signatures required. Typically no more than five or six should be necessary. All reviewers must have sufficient technical background to understand the documents they are reviewing. In every instance, the quality assurance unit must be a part of the formal approval process. 

Corresponding investigational newdrug (IND)/NDA/ANDA number, if applicable Name of author Approval signatures and dates... 

Signatures and dates of the person(s) responsible for approving the record of the investigation... 

Install and operate. Provide a review team to listen to any concerns or problems during the shake-down phase of implementation. It is sometimes difficult to keep up with all of the signatures and the flow of approvals, the handling of the pre-startup requirements, and the training requirements. Many medium-to large-sized organizations are implementing electronic MOC approval systems. 

The second-level supervisor or department head ensures that PSSR requirements have been addressed and documented in the PSSR Form. He may elect to secure additional approvals. His authorization signature (line 9) grants approval to start up the new or changed facilities. If any of the pre-startup requirements have not been met satisfactorily, he notifies the supervisor of the affected process unit to correct the deficiencies and repeat the Pre-Startup Safety Review. (Note Authorization to proceed with the change, completion of the PSSR, and approval for startup may occur at the same time for changes of a minor nature.)... 

Verify Clean and Approve for Use Signature of IT Service Engineer Date ... 

Contain signamres and date for each reviewer and approver with an explanation and meaning of the signature... 

Where e-mail is routinely used to communicate authorization and approvals, regulatory authorities will expect to see evidence that the authorization and approval mechanism is secure and robust. In such cases Public Key Infrastructure (PKI) techniques and use of Digital Signatures will bring additional security necessary to ensure robustness and security of transfers. 

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