Sign-off

It is essential that as-built architectural/constmction drawings are given to maintenance at the completion of every job, together with all other job documents, such as equipment information, operating instmctions, test data, supply information, etc. These documents are needed to operate and maintain the faciHty effectively. At the completion of any project, there should be an official acceptance of documentation by the maintenance/operation department. No job is complete without this formal acceptance and sign off. 

Match batch size to container size of critical components, using an integral number of whole containers, where possible Double check materials being added to reactor Complete batch loading sheets for each batch run Use of operator sign-off sheets Preweigh reactants before transferring to reactor Verify raw materials (certificate of analysis for critical materials)... 

Sign off on each package unit/partial package unit... 

Operator makes a Sign off of critical steps (double checking) sequential error, Install permissive interlocks to ensure key Omits steps steps are done in proper order Repeats steps Automate process steps Executes in wrong order CCPS G-15 CCPS G-32... 

Although a eover sheet is not mandatory, it is reeommended and ean be eflfeetive to make sure that some type of sign-off is ineorporated. This following information should be ineluded ... 

The report says that when communicating by radio, no action should be taken until the message has been acknowledged, but this is nowhere near sufficient. Power should not have been restored until the crews working on both units had signed off written per-mits-to-work. Verbal communication alone is never adequate. 

AP Approver—Allocates resources, signs off, can veto. Delegates... 

During the evening the process foreman wanted to use the line the plumbers were working on. He checked that the line was safe to use and he asked the shift mechanic to sign off the permit. Next morning the plumbers, not knowing that their permit had been withdrawn, started work on the line while it was in use. 

They had not informed the plant about this and assumed that the pump was "signed off" for more than one day. 

Completed work plans and any signed-off work orders should be submitted by the supervisor to their respective maintenance supervisor no later than the day after the job is completed. The maintenance supervisor should examine these documents for completeness and accuracy. 

If the work as called for on the work order is done in its entirety including steam tracing, insulation, clean up, etc., then the work order should be signed off. The supervisor should return the signed-off work order and the work plan to his supervisor who forwards them to planning. 

If for any reason the work as defined by the work order cannot be completed during the shutdown period, the work order should not be signed off. Instead, it should... 

A document control function is required to regulate the authorisation and circulation of such documents. This involves the sign-off on a master copy of the document by authorized personnel, followed by a recorded circulation of official copies to relevant departments. If a document needs to be updated, the revised version should be reviewed and approved by the same functions that approved the original. The revised version is then issued with a new version number and date, and all copies of the obsolete version should be destroyed other than the obsolete master, which may be kept for historical traceability. 

This requires agreement from the Steering Gommittee, which then signs off the draft and releases it to the three regulatory authorities. 

All formulas are to be written out by hand with the specific numbers in the right places on a sheet provided for the purpose, and the calculations are to be done by calculator. Caution Write the numbers exactly as printed, do not round any digits, or the quality assurance unit (a sort of corporate vice squad) will not approve the report out of fear that someone could have cheated. A validated program can be used. While an Excel spreadsheet as such needs no validation, a simple cell-formula calls for extensive tests and documentation and proof that the sheet is password protected against fraudulent manipulation. On top of that, the analyst s supervisor is required to confirm the calculation and sign off on... 

The manufacturing and quality control departments face higher costs because they have to eliminate process and measurement variability, even if they are already operating at the technological limit. They will have to add people to their staffs to mn all of the investigations and handle the additional paperwork (because malicious intent is suspected, peers and supervisors have to sign off at every step to confirm that each SOP was strictly adhered to whether the SOPs made sense, scientifically speaking, or were installed to satisfy formalistic requirements is of no interest here). 

Identify available information, including information from quality control charts, performance in proficiency testing rounds, literature and validation information on related methods and data concerning comparison with other methods. Use the available information and professional judgement to review each relevant validation issue and sign-off issues adequately addressed and documented. 

Tests not signed off by QA unit but by person responsible for the work... 

Documentation Manufacturing steps are not signed off, changes are not explained, and obsolete copies of documents are used. 

Finally, a certificate page should be included, verifying that the entire IQ protocol was completed successfully for a particular instrument. This should include the instrument s serial number, protocol approval sign-offs and any remarks. 

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