SCHEDULES AND DOCUMENTATION

Each winery should develop a series of standard operating procedures (SOPs) for each operation of the cleaning and sanitizing program. The SOPs must include specific protocols, schedules, and methods to document implementation of the approved protocols and schedules. 

Wineries will apply different procedures and schedules for cleaning and sanitizing, and it is very important to document the approved procedures. 

Equipment and Description Procedure Number Frequency Times Notes Employee Initials 

Crusher (line 2) Rinse Clean Sanitize 9.01 After every lot  

---

Consultations with other practitioners should be scheduled and documented in the same manner as referrals. Consultation creates a joint venture in which liability for negligence may be shared. For this reason consultants should be selected with due care. Patients records should contain any correspondence to consultants, the consultants written recommendations, and accounts of the action taken based on consultants findings. 

Schedule and document physical inspections for a long term project or one involving construction as in this example. 

Preventive maintenance on vital equipment should be properly scheduled, carried out and documented. This program must be separate from the regulatory inspection. 

The technical package may specify a scope and frequency for periodic audits and performance criteria that could lead to changing the audit frequency. It may be a general safety and environmental performance audit or a special audit for items such as raw material storage and handling, quality control methods and documentation. The proprietary nature of a process or product or the complexity of the toll could be a reason to establish a more frequent audit schedule for certain tolls. Audits can also be conducted to follow-up on previously identified shortcomings to document that they were addressed properly. 

Preventive maintenance on vital equipment, such as tractor units, tanks, pumps, hoses, hard arms, pipelines, and mooring facilities, should be properly scheduled, carried out and documented. This program should be separate from the regulatory inspection. Verify from records. 

Documentation procedures have proven more user-friendly" than we had anticipated and have been well received by Manwood users. This has enabled us to install these changes ahead of schedule and with less demand on staff than called for in the plan. 

It is imperative to the success of a project that it be clearly defined before it is undertaken. Any definition should include the criteria for determining successful completion of the project. It is reasonable to expect changes to occur once the project is under way, but these changes should be documented along with any resulting impact on schedule and budget. 

Are all raw materials used onsite documented in an inventory Provide a schedule and identify the sources of raw materials. 

Activities documenting and tracking implementation of corrective actions or safety improvements are not part of a PrHA report. However, the PSM Rule requires a documented, integrated system for managing and monitoring action items. This system must assure that action items and recommendations are addressed and documented in a timely manner. Implementation schedules for corrective actions or safety improvements must be tracked. Finally, the system must assure that all affected operating and maintenance personnel and other affected employees are notified of planned actions. 

Schedule interviews at a convenient time for each witness. Make appointments with witnesses through the appropriate charmels, such as with union and contract personnel. Select a schedule that minimizes contact between witnesses to minimize the sharing of stories between witnesses. For example, schedule each initial interview for 30 minutes. Allow 30 minutes between interviews to complete the documentation of the last interview and prepare for the next one. This gap minimizes contact between witnesses. Adjust the schedule and interview list based on data as they appear. 

Schedule and procedure must be documented in the quality manual... 

Regular management reviews are required by ISO/IEC 17025. They can show that the management system and the testing activities are suitable and effective. They have to be planned. The schedule and the procedure have to be documented in the quality manual. 

The review requires that all the data be collated for presentation, which is a useful discipline. An opportunity is also provided for practical problems to be discussed and acted upon. All decisions should be documented and it is good practice for the sponsor to confirm the main outcome decision in writing to the CRO. Any significant modifications to the protocol will have to be put before the lEC before proceeding. The volunteers also need to be updated about any changes to the schedule and adverse events as the study unfolds. As always, a volunteer must be free to withdraw from a study at any stage. 

Preparation In preparing for an audit, all data and documentation for the study are assembled for the inspectors to view (Figure 8.3). The study director, or other designated technical contact, should review the files and prepare to answer any questions. The master schedule and all files assembled by the quality assurance unit should be reviewed. An agenda, a work space, and a test facility floor plan should be prepared for the inspectors. The staff should be fully briefed and prepared for the visit. 

A document that indicates cleany what is provided in terms of technology, quality, schedule, and cost A basis in enough detail to be used in controlhng the project and its costs to permit proper evaluation of any proposed changes A device to permit subsequent evaluation of the performance compared to the intended performance A document to control the detailed estimate for the final design, construction, and design... 

Current quality system models call for audits to be conducted at planned intervals to evaluate effective implementation and maintenance of the quality system and to determine if processes and products meet established parameters and specifications. International standards provide guidance on auditing [13]. Audit procedures should be developed and documented to ensure that the planned audit schedule takes into account the relative risks of the various quality system activities. Factors that can be incorporated into a risk-based approach to planning audit frequency and scope include the following [6] ... 

A VMP should be divided into chapters covering different subjects. First, an introduction should state the manufacture s validation policy, general description of the scope of those validation activities covered by the VMP, and their objectives, derivation, location, and schedule. Then, it must declare all validation activities and their organizational structure in terms of personnel responsibility for the VMP, validation protocols, validation work, report and document preparation projects, approval of the same validation protocols, reports in all stages of validation processes, and the training needs in support of validation. Other requirements of the VMP are cross references to other documents and to specific characteristics of the processes that are critical for yielding a quality product. Next, all validation activities comprised in the VMP should be summarized and compiled in a matrix format. Such a matrix should provide an overview and contain all items covered by the VMP that... 

The schedules shown to the committee were simply lists of things that had to be done and the time estimated to complete each of them. Alternative paths that would be generated as decisions were made were not evident, nor were any time-related probabilities assigned. The schedules presented to the committee are extremely vulnerable to unforeseen or external events. Moreover, the committee was not provided with total project cost estimates, even of a conceptual or preliminary nature. Without these estimates, it is extremely difficult to evaluate engineering decisions and select the most cost-effective technologies. Based on the lack of documentation, the committee concluded that an adequate preproject plan for a modified baseline process at Pueblo may not exist. If this is true, the completion of the project on schedule and within budget is unlikely. 

Finding 3-11. Preproject planning is key to successful large endeavors. OMB Circulars A-94 and A-ll provide guidance for the planning of such projects, particularly with regard to schedules and risk analyses. A planning document of this nature was not provided to the committee. 

---