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Automated Audit Software Solutions |
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Compliance Programs for Regulated Industry
Dreading the next time regulators visit? Challenged by your customer's audits? Have a supplier that you wish were performing better? Would you like help building and maintaining a complete compliance program that is proven to change behaviors?
Full Service Compliance Management Systems!
If you've any experience at all with regulatory compliance and audit systems, you'll probably know at least three things: audits are not the most exciting way to do business, regulatory compliance systems can be really, I mean really, complicated and lastly formal programs don't change behaviors in a meaningful and sustainable way.
Byte Size ComplianceSM and Byte Size AuditsSM are set to change all that ... Byte Size Compliance is a totally different method to create a regulatory compliance program. For a start, it's not overwhelming. Byte Size Compliance has been developed specifically for large, cumbersome regulatory requirements. It breaks the process down into "byte size pieces." And then it stitches the pieces together into a broad and comprehensive program.
Then Byte Size AuditsSM provide the feedback needed to change behavior. Scoring is consistent. Specific recommendations and action plans urge progress.
Nothing is left out in this proprietary system. The policy, the procedure, the training and design criteria, the inspections, self-assessments and audits are all included and work together to modify behavior in a positive way. The next time someone asks you how to eat a COMPLIANCE ELEPHANT, tell them "one byte at a time."
Byte Size Compliance and Audit System BENEFITS:
- Changes BEHAVIOR in both stepwise and incremental fashion
- INTEGRATES policy, procedure, training, design criteria and inspections
- Insures CONSISTENT audit scoring from plant to plant or over time
- Permits COMPARISON from plant to plant,
- and TRENDING over time, down to individual audit questions
- Provides specific SUGGESTIONS for each area of non-compliance
- Creates the feedback necessary to SUSTAIN compliance
- IMPROVES results on 3rd Party or Regulatory audits
- Saves TIME in the creation of your compliance system or audit
- STIMULATES interest and awareness
- QUALIFIES vendors
- Reduces EFFORT in the creation of your program and execution of audits.
- Predictable COST, usually in the form of an un-metered, fixed monthly rate
Byte Size Compliance and Audit System FEATURES:
- Full "Policy Manual" (creation and updates)
- Full "Procedure Manual" (creation and updates)
- "On Call" for questions or crisis
- Detailed list of training objectives
- Training Material
- Instruction (optional)
- Detailed, related design criteria
- Vendor Qualification Requirements
- Review of Vendor Submissions
- Quarterly Newsletter
- Language translations (optional)
- Preparation for 3rd-party Audits or Inspections
- Facility Self-Assessment
- Formal Internal Audit
- Scoring criteria for each question
- Questions can be weighted
- Written report with recommendations
- "Action Plan" for gaps
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Audit System |
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The ByteSize Audit System is a database-driven audit tool developed in concert with the ByteSize Compliance System, virtually guaranteeing that every element of the regulation or requirement is audited. It is also possible to convert an existing audit into the Byte Size Audit system.
The audit system is built by your consultant using your regulation or existing audit, in collaboration with your subject matter experts. Each audit requirement is carefully considered both to describe what is required and how it will be scored.
Critical items can be highlighted by weighting their score more heavily, or by making some minimum level of compliance a mandatory element to pass the audit. For some items, your consultant will suggest you do both.
Behavior Change
Step-Changes in behavior are encouraged by creating two different passing levels for the audit. A "minimum requirement" level encourages facilities to rapidly improve. Then a second "prestige" level encourages facilities to continue to improve further. The individual mandatory items also promote step-changes in behavior.
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Applicable Systems |
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The ByteSize Compliance and ByteSizeAudit Systems are applicable to many different kinds of requirements. Almost any regulation, guidance or internal requirement can benefit from using this system. Interestingly, expert knowledge of the requirements is not needed by your consultant (you provide much of that expertise in an easy, facilitated forum).
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Compliance System |
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The ByteSize Compliance System is the starting point for a comprehensive program. Your consultant starts with a regulatory or guidance document or even a simple outline of desired outcomes. Each element is considered one at a time. By taking only one "byte" at a time and considering it fully, your consultant can quickly outline the policy, procedure, design, training and inspection needs.
Simple and proven worksheets are used to develop each element. Or they can be developed directly by your consultant within the ByteSize Audit database.
Then, the process is repeated for each element of the regulation, guidance or outline. This is a simple, if repetitive process.
Finally, all the pieces are stitched together using the integrated ByteSize Compliance and Audit database. The result is a comprehensive policy manual, a comprehensive procedure manual, a comprehensive list of training and design requirements and a comprehensive audit.
As an added benefit, the headlines and sequences are the same for each of these documents, making it simple to read, review and understand what requirement each element is derived from. |
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