Ease Your Audit Preparation With an Automated Document Control

Organizations operating in a regulated environment continually face the daunting task of managing volumes of documents and achieving a positive audit score during inspections. With the growth of competition and regulatory pressure, many companies may come across an unexpected inspection by authorities such as the US FDA. In such instances, ensuring effective document management and a reliable audit trail can help in preparation at short notice as documents and processes are the pillars of a sound enterprise-wide quality system.

One of the key issues that surfaces in relation to a poor audit score is the lack of synchronization between documents or underlying processes and actual change management. For instance, in many cases, due to multiple locations or suppliers, a change in the document may not result in the actual change in the process. This can easily result in non-compliance to a documented process and thus a negative inspection outcome following an audit. Effective document management demonstrates the organization is following the industry best practices across a wide range of activities and departments.

This article sheds light on the features of an effective document control system that plays a critical role in raising the audit preparedness.

1. A document system that offers document control in a secure environment: With the introduction of an electronic document system, you can fully automate the document life cycle while ensuring secure access to critical information. The system acts as a controlled document repository and offers automation features such as templates library, document revision control, electronic signatures, easy document search facilities, notifications, escalations and approvals - all of which result in an effective audit trail and traceable document history.

2. A web-based document control system for remote access: As the supplier and customer networks expand around the globe, many document systems fail due to their inability to provide a mobile document management solution. These 100% web-based, document control solutions are designed to allow the field auditors and suppliers to trigger a process change in real-time, attach the evidence documents to a non-conformance, remotely access, and fill in the audit questionnaire that elicits a change in the process. This reduces time and errors in transcribing the documents and carrying out the actual change.

3. A centralized document control solution that integrates with training management across the enterprise: A well-developed document control system can seamlessly integrate with processes and trigger a process change throughout the organization, be it a change in the manufacturing process or supply chain process, a comprehensive document control system will alert the affected departments and trigger training requirements. These training requirements could be for the personnel directly involved, or to enhance the competencies required for an audit type. A tight integration between document control system and staff training management can assist in enhancing the audit score.

Conclusion

By integrating a document control system with the organization's core processes and other business areas, organizations can significantly enhance their audit preparedness. A robust document control system is the backbone of flawless audits and a high audit score - all of which will undoubtedly result in motivated, success driven employees and happy customers!

Kanupriya is a copywriter for Proquis. Proquis offers web-based compliance management and process mapping / analysis software. Proquis software provides enterprise-wide automation of processes, complete audit trail and an efficient document change management. Visit http://www.proquis.com to request a live demonstration of Proquis software.

Self Insurance Statutory Audit Preparation

Statutory audit preparation is critical, particularly at the corporate level. It's essential to have a full-spectrum statutory audit function in place at all times. Self insured businesses require a complete information system based on formal compliance criteria.

Preliminary Meeting

The usual process for statutory audits involves a preliminary meeting between the regulator and the organisation to be audited.

The meeting creates a format and working context for the audit and defines key issues such as:

Providing a knowledge base for the audit program and explaining the compliance issues;
Defining the audit functions;
Identifying which areas of compliance and/or locations are to be audited;
Scheduling the audit - Managing time frames, setting dates and specifying the audit functions to be carried out;
Clarifying audit standards and required levels of information to be assessed.

This meeting is a briefing, and is best practice for regulators, ensuring that audit subjects are fully informed of the regulator's requirements.

Important: Senior managers should be present at this meeting if at all possible. If not, fully qualified senior level attendees must be substituted. Statutory audits can directly affect business operations, particularly business licensing. It is strongly advised that business management take advantage of this opportunity to ask questions and seek clarifications from regulators.

Planning Preparation

A structured, holistic preparation for the regulatory audit is essential. Each element subject to audit should be mapped, and a management program for preparation of information prepared accordingly. This approach also ensures there'll be no missing information or other embarrassments when the audit is conducted.

(Note: Fully compliant reporting systems produce information in the formats required by regulators. Other systems may require reworking, which needs to be scheduled on your preparation plan to ensure completion prior to audit.)

Preparation should be carefully time managed, to ensure full documentation is available for the audit. Scheduling completion should also allow time for management review and any further work to be done well before the audit date.

Planning implementation

The preparation program should be managed by a delegated, fully qualified person who is fully aware of the entire range of audit issues. The preferred person is an OHS professional, or local manager with current OHS training.

Delegations for preparation functions may be given to appropriate individuals with expertise in the specific audit functions.

Delegation specifically should not be given to any person who's in any way unsure or unfamiliar with the statutory issues, documentation and compliance requirements of the audit.

Planning stages:

Creation of a complete timetable for all audit subjects;
Defining the evidence and information requirements relevant to the audit;
Appointing participants in the audit preparation activity;
Creation of criteria to ensure preparations meets audit standards.

Audit information preparation

Quality controls on information provided to the audit must meet statutory obligations:

Information standards must fully satisfy the audit requirements.
The information should be acquired from documentation that has been prepared over a good representative timeframe.
Data must provide statutory indicators as required by law.

Audit site preparation

Areas subject to auditing must be assessed to ensure compliance with regulatory requirements. Supporting evidence should originate from sites to be audited.

Personnel preparation

Regulators use sampling methodology when conducting audit operations. A suitable number of qualified staff familiar with the issues at different levels within the organisation will be required to assist the regulators during the audit. Safety management consulting services can assist in organising staff to meet these needs.

Appropriate briefings should be conducted to provide:

A high level of knowledge of the audit subjects;
Good comprehension of the criteria to be audited;
Clarification of issues among the staff selected.

Facilitate the audit activity

It is extremely important that the preparation program actively assists in the audit process, providing good quality information for the regulator.

This approach provides:

Full management oversight of all areas subject to audit;
Direct benefits to the organisation, ensuring compliance at all levels.

Common Problems

It must be emphasised that the audit is a potential asset to the business.

Failure to meet audit requirements indicates the business self insurance licence is at risk.

Lack of direction and facilitation of the audit activity will also allow auditors to deviate from the scope of the audit activity to be conducted.

Lane Safety Systems offers safety consulting, risk management, compliance management and safety management systems for self-insured businesses across Australia. For more information, visit Self Insurance