Opportunities for Improvement – Internal Audits and Management Review.
Opportunities for improvement can be identified during the performance of a Quality Management System (QMS) Internal Audit. When findings are analyzed with a critical review by management, valuable insights can be gained into increased profit, efficiency, and customer satisfaction.
The Benefits of Effective Auditing
Often an internal audit is viewed by management as an interruption to the normal flow of business. Employees can be apprehensive to share insights or participate fully because they fear that confidentiality is not ensured. The truth of the matter is however, that when planned and executed in a proper fashion the internal audit can cause minimal interruption and maintain the confidentiality of those who provide comments.
In essence an internal audits should objectively and impartially evaluate the outputs of processes to ensure that these processes are meeting the planned expectations and goals of the QMS.
By taking the opportunity to take an impartial look at a process, internal auditors can identify problems that could go unnoticed during day-to-day activities. In addition, they will be able to identify issues with linkages between processes that can cause inefficiency, thereby identifying opportunities to improve the overall effectiveness of the QMS. Taking action on these improvement opportunities can lead to cost savings and increased profitability.
Third Party Internal Audits
Third party internal audits can provide fresh insights into an organization’s opportunities. A third party auditor will not only have exceptional experience and expertise in the auditing process, but will also have perspectives gained from auditing other entities. More importantly, an external auditor will not be limited to the internal politics and culture of the organization, thus ensuring a greater degree of objectivity. Additionally third party internal audits are also useful if an organization’s team members are not available to conduct an audit.
Management should be active in establishing parameters when performing an audit with an auditor outside of the organization. These include defining the criteria, scope, and objectives of the audit. They should have previous audit reports available for review, especially any findings. Once these boundaries have been established, management should ensure that the required time and resources to conduct the audit are available.
Effective Management Review
Once an audit has been completed, management should review findings and recommendations. While this process is often limited to problem solving of nonconformities and corrective actions, time should earnestly be spent evaluating areas of improvement. These areas of improvement can range from changes to corporate governance, improvements to work environments, and improvement of organizational communication skills.
Opportunities Are Everywhere
Every workflow or process has opportunities for improvement. Organizations that strive to realize these opportunities, endeavor to engage their entire workforce in providing feedback, thereby creating an organizational culture of continuous improvement. This is because front-line workers can provide a more granular perspective than an organization’s managers and senior leaders.
CVG Strategy ISO 9001 Consultants
CVG Strategy quality consultancy firm can help your organization implement an ISO 9001system effectively and painlessly. Our consulting services will guide you through all phases of QMS, from assessment and development to the certification process. This includes:
- GAP Analysis and Reporting
- QMS Plan and Schedule
- Preparation of Procedures, Work Instructions, Forms and Policy
- Internal Auditor Training
- Coaching and Implementation
- Pre-Audit Support
- Post-Audit Support
CVG Strategy also provides the inclusion of statutory requirements for export compliance into your program. A compliance program is a requirement for both the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations. (EAR). Ask our experts how we can provide this feature into your quality management system.
There are many consulting companies providing support in ISO 9001:2015. What sets CVG Strategy apart from the rest is our approach. We fine-tune our statement of work depending on your capability and goals. Some clients have us serve as an advisor while they generate the documentation and implement the program themselves.
Many of our clients outsource the Quality Manager role to one of our experts, and we write the quality manual and supporting documentation set and provide all the training. Some use our expertise to include other quality guidelines and standards into their ISO 9001:2015 QMS including food, hazardous materials and department of defense.
Other Quality Management Systems
CVG Strategy has experience in a large number of quality management systems standards. In addition to ISO 9001:2015 our Global Exemplar Lead Auditors can assist you designing and implementing a QMS to the following standards:
- ISO 27001
- ISO 13485:2016
- FDA Title 21 Part 820
- EN ISO 14971:2019
CVG Strategy can provide a QMS that incorporates multiple quality standards. This includes incorporating management strategies for ensuring compliance to industry regulations such as EU Directive 98/79EC for medical devices.