Quality Management System guidelines hold the torch to an organization's quality policy and implementation

Key Takeaway:

Quality is at the core of an organization's business. Quality Management Systems (QMS)are well-defined processes that help organizations build quality into their products and services.

Organizations can do this by adhering to QMS guidelines issued by various standards such as those laid out by the ISO. Individual organizations, based on their type of business, build quality processes based on these guidelines. Relevant aspects of these guidelines have to be implemented into the organization. Respective guidelines of appropriate standards have to be applied depending on which suits their organization the best.

Broadly, these are what organizations can seek to achieve by implementing an effective set of QMS guidelines:

• They can systematically develop and communicate a customer-focused mission;
• They can put in place strategies and action plans required for this;
• Referring to these guidelines helps employees understand and respond to their customers' needs and expectations better and thus increase their satisfaction since there is improved work processes and environment;
• These guidelines serve as a tool with which to gather and analyze key performance indicators that are vital for improving organizational and process results.

Benefits of adhering to QMS guidelines

Quality Management System guidelines serve as a reference point for organizations to look up to and continuously improve their processes and quality. QMS guidelines help organizations in the following ways:

What should the quality management system cover?

The QMS in a medical device organization should cover the following:

• Control of documents
• Control of records
• Management review
• Internal audits
• Corrective and preventive action

General requirements for organizations that audit

GHTF lists a few general requirements from auditing organizations. These include:

Audit types

Apart from describing the audit scope and methodology in detail; the GHTF also has a description of the types of quality audits for the medical device industry. They are:

Read More: https://www.linkedin.com/pulse/quality-management-system-guidelines-hold-torch-policy-ronald-gardner

Good Internal Audit Report Writing Skills are very crucial for an auditor

An internal audit is an important exercise that every organization carries out to ensure that its processes and procedures are adhering to set guidelines and are meeting regulatory requirements. Once an internal audit is carried out; the task of the auditor is to present the findings in an audit report. This is where internal audit report writing skills come into play.

Internal audit report writing skills go a long way in putting the audit result in proper perspective. While the core skill of the auditor is in auditing; internal audit report writing skills are complementary to this core skill, but extremely important nevertheless, as it is these skills that help the management make sense of the audit report.

• To make the auditor's observations known, so that they lead to further action from concerned management personnel, and
• Bringing about a new process or persuading people to look at a particular aspect from a different outlook 

What go into honing internal audit report writing skills?

The idea of ingraining internal audit report writing skills is that they should help the auditor convey what she wants to, to the concerned persons in the organization. This calls for some level of expertise and finesse. Of course, this can be inculcated and learn over time. In other words, internal audit report writing skills are no rocket science and can be nurtured and polished over time.

Some elements of good internal audit report writing skills

Although there are no strict rules for how an internal audit report is to be written; internal audit report writing skills need to be finessed to the point where the auditor is able to convey the message across without being too soft or too bombastic. Good internal audit report writing skills also consist of the ability to write an internal audit report that doesn't clutter itself with too much information that may not be eventually used by management, thus making it useless.

A good guideline for fine-tuning internal audit report writing skills could be summarized as ABC:

Assertiveness: Good internal audit report writing skills begin with arriving straight to the point. An auditor who thinks of arriving at important points at the later point of the presentation is not likely to hold the attention of the reader. Managements are usually very aggressive and active, and look for action items straightaway. Keeping the best for the last works in some instances, but not as part of internal audit report writing skills. Following this method makes the report digressing.

Brevity: Isn't it said the brevity is the soul of wit? This holds good for audit report writing, as well. Grandiloquent use of words and fluffy passages are to be avoided if the report has to make an impact.

Conviction: Many internal auditors think that dressing up the difficult or delicate areas of the audit report is a part of internal audit report writing skills. They could not be more mistaken. The auditor's task is to look for loopholes and lacunae; any attempt to camouflage it shows the auditor in poor light. The auditor has to have the conviction to a spade a spade. This part of internal audit report writing skills calls for clarity.

 Read more : https://www.globalcompliancepanel.com/control/internal-audit-report-writing-skills

Principles of Good Clinical Practices (GCP) Audits

Good Clinical Practices (GCP) audits are crucial to Clinical Research Organizations (CRO's). This is because they deal with very vital human life for their research. The implications of the research can be very profound. They can change the way diseases are managed, or if done incorrectly or without adherence to sound Good Clinical Practices audit practices, could lead to serious repercussions for the subjects.

GCP audits and regulatory bodies

The core reason why Good Clinical Practices audits are very important is that regulatory bodies across the world have strict guidelines on how to implement them. The International Conference on Harmonization (ICH), a global harmonization taskforce, has many guidelines on how to implement Good Clinical Practices audits that comply with best practices. Likewise, the FDA too, has very stringent compliance Good Clinical Practices requirements that CRO audits have to adhere to.

GCP audits begin with the sponsor. The sponsor is the organization that conducts the clinical research study, and is thus responsible for ensuring that the Good Clinical Practices audits are carried out for the study they undertake. The sponsor should ensure the adherence of Good Clinical Practices audit standards and methodologies, as well as the safety and rights of the subjects. An established good practice is to have the internal audit done and then getting it corroborated by an external one.

The role of the auditor is all important

Another key role in Good Clinical Practices audits is that of the auditors. Whilst they can be either internal or external, there are different rules that govern the conduct of each of these types of GCP auditors. There are clear rules as to their

• Qualification
• Knowledge
• Skills
• Responsibilities
• Audit plan (written procedures)
• Goal setting

During the audit

During the actual conduct of the Good Clinical Practices audits; the auditor has to explain to the sponsor the purpose of the audit, the documents required for this, and the requirements on the part of the CRO for ensuring the smooth conduct of the Good Clinical Practices audit, and should provide a checklist of all these.

After the audit

The Good Clinical Practices auditor should suggest Corrective and Preventive Actions. These findings should be reported to the person or office designated by the regulatory bodies, after which an Audit Certificate is issued, and the Good Clinical Practices (GCP) audit records are filed and maintained according to set procedures. 

Read More: https://www.globalcompliancepanel.com/control/good-clinical-practices-audits

Quality Audits for the Medical Device Industry

Quality management systems of medical devices have to go through well-defined quality audits. Medical device companies need to implement these in order to show compliance with quality.

ISO 13485 is the quality management standard for medical devices. Based on the process approach of this document and that of 21 CFR part 820; the Global Harmonization Task Force (GHTF) has set out processes for audits relating to the quality management systems of medical devices. The GHTF believes that insertion of quality management system requirements based on ISO 13485 is a first step towards global harmonization of medical devices. These guidelines are meant to lead regulators into articulating regulatory systems for medical devices.

Purpose of quality audits according to GHTF

The GHTF spells out the rationale for carrying out quality audits for the medical device industry. The benefits of carrying these out can be seen in the following:

• Assurance that a high quality medical device will be made available
• Quality audits for the medical device industry make available a harmonized, consistent standard that can be used by future generations
• These audits are independent, verifiable and objective assessment of the manufacturer's compliance with regulatory requirements
• The results of these audits can serve as an important guide for marketing medical devices.

Definition of quality audit

GHTF describes the quality audit as the organizational responsibilities, processes, structure, resources and procedures taken to implement a quality management system.

What should the quality management system cover?

The QMS in a medical device organization should cover the following:

1. Control of documents
2. Control of records
3. Management review
4. Internal audits
5. Corrective and preventive action

General requirements for organizations that audit

GHTF lists a few general requirements from auditing organizations. These include:

Audit types

Apart from describing the audit scope and methodology in detail; the GHTF also has a description of the types of quality audits for the medical device industry. They are:

Read More : https://www.globalcompliancepanel.com/control/quality-audits-for-the-medical-device 

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