Documentation: Good documentation is the foundation of a QMS

A quality management system (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives and thus consistently delivering a quality product or service to the customer.  A QMS helps to coordinate and direct an organization’s activities to meet customer and regulatory requirements and continually improve its effectiveness and efficiency.  The QMS documentation must accurately and succinctly document the organisation’s structure, procedures, processes and resources.

A well designed documented system has many benefits, it ensures quality standards are routinely met, minimizes the potential for error, reduces downtime when deviations occur due to being able to quickly access relevant data, and allows for easy monitoring of the processes such that process outputs are analysed and appropriate adjustments are made.  QMS documentation fulfills many functions such as communication of information, providing evidence of conformity and sharing knowledge and as such many different types and levels of documents are needed, for example a quality manual, quality policy, documented procedures and work instructions.

A one size fits all approach won’t work, each document type must be fit for purpose such that it is readily understood by relevant personnel and can be effectively implemented.  Documentation must also be lean, as too many documents will result in the processes and respective QMS being harder to both use and maintain while also being bureaucratic.  Documentation is also required for regulatory purposes and must demonstrate the effective planning, operation and control of the organisation’s processes and the implementation and continual improvement of the effectiveness of its QMS.  It is evident that good documentation is critical to a functioning QMS, in fact it forms the foundation of the organisations QMS as it gives effect to the QMS for the life-cycle of the product/service being delivered.

Is your QMS documentation fit for purpose?

Fit for purpose QMS documentation ensures that all processes are understood and consistently executed by employees such that a quality product/service is delivered to the customer each and every time.  If your organisations documentation doesn’t meet this standard it will result in regulatory non-compliance, significant costs to your organisation in terms of resources to rectify issues, and may impact your organisations reputation for example as a result of delays in processing customer orders or failing to deliver a quality product or service to your customer.

RRL can help your organisation achieve fit for purpose QMS documentation whether you are a start-up company embarking on designing a QMS and documentation of same and need to get it right first time or QMS documentation in place isn’t fit for purpose and is thereby hindering effective and efficient operation of the QMS.

What does fit for purpose QMS documentation look like and how can you achieve it?

Realisation of fit for purpose documentation is based on PDCA (Plan-do-Check-Act) cycle and can be achieved in 5 steps which are detailed below.  Fit for purpose documentation must be lean to facilitate implementation and maintenance while the documents must clearly describe all QMS processes using simple, concise unambiguous language to ensure that processes are understood and can be easily implemented.

To achieve fit for purpose documentation you must first identify the documentation that your organisation needs for implementation of its QMS and the medium you want to use either hard copy or electronic media.  The amount of documentation needed depends on the size of the organisation and its business, the complexity of the processes and their interactions and the competence of the personnel.  Many organisations find it useful to use a process map to document the processes and their interactions and use this as a tool to decide on what documents are needed, good planning at this stage will save time and effort later.

The next step is to decide on the structure of the QMS documentation, which usually follows the organisations processes or the structure of the applicable quality standard or a combination of both.  The structure or hierarchy of the documentation facilitates distribution, maintenance and understanding of the documentation.  Following the identification and structure of the documents needed Step 3 is where you generate the required documents, this is the most difficult part of the realisation process as the documents themselves will determine employees understanding of the processes such that they can implement and document them accordingly as quality records.  Implementation of the documentation system is the next phase and is documented in the document control procedure which must be robust and stringently followed.

The final step is maintenance and improvement of the QMS documentation throughout the lifecycle of the product or service. Maintenance is performed by ensuring that QMS documents are controlled as per document control procedure and improvement is achieved via analysis of QMS outputs and taking appropriate action to continuously improve effectiveness and efficiency of the QMS.

Step 1:   Identify documentation

Identify all your processes and the interaction between them using a Process Map, analysis of the processes should then be used to determine the amount of documentation needed for the QMS. QMS standards will determine mandatory documents, for example ISO13485:2016 lists Quality Manual, Quality Policy, Quality Objectives, Quality Records and six procedures as listed below as mandatory documentation:

  1. Control of Documents
  2. Control of Records
  3. Internal Audit
  4. Control of Nonconforming Product
  5. Corrective Action
  6. Preventive Action

Thereafter you only require procedures to cover each section of the standard that applies to your business and the complexity of the business will dictate the amount of documentation and level of detail needed.

Step 2:   Identify structure of documentation.

This structure is applicable to all organisations regardless of its size or complexity and we would recommend that this structure is adopted for your organisation.

Figure 1 Hierarchy of Document

Figure 1 describes a typical QMS documentation hierarchy with different document types at each level as follows:

Quality Manual

Describes both the QMS in place and what you are going to do as an organisation to implement the QMS.  The Quality Manual should include the scope of the QMS, details of and justification for any exclusion, references to documented procedures and a description of the processes of the QMS and their interactions which is usually presented as a diagram.

Quality procedures

Describes how the organisation implements the QMS by documenting the applicable processes. Format can include text, flowcharts, tables, a combination of the above as best meets the needs of the organisation. Procedures usually cross reference work instructions.

Work Instructions

Describe an activity within a process and provide detailed descriptions of how to perform and record tasks. The structure, format and level of detail required depends on the complexity of the work, methods used, training undertaken and competence of personnel who execute the work instructions.

Quality Records

Serve as evidence that the organisation has done the work documenting the actions of an activity or process.

Step 3:   Generate QMS documents

QMS documents detail the organisation’s structure, procedures, processes and resources and when followed result in a quality product or service being consistently delivered to the customer.  Good documentation will determine employees understanding of the processes such that they can implement and document them accordingly as quality records, thus documents need to be easy to read, have a natural logical flow, use simple & clear language and be concise.  These attributes will ensure an understanding of the content and information being conveyed. If time and effort is employed at this stage in getting the documents to required standard it will avoid time and effort later in revision of documents.

Documents should be generated by the process owners as they are the people who best understand the processes.  The first documents that need to be generated are the quality procedures of which the document control procedure should be drafted first. The document control procedure describes the structure of all document types within the QMS and so is the first building block in the design of QMS documentation.  The document control procedure addresses the following:

  • Review and approval of documents for adequacy prior to issue
  • Review of documents and update as necessary and re-approval
  • Ensures correct revision status of and changes to documents are identified
  • Ensures relevant versions of applicable documents are available at points of use
  • Ensures documents remain legible and readily identifiable
  • Ensures documents of external origin are identified and their distribution controlled
  • Prevents deterioration or loss of documents
  • Prevents unintended use of obsolete documents and application of suitable identification to them.

The next quality procedure documents to be generated should be those mandated by the quality standard your organisation is following and as you draft these documents you can start generating the Quality Manual which will reference these documents.

The last documents to be generated are those required to cover each section of the standard that applies to your business.  Once all the quality procedures are generated you can start drafting the work instructions, and once all the procedures and work instructions are generated cross check them against your Quality Manual to ensure the Quality Manual gives an accurate overview of your QMS.

Step 4:   Implement documentation system

Document control procedure details the documentation system in place and how it is to be implemented.  The system in place must ensure that all documents are controlled, legible, readily identifiable, retrievable, available at points of use and reviewed regularly for ongoing suitability throughout product/service lifecycle.  This procedure must be followed for all controlled documents.  Documents detail the organisation’s structure, procedures, processes and resources and are needed as objective evidence for regulatory compliance and are auditable thus document control procedure is critical as if it isn’t operating properly you will very quickly run into compliance problems and will have to apply costly resources to address problems.

Step 5:   Maintenance and Improvement

Maintenance and continuous improvement of documentation is very important.  Documentation needs to be maintained in line with document control procedure such that the organisation is in compliance with QMS and regulations.  Documentation needs to be regularly reviewed and data from QMS processes evaluated to identify any changes required.  Updates and improvements are identified because of changes in processes, non-conformances, audits, training, identified improvements and changes to standards.

Conclusion

Good documentation will greatly improve your organisations effectiveness and efficiency by ensuring that your QMS has a strong foundation.  Good documentation is easily achieved by following the 5 basic steps outlined above particularly if you are at the start (designing the process) of the process. If you have identified that there is a need to update your QMS documentation you need to decide whether it is the structure, content or a combination of both that is the root cause of the problem, this can be done by auditing your QMS documentation.

RRL can help your organisation design, generate and implement quality documentation and an efficient and effective documentation system or help you update your existing QMS documentation to ensure it is fit for purpose and therefore ensure your QMS delivers a quality product /service to your customer.

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