What are the common pitfalls and mistakes to avoid when managing quality records?

Aunque suene extra?o, he podido observar (durante auditorías) que algunas organizaciones desarrollan un número importante de formularios en cada uno de sus procesos. Esto no sería inadecuado, cuando el requerimiento es por necesidad o es solicitado por una norma legal del sector de la organización. Sin embargo, hacerlo sólo por dejar evidencias del trabajo realizado por el personal, pudiera convertirse en el tiempo como algo perjudicial. Ello debido a que, si en realidad no es necesario y no brinda ninguna utilidad, el personal simplemente dejará de completarlo. Y lo que pudiera ser peor, días antes de alguna auditoría, ocupará su tiempo en inventar datos para tener qué mostrar al auditor.

>Incomplete Documentation >Lack of Standardization >Insufficient Training >Ineffective Change Management >Lack of Cross-Functional Communication

1) Multiple formats, terminology, and techniques for documenting and keeping records of?quality. 2) providing inaccurate data in records or neglecting to record relevant details. 3) Poor organization and retrieval systems that make it challenging to find particular records when required. 4) Failure to adhere to industry regulations 5) Personnel in charge of maintaining quality records have not received enough training, which can result in mistakes and oversights. 6) Failed to conduct or neglecting reviews on regular time intervals

Common pitfalls and mistakes to avoid when managing quality records include: 1.Incomplete Documentation:Ensure all necessary information is captured to maintain accuracy and compliance. 2.Lack of Organization:Implement a systematic filing system to easily locate and retrieve records. 3.Poor Version Control:Maintain clear versioning to prevent confusion and ensure the use of the latest documents. 4.Insufficient Security:Protect sensitive information from unauthorized access or loss. 5.Failure to Back Up:Regularly back up records to prevent data loss in case of system failures. 6.Ignoring Retention Policies:Adhere to retention requirements to avoid legal and regulatory issues. 7.Inadequate Training

Registrar é uma das coisas mais importantes na gest?o da qualidade. Porém ainda é muito negligenciada, muitos encaram o registro apenas como algo burocrático. Esquecem que o registro é uma fonte de dados. Mas algo muito importante nesse processo é automatiza??o desses registro, facilita o controle e a seguran?a.

Respecto a la organización de registros, mi recomendación es llevar un control de los mismos según los procesos que hacen uso de ellos. En la medida de lo posible, hacer uso de registros en formato electrónico, pues agilizan su control respecto a la preservación y accesos. Quienes cuentan con recursos para adquirir softwares comerciales para el control de la documentación, es de una gran ayuda. También se puede crear plataformas a medida, dise?ados por el propio personal de la organización (procesos de TI). En mi caso, como profesional independiente, conservo los registros de mis procesos en la nube (Google Drive), pero desde este a?o estoy trasladando registros de algunos procesos a Notion y me estoy organizando mejor (?recomendado!).

Try to follow the pyramid of documentation - policies, procedures, work instructions/templates and records - to structure your management system or try to keep documents related to a particular process together. Your document numbering and/or file tagging can be incredibly useful to allow users to find the documents they need.

One simple expectation an organization should implement for their staff is to list references. It does not have to be complex. For instance, suppose a company uses Windchill for storing documents (QMS documents, manufacturing instructions, preventive maintenance documents, quality records, change orders, etc). Then, suppose they use Electronic-CAPA for nonconformance & CAPA records, and SAP for production records. When listing a document, add the repository in parenthesis. "Refer to document D001234 rev X (Windchill)" or "Refer to NC-xyz (E-CAPA)". One small change such as this makes the organization much easier to follow for everyone.

Poor organization can be solved by saving everything in a centralized location organized by folders using a common naming scheme. Alternatively, digital records can be saved in a database where it's saved as structured data grouped by tables that can be setup to enforce data validation.

Es importante que los registros se controlen en folders de fácil acceso o sharepoints para consultarlos cuándo sean requeridos. Estos registros idealmente deben ser organizados de acuerdo a las necesidades de cada proceso involucrado del SGC.

Neglecting privacy controls and protection of quality records in the pharmaceutical industry is a risk that cannot be underestimated. Quality records, holding valuable data like trade secrets, customer information, and audit outcomes, require stringent confidentiality. Disregarding their security can lead to severe legal, financial, and reputational consequences. To navigate this challenge, it's paramount to enforce robust security measures. Encryption, access controls, strong passwords, firewalls, and physical locks form a shield against unauthorized access, modifications, or destruction. By prioritizing the safeguarding of quality records, the pharmaceutical sector can mitigate potential pitfalls and maintain its integrity.

Change control should be well defined by document type and approvals required. Use business rules within your document management system or independent change analysts to ensure that required approval roles are associated with every change. Create procedures and work instructions that clearly tell each function what their role is during a review. For instance, a statistician approver should review the statistical plans and results for accuracy and relevance. Quality engineer approvers should review the record for accurate references and compliance to procedural requirements. R&D approvers should review the record for potential impact to the design and ensure design control is followed as appropriate. And so on.

If stored in a database, access control and data validation can be enforced. Change-logging audit trails can also be made to show the original row value and new row value to compare what was changed.

Inadequate control A fourth mistake is to fail to control the quality and accuracy of quality records. Quality records should reflect the actual state and performance of the quality system. They should also be consistent and compatible with each other. If you do not control the quality and accuracy of quality records, you may end up with inaccurate, outdated, or contradictory records that do not support your quality objectives or decisions. You may also face nonconformities or discrepancies during audits or inspections. To avoid To avoid this mistake, you should establish a quality records control process that ensures the validation, verification, correction, and updating of quality records.

This is a common issue if it is too difficult to amend your documentation; staff will abandon the management system documentation and create their own or retain information in their heads.

Too often, companies have old procedures that are not regularly updated. Improvements should occur naturally as folks come and go. Good ideas should be implemented to procedures. Inefficient processes should be reviewed for improvements and updated. The internal customers who follow given procedures should be surveyed for improvement ideas. The mantra of "we've always done it this way" should be challenged, as appropriate.

I would add the following reasons: lack of regular audits, insufficient training, and poor overall awareness of quality standards.

Tener un formato no es suficiente, siempre podrá estar sujeto a la mejora continua. Es decir, no por existir ya debe ser definitivo, derivado de problemas de calidad, o alguna necesidad del proceso, los formatos pueden ser mejorados.