Life Sciences Quality Managers ensure that products meet the required national and international standards and regulations, and that such products are safe for use in every life cycle stage, from development to manufacturing and distribution.
In the highly regulated and controlled life sciences industry, it’s of critical importance that quality is managed not just within a life sciences company’s internal processes, but throughout the various supply chains and with all third-party contractors.
A transparently and competently managed localisation supply chain fits into the life sciences quality management framework.
This is how we keep the gate for you in the language services supply chain.
The timber frame: Quality Management System
The timber frame of the Quality Manager’s gate is the Quality Management System.
A QMS establishes and documents the processes, procedures and responsibilities for achieving quality policies and objectives within a specific process or for a given product, in compliance with relevant standards and regulations.
Life Sciences Quality Managers coordinate and direct quality management activities, establish controls and track results. They ensure that the QMS and all its elements are documented clearly and transparently, and that management is kept informed of the QMS’ performance.
In the language services industry, the specialist ISO 17100 standard for translation services provides requirements for the core processes and resources in a quality translation service. It controls the translation process from start to finish:
- Skills and qualifications of translators, revisers and reviewers
- Project management processes and project managers’ skills
- Client agreements, handling of data and data protection
- Detailed translation, revision, review and proofreading processes
- Feedback and updating of required competences
At Sandberg, our ISO 17100 compliant Quality Management System is at the heart of all our translation processes.
The Sandberg QMS governs how our trained, qualified translators and revisers are selected, and how they carry out the detailed stages of a professional translation, checking and revision process, guaranteeing its traceability at every step of the process. It also ensures that our project managers handle client materials and the translation process in total confidence and control, as defined in our client data security policy.
And it spurs us on to continuously improve.
The swing: performance & measurement
A gate is pointless if it’s not used, so if the QMS is the timber frame of the Quality Manager’s gate, performance and measurement are the gate’s swing open and closed.
A Life Sciences Quality Manager ensures that appropriate process and quality controls are established, implemented and tracked throughout the life cycle of a product or a process. They define performance indicators to measure quality, and to limit defects and nonconformances.
In the language services industry, translation quality is measured in terms of the translation’s fitness for purpose against the client’s specifications, as well as its fluency and linguistic accuracy.
At Sandberg, we use a quality control system called multidimensional quality metrics (MQM) which has been specifically tailored for the translation process.
Within the MQM, a series of error typology categories such as accuracy, fluency, terminology and style are objectively assessed and weighted against customised severity levels.
|Type of error||We check…|
|Capitalisation||that capitalisation is the same in the source and target text, except when the target language requires different capitalisation because of its own grammar rules.|
|Consistency||for duplicate words in the target text and verify that identical segments have been translated consistently throughout the text.|
|Incorrect terminology||that terms have been translated in accordance with the term base or glossary provided for the project.|
|Numbers and units of measurement||that numbers in the target text match those in the source text and that the number formats and units are consistent with conventions in the target language.|
|Punctuation||for punctuation differences between the source and target text. Our QA software takes into consideration the different grammatical rules in each language in order to avoid flagging differences that are in fact intentional, e.g. the decimal separator, which is 2.5 in English but may be 2,5 in another language.|
|Spaces||that there are no double whitespace characters in the translation.|
|Spelling||for misspellings in the target text. This QA step helps to polish the original document, too.|
|Untranslated text||that there are no segments where the target segment has been left the same as the source segment.|
Quality Assurance at Sandberg
As the gate swings with documentation moving in and out of the translation process, an objective quality control system such as the MQM ensures that translation quality is kept consistently high, and that the translation is fit for your purpose.
The maintenance: compliance & auditing
Come rain or shine, a gate’s timber frame must be maintained, and its hinges oiled for better swing. The third element in successful gatekeeping – or quality management – is regular check-up and maintenance.
A Life Sciences Quality Manager audits compliance to the quality management system both internally and within any external supply chains. They investigate nonconformances, identifying root causes and creating new strategies to limit defects. They appoint external auditors to verify compliance and to engender trust with stakeholders.
In the translation supply chain for the life sciences industry, total transparency around compliance with specifications and quality controls is paramount.
Sandberg’s processes and documentation are independently audited and certified compliant to the specialist industry standard ISO 17100 for translation services, as well as to ISO standard 18587 for machine-translation post-editing.
Our multidimensional quality metrics are transparently tailored to your specific content and context, and regular reporting ensures you are kept up-to-date with compliance and performance.
What good quality looks like
There are many parallels between the quality management gates we keep in the life sciences and localisation sectors, and the same principles apply in both.
A robust Quality Management System ensures compliance with relevant industry standards and regulations, whether it is within the life cycle of a life sciences process or product, or in the provision of first-class translation services.
Appropriate quality controls are implemented well, and performance and quality are tracked using industry-approved methods and systems, through a transparent, tailored approach.
Compliance is audited, and nonconformances identified and traced. New strategies and processes are put in place to foster a cycle of continuous improvement.
Whether the gate swings open or remains closed when running quality control on a medical device, pharmaceutical product or life sciences translation, it is with the ultimate aim of producing safe results in a controlled environment with maximum transparency and compliance with requirements.
This is what good quality looks like. These are the gates we are committed to keeping as modern-day gatekeepers.